A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.
Phase: PHASE3
Conditions: Peanut Allergy
Sponsor: DBV Technologies

A D O U B L E -B LI N D, P L A C E B O -C O N T R O L L E D, R A N D O MI Z E D P H A S E III 
T RI A L T O A S S E S S T H E S A F E T Y A N D E F FI C A C Y O F VI A S KI N ®  P E A N U T  
I N P E A N U T-A L L E R GI C Y O U N G C HI L D R E N 1 -3 Y E A R S O F A G E  
E PI T O P E  S T U D Y  
S p o ns or:  
D B V T E C H N O L O GI E S S. A.  
1 7 7 -1 8 1 a ve n u e Pierre Br oss olette
9 2 1 2 0 M o ntr o u ge - F R A N C E  
Tel:
Fa x:
Cli nic al Rese arc h 
Or g a niz ati o n:  
P har m  Researc h Ass ociat es ( U K) L T D  
5 0 0 S o ut h Oa k Wa y, Gree n Par k, Rea di n g R G 2 6 A D, 
U NI T E D KI N G D O M  
S p o ns or Pr ot oc ol N o.:  
E PI T O P E  (E PI T  i n T O d dlers wit h  P E a n ut Aller g y)  –  
V 7 1 2 -3 0 4  
I N D N o.: 
1 4 3 6 6  
E u dr a C T N o.:  
2 0 1 6 -0 0 3 6 7 9 -2 3  
In vesti g ati o n al M e dici n al 
P r o d uct N a me:  
D B V 7 1 2  (Vias ki n ®  Pea n ut ) 
De vel o p me nt P h ase:  
III 
Versi o n s a n d D ate s of 
Pr ot oc ol:  
Versi o n 7. 0, 1 5  N o ve m b er  2 0 1 9  
Versi o n 6 . 0, 2 8  A u g ust  2 0 1 8  
Versi o n  4. 0, 0 9 N o ve m b er  2 0 1 7  
V ersi o n 3 . 0, 1 1  Se pte m b er 2 0 1 7  
Versi o n 2. 0, 1 2 Ma y 2 0 1 7  
Versi o n 1. 0, 2 7 Se pte m b er 2 0 1 6  
T he st u dy will be c o n d ucte d acc or di n g t o t he pr ot o c ol a n d i n c o m pli a nce wit h G o o d 
Cli nic al Pr actice ( G C P), wit h t he Decl ar ati o n of Helsi nki a n d wit h ot her a p plic a ble 
re g ul at ory re q uire me nts. 
T his d oc u me nt c o ntai ns pr o prietar y a n d c o nfi de ntial i nf or mati o n of D B V Tec h n ol o gies.  
D o n ot use, discl ose, distri b ute or re pr o d uce, i n w h ole or i n part, f or a n y p ur p ose wit h o ut writte n 
per missi o n fr o m t he S p o ns or.  
C O N FI D E N TI A L  
P P D

P P D
P P D
P P D

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
Decl ar ati o n of t he I n vesti g at or  
Title: A d o u ble -bli n d, pl ace b o -c o ntr olle d, r a n d o mize d p h ase III tri al t o assess t he s afet y a n d 
effic a c y of Vi as ki n ®  Pe a n ut i n pe a n ut -aller gic y o u n g c hil dre n 1 -3 ye ars of a ge  (E PI T O P E 
st u d y) 
I h ave re a d a n d u n d erst o o d a n d a gree t o a bi de by all t he c o n diti o ns a n d i nstr ucti o ns c o nt ai ne d i n 
t his pr ot oc ol. 
 
All d oc u me nt ati o n f or t his st u dy t h at is s u p plie d t o me a n d t h at h as n ot bee n previ o usly p u blis he d 
will be ke pt i n t he strictest c o nfi de nce. T his d oc u me nt ati o n i ncl u des t his st u dy pr ot oc ol, 
I nvesti g at or's Br oc h ure (I B), ele ctr o nic c ase r e p ort f or m ( C R F ), a n d ot her scie ntific d at a. 
T he st u dy will n ot be c o m me nce d wit h o ut t he pri or writte n a p pr ov al of a pr o perly c o nstit ute d 
I nstit uti o n al Revie w B o ar d (I R B) or I n de pe n de nt Et hics C o m mittee (I E C). N o c h a n ges will be m a de 
t o t he st u dy pr ot o c ol wit h o ut t he pri or writte n a p pr ov al of t he S p o ns or a n d t he I R B or I E C, exce pt 
w here necess ary t o eli mi n ate a n i m me di ate h az ar d t o t he s u bjects. 
 
Res p o nsi ble I n vesti g at or of t he l oc al st u d y ce nter  
 
 
 
 
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Si g nat ure  
Date  
 
 
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Na me ( bl oc k letters)  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Title ( bl oc k letters)  
 
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I nstit uti o n ( bl oc k letters) 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
P h o ne n u m ber  
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
P R O T O C O L  S Y N O P SI S  
Title  
A d o u ble -bli n d, place b o -c o ntr olle d, ra n d o mize d p hase III trial t o assess t he safet y a n d efficac y 
of Vias ki n ®  Pea n ut i n pea n ut -aller gic y o u n g c hil dre n 1 -3 years of a ge.  
S p o ns or St u d y N o.  
E PI T O P E  ( V 7 1 2-3 0 4)  
P h ase  
III  
S p o ns or  
D B V Tec h n ol o gies  S. A.  
St u d y Ce nters  
T his is a m ultice nter st u d y t o be c o n d ucte d  i n A ustralia, E ur o pe a n d N ort h A merica. Bet wee n 
5 0 -7 0  sites fr o m at least 8  c o u ntries c o ul d partici pate.
O bjecti ve  
T o verif y t he safet y a n d l ocal t olera nce of t he 2 D B V 7 1 2  d oses of 1 0 0 a n d 2 5 0 µ g a n d t o 
assess t he  efficac y  a n d safet y  of D B V 7 1 2  t o i n d uce dese nsitizati o n t o pea n ut i n pea n ut -
aller gic s u bjects 1 t o 3 years of a ge after a 1 2 -m o nt h treat me nt  peri o d  b y E Pic uta ne o us 
I m m u n o T hera p y ( E PI T). 
Desi g n  
I n pre vi o us cli nical st u dies i n pea n ut aller gic c hil dre n 4 t o 1 1 year s ol d, D B V 7 1 2  2 5 0  μ g has 
bee n de m o nstrate d as a safe a n d effecti ve treat me nt f or i n d uci n g dese nsitizati o n t o pea n ut.  
H o we v er,  D B V 7 1 2  has ne ver bee n assesse d  i n y o u n ger c hil dre n fr o m 1 t o 3  year s ol d . T he 
prese nt st u d y is desi g ne d t o assess i n t his p o p ulati o n t he safet y of 2 d oses of D B V 7 1 2  i n t he 
first part of t he st u d y ( Part A) a n d t he n t o de m o nstrate t he efficac y a n d safet y of t he selecte d 
d ose i n t he sec o n d part ( Part B).  
T his is a 1 2 -m o nt h, d o u ble -bli n d, place b o -c o ntr olle d, ra n d o mize d p hase III trial t o assess t he 
safet y a n d efficac y of D B V 7 1 2 ( d oses of 1 0 0 μ g or 2 5 0 μ g pea n ut pr otei n per patc h) i n pea n ut-
aller gic c hil dre n 1 t o 3 years of a ge.  
T he trial will be c o n d ucte d i n a p pr o xi matel y 5 0 -7 0 sites i n at least 8  c o u ntries wit h 
I n vesti gat ors a n d staffs trai ne d a n d e x perie nce d in t he dia g n osis a n d t he ma na g e me nt of 
pea n ut aller g y a n d a na p h yla xis, a n d ca pa ble of perf or mi n g D o u ble -Bli n d, Place b o -C o ntr olle d 
F o o d C halle n ges ( D B P C F Cs) i n y o u n g c hil dre n.  
Pea n ut aller gic c hil dre n meeti n g t he f oll o wi n g ke y i ncl usi o n criteria will be sel ecte d: 
•
P h ysicia n -dia g n ose d pea n ut aller g y or hi g h s us pici o n of pea n ut aller g y as assesse d
b y t he p h ysicia n: c hil d prese nti n g si g ns, s y m pt o ms a n d a me dical a n d/ or a fa mil y
hist or y p utti n g hi m/ her at hi g h ris k of ha vi n g a pea n ut aller g y a n d/ or hist or y of
pr ese nce of pea n ut -s pecific I g E a n d/ or p ositi ve S P T;
•
S u bject c urre ntl y f oll o wi n g a strict pea n ut -free diet;
•
P ea n ut s pecific I g E  (I m m u n o C A P s yste m) > 0. 7 k U/ L;
•
P ositi ve pea n ut S P T wit h a lar gest w heal dia meter ≥ 6 m m;
•
P ositi ve D B P C F C t o pea n ut , wit h s y m pt o ms meeti n g t he c halle n ge st o p pi n g criteria
at a n E D ≤ 3 0 0  m g pea n ut pr otei n.
D uri n g t he ma xi m u m 6 -wee k scree ni n g peri o d, s u bjects will u n der g o a n e ntr y/scree ni n g 
D B P C F C t o pea n ut t o c o nfir m t heir aller g y t o pea n ut a n d t o deter mi ne t heir e ntr y o r scree ni n g 
pea n ut E D. T he starti n g d ose of t he c halle n ge will be 1  m g pea n ut pr otei n a n d will escalate 
u p t o t he hi g hest d ose of 3 0 0  m g pea n ut pr otei n. S u bjects w h o react at or bel o w t he d ose of 
3 0 0  m g pea n ut pr otei n are c o nsi dere d eli gi ble.   
A p ost -treatme nt D B P C F C will be perf or me d at M o nt h 1 2, starti n g at t he d ose of 1 m g pea n ut 
pr otei n a n d pr ocee di n g u p t o t he hi g hest d ose of 2, 0 0 0 m g pea n ut pr otei n. T he pri mar y 
efficac y e n d p oi nt of t his p hase III st u d y is t he differe nce bet wee n t he perce nta ge of treat me nt 
res p o n ders i n t he selecte d D B V 7 1 2 d ose gr o u p ( 2 5 0 µ g) c o m pare d t o t he place b o gr o u p at 
M o nt h 1 2, deter mi ne d o n t he pea n ut pr otei n E D d uri n g t he f o o d c halle n ge.  
Ot her efficac y assess me nts at m o nt hs 3, 6 a n d 1 2, i ncl u de i m m u n ol o gical c ha n ges i n pea n ut -
s pecific I g E a n d I g G 4 s u bt y pe a n d S P Ts. 
Ke y assess me nts of gl o bal safet y will be perf or me d at eac h st u d y visit i ncl u di n g s ki n 
o bser vati o n of t he patc h areas of a p plicati o n, vital si g ns, p h ysical e xa mi nati o ns, cli nical 
la b orat or y assess me nts. At o pic der matitis will als o be assesse d at baseli ne a n d at m o nt hs 3, 6 
a n d 1 2 usi n g t he S C O Rri n g At o pic Der matitis ( S C O R A D).  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
I n bet wee n visits, occ ure nce of l ocal s ki n reacti o ns will be s pecificall y s olicite d a n d t heir 
se v erit y gra d e d o n a dail y basis b y t he parents/ g uar dia ns i n a diar y, f or at least 6  m o nt hs f or 
part A s u bjects, a n d d uri n g t he w h ole treat me nt d urati o n f or part B s u bjects (see t hereafter t he 
desi g n of Parts A a n d B). A n y ot her A Es (i ncl u di n g l ocal s ki n reacti o ns occ urri n g after t he 
first 6 m o nt hs of treat me nt f or part A s u bjects), a n d a n y c o nc o mita nt me dicati o ns will als o be 
re p orte d i n t he diar y b y t he pare nts/ g uar dia ns a n d t his will be re vie we d b y t he site me dical 
staff at eac h s u bject visit. 
At scree ni n g, at M o nt h 1 2 a n d at t he e n d of st u d y visi t, t he s u bjects’ pare nts/ g uar dia ns will 
c o m plete q ualit y of life q uesti o n naires ( F o o d Aller g y Q ualit y of Life Q uesti o n naire [ F A Q L Q] 
/ F o o d Aller g y I n de pe n de nt Meas ure-pare nt f or m [ F AI M] / E ur o Q ol -5 D -5 L ( E Q -5 D -5 L) 
[ part B o nl y, see t hereafter f or desi g n of Part B]) t o assess t he i m pact of D B V 7 1 2 1 2 -m o nt h 
treat me nt o n t heir q ualit y of life. 
T he o verall ma xi m u m st u d y d urati o n f or eac h s u bject is a p pr o xi matel y 6 2 wee ks ( 6-wee k 
scree ni n g 
peri o d, 
1 2-m o nt h 
treat me nt 
peri o d 
a n d 
4 -wee k 
f oll o w -u p 
peri o d).  
T he s u bjects will atte n d a t otal of 1 2 st u d y visits:  
•  
3 visits d uri n g t he scree ni n g p hase,  
•  
8 visits d uri n g t he treat me nt peri o d ( + 1 a d diti o nal Visit 7 bis f or t he s u bjects i n Part 
A i n t he e ve nt ualit y of d ose s witc hi n g f or safet y reas o n. After i nteri m safet y a nal ysis, 
b ot h d oses of D B V 7 1 2 were s h o w n t o be safe, a n d n o d ose s witc hi n g is re q uire d. As 
a c o nse q ue nce, Visit 7 bis will be n o t a p plica ble; see secti o n 3. 1. 1 ), 
•  
1  visit at t he e n d of t he f oll o w -u p peri o d.  
I n a d diti o n, 5 tele p h o ne c o ntacts will be ma de d uri n g t he treat me nt peri o d.  
After c o m pleti o n of t his 1 2 -m o nt h bli n de d st u d y, eli gi ble s u bjects will be offere d t he 
o p p ort u nit y t o partici pate i n a n e xte nsi o n st u d y t o recei ve treat me nt wit h D B V 7 1 2 2 5 0  µ g f or 
2 4 a d diti o nal m o nt hs if t he y were i nitiall y ra n d o mize d i n t he D B V 7 1 2 1 0 0  µ g or 2 5 0  µ g 
gr o u ps , or f or 3 6 m o nt hs if t he y were ra n d o mize d i n t he place b o gr o u p . 
T he st u d y will be c o n d ucte d i n 2 parts, A a n d B.  
St u d y P art A  
I n t he first part, t he safet y of 2 d oses of D B V 7 1 2, 1 0 0 μ g a n d 2 5 0 μ g was e val uate d wit h a 
d o u ble -bli n d place b o -c o ntr olle d desi g n. Fift y s u bjects were t o be ra n d o mize d eit her i n t he 
place b o ar m or i n t he 2 acti ve ar ms, wit h a 1: 2: 2 rati o, i.e. 1 0  s u bjects i n t he place b o ar m a n d 
2 0 s u bjects i n eac h of t he 2 acti ve ar ms, D B V 7 1 2 1 0 0 μ g a n d D B V 7 1 2 2 5 0 μ g.  
A safet y a n al ysis was t o be perf or me d after t he first 3 m o nt hs of treat me nt t o esti mate t he 
safet y pr ofiles of t he 2 st u die d d oses of D B V 7 1 2. T he safet y a n d t olera bilit y assess me nt was 
t o be assesse d b y a n i n de pe n de nt Data a n d Safet y M o nit ori n g B oar d ( D S M B).  
As a res ult of t his t olera bilit y a n d safet y re vie w, 4 sit uati o ns c o ul d ha ve bee n e nc o u ntere d:  
1.  B ot h d oses are c o nsi dere d well t olerate d wit h a g o o d safet y pr ofile. T he 2 5 0  μ g d ose 
w o ul d t he n be selecte d f or t he c o nti n uati o n of t he st u d y i n Part B. I n parallel, all 
s u bjects still i n Part A at t h e m o me nt of t he decisi o n w o ul d re mai n u n der t he 
treat me nt ar m t he y were u n der u ntil t heir M o nt h 1 2 treat me nt peri o d: s u bjects u n der 
D B V 7 1 2 2 5 0 μ g d ose i n Part A w o ul d c o nti n ue wit h t he sa me d ose u p t o M o nt h 1 2, 
s u bjects u n der D B V 7 1 2 1 0 0 μ g d ose i n Part A w o ul d c o nti n ue wit h t he sa me d ose 
u p t o M o nt h 1 2, a n d s u b jects u n der place b o w o ul d re mai n u n der place b o u p t o M o nt h 
1 2. T here w o ul d be n o Visit 7 bis t o perf or m i n t his sit uati o n.  
2.  T he D B V 7 1 2 2 5 0 μ g d ose has a better t olera bilit y/safet y pr ofile t ha n t he 1 0 0 μ g d ose. 
T he 2 5 0  μ g d ose w o ul d t he n be selecte d f or t he c o nti n uati o n of t he st u d y i n Part B. 
I n parallel, all s u bjects still i n Part A at t he m o me nt of t he decisi o n w o ul d c o me f or 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
t he Visit 7 bis t o recei ve a ne w treat me nt b o x wit h t he ri g ht treat me nt: s u bjects u n der 
D B V 7 1 2 2 5 0 μ g d ose i n Part A (t he safest d ose ) w o ul d recei ve a ne w b o x of D B V 7 1 2 
2 5 0 µ g s o t hat t he y c o ul d c o nti n ue wit h t he sa me safe d ose u p t o M o nt h 1 2, s u bjects 
u n der D B V 7 1 2 1 0 0 μ g d ose i n Part A ( d ose c o nsi dere d n ot safe) w o ul d recei ve a 
ne w b o x of D B V 7 1 2 2 5 0 µ g s o t hat t he y were treate d wit h a safe d ose u p t o M o nt h 
1 2 a n d s u bjects u n der place b o w o ul d recei ve a ne w b o x wit h place b o u p t o M o nt h 
1 2. It w o ul d ha ve bee n i m p orta nt t hat all s u bjects c o me bac k f or t he  Visit  7 bis t o 
kee p t he bli n di n g wit h re gar d t o t he s u bjects w h o nee d t o c ha n ge t heir treat me nt d ose. 
3.  T he hi g hest d ose of D B V 7 1 2 2 5 0 μ g is n ot c o nsi dere d as ha vi n g a n acce pta ble safet y 
pr ofile a n d o nl y t he D B V 7 1 2 1 0 0 μ g d ose is c o nsi dere d ha vi n g a fa v ora ble safet y 
pr ofile. T he D B V 7 1 2 1 0 0 μ g d ose w o ul d be selecte d f or t he c o nti n uati o n of t he  st u d y 
i n Part B. I n parallel, all s u bjects still i n Part A at t he m o me nt of t he decisi o n w o ul d 
c o me f or t he Visit 7 bis t o recei ve a ne w treat me nt b o x wit h t he ri g ht treat me nt: 
s u bjects u n der D B V 7 1 2 2 5 0 μ g d ose i n Part A ( d ose c o nsi dere d n ot safe) w o ul d 
recei ve a ne w b o x of D B V 7 1 2 1 0 0  µ g s o t hat t he y were treate d wit h a safe d ose u p 
u ntil M o nt h 1 2; s u bjects u n der D B V 7 1 2 1 0 0  μ g d ose i n Part A (t he safe d ose) w o ul d 
recei ve a ne w b o x of D B V 7 1 2 1 0 0 µ g s o t hat t he y c o ul d c o nti n ue wit h t he sa me safe 
d ose u p u ntil  M o nt h 1 2, a n d s u bjects u n der place b o w o ul d recei ve a ne w b o x wit h 
place b o u p u ntil M o nt h 1 2. I n t his sit uati o n t o o, it w o ul d ha ve bee n i m p orta nt t hat 
all s u bjects c o me bac k f or t he Visit 7 bis t o kee p t he bli n di n g wit h re g ar d t o t he 
s u bjects w h o nee d t o c ha n ge t heir treat me nt d ose.  
4.  B ot h d oses are c o nsi dere d b y t he D S M B as ha vi n g a n u nfa v ora ble safet y pr ofile or 
t olera bilit y. T he st u d y w o ul d t he n be st o p pe d a n d all s u bjects w o ul d ha v e t o st o p 
a p pl yi n g t he patc h es a n d w o ul d be wit h dra w n fr o m t he st u d y.  
He n ce,  t he 5 0 first s u bjects i ncl u de d i n t he 3 i nitial treat me nt ar ms i n Part A were t o c o nti n ue 
bli n dl y t heir assi g ne d treat me nt u ntil t he e n d of t he st u d y (i.e. 1 2 m o nt hs of treat me nt; 
Sit uati o n n° 1), or were t o st o p t heir treat me nt pre mat urel y ( Sit uati o n n° 4) , or were t o s witc h 
t o t he safest 
D B V 7 1 2 d ose ( Sit uati o n n° 2 or n° 3), acc or di n g t o t he decisi o n or 
rec o m me n dati o n ma de b y t he D S M B. 
U p o n re vie w of t he 3 -m o nt h safet y data of t he 5 1 s u bjects act uall y ra n d o mize d i n part A, t he 
D S M B ha d n o safet y c o ncer n a n d c o nsi dere d b ot h d oses as well t olerate d wit h a g o o d safet y 
pr ofile (sce nari o “ 1” as descri be d a b o ve). As a c o nse q ue nce:  
•  
T he d ose selecte d f or part B is t he 2 5 0 -µ g d ose;  
•  
All s u bjects fr o m part A were t o re mai n i n t heir i nitial ra n d o mize d treat me nt ar m 
u nti l t he e n d of 1 2-m o nt h treat me nt ( place b o, D B V 7 1 2 1 0 0  µ g or D B V 7 1 2 2 5 0  µ g).  
After all s u bjects fr o m Part A c o m plete t he st u d y, Part A data will be u n bli n de d f or a n al ysis.  
St u d y P art B  
T he sec o n d part of t he st u d y ai ms t o assess t he safet y a n d efficac y of t he selecte d d ose after 
1 2 -m o nt h treat me nt vers us pla ce b o. T his part was t o be i nitiate d after t he c h oice of t he hi g hest 
safe d ose u p o n t he D S M B meeti n g. As fr o m pr ot oc ol v 6. 0, t he sele cte d hi g hest safe d ose f or 
part B u p o n D S M B rec o m me n dati o n is 2 5 0  µ g. A d diti o nal s u bjects will be recr uite d i n t he 
acti ve selecte d d ose ar m a n d i n t he place b o ar m, t o reac h t he tar gete d t otal n u m ber of s u bjects.  
I n acc or da nce wit h t he calc ulate d sa m ple size f or t his st u d y, a t otal of 3 5 0 a d diti o nal s u bjects 
will be ra n d o mize d i n t he sec o n d part ( Part B)  of t he st u d y. T hese s u bjects will be ra n d o mize d 
wit h a 2: 1 rati o i n eit her t he acti ve or place b o ar m, 2 3 3 s u bjects i n t he acti ve ar m a n d 1 1 7 
s u bjects i n t he place b o ar m.  
A n i nteri m a nal ysis t o e vi de nce t he treat me nt acti vit y o n t he i m m u ne s yste m  of 1 t o 3 years 
ol d c hil dre n is pla n ne d after t he first 5 0 s u bjects fr o m part B ha ve recei ve d 6 m o nt hs of acti ve 
treat me nt wit h t he selecte d D B V 7 1 2 d ose of 2 5 0 µ g ( Visit 8). T his a nal ysis, e nc o m passi n g 
pea n ut -s pecific I g E, pea n ut-s pecific I m m u n o gl o b uli n G 4 s u bt y pe (I g G 4), S P T a n d mai n 
safet y data, will s pecificall y be c o n d ucte d o n t he meas ure me nts of t he pea n ut -s pecific I g G 4. 
T he relati ve c h a n ge fr o m baseli ne of t he pea n ut -s pecific I g G 4 le vels i n t he D B V 7 1 2 2 5 0 µ g 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
treat me nt gr o u p at M o nt h 6 will be n u mericall y c o m pare d t o t he relati ve c ha n ge fr o m baseli ne 
of t he pea n ut -s pecific I g G 4 le vels i n t he place b o gr o u p at M o nt h 6. T he me dia n relati ve 
c h a n ge i n I g G 4 of t he D B V 7 1 2 2 5 0  µ g treat me nt gr o u p is e x pecte d t o be greater t ha n t he 
me dia n relati ve c ha n ge i n I g G 4 of t he place b o treat me nt gr o u p.  
I n t he sit uati o n w here t he me dia n relati ve c ha n ge fr o m baseli ne of t he pea n ut s pecific I g G 4 is 
e q ual or l o wer t ha n t he me dia n relati ve c ha n ge i n t he place b o gr o u p, t he pre mat ure st o p of t he 
st u d y f or lac k of e vi de nce of t hera pe utic be nefit will be c o nsi dere d.  T his u n bli n de d data 
re vie w 
will be c o n d ucte d b y t he 
D S M B 
w h o 
will be res p o nsi ble of iss ui n g t he 
rec o m me n dati o n t o t he s p o ns or. 
Tre at m e nt  
T he I n vesti gati o nal me dici nal Pr o d uct (I M P), D B V 7 1 2 , is a n e pic uta ne o us deli ver y s yste m 
( Vias ki n®  patc h) c o ntai ni n g a  s oli d de p osit of a f or m ulati o n of pea n ut pr otei n e xtract 
 
 
 
 
 
 
 
T he Vias ki n ®  patc h als o i ncl u des a h y p oaller ge nic a d hesi ve 
fil m t hat will hel p pre ve nt t he Vias ki n®  patc h fr o m c o mi n g off i na d verte ntl y.  
T he place b o treat me nt will c o nsist of a si milar f or m ulati o n, b ut de v oi d of pea n ut pr otei n.  
O nl y 1 patc h is t o be a p plie d per da y (e ver y 2 4 h o urs). A p plicati o n of t he Vias ki n ®  patc h   at a 
si milar ti me f or eac h dail y a p plicati o n (a m or p m) is rec o m me n de d. A leaflet wit h saf et y 
preca uti o ns f or usi n g t he Vias ki n ®  patc h will be gi ve n t o eac h s u bject a n d pare nt s/ gu ar dia ns. 
D ur ati o n of tre at m e nt  
Re p eate d dail y a p plicati o n of a Vias ki n ®  pat c h is pla n ne d f or 1 2 m o nt hs f or all s u bjects: a 
bli n de d 1 2 -m o nt h peri o d of treat me nt wit h D B V 7 1 2  vers us place b o.  At t he start of treat me nt, 
t he d urati o n of dail y a p plicati o n of t he Vias ki n®  patc h will be pr o gressi vel y i ncrease d f or t he 
first 4  wee ks as f oll o ws:  
•  2  h o urs  ( ± 3 0  m in utes ) per da y  t he 1 st wee k;  
•  4  h o urs  ( ± 3 0  m in utes ) per da y t he 2 n d wee k ; 
•  8  h o urs  ( ± 1  h o u r) per da y t he 3 r d wee k ; 
•  1 2  h o urs ( ± 2  h o ur s) per da y t he 4 t h wee k .  
Fr o m t he first da y of t he 5 t h wee k o n war ds ( Da y  2 9 ), t he d urati o n of a p plicati o n will be 
2 4  h o urs  ( ± 4  h o urs ) f or eac h patc h a p plie d dail y u ntil t he e n d of t he treat me nt peri o d. 
H o we v er, i n case of l ocal u n beara ble or i nte nse s ki n reacti o ns, t his peri o d of pr o gressi ve 
i ncrease d urati o n of dail y a p plicati o n of t he patc h ca n be e xte n de d be y o n d t he 4 wee ks 
descri be d a b o ve.  
N u m ber of S u bjects  
T he t otal n u m ber of s u bjects t o ra n d o mize i n E PI T O P E will be a p pr o xi matel y 4 0 0 (see t he 
ta ble bel o w). 
 
R a n d o mize d s u bjects  
D B V 7 1 2  
1 0 0  µ g  
D B V 7 1 2  
2 5 0  µ g  
Pl ace b o  
T ot al   
Part A  
2 0  
2 0  
1 0  
5 0  
Part B  
0  
2 3 3  
1 1 7  
3 5 0  
I n t his a g e p o p ulati o n, t he esti mate d scree n fail ure rate c o ul d be u p t o 6 0 % base d o n pre vi o us 
e x perie nce i n 4 t o 1 1 years ol d s u bject p o p ulati o n a n d site distri b uti o n. T heref ore, 
a p pr o xi matel y 1, 0 0 0 pea n ut -aller gic c hil dre n 1 t o 3 years w o ul d nee d t o be s cree ne d t o get 
t he 4 0 0 ra n d o mize d s u bjects. Details f or Part A a n d Part B are prese nte d bel o w.  
P art A  
D uri n g t he first safet y part of t he st u d y ( Part A), 5 0 s u bjects ( 1 0 place b o s u bjects, 2 0 s u bjects 
at t he 1 0 0 µ g D B V 7 1 2  d ose, 2 0 s u bjects at t he 2 5 0 µ g D B V 7 1 2  d ose) will be ra n d o mize d. 
T he 2 0 s u bjects i nitiall y ra n d o mize d at t he d ose of D B V 7 1 2  n ot retai ne d will c o nti n ue at t hat 
d ose u p t o M o nt h 1 2 if t here are n o safet y c o ncer ns re gar di n g t his d ose.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
After t he 3 -m o nt h safet y D S M B a nal ysis, 2 5 0 µ g was selecte d as t he hi g hest safe d ose. 
P art B  
T he sa m ple size f or t he efficac y part of t he st u d y is calc ulate d bas e d o n t he f oll o wi n g 
ass u m pti o ns:  
- A 2: 1 rati o i n fa v or of t he D B V 7 1 2  d ose vers us place b o;  
- A 4 0 % res p o nse rate f or D B V 7 1 2  ( o pti mal acti ve d ose) a n d a 1 0 % res p o nse rate f or place b o 
usi n g missi n g =fail ure i m p utati o n met h o d  ( base d o n a ma xi m u m dr o p -o ut rate of 1 5 %) . T his 
will gi ve a 3 0 % a bs ol ute differe nce f or t he pri mar y e n d p oi nt bet wee n acti ve a n d place b o at 
1 2 m o nt hs of treat me nt;  
- A l o wer b o u n d of t he 9 5 %  c o nfi de nce i nter val ( CI ) of t he differe nce bet wee n t he selecte d 
acti ve treat me nt a n d p lace b o res p o nse rates ≥1 5 %;  
- Ne wc o m be met h o d is use d f or t he c o m p utati o n of t he CI.  
He n ce, t he mi ni m u m  n u m ber of s u bjects nee de d t o e ns ure  a p o wer of at least 9 0 %  is 3 5 0 
(a p pr o xi matel y 2 3 3  s u bjects i n t otal i n t he selecte d acti ve D B V 7 1 2  gr o u p [ 2 5 0 µ g] a n d 
1 1 7  s u bjects i n t he place b o gr o u p). 
P ote nti al s a m ple size reesti m ati o n  f or P art B 
T he a n al ysis of Part A s h o ul d pr o vi de a m ore acc urate assess me nt of w het her t he sa m ple size 
f or Part B is a p pr o priate or w het her it nee ds t o be a dj uste d.  T he c urre nt sa m ple size calc ulati o n 
was d o ne at a ti me w he n n o data i n 1 -3 year -ol d s u bjects e xiste d f or D B V 7 1 2. T heref ore, t he 
u n bli n de d data fr o m Part A is esse ntial i n refi ni n g t he c urre nt sa m ple size calc ulati o n f or Part 
B.  
Sa m ple size a dj ust me nt c o ul d be pr o p ose d base d o n a c o m bi nati o n of ( b ut n ot li mite d t o):  
•  
a f or mal c o m p utati o n of pr o ba bilit y of s uccess  
•  
a reassess me nt of place b o res p o nse rate ass u m pti o n  
If, f or i nsta nce, t he e xact o bser ve d perce nta ges of res p o n ders i n part A are belie ve d t o be t he 
“tr ue” rates i n t he p o p ulati o n, t he n:a hi g her place b o rate c o ul d re q uire a greater sa m ple size, 
as s h o w n i n e x a m ples bel o w.  
Pl ace b o res p o n der r ate  
D B V 7 1 2  2 5 0 µ g res p o n der r ate  
T ot al S a m ple Size  
1 0 %  
4 0 %  
3 5 0  
2 0 %  
5 0 %  
4 6 2  
3 0 %  
6 0 %  
5 1 9  
Re g ulat ors a n d i nstit uti o nal re vie w b oar ds will be i nf or me d if a n y sa m ple size a dj ust me nts 
are nee de d. 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
P o p ul ati o n  
S u bjects will be e nr olle d i n t his st u d y o nl y if t he y meet, a m o n g ot hers, t he f oll o wi n g  eli gi bilit y 
criteria:  
K e y  i ncl usi o n criteria 
•  Male or fe male fr o m 1 -3 years of a ge at Visit  1 ; 
•  P h ysicia n -dia g n ose d pea n ut aller g y  or hi g h s us pici o n of pea n ut aller g y as assesse d b y 
t he p h ysicia n: c hil d prese nti n g si g ns, s y m pt o ms a n d a me dical a n d/ or a fa mil y hist or y 
p utti n g hi m/ her at hi g h ris k  of ha vi n g a  pea n ut aller g y a n d/ or hist or y of prese nce of 
pea n ut -s pecific I g E a n d/ or p ositi ve S P T ; 
•  S u bject  c urre ntl y f oll o wi n g a strict pea n ut -free diet; 
•  Pea n ut -s pecific I g E le vel (I m m u n o C A P s yste m) > 0. 7  k U/ L ; 
•  P ositi ve pea n ut S P T wit h a lar gest w heal dia meter ≥ 6  m m ; 
•  P ositi ve D B P C F C t o pea n ut, wit h s y m pt o ms meeti n g t he c halle n ge st o p pi n g criteria at 
a n E D  ≤ 3 0 0  m g pea n ut pr otei n.  
Ke y e x cl usi o n criteria  
•  Dia g n os is of ast h ma  t hat f ulfills a n y of t he f oll o wi n g criteria: 
o  U nc o ntr olle d ast h ma (as per Gl o bal I nitiati ve f or Ast h ma [GI N A ] latest g ui deli nes); 
o  Ast h ma re q uiri n g c o ntr oller treat me nt ste p 3 or hi g her (as per GI N A latest 
g ui deli nes: eit her 
m o derate [ d o u ble l o w d ose] of i n hale d c ortic oster oi d, or 
ass ociati o n of i n hale d c ortic oster oi d wit h le u k otrie ne r ece pt or a nta g o nist . L o n g 
acti n g beta a g o nists are n ot rec o m me n de d bel o w 5 years ) 
o  Hist or y of 2 or m ore s yste mic c ortic oi d c o urses wit hi n t he 3 pre vi o us m o nt hs pri or 
t o Visit 1 or 1 s yste mic c ortic oi d c o urse wit hi n t he 4 wee ks pri or t o Visit 1 f or 
treati n g a dia g n ose d ast h ma.  
o  Pri or i nt u bati o n/ mec ha nical ve ntilati o n f or ast h ma wit hi n o ne year pri or t o Visit 1  
•  Prese n ce of m ore t ha n 3  e pis o des of w heezi n g i n t he past year (eac h lasti n g m ore t ha n 
1 0 c o nsec uti ve da ys , a part fr o m c ol ds) or prese nce of res pirat or y s y m pt o ms  ( w heezi n g, 
c o u g h, hea v y breat hi n g)  bet wee n t hese e pis o des, a n d/ or ot her res pirat or y s y m pt o ms 
s u g gesti n g eit her u n dia g n ose d ast h ma or ast h ma n ot c o ntr olle d b y ast h ma treat me nt (as 
per GI N A latest g ui deli nes).  
•  Pea n ut all er gic s u bjects prese nti n g a me dical hist or y of se vere a na p h yla xis t o pea n ut 
will be e x cl u de d fr o m t his st u d y. Se vere a na p h yla xis is defi ne d b y t he Gra d e 3 of t he 
A na p h yla xis Sta gi n g S yste m , i ncl u di n g: 
o  Se vere h y p o xia, persiste nt h y p ote nsi o n or m ore t ha n 2 0 %  dr o p i n bl o o d press ure , 
ne ur ol o gical c o m pr o mise, or  
o  C ya n osis or S p O 2 ≤ 9 2 % at a n y sta ge, c o nf usi o n, car di o vasc ular c olla pse, l oss of 
c o nsci o us ness, bra d yc har dia, car diac arrest.  
•  Pri or hist or y of a n y i m m u n ot hera p y t o a n y f o o d (e. g. oral i m m u n ot hera p y, s u bli n g ual 
i m m u n ot hera p y, s pecific oral t olera nce i n d ucti o n). S u bjects w h o recei ve d a pri or oral 
i m m u n ot hera p y of less t ha n 1 m o nt h-d urati o n w hic h e n de d at least 3  m o nt hs bef ore 
Visit 1 are eli gi ble f or i ncl usi o n .  
•  S u bjects recei vi n g or pla n ni n g t o recei ve a n y  i m m u n ot hera p y (aer oaller ge ns, ve n o m s, 
a nti-i nfecti ve…)  d uri n g t heir partici pati o n i n t he st u d y. T hese i m m u n ot hera pies m ust be 
disc o nti n ue d at t he ti me of Visi t 1 . 
•  Ge n eralize d 
der mat ol o gic 
disease (e. g. se vere at o pic der matitis, u nc o ntr olle d 
ge n eralize d ecze ma, ic ht h y osis v ul garis) e xte n di n g wi del y o n t he s ki n a n d es peciall y o n 
t he bac k wit h n o i ntact z o nes t o a p pl y t he Vias ki n ®  patc h es.  
Criteri a f or 
E v al u ati o n of Effic ac y  
Pri m ar y effic ac y e n d p oi nt:  
T he pri mar y efficac y e n d p oi nt is t he differe nce bet wee n t he perce nta ge of treat me nt 
res p o n ders i n t he selecte d acti ve D B V 7 1 2  gr o u p ( 2 5 0 µ g) c o m pare d t o t he place b o gr o u p  after 
1 2 m o nt hs of E PI T treat me nt . 
A s u bject is defi ne d as a treat me nt res p o n der  if: 
o  
T he i nitial E D was > 1 0 m g pea n ut pr otei n a n d t he E D is ≥1, 0 0 0 m g pea n ut pr otei n at t he 
p ost -treat me nt D B P C F C at M o nt h 1 2, 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
O R  
o  
T he i nitial E D was ≤1 0 m g pea n ut pr otei n a n d t he E D is ≥3 0 0 m g pea n ut pr otei n at t he 
p ost -treat me nt D B P C F C at M o nt h 1 2. 
Sec o n d ar y effic ac y e n d p oi nts:  
C ha n ge fr o m baseli ne  t o M o nt h 1 2 i n c u m ulati ve reacti ve d ose  ( C R D) a n d E D  i n t he selecte d 
acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g)  vers us t he place b o gr o u p . 
Ot her effic ac y e n d p oi nts:  
 
•  
T he p erce nta ge of s u bjects reac hi n g a c u m ulati ve d ose  ≥1, 4 4 4  m g pea n ut pr otei n at 
t he p ost-treat me nt D B P C F C at M o nt h 1 2 i n t he selecte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 
µ g)  vers us t he place b o gr o u p; 
•  
T he p erce nta ge  of s u bjects reac hi n g a c u m ulati ve d ose ≥3, 4 4 4  m g pea n ut pr otei n at 
t he p ost-treat me nt D B P C F C at M o nt h 1 2 i n t he selecte d acti ve D B V 7 1 2  gr o u p  
( 2 5 0 µ g)  vers us t he place b o gr o u p; 
•  
T he p erce nta ge of s u bjects u nres p o nsi ve (t h ose s h o wi n g n o s y m pt o ms lea di n g t o 
D B P C F C st o p) t o t he hi g hest d ose of pea n ut pr otei n ( 2, 0 0 0  m g pea n ut pr otei n) i n t he 
selecte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g)  vers u s t he place b o gr o u p. 
•  
C ha n ge fr o m baseli ne i n pea n ut -s pecific I g E a n d I g G 4 at m o nt hs 3, 6 a n d 1 2 i n t he 
selecte d acti ve D B V 7 1 2  gr o u p ( 2 5 0  µ g) vers us t he place b o gr o u p; 
•  
C ha n ge fr o m baseli ne i n pea n ut S P T at m o nt hs  3, 6 a n d 1 2 i n t he selecte d acti ve 
D B V 7 1 2  gr o u p ( 2 5 0 µ g) vers us t he place b o gr o u p; 
•  
Descri pti o n of t h e q ualit y of life q uesti o n naires ( Pare nt F A Q L Q/ F AI M) a n d c h a n ge 
fr o m baseli ne i n F A Q L Q/ F AI M sc ores at M o nt h  1 2 (f or t h ose c o u ntries w here t he 
tra nslate d a n d vali date d q uesti o n naires were a v aila ble) i n t he selecte d acti ve 
D B V 7 1 2  gr o u p ( 2 5 0 µ g) vers us t he place b o gr o u p.  
 
Criteri a f or 
E v al u ati o n of S afet y  
T he f oll o wi n g safet y criteria will be e val uate d  d uri n g t he st u d y a n d at t he 3 -m o nt h  i nteri m 
a n al ysis:  
•  
A d verse e ve nts a n d Treat me nt -E mer ge nt A d verse E ve nts ( T E A Es) b y S yste m Or ga n 
Class ( S O C) a n d Preferre d Ter ms ( P Ts);  
•  
T E A Es b y ma xi m u m se verit y a n d relate d ness t o D B V 7 1 2 ; 
•  
I nci de n ce, d urati o n a n d ma xi m u m se verit y of l ocal c uta ne o us D B V 7 1 2 -i n d uce d A Es 
as assesse d b y t he s u bjects;  
•  
I nci de n ce a n d  se verit y of l ocal c uta ne o us D B V 7 1 2 -i n d uce d A Es as assesse d b y t he 
I n vesti gat ors; 
•  
L ocal A d verse E ve nts of S pecial I nterest ( A E SI s) (i.e., reacti o ns at patc h sites 
p ote ntiall y lea di n g t o s ki n barrier disr u pti o n) a n d  s yste mic A E SIs (i.e. a n a p h yla xis, 
or s yste mic h y perse nsiti vit y reacti o ns lea di n g t o e pi ne p hri ne i nta ke) , w hate v er t he 
ca usal relati o ns hi p t o I M P; 
•  
Seri o us A Es ( S A Es) b y S O C, a n d P Ts, ma xi m u m se verit y a n d relate d ness t o 
D B V 7 1 2 ; 
•  
La b orat or y data, p h ysical e xa mi nati o ns a n d vital si g ns;  
Safet y of st u d y pr oce d ure:  
•  
S y m pt o ms elicite d d uri n g D B P C F Cs b y se verit y a n d c ha n ge i n t he se v erit y of 
s y m pt o ms i n t he selecte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g) vers us t he place b o gr o u p; 
•  
S A Es elicite d d uri n g D B P C F Cs . 
E x pl or at or y V ari a bles  
•  
T he c h a n ge fr o m baseli ne i n  t otal I g E, a n d i n I g E a n d I g G 4 s pecific t o pea n ut pr otei n 
c o m p o ne nts at 3 , 6 a n d  1 2 m o nt hs f or b ot h D B V 7 1 2  gr o u ps vers us t he place b o 
gr o u p;  
•  
Descri pti o n of reacti o ns tri g gere d b y acci de ntal c o ns u m pti o n of pea n ut d uri n g t he 
st u d y a n d a nal ysis of “ Ris k-ta ki n g be ha vi or” of par e nts’ s u bjects ( v ol u ntar y pea n ut 
c o ns u m pti o n); 
•  
E pi ge n etic m o dificati o ns of t he pr o m oters of s pecific ge nes;  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  
Se nsitizat i o n stat us t o s o me ot her aller ge ns a n d t heir e v ol uti o n o ver t he st u d y peri o d; 
•  
S C O R A D e v ol uti o n o ver ti me  
•  
 
•  
Q ualit y  of Life a nal ysis usi n g t he E Q -5 D -5 L  
•  
Bas o p hil acti vati o n test ( B A T) a nal yses ( U S eli gi ble sites o nl y) 
•  
 
. 
St atistic al Met h o ds  
A n al ysis p o p ul ati o ns : 
•  
Safet y p o p ulati o n : 
All s u bjects w h o are ra n d o mize d a n d ha ve recei ve d at least 1  d ose of I M P i n Part B. 
T his p o p ulati o n will be use d t o assess c o m parati ve safet y i nf or mati o n.  
•  
I nte nt-t o-treat (I T T) p o p ulati o n: 
All s u bjects w h o are ra n d o mize d i n Part B . T his p o p ulati o n will be use d t o assess 
c o m parati ve efficac y i nf or mati o n.  
•  
Per -pr ot oc ol ( P P) p o p ulati o n : 
All  s u bjects i n t he I T T p o p ulati o n w h o d o n ot ha ve maj or de viati o ns fr o m t he 
pr ot oc ol t hat ma y affect t he pri mar y efficac y e n d p oi nt. T he P P p o p ulati o n will be 
use d t o perf or m r o b ust ness a nal yses of t he pri mar y efficac y e val uati o n.  
•  
Part A p o p ulati o n:  
All s u bjects w h o are ra n d o mize d i n Part A. T his p o p ulati o n will be use d f or 
descri pti ve  efficac y a n d safet y a nal yses.  
Pri m ar y effic ac y a n al ysis:  
T he pri mar y efficac y e n d p oi nt i n t his st u d y is t he differe nce bet wee n t he perce nta ge of 
treat me nt res p o n ders i n t he selecte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g) c o m pare d t o t he place b o 
gr o u p  after 1 2  m o nt hs of E PI T treat me nt . 
T he pri mar y efficac y a nal ysis will be  perf or me d  o n t he I T T p o p ulati o n  usi n g missi n g =fail ure  
i m p utati o n met h o d (i.e. s u bjects wit h missi n g D B P C F C pea n ut E D  val ue at M o nt h  1 2 will be 
c o nsi dere d as n o n -res p o n ders). 
T he pri mar y meas ure of treat me nt effect will be t he differe nce i n res p o nse rates bet wee n 
acti ve a n d place b o treat me nt gr o u ps. T he pri mar y a nal ysis will a p pl y a Wal d test at a 2 -si de d 
5 % si g nifica n ce le vel t o e val uate a n ull h y p ot hesis of n o differe nce, a n d  a 2 -si de d 9 5 % 
Ne wc o m be CI f or t he differe nce i n res p o nse rates will be calc ulate d. T he pre -s pecifie d 
t hres ol d f or t he pri mar y a nal ysis will be defi ne d b y a ≥1 5 % l o wer CI  b o u n d, a n d t his c o n diti o n 
will deter mi ne w het her t he pri mar y o bjecti ve has bee n s ucce ssf ull y met. 
A s u p p orti ve a n al ysis will be perf or me d i n s u bjects ra n d o mize d i n part s A a n d B, usi n g t he 
sa me statistical met h o d as f or t he pri mar y a nal ysis. 
Sec o n d ar y effic ac y a n al yses:  
T he pea n ut pr otei n C R D at 
M o nt h  1 2 a n d t he pea n ut pr otei n E D at 
M o nt h  1 2 will be 
s u m marize d descri pti vel y b y treat me nt gr o u p f or t he I T T p o p ulati o n usi n g Baseli ne -
O bser vati o n -Carrie d -F or war d i m p utati o n, as well as f or t he P P p o p ulati o n. I n a d diti o n, t he 
pea n ut pr otei n C R D a n d t he pea n ut pr otei n E D i n eac h treat me nt gr o u p at M o nt h  1 2 will be 
c o m pare d. 
I n or der t o ha n dle m ulti ple ke y efficac y sec o n dar y e n d p oi nts, t he o verall t y pe-I err or will be 
c o ntr olle d b y t he use of a hierarc hical i nfere ntial a p pr oac h.  
S afet y A n al yses:  
A d verse E ve nts  
T E A Es will be defi ne d as a n y A Es, re gar dless of relati o ns hi p t o I M P, w hic h occ ur d uri n g or 
after t he i nitial patc h a p plicati o n or a n y e ve nt alrea d y prese nt t hat w orse ns i n eit her se v erit y 
or relati o ns hi p t o D B V 7 1 2  or place b o.  
A n o verall s u m mar y of T E A Es will be  pr o vi de d s h o wi n g t he n u m ber a n d perce nta ge of 
s u bjects wit h a n y T E A Es, a n y p ote ntiall y dr u g-relate d T E A Es, a n y D B V 7 1 2 -i n d uce d L ocal 
T E A E, a n y se v ere D B V 7 1 2 -i n d uce d l ocal T E A E, a n y se vere T E A Es, a n y se vere p ote ntiall y 
dr u g -relate d T E A Es, a n y seri o us T E A Es, a n y p ote ntiall y dr u g-relate d seri o us T E A Es, a n y 
C CI

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
T E A Es lea di n g t o disc o nti n uati o n a n d a n y T E A Es lea di n g t o deat h. T he n u m ber of e ve nts 
will als o be prese nte d.  
T he n u m ber o f T E A Es, as well as t he n u m ber a n d perce nta ge of s u bjects w h o e x perie nce d at 
least o ne T E A E will be s u m marize d b y S O C a n d P T.  
T he i nci de n ce of t he f oll o wi n g e ve nts will be s u m marize d:  
•  
T E A Es b y ma xi m u m se verit y, b y d urati o n a n d b y relate d ness t o Vias ki n ®  p atc h; 
•  
L ocal s ki n reacti o ns at sites of Vias ki n ®  patc h a p plicati o n as assesse d b y t he s u bjects 
(i nci de n ce, d urati o n a n d se verit y, 0 t o 3 gra di n g scale); 
•  
L ocal s ki n reacti o ns at sites of Vias ki n ®  patc h a p plicati o n as assesse d b y t he 
I n vesti gat or (se verit y, 0 t o 4 gra di n g scale at eac h ti me p oi nt); 
•  
S A Es, seri o us T E A Es a n d seri o us p ote ntiall y I M P-relate d T E A Es; 
•  
P ote ntiall y I M P-relate d T E A Es; 
•  
T E A Es lea di n g t o st u d y treat me nt disc o nti n uati o n  a n d T E A Es lea di n g t o e pi ne p hri ne 
i nta ke; 
•  
L ocal a n d s yste mic A E SI s. 
A d dit i o nall y, t he pr o p orti o ns of patc h es d uri n g t he o ne-year e x p os ure peri o d t hat le d t o mil d, 
m o derate or se v ere T E A E c o nsi dere d relate d t o Vias ki n ®  patc hes , will be s u m marize d.  
All A Es will be liste d as well as S A Es a n d T E A Es lea di n g t o a n e pi ne p hri ne i nta ke.  
T he reacti o ns i n d uce d b y a D B P C F C beca use t he y are e x pressl y pr o v o ke d, will be 
differe ntiate d fr o m t h ose A Es occ urri n g o utsi de of a c halle n ge. O bjecti ve a n d s u bjecti ve 
s y m pt o ms/reacti o ns elicite d d uri n g a c halle n ge will be s u m marize d se paratel y:  
•  
S y m pt o ms elicite d d uri n g a pea n ut f o o d c halle n ge b y se verit y;  
•  
S A Es elicite d d uri n g a pea n ut f o o d c halle n ge.  
Ot her s afet y assess m e nts  
La b orat or y tests ( he mat ol o g y a n d bi oc he mistr y), vital si g ns , p h ysical e xa mi nati o n  
 
 be s u m marize d a n d liste d b y visit. 
I nteri m a n al yses 
E n d of P art A safet y a n al ysis  
A safet y a n al ysis was t o be c o n d ucte d o n t he i nitial first 5 0 s u bjects i ncl u de d i n t he 3 treat me nt 
ar ms, D B V 7 1 2  1 0 0 μ g , D B V 7 1 2  2 5 0 μ g a n d place b o after 3  m o nt hs  of patc h a p plicati o n. 
T hese safet y data was t o be re vie we d b y  t he D S M B a n d t heir me m bers were t o release t heir 
rec o m me n dati o n o n t he safe d ose t o select f or t he st ud y part B. U p o n re vie w of t he 3 -m o nt h 
safet y data of  t he 5 1 ra n d o mize d s u bjects i n part A, t he D S M B ha d n o safet y c o ncer n a n d 
c o nsi dere d b ot h d oses as well t olerate d wit h a g o o d safet y pr ofile . T he 2 5 0-µ g d ose was 
selecte d f or part B. 
F or t he s u bjects i n t he Part A, de pe n di n g o n t he D S M B rec o m me n dati o ns, t he d ose of t he 2 
D B V 7 1 2  gr o u ps were eit her t o be ke pt u nc ha n ge d or a dj uste d . The st u d y c o ul d als o be 
defi niti vel y disc o nti n ue d . U p o n D S M B rec o m me n dati o ns, all s u bjects fr o m Part A are t o 
re main i n t heir i nitiall y ra n d o mize d treat me nt ar m.  
I nteri m f utilit y a n al ysis of t he I g G 4 i m m u n ol o gic al res p o nse at M o nt h 6  
T his a n al ysis will be c o n d ucte d w he n 5 0 s u bjects fr o m Part B ha ve reac he d 6 m o nt hs of acti ve 
treat me nt wit h t he acti ve D B V 7 1 2  d ose selecte d i n t he Part A ( 2 5 0 µ g) . T his a nal ysis will  be 
c o n d ucte d m ore s pecificall y o n pea n ut s pecific I g G 4  meas ure me nts . T he me dia n relati ve  
c h a n ge fr o m baseli ne of t he pea n ut s pecific I g G 4 le vels i n t he selecte d acti ve D B V 7 1 2  
treat me nt gr o u p ( 2 5 0 µ g) will  be c o m pare d t o t he me dia n relati ve c ha n ge fr o m baseli ne of t he 
pea n ut s pecific I g G 4 le vels  i n t he place b o gr o u p. T he me dia n val ue  of t he selecte d acti ve 
gr o u p ( 2 5 0 µ g) is e x pecte d t o be greater t ha n t he me dia n val ue of t he place b o gr o u p.  
I n t he sit uati o n w here t he c ha n ge fr o m baseli ne of t he pea n ut s pecific I g G 4 is e q ual t o or 
l o wer t ha n t he c ha n ge i n t he place b o gr o u p, t he pre mat ure st o p of t he st u d y f or lac k of 
e vi de n ce of treat me nt acti vit y  will be c o nsi dere d. T his u n bli n d e d  data re vie w will be 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
c o n d uct e d b y t he D S M B w h o will be res p o nsi ble of iss ui n g t he rec o m me n dati o n t o t he 
S p o ns or.  
P art A a n al ysis  
A n a n al ysis will be c o n d ucte d w he n  all s u bjects fr o m Part A will ha ve ter mi nate d t he st u d y. 
T he ai m is t o descri be t he efficac y a n d safet y data a m o n g all s u bjects e nr olle d i n Part A. All 
a n al yses will be detaile d i n a se parate i nteri m Statistical A nal ysis Pla n.  
 
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
St u d y Desi g n  
 
Base d o n  t he I nteri m Safet y A nal ysis, t he D B V 7 1 2  Selecte d d ose f or Part B is 2 5 0 µ g , a n d all su bjects fr o m Part  A are 
t o c o nti n ue t heir treat me nt u ntil t he e n d of t he st u d y as per t heir i nitiall y ra n d o mize d  ar m ( Place b o, D B V 7 1 2  1 0 0  µ g or 
D B V 7 1 2  2 5 0  µ g) . As a c o nse q ue n ce, t he V isit 7 bis  f or d ose s witc hi n g i n Part A is n ot a p plica ble.  
A b bre viati o ns: D = Da y; D B P C F C  =  D o u ble -bli n d, place b o -c o ntr olle d f o o d c halle n ge; M = M o nt h; s = s u bject; V = 
Visit ; w = wee ks.  
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
Sc he d ule of Pr o ce d ures  
 
St u d y Assess me nts  
Scree ni n g  
( M a x 4 2 d; m ore if 
D B P C F C p ost p o ne d 1)  
 
Tre at me nt Peri o d  
( 1 2 m o nt hs) 
E n d of 
St u d y  
E arl y 
Ter m  
U nsc h. 
Visit  
Visit t a gs –  P C ( P h o ne C all)  
V 1  
V 2  
V 3 2 
V 4 2 P C 1  
V 5  
P C 2  
V 6  
P C 3  
V 7  
P C 4  V 7 bis 3 V 8  
P C 5  V 9  
V 1 0  
V 1 1  
V 1 2  
E T  
U V 5   
D ur ati o n i n st u d y  
 D -4 2/ D -3  
 
 
D 1  
D 4  
D 8  
D 2 2  M 1  
M 2  
M 3  M 4. 5  M 3 -1 2  M 6  M 7. 5  M 9  M 1 2  M 1 2  
M 1 2   
  
 
Ti me Wi n d o ws  
4 2 d  
( ma x) 
bef ore 
V 4  
A n y -ti me  
u p t o  
D -2  
Wit hi n 
1  w of 
V 2 u p t o 
D -1  
  
± 2 d  ± 3 d  ± 2 d  ± 3 d  ± 3 d  ± 7 d  ± 7 d  
± 7 d  
± 7 d  ± 7 d  ± 7 d  ± 7 d  
Ma x 
V 1 0 
+ 1 w  
V 1 1 +  
4  w 4 
  
 
I nf or me d c o nse nt 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C hec k eli gi bilit y 6 
(i ncl usi o n/e xcl usi o n criteria) 
X  
 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease/ Me dical hist or y 7 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pare ntal me dical hist or y of at o p y  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
De m o gra p hics  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
P h ysical e xa mi nati o n 8   
X  
X 1 0 
X 1 0 
X  
 
X  
 
X  
 
X  
 
X  
X  
 
X  
X 1 0 X 1 0 
X  
X  
X  
Vital si g ns 9 
X  
X 1 0 
X 1 0 
X  
 
X  
 
X  
 
X  
 
X  
X  
 
X  
X 1 0 X 1 0 
X  
X  
X  
S C O R A D  
X  
 
 
 
 
 
 
 
 
X  
 
 
X  
 
 
X  
 
 
 
 
S P T  
X  
 
 
 
 
 
 
 
 
X  
 
 
X  
 
 
X  
 
 
X  
 
I m m u n ol o gical mar kers1 1 
X  
 
 
 
 
 
 
 
 
X  
 
 
X  
 
 
X  
 
 
X  
 
La b orat or y tests 1 2 
X  
 
 
 
 
 
 
 
 
X  
 
 
X  
 
 
X  
 
 
X  
X  
F A Q L Q/ F AI M / E Q-5 D -5 L 1 3 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
X  
 
 
E pi ge n etic a nal yses  
X  
 
 
 
 
 
 
 
 
X  
 
 
X  
 
 
X  
 
 
 
 
B A T 1 4  
X  
 
 
 
 
 
 
 
 
X  
 
 
X  
 
 
X  
 
 
X  
 
D B P C F C 1 
 
X  
X  
 
 
 
 
 
 
 
 
 
 
 
 
X  
X  
 
 
 
Ra n d o mizati o n  
 
 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A d verse e v e nts  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
C o nc o mita nt me dicati o ns  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
Dis pe nse f o o d sa m pli n g kit a n d 
i nstr ucti o ns 
 
 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C hec k f or a n y acci de ntal pea n ut 
c o ns u m pti o n  
 
 
 
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
S u bject partici pati o n  car d 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
S u bject diar y ( dis pe nse/c h ec k)  
 
 
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
 
X  
X  
Dis pe nse I M P t o t he s u bject 
 
 
 
X  
 
X  
 
X  
 
X  
 
X  
X  
 
X  
X  
 
 
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
St u d y Assess me nts  
Scree ni n g  
( M a x 4 2 d; m ore if 
D B P C F C p ost p o ne d 1)  
 
Tre at me nt Peri o d  
( 1 2 m o nt hs) 
E n d of 
St u d y  
E arl y 
Ter m  
U nsc h. 
Visit  
Visit t a gs –  P C ( P h o ne C all)  
V 1  
V 2  
V 3 2 
V 4 2 P C 1  
V 5  
P C 2  
V 6  
P C 3  
V 7  
P C 4  V 7 bis 3 V 8  
P C 5  V 9  
V 1 0  
V 1 1  
V 1 2  
E T  
U V 5   
D ur ati o n i n st u d y  
 D -4 2/ D -3  
 
 
D 1  
D 4  
D 8  
D 2 2  M 1  
M 2  
M 3  M 4. 5  M 3 -1 2  M 6  M 7. 5  M 9  M 1 2  M 1 2  
M 1 2   
  
 
Ti me Wi n d o ws  
4 2 d  
( ma x) 
bef ore 
V 4  
A n y -ti me  
u p t o  
D -2  
Wit hi n 
1  w of 
V 2 u p t o 
D -1  
  
± 2 d  ± 3 d  ± 2 d  ± 3 d  ± 3 d  ± 7 d  ± 7 d  
± 7 d  
± 7 d  ± 7 d  ± 7 d  ± 7 d  
Ma x 
V 1 0 
+ 1 w  
V 1 1 +  
4  w 4 
  
 
A p pl y 1 Vias ki n ®  patc h at site  
 
 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C hec k t he use d/ u n use d I M P 
 
 
 
 
 
X  
 
X  
 
X  
 
X  
X  
 
X  
X  
X  
 
X  
X  
C hec k s ki n reacti o ns u n der t he 
patc h a n d gra di n g 1 6 
 
 
 
X  
 
X  
 
X  
 
X  
 
X  
X  
 
X  
X  
X  
 
X  
X  
P h ot o gra p hs of t he bac k a n d 
d o w nl oa d t he p h ot os ta ke n b y 
s u bject’s pare nts (if a n y) 
 
 
 
X  
 
X  
 
X  
 
X  
 
X  
X  
 
X  
X  
X  
 
X  
X  
Dis pe nse e pi ne p hri ne a ut o -i nject or 
a n d a n a p h yla xis e mer ge n c y acti o n 
pla n ( Safet y leaflet) / ca mera  or a 
s pecific de vice/ h y dr oc ortis o ne 1 % 
 
 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Re vie w utilizati o n of e pi ne p hri ne 
a ut o -i nject or a n d a na p h yla xis 
e mer ge nc y acti o n pla n ( w he n 
re q uire d) 
 
 
 
 
 
X  
 
X  
 
X  
 
X  
X  
 
X  
X  
 
 
 
 
Ti me u n der o bser vati o n bef ore 
disc h ar ge  
 
3 h  
3 h  
3 h  
 
 
 
 
 
 
 
 
 
 
 
3 h  
3 h  
 
 
 
A b bre viati o ns: B A T = Bas o p hil acti vati o n test; D  =  Da y; D B P C F C  =  D o u ble -bli n d, place b o -c o ntr olle d f o o d c h alle n ge; d  = da ys; E T  =  Earl y ter mi nati o n; 
F A Q L Q/ F AI M  =  F o o d Aller g y Q ualit y of Life Q uesti o n naire/ F o o d Aller g y I n de pe n de nt Meas ure; h  =  h o urs; I M P =  I n vesti gati o nal me dici nal Pr o d uct; M  =  M o nt h; 
P C  =  P h o ne c o ntact; S C O R A D  =  Sc ori n g at o pic der matitis; S P T  =  S ki n pric k test; U V  =  U nsc he d ule d Visit; V  =  Visit.  
1  
If t he s u bject has a c o nc o mita nt disease w hic h te m p oraril y c o ntra-i n dicates t he perf or ma nce of t he D B P C F C, t he test is t o be p ost p o ne d u ntil at least 7 da ys 
after rec o ver y  
2  
Visit 4 ma y ta ke place o n t he sa me da y as Visit  3, b ut t his w o ul d res ult i n a ver y l o n g da y f or t he s u bject ( pare nts/ g uar dia ns) as all Visit  4 pr oce d ures w o ul d 
t he n ha v e t o ta ke place t hat sa me da y. 
3  
T he Visit 7 bis was t o be c o n d ucte d f or Part A s u bjects o nl y  i n t he e ve nt ualit y of  a d ose  s witc hi n g f or safet y reas o n. After re vie w of t he 3 -m o nt h safet y data, 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
b ot h d oses of D B V 7 1 2  were c o nsi dere d as safe, a n d n o d ose s witc hi n g is re q uire d. As a c o nse q ue nce, Visit 7 bis will n ot be perf or me d.  
4  
Visit 1 2 will ta k e place o nl y f or s u bjects n ot r olli n g o ver i nt o t he e xte nsi o n f oll o w -u p st u d y  
5  
U nsc h e d ule d Visit c o ul d be c o n d ucte d i n case of A Es, nee d f or treat me nt re -s u p pl y, etc. Pr oce d ures will b e o pti o nal a n d perf or me d as dee me d necessar y b y 
t he i n vesti gat or. 
6  
At V 1, all selecti o n criteria c o ul d be verifie d e xce pt f or t h ose t hat de p e n d o n t he res ults of t he i m m u n ol o gical mar kers test i n g ( pea n ut-s pecific I g E) a n d o n t he 
o utc o me of t he e ntr y/scree ni n g D B P C F C.  
7  
I ncl u di n g hist or y of pea n ut aller g y. 
8  
I ncl u di n g a c o m plete s ki n e x a mi nati o n, b o d y wei g ht a n d hei g ht. 
9  
Bl o o d press ure, heart rate a n d res pirat or y rate.  
1 0  T hese e x a mi nati o ns are t o be d o ne bef ore t he D B P C F C. A d diti o nall y, t he y ca n be re peate d d uri n g t he D B P C F C pr oce d ure o n b ot h da ys a n yti me if j u d ge d 
necessar y b y t he I n vesti gat or.  
1 1  Pea n ut -s pecific I g E, pea n ut-s pecific I g G 4, pea n ut-s pecific I g E a n d pea n ut s pecific I g G 4 t o Ara h 1, Ara h 2, Ara h 3, a n d t otal I g E  will be e v al uate d at Visits 
1, 7, 8, 1 0. T otal I g E will be assesse d i n Part B s u bjects o nl y. I g E s pecific t o c o w’s mil k, e g g w hite, h o use d ust mites, a n d grass p olle n will be assesse d at Visit 1 
a n d Visit 1 0 o nl y a n d i n case of a n earl y ter mi nati o n visit.   
1 2  La b orat or y tests perf or me d ce ntrall y. He mat ol o g y: he m o gl o bi n, he mat ocrit, platelets, re d bl o o d cells, w hite bl o o d cells wit h differe ntial cell c o u nt. 
Bi oc h e mistr y: as partate a mi n otra nsferase, ala ni ne a mi n otra nsferase, t otal bilir u bi n, t otal pr otei n, bl o o d urea nitr o ge n, creati ni ne.  
1 3  F or b ot h F A Q L Q a n d F AI M, Pare ntal F or m will be use d. T he tra nslate d f or ms of F A Q L Q a n d F AI M will be c o m plete d i n c o u ntries w h ere t he y are a v aila ble 
i n l ocal la n g ua ges. T he E Q -5 D -5 L q uesti o n naire will be c o m plete d b y pare nts/ g u ar dia ns f or s u bjects ra n d o mize d i n part B o nl y.  
1 4  B A T perf or me d ce ntrall y i n U S eli gi ble sites o nl y.  
 
  
1 6  C hec k t he reacti o n of t he s ki n o n t he bac k of t he s u bject a n d gra de t he se verit y of t he l ocal s ki n reacti o ns. At Visit 4, gra di n g is t o be assesse d : bef ore patc h 
a p plicati o n,  3 0  mi n utes , 1 h o ur  a n d 2  h o urs  d uri n g t he patc h a p plicati o n a n d 1 h  after t he patc h re m o val, t o d oc u me nt a n y reacti o n. P h ot o gra p hs will be ta k e n at 
eac h gra di n g ti me p oi nt.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
List of St u d y Pers o n nel  
S p o ns or  
 
S V P Gl o b al Cli nic al Devel o p me nt  
D B V Tec h n ol o gies S. A.  
1 7 7 -1 8 1 a ve n u e  Pierre Br oss olette  
9 2 1 2 0 M o ntr o u ge - F R A N C E  
Tel: 
 
E -mail:  
  
 
Direct or Cli nic al Pr ojects , 
D B V Tec h n ol o gies S. A. ( sa me a d dress as a b o v e ) 
Tel : 
 
E -mail : 
 
 
Direct or of Pr oject M a n a ge me nt, acti n g as  Cli nic al 
Pr oject M a n a ger , 
D B V Tec h n ol o gies S. A. ( sa me a d dress as a b o v e) 
Tel : 
 
•  
E -mail : 
 
 
M e dic al M o nit or  
D B V Tec h n ol o gies S. A. (sa me a d dress as a b o v e)  
Tel: 
 
E -mail: 
  
Ce ntr al L a b or at or y / Kit 
S u p pl y / S a m ples S hi p me nt  
( Bi oc he mistr y, 
He m at ol o g y,  
I m m u n ol o gic al M ar kers) 
 
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
C CI
P P D
P P D
P P D
P P D

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
T A B L E O F C O N T E N T S  
P R O T O C O L S Y N O P SI S  .................................................................................................. 4  
St u d y Desi g n  ..................................................................................................................... 1 4  
Sc he d ule of Pr oce d ur es .................................................................................................... 1 5  
List of St u d y Pers o n nel  .................................................................................................... 1 8  
T A B L E O F C O N T E N T S  ................................................................................................ 1 9  
T a bles i n Te xt  ................................................................................................................... 2 3  
Fi g ures i n Te xt .................................................................................................................. 2 3  
List of A p pe n dices  ............................................................................................................ 2 4  
List of A b bre v i ati o ns a n d Defi niti o ns of Ter ms ............................................................ 2 5  
1  
I N T R O D U C TI O N................................................................................................ 2 7  
1. 1  
B ac k gr o u n d  ...................................................................................................... 2 7  
1. 2  
R ati o n ale  .......................................................................................................... 2 8  
1. 3  
Ris k -Be nefit Ass ess m e nt  ................................................................................. 2 9  
2  
S T U D Y O B J E C TI V E S  ........................................................................................ 3 0  
3  
O V E R A L L D E SI G N A N D P L A N O F T H E S T U D Y  ....................................... 3 0  
3. 1  
O ver vie w  .......................................................................................................... 3 0  
3. 1. 1  
St u d y part A ...................................................................................................... 3 2  
3. 1. 2  
St u d y part B  ...................................................................................................... 3 3  
3. 2  
St u d y Sc he m atic Di a gr a m  .............................................................................. 3 4  
3. 3  
Criteri a f or E v al u ati o n of t he St u d y  .............................................................. 3 5  
3. 3. 1  
Efficac y Criteria  ............................................................................................... 3 5  
3. 3. 1. 1  
Pr i m ary Effic acy E n d p oi nt ............................................................................. 3 5  
3. 3. 1. 2  
Sec o n d ary Effic acy E n d p oi nts  ........................................................................ 3 5  
3. 3. 1. 3  
Ot her Effic acy E n d p oi nts  ................................................................................ 3 5  
3. 3. 2  
Safet y Criteria ................................................................................................... 3 6  
3. 3. 3  
E x pl or at or y Criteria  .......................................................................................... 3 6  
3. 4  
J ustific ati o n of t he St u d y Desi g n  ................................................................... 3 7  
4  
S T U D Y P O P U L A TI O N  ...................................................................................... 3 8  
4. 1  
I ncl usi o n Criteri a  ............................................................................................ 3 9  
4. 2  
E xcl usi o n Criteri a  ........................................................................................... 3 9  
4. 3  
P atie nt Wit h dr a w al a n d Re pl ace me nt  .......................................................... 4 1  
4. 3. 1  
S u bjects St o p pi n g R ules  ................................................................................... 4 1  
4. 3. 2  
St u d y St o p pi n g R ules  ....................................................................................... 4 2  
4. 3. 3  
Re place me nt of Wit h dra w n S u bjects  ............................................................... 4 2  
4. 3. 4  
Data C ollecti o n a n d F oll o w -u p after Wit h dra wal  ............................................ 4 2  
4. 4  
Pl a n ne d S a m ple Size a n d N u m ber of St u d y Ce nters  ................................... 4 3  
4. 5  
S u bject I de ntific ati o n a n d R a n d o miz ati o n  ................................................... 4 3  
4. 5. 1  
S u bject I d e ntificati o n  ....................................................................................... 4 3  
4. 5. 2  
Ra n d o mizati o n Sc he me  .................................................................................... 4 3  
4. 5. 3  
All ocati o n/ Ra n d o mizati o n of S u bjects t o Treat me nt  ....................................... 4 3  
5  
I N V E S TI G A TI O N A L M E DI CI N A L P R O D U C T ............................................ 4 4  
5. 1  
I de ntit y ............................................................................................................. 4 4  
5. 2  
A d mi nistr ati o n  ................................................................................................. 4 4  
5. 2. 1  
A dj ust me nt of Vias ki n ®  Patc h A p plicati o n i n Case of L ocal or S yste mic 
Reacti o ns  .......................................................................................................... 4 6  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
2 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
5. 2. 2  
Safet y Preca uti o n I nf or m ati o n .......................................................................... 4 7  
5. 3  
P ac k a gi n g, L a beli n g a n d St or a ge  .................................................................. 4 8  
5. 4  
Bli n di n g a n d Bre a ki n g t he Bli n d  ................................................................... 4 8  
5. 5  
Dr u g Acc o u nt a bilit y  ........................................................................................ 4 9  
5. 6  
C o m pli a nce  ...................................................................................................... 4 9  
5. 7  
Pri or a n d C o nc o mit a nt Me dic ati o n  ............................................................... 5 0  
5. 7. 1  
Per mitte d C o nc o mita nt Me dicati o n  .................................................................. 5 0  
5. 7. 2  
Pr o hi bite d Pri or a n d C o nc o mita nt Me dicati o n  ................................................. 5 1  
6  
V A RI A B L E S A N D M E T H O D S O F A S S E S S M E N T  ....................................... 5 2  
6. 1  
Effic ac y V ari a bles  ........................................................................................... 5 2  
6. 1. 1  
Res p o nse t o Treat me nt –  D B P C F C t o Pea n ut  .................................................. 5 2  
6. 1. 1. 1  
Pre p ar ati o n of Pe a n ut pr otei n a n d Pl ace b o F or m ul as  .................................. 5 3  
6. 1. 1. 2  
Ti me I nterv al a n d D oses  ................................................................................. 5 3  
6. 1. 1. 3  
E ntry/scree ni n g D B P C F C  .............................................................................. 5 4  
6. 1. 1. 4  
P ost -tre at me nt D B P C F C t o Pe a n ut at M o nt h 1 2 ........................................... 5 9  
6. 2  
S afet y V ari a bles  ............................................................................................... 5 9  
6. 2. 1  
A d verse E v e nts  ................................................................................................. 5 9  
6. 2. 1. 1  
C ollecti o n of A dverse Eve nts  .......................................................................... 5 9  
6. 2. 1. 2  
Defi niti o ns  ....................................................................................................... 6 0  
6. 2. 1. 3  
Assess me nt of A dverse E ve nts  ......................................................................... 6 0  
6. 2. 1. 4  
Rec or di n g A dvers e Eve nts  .............................................................................. 6 5  
6. 2. 1. 5  
Re p orti n g Seri o us A dverse Eve nts a n d A E SI of all er gic syste mic r e acti o n  ... 6 5  
6. 2. 1. 6  
F oll o w -u p of A dverse Eve nts  .......................................................................... 6 6  
6. 2. 1. 7  
Tre at me nt of Over d ose of St u dy Me dic ati o n  .................................................. 6 7  
6. 2. 2  
La b orat or y Varia bl es  ........................................................................................ 6 7  
6. 2. 3  
Vital Si g ns  ........................................................................................................ 6 8  
6. 2. 4  
P h ysical E xa mi nati o ns  ..................................................................................... 6 8  
6. 2. 5  
S u bject Diaries  ................................................................................................. 6 9  
6. 2. 6  
S ki n Reacti o n a n d P h ot o gra p h y  ....................................................................... 7 0  
 
 
 7 1  
6. 3  
De m o gr a p hics a n d B aseli ne C h ar acteristics  ................................................ 7 2  
6. 3. 1  
Patie nt De m o gra p h y  ......................................................................................... 7 2  
6. 3. 2  
Disease Hist or y a n d M e dical Hist or y  ............................................................... 7 2  
6. 3. 3  
Pri or a n d C o nc o mita nt Me dicati o ns  ................................................................. 7 3  
6. 4  
E x pl or at or y V ari a bles  .................................................................................... 7 3  
6. 4. 1  
I m m u n ol o gical Mar kers ................................................................................... 7 3  
6. 4. 2  
S ki n Pric k Test  ................................................................................................. 7 3  
6. 4. 3  
Q ualit y of Life Q uesti o n naires  ......................................................................... 7 4  
6. 4. 3. 1  
F o o d Aller gy Q u ality of Life Q uesti o n n aires / F o o d Aller gy I n de pe n d e nt 
Me as ure  .......................................................................................................... 7 4  
6. 4. 3. 2  
Ge neric Q u ality of Life Q uesti o n n aire: E Q -5 D -5 L  ........................................ 7 4  
6. 4. 4  
Acci de ntal C o ns u m pti o n of Pea n uts  ................................................................ 7 4  
6. 4. 5  
E pi ge netic a nal ys es  .......................................................................................... 7 4  
6. 4. 6  
Sc ori n g At o pic Der matitis  ................................................................................ 7 4  
6. 4. 7  
Bas o p hil Acti vati o n Test ( U nite d States eli gi ble sites o nl y)  ............................ 7 5  
6. 4. 8  
Ot her Ca n di date E x pl orat or y Bi o mar kers  ........................................................ 7 5  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
2 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
7  
S T U D Y C O N D U C T  ............................................................................................. 7 5  
7. 1  
Sc he d ule of Pr oce d ures  ................................................................................... 7 5  
7. 2  
Pr oce d ures b y Visit  ......................................................................................... 7 6  
7. 2. 1  
Visi t 1, Scree ni n g ( Da y -4 2/ D -3)  ..................................................................... 7 6  
7. 2. 2  
Visit  2, Scree ni n g (t hr o u g h Da y  -2)  ................................................................. 7 7  
7. 2. 3  
Visit 3, Scree ni n g ( wit hi n 1 wee k of Visit 2 a n d t hr o u g h Da y  -1) ................... 7 7  
7. 2. 4  
Visit 4 ( Da y 1), First D a y of Treat me nt  ........................................................... 7 8  
7. 2. 5  
P h o ne C o ntacts ( Da y 4 ± 2  da ys a n d Da y 2 2 ± 2  d a ys), Treat me nt Peri o d  ......... 7 9  
7. 2. 6  
Visit 5 ( Da y 8 ± 3  da ys), Visit 6 ( M o nt h 1 ± 3  da ys) a n d Visit 9 
( M o nt h 9 ± 7  da ys), Treat me nt Peri o d  ............................................................... 7 9  
7. 2. 7  
P h o ne C o ntacts ( M o nt h 2 ± 3  da ys, M o nt h 4. 5 ± 7  da ys a n d M o nt h 7. 5 ± 7  da ys), 
Treat me nt Peri o d  .............................................................................................. 8 0  
7. 2. 8  
Visit 7 ( M o nt h 3 ± 7  da ys), Visit 7 bis ( bet wee n M o nt h 3 a n d 1 2 –  de pe n di n g o n 
t he i ncl usi o n d urati o n) a n d Visit 8 ( M o nt h 6 ± 7 d a ys), Treat me nt Peri o d  ....... 8 0  
7. 2. 9  
Visit 1 0 ( M o nt h 1 2 ± 7  da ys), Treat me nt Peri o d  ............................................... 8 2  
7. 2. 1 0  
Visit 1 1 ( ≤1 wee k aft er Visit 1 0), E n d of Treat m e nt Peri o d  ............................ 8 3  
7. 2. 1 1  
Visit 1 2 ( 4 wee ks aft er Visit 1 1), E n d of St u d y Peri o d  .................................... 8 4  
7. 2. 1 2  
Earl y Ter mi nati o n Visit  .................................................................................... 8 4  
7. 2. 1 3  
U nsc he d ule d Visit  ............................................................................................ 8 5  
8  
S T A TI S TI C A L M E T H O D S  ............................................................................... 8 6  
8. 1  
St u d y S u bjects  ................................................................................................. 8 6  
8. 1. 1  
A nal ysis P o p ulati o ns  ........................................................................................ 8 6  
8. 1. 1. 1  
S afety P o p ul ati o n  ............................................................................................ 8 6  
8. 1. 1. 2  
I nte nt-t o-tre at P o p ul ati o n ............................................................................... 8 6  
8. 1. 1. 3  
Per -pr ot oc ol P o p ul ati o n  ................................................................................. 8 6  
8. 1. 1. 4  
P art A P o p ul ati o n  ........................................................................................... 8 7  
8. 1. 2  
Dis p ositi o n of S u bjects  ..................................................................................... 8 7  
8. 1. 3  
Pr ot oc ol De viati o ns  .......................................................................................... 8 7  
8. 2  
Ge ne r al C o nsi der ati o ns  .................................................................................. 8 7  
8. 2. 1  
Statistical Met h o ds  ........................................................................................... 8 7  
8. 2. 2  
A nal ysis a n d Data C o n ve nti o ns  ....................................................................... 8 7  
8. 2. 2. 1  
Defi niti o n of B aseli ne  ..................................................................................... 8 7  
8. 2. 2. 2  
Visit Wi n d o ws .................................................................................................. 8 8  
8. 2. 2. 3  
U nsc he d ule d Assess me nts  ............................................................................... 8 8  
8. 2. 2. 4  
Missi n g D at a C o nve nti o ns  .............................................................................. 8 8  
8. 2. 2. 5  
P o oli n g of Ce nters  .......................................................................................... 8 8  
8. 3  
De m o gr a p hics, Dise ase a n d Me dic al Hist ories, B aseli ne C h ar acteristics, 
a n d C o nc o mit a nt Me dic ati o ns  ........................................................................................ 8 8  
8. 4  
Tre at me nt C o m pli a nce a n d E x p os ure  .......................................................... 8 9  
8. 5  
Effic ac y A n al yses  ............................................................................................. 8 9  
8. 5. 1  
Pri mar y Efficac y A nal ysis ................................................................................ 8 9  
8. 5. 1. 1  
St atistic al Met h o ds  .......................................................................................... 8 9  
8. 5. 1. 2  
S u p p ortive A n alysis  ......................................................................................... 8 9  
8. 5. 1. 3  
S u b gr o u p A n alyses  .......................................................................................... 8 9  
8. 5. 2  
Sec o n dar y Efficac y A nal yses  ........................................................................... 9 0  
8. 5. 3  
Pre -defi ne d Hierarc hical Or der f or t he A n al ysis of Efficac y E n d p oi nts  .......... 9 0  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
2 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
8. 5. 4  
Ot her Effi cac y A nal yses  ................................................................................... 9 0  
8. 6  
S afet y A n al yses  ................................................................................................ 9 1  
8. 6. 1  
A d verse E v e nts  ................................................................................................. 9 1  
8. 6. 2  
La b orat or y Ass ess me nts  ................................................................................... 9 2  
8. 6. 3  
Vital Si g ns  ........................................................................................................ 9 2  
8. 6. 4  
P h ysical E xa mi nati o n  ....................................................................................... 9 3  
8. 6. 5  
S u bject Diaries  ................................................................................................. 9 3  
8. 6. 6  
S ki n Reacti o ns  .................................................................................................. 9 3  
8. 6. 7  
S y m pt o matic Reacti o ns d uri n g t he D B P C F C  .................................................. 9 3  
8. 7  
E x pl or at or y A n al yses  ...................................................................................... 9 3  
 
 
8. 9  
I nteri m A n al yses .............................................................................................. 9 5  
8. 9. 1  
E n d of  Part A –  3 -m o nt h Safet y a nal ysis  ......................................................... 9 5  
8. 9. 2  
I nteri m a nal ysis of i m m u n ol o gical acti vit y ...................................................... 9 5  
8. 9. 3  
Part A a nal ysis  .................................................................................................. 9 5  
8. 1 0  
Deter mi n ati o n of S a m ple Size  ........................................................................ 9 5  
9  
E T HI C A L, L E G A L, A N D A D MI NI S T R A TI V E A S P E C T S  .......................... 9 7  
9. 1  
I nf or me d C o nse nt ............................................................................................ 9 7  
9. 2  
D at a Q u alit y Ass ur a nce  .................................................................................. 9 8  
9. 3  
D at a b ase M a n a ge me nt a n d Q u alit y C o ntr ol  ................................................ 9 8  
9. 4  
S o urce D oc u me nt ati o n  .................................................................................... 9 8  
9. 5  
D at a C ollecti o n/ electr o nic C ase Re p ort F o r m (e -C R F)  .............................. 9 9  
9. 6  
Access t o S o urce D at a  ................................................................................... 1 0 0  
9. 6. 1  
R o uti ne M o nit ori n g  ........................................................................................ 1 0 0  
9. 6. 2  
I ns p ecti o ns a n d A u diti n g Pr oce d ures ............................................................. 1 0 0  
9. 7  
D at a Pr ocessi n g  ............................................................................................. 1 0 0  
9. 8  
Arc hi vi n g St u d y Rec or ds  .............................................................................. 1 0 1  
9. 9  
G o o d Cli nic al Pr actice  .................................................................................. 1 0 1  
9. 1 0  
P r ot oc ol A p pr o v al a n d A me n d me nt  ............................................................ 1 0 1  
9. 1 1  
D at a a n d S afet y M o nit o ri n g B o ar d  ............................................................. 1 0 2  
9. 1 2  
D ur ati o n of t he St u d y  .................................................................................... 1 0 2  
9. 1 3  
Pre m at ure Ter mi n ati o n of t he St u d y  .......................................................... 1 0 3  
9. 1 4  
C o nfi de nti alit y  ............................................................................................... 1 0 3  
9. 1 5  
C o ntr act u al a n d Fi n a nci al Det ails  ............................................................... 1 0 3  
9. 1 6  
Li a bilit y a n d I ns ur a nce  ................................................................................. 1 0 4  
9. 1 7  
P u blic ati o n P olic y  .......................................................................................... 1 0 4  
9. 1 8  
St u d y Ce nter File M a n a ge me nt  ................................................................... 1 0 4  
9. 1 9  
Cli nic al St u d y Re p ort  ................................................................................... 1 0 5  
1 0  
Liter at ure Cite d  ................................................................................................. 1 0 6  
1 1  
A P P E N DI C E S  .................................................................................................... 1 1 0  
 
 
 
 
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
2 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 
 
 
T a bles i n Te xt  
Ta ble  1: List of S olicite d A d verse E v e nts ( A p plica ble f or Part B O nl y)  ...................6 0  
Ta ble 2: Gra di n g of L ocal S ki n Reacti o ns b y t he Pare nts/ G uar di a ns  ........................6 9  
Ta ble  3: S ki n Reacti o n Gra di n g S yste m  .....................................................................7 0  
Ta ble  4: Pre -defi ne d Hierarc hi cal Or der f or A nal ysis of Efficac y E n d p oi nts —  I T T 
p o p ulati o n  .............................................................................................................9 0  
Ta ble  5: Criteria t o Assess Cli nic all y Rele va nt A b n or malities i n Vital Si g ns  ...........9 3  
Ta ble 6: Ra n d o mize d S u bjects ....................................................................................9 6  
Ta ble 7: E xa m ples of E x act O bser ve d Perce nta ges of Res p o n ders i n Part A  ............9 7  
Fi g ures i n T e xt 
Fi g ure  1: St u d y Desi g n  ...............................................................................................3 4  
Fi g ure  2: Sc he matic R e prese ntati o n of Vias ki n ®  Patc h A p plicati o n o n t he Bac k of 
t he S u bjects ..........................................................................................................4 5  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
2 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
List of A p pe n dices  
A p pe n di x 1  
Declarati o n of Helsi n ki  
A p pe n di x 2  
Acti vit y of C ortic oster oi ds  
A p pe n di x 3  
S h ort -acti n g a n d L o n g -acti n g A nti hista mi nes base d o n Ter mi nal 
Eli mi nati o n Half -Li ves  
A p pe n di x 4  
A na p h yla xis Sta gi n g S yste m  
A p pe n di x 5  
Oral F o o d C halle n g e S y m pt o m Sc ore S heet  
A p pe n di x 6  
F A Q L Q/ F AI M Pare nt Q uesti o n naires  
A p pe n di x 7  
S C O R A D  
A p pe n di x 8  
Ma na ge me nt of ast h ma i n c hil dre n 5 years a n d y o u n ger as per 
Gl o bal I nitiati ve f or Ast h ma ( GI N A) Pr o gra m  
A p pe n di x 9  
Pea n ut F o o d C halle n ge Refere n ce Safet y I nf or mati o n 
A p pe n di x 1 0  
E Q -5 D -5 L Q u esti o n naire  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
2 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
List of A b bre vi ati o ns a n d Defi niti o ns of Ter ms  
A E  
A d verse E v e nt  
A E SI  
A d verse E v e nt of S pecial I nterest  
A P C  
A nti ge n -Prese nti n g Cells  
A T C  
A nat o mical T hera pe utic C he mical ( Classificati o n S yste m)  
B A T  
Bas o p hil Acti vati o n Test  
CI  
C o nfi de nce I nter val  
C R D  
C u m ulati ve Reacti ve D ose  
C R O  
C o ntract Researc h Or g a nizati o n  
C S R  
Cli nical St u d y Re p ort  
C T C A E  
C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts  
D B P C F C  
D o u ble -Bli n d, Place b o -C o ntr olle d F o o d C halle n ge  
D S M B  
Data a n d Safet y M o nit ori n g B oar d  
E C G  
Electr o C ar di oG ra m 
e-C R F  
Electr o nic Case Re p ort F or m  
E D  
Eliciti n g D ose  
E D C  
Electr o nic Data Ca pt ure  
E PI T  
E Pic uta ne o us I m m u n o T hera p y  
E Q -5 D -5 L  
E ur o Q ol -5 D -5 L  
F A Q L Q/ F AI M  
 
F o o d Aller g y Q ualit y of Life Q uesti o n nair e/ F o o d Aller g y 
I n d e pe n de nt M eas ure 
F D A  
F o o d a n d Dr u g A d mi nistrati o n  
G A 2L E N  
Gl o bal Aller g y a n d Ast h ma E ur o pea n Net w or k  
G C P  
G o o d Cli nical Practice  
GI N A  
Gl o bal I N itiati ve f or Ast h ma 
I B 
I n v esti gat or’s Br oc h ure 
I C F 
I nf or me d C o nse nt F or m  
I C H 
I nter nati o nal C o nfere nce o n Har m o nizati o n 
I E C 
I n d e pe n de nt Et hics C o m mittee 
I g E, I g G 4 
I m m u n o gl o b uli n E, I m m u n o gl o b uli n G 4 s u bt y pe 
I M P 
I n v esti gati o nal Me dici nal Pr o d uct 
I N D 
I n v esti gati o nal Ne w Dr u g 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
2 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
I R B 
I nstit uti o nal Re vie w B oar d 
I T T 
I nte nt T o Treat 
I V 
I ntr a ve n o us 
I W R S 
I nteracti ve We b Res p o ns e S yste m 
L E A P  
Lear ni n g Earl y A b o ut Pea n ut Aller g y  
Me d D R A  
Me dical Dicti o nar y f or R e g ulat or y Acti vities  
OI T  
Oral I m m u n o T hera p y  
P P  
Per -Pr ot oc ol  
P T  
Preferre d Ter m  
Sa O 2  
O x y ge n sat urati o n as me as ure d b y bl o o d a nal ysis 
S A P  
Statistical A nal ysis Pla n  
S C O R A D  
S C O Ri n g At o pic Der matitis  
S LI T  
S u b Li n g ual I m m u n o T hera p y  
S O C  
S yste m Or ga n Class  
S p O 2  
O x y ge n sat urati o n  as me as ure d b y p ulse o x y metr y  
S P T  
S ki n Pric k Test  
S U S A R  
S us pecte d U ne x p ecte d S eri o us A d verse Reacti o n  
T E A E  
Treat me nt -E mer ge nt A d verse E ve nt  
U S( A)  
U nite d States ( of A meri ca)  
W H O  
W orl d Healt h Or ga nizati o n  
 
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
2 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
1  
I N T R O D U C TI O N 
1. 1  
B ac k gr o u n d 
Pea n ut aller g y is t he m ost c o m m o n ca use of fatal f o o d aller g y reacti o ns (1 , 2 ). A n 
esti mate d 1 % of t he p o p ulati o n of t he U nite d States of A merica ( U S A), o ver 3 milli o n 
pe o ple, is aller gic t o pea n uts or tree n uts ( 3 ). T he pre vale nce of pea n ut aller g y i n c hil dre n 
has bee n i ncreasi n g o ver t he last 2 deca des, as i n dicate d b y s ur ve ys c o n d uct e d i n t he U S A 
a n d U nite d Ki n g d o m: t he rate of pea n ut aller g y i n c hil dre n d o u ble d wit hi n a ra n ge of 5 t o 
6 years (4 , 5 ) a n d m ore t ha n tri ple d bet wee n 1 9 9 7 a n d 2 0 0 8 wit h a pre vale nce of 0. 4 % i n 
1 9 9 7, 0. 8 % i n 2 0 0 2 a n d 1. 4 % i n 2 0 0 8 ( 3 ). St u dies i n dicate t hat pea n ut aller g y mi g ht 
res ol ve i n a b o ut 2 0 % of cases (6 – 9 ), b ut 
ma y rec ur i n s o me dese nsitize d 
i n di vi d uals, ma ki n g t his aller g y a life-l o n g afflicti o n i n t he vast maj orit y of cases. 
A rec e nt ra n d o mize d st u d y of pea n ut  c o ns u m pti o n  i n i nfa nts at hi g h  ris k of de vel o pi n g 
pea n ut aller g y, t he Lear ni n g Earl y A b o ut Pea n ut Aller g y ( L E A P) st u d y, has e val uate d t he 
strate gies of pea n ut c o ns u m pti o n or a v oi da nce at ver y earl y a ges, bet wee n 4 a n d 1 1 
m o nt hs of a ge ( 1 0 ). I n t he s u bset of i nfa nts at hi g h ris k t o de vel o p pea n ut aller g y, 
w hic h were i nfa nts wit h ecze ma, p ositi ve e g g S ki n Pric k Test ( S P T), ne gati ve or 
sli g htl y p ositi ve pea n ut S P T, t he res ults of t his pr os pecti ve st u d y de m o nstrate d 
t hat earl y pea n ut c o ns u m pti o n d uri n g i nfa nc y 
mi g ht be prefera ble t o a v oi da nce 
f or pre ve nti n g t he occ urre nce of pea n ut aller g y i n i nfa nts at hi g h ris k.  
Pea n ut  aller g y  falls wit hi n  t he I m m u n o gl o b uli n E (I g E)- me diat e d  cate g or y of  f o o d 
aller gies, wit h i m me diate reacti o ns tri g gere d b y circ ulati n g aller ge n-s pecific I g E u p o n 
e x p os ure t o t he aller ge n ( 1 1 ). I g E- me diate d aller gic reacti o ns t o f o o ds ha ve a ra pi d o nset, 
us ua ll y wit hi n  a fe w mi n utes  f oll o wi n g e x p os ure t o t he aller ge n. I g E- me diate d aller gic 
reacti o ns t o pea n ut pr o v o ke c haracteristic res p o nses i n t he s ki n, gastr oi ntesti nal 
tract, u p per a n d l o wer res pirat or y tract a n d car di o vasc ular s yste m (1 2 ). I g E- me diate d 
reacti o ns t o f o o d ma y als o tri g ger ge neralize d reacti o ns, t hat is a na p h yla xis, a se vere, 
p ote ntiall y fatal, s yste mic aller gic reacti o n t hat occ urs s u d de nl y after c o ntact wit h a n 
aller g y-ca usi n g s u bsta nce ( 1 3 ).  
T he  c o m plete mec h a nis m of I g E- m e diate d f o o d aller g y re mai ns u n k n o w n. H o we ver, it is 
t h o u g ht t hat t he de vel o p me nt of a n I g E- me di ate d res p o nse t o a n aller ge n is t he res ult of a 
series of m olec ular a n d cell ular i nteracti o ns i n v ol vi n g A nti ge n- Prese nti n g Cells ( A P Cs), 
T cells a n d 
B cells ( 1 4 , 1 5 ). 
U p o n re-e x p os ure t o t he se nsitizi n g f o o d, t he 
aller ge n cr ossli n ks t he s pecific I g Es b o u n d o n mast cells a n d bas o p hils, tri g geri n g 
release of vas oacti ve a n d i nfla m mat or y 
me diat ors s uc h as hista mi ne, le u k otrie nes, 
pr osta gla n di ns, a n d platelet-acti vati n g fact or. T he massi ve release of t hese me diat ors 
i n d uces i m me diate aller gic s yste mic s y m pt o ms, i ncl u di n g a na p h yla xis. 
T here are n o a p pr o ve d treat me nts a vaila ble f or pea n ut aller g y ( 1 6 ). C urre ntl y, t he o nl y 
t hera peutic  o pti o n  a v aila ble  f or pe a n ut-aller gic  s u bjects is strict a v oi da nce. H o we ver, si nc e 
pea n ut  is a u bi q uit o us  i n gre die nt i n ma n y f o o ds, strict a v oi da nce is diffi c ult t o ac hie ve, 
a n d acci de ntal i n gesti o n of pea n ut b y pea n ut-aller gic s u bjects ma y res ult i n se vere 
reacti o ns a n d fatal o utc o mes (1 7 ). 
T he  o nl y a vaila ble c o u nter meas ure  i n cas e of se vere  s yste mic a n d/ or life-t hreat e ni n g 
reacti o ns/a n a p h yla xis t o pea n uts is i njecta bl e e pi n e p hri ne as rec o m me n de d b y t he W orl d 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
2 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
Aller g y Or ga nizati o n ( 1 8 ). E pi ne p hri ne re mai ns a resc ue t hera pe utic a ge nt a n d is n ot 
de si g ne d f or a r o uti ne us e.  
Vari o us  n o n-s pecific  a n d  f o o d aller ge n-s pecifi c  treat me nt a p pr oac hes h a ve  bee n  u n der 
e val uati o n. N o n -s pecific a p pr oac h es t o f o o d aller g y i ncl u de t he use of m o n o cl o nal  anti -I g E 
a nti b o dies, w hic h mi g ht i ncrease t he Eliciti n g D ose ( E D) t hres h ol d f or t he f o o d aller ge n 
(1 9 , 2 0 ). F o o d aller ge n-s pecific a p pr oac hes i n cli nical de vel o p me nt i ncl u de 
Oral 
I m m u n o T hera p y ( OI T), 
S u b Li n g ual I m m u n o T hera p y ( S LI T), a n d 
E Pic uta ne o us 
I m m u n o T hera p y ( E PI T) (2 1 ). F o o d-s pecific a p pr oac hes ma y be a d va nta ge o us as t he y 
tar get t he s pecific f o o ds t hat ca use t he se vere I g E- me diate d a na p h ylactic reacti o ns (2 2 ). 
St u dies o n S LI T a n d OI T ha ve de m o nstrate d s o me e nc o ura gi n g efficac y res ults (cli nical 
dese nsitizati o n), 
i ncl u di n g 
be neficial 
i m m u n ol o gic 
c ha n ges 
( 2 3 – 2 6 ). 
Oral 
i m m u n ot hera p y has s h o w n e vi de nce f or i n d uci n g dese nsitizati o n i n 
m ost s u bjects, 
wit h i m m u n ol o gic c ha n ges o ver ti me ( 2 5 – 2 7 ). T hese a d va nces are, h o we ver, ha m pere d 
b y t he si g nifica nt ris k of si de effects a n d occ urre nce of e osi n o p hilic es o p ha gitis i n t he 
c o nte xt of 
OI T ( 2 8 – 3 2 ). S u bli n g ual i m m u n ot hera p y 
f or 
pea n ut 
aller g y 
has 
de m o nstrate d e vi de nce of cli nical s uccess, 
wit h s o me s u bjects s h o wi n g si g ns of 
dese nsitizati o n 
wit h a 
m ore satisfact or y safet y pr ofile c o m pare d t o OI T a n d wit h 
si g nifica nt i m m u n ol o gic c ha n ges n ote d d uri n g t he first year of t hera p y (2 4 ). Des pite t he 
e vi de nt i nterest of cli nicia ns t o f urt her e val uate t hese treat me nt pr oce d ures, OI T a n d 
S LI T will n ot li kel y be a p plica ble acr oss all a ges a n d ris k cate g ories of pea n ut-aller gic 
c hil dre n a n d a d ults. Alter nati ve i m m u n ot hera pe utic a p pr oac hes f or pea n ut aller g y are 
t heref ore nee de d, wit h a cli nicall y mea ni n gf ul be nefit a n d i m pr o ve d safet y pr ofile. 
T he I n vesti gati o nal M e dici nal Pr o d uct (I M P) , D B V 7 1 2 ( or Vias ki n ®  Pea n ut), c o nsists of 
a n e pic uta ne o us deli ver y  s ystem  ( Vias ki n®  patc h)  co ntai ni n g  a s oli d de p osit  of a 
f or m ulati o n of pea n ut  pr otei n  e xtract. T he  pea n ut  pr otei n  aller ge ns are de p osite d  o n t he 
ba c ki n g of a n  occl usi ve  cha m ber  b y  electr os pra yi n g a li q ui d f or m ulati o n of t he pea n ut 
pr otei n e xtract. T he dr u g s u bsta nce is a n u n m o difie d, l y o p hilize d pea n ut e xtract pr o d uce d 
fr o m t he e xtracti o n a n d  freeze dr yi n g of  defatte d  pea n ut  fl o ur, d eri ve d  fr o m t he pea n ut 
see d, Ar ac his hy p o g a e a .  
F urt her de tails can b e f o u n d i n t he In vesti g at or’ s Br oc h ure ( I B), 
w hich c o ntai ns 
c o m pre he nsi ve i nf or mati o n o n t he I M P. 
1. 2  
R at i o n ale 
D B V 7 1 2  is a rea d y-t o-use  a n d eas y-t o-a d mi nister f or m o f aller ge n i mm u n ot hera p y, 
partic ular l y a d a pte d t o t he pe diatric  p o p ulati o n. It  is i nte n de d t o i n d uce cli nical 
dese nsit izati o n/t olerizati o n t o pea n ut i n s u bjects aller gic t o pea n ut t hr o u g h i nteracti o n wit h 
t he l ocal A P Cs  s uc h as t he e pi der mic La n ger ha ns  a n d de n dritic  cells. B y  uti lizi n g t he 
e pic utane o us r o ute of a d mi nistrati o n, D B V 7 1 2 is a ble t o i nitiate t h ese i m m u n o m o d ulat or y 
pr ocesses  w hile mi ni mizi n g  t he p ote ntial s afet y c o ncer ns ass ociate d  wit h s yste mic 
e x p os ure t o pe a n ut aller g e nic pr otei ns. 
I n t he 1 2- m o nt h, P ha se II b VI P E S  st u d y, a m o n g t he 3 d oses teste d ( 5 0 µ g, 1 0 0 µ g  a n d 
2 5 0 µ g), t he hi g hest d ose of 2 5 0 µ g D B V 7 1 2 dis pla ye d a str o n g efficac y wit h t he hi g hest 
ma g nit u de of effect i n c hil dre n wit h a g o o d saf et y pr ofile. T he efficac y a n d safet y of 1 2-
m o nt h treat me nt wit h D B V 7 1 2 at 2 5 0 µ g were f urt her c o nfir me d i n t he pi v otal P hase III 
P E PI T E S  st u d y i n c hil dre n a ge d 4 t o 1 1 years.  A d diti o nal  6- m o nt h  safet y data  fr o m t he 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
2 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
i nteri m a nal ysi s of t he P hase III R E A LI S E st u d y are als o c o nsiste nt wit h t he g o o d 
t olera bilit y pr ofile of D B V 7 1 2 2 5 0 µ g i n c hil dre n . 
T he  chil dre n  p o p ulati o n  i nte n de d t o be st u die d i n t his st u d y is y o u n ger c o m pare d t o t he 
o ne of  t he pre vi o us P has es II a n d III st u dies wit h D B V 7 1 2. H o we v er, e ve n if t he s ki n of 
i nfa nts e x hi bits  disti nct  a nat o mical a n d f u ncti o n al pr o perties, n o  maj or  differe n ces  are 
re p orte d after 1 2 m o nt hs of a ge i n ter m of t hic k ness of strat u m c or ne u m, acti n g as barrier 
(air-li q ui d i nterface), e xce pt f or s maller c or ne oc ytes s u g gesti n g a m ore ra pi d t ur n o ver of 
strat u m c or ne u m (3 3 ). T he per mea bilit y barrier f u ncti o n bec o mes a d ult-li ke after t he first 
ye ar of life ( e. g. tra ns- e pi der mal water l oss is si milar) b ut s o me s ki n c haracteristics s uc h 
as ca p acita n ce v al ues  w hic h  are hi g her  i n i nfa nts/t o d dlers a ged  8  t o 2 4 m o nt hs, a n d p H 
w hic h  is less aci dic i n i nf a nt t ha n i n t he ol der c hil d/ a d ult,  s u g gest t h at ar o u n d  1 2- 2 4 m o nt hs 
of a ge, t he s ki n i s still mat uri n g. 
After t he a ge o f 2 years, n o mar ke d differe nce s wit h a d ult are re p ort ed in s ki n str uct ure 
a n d c haracteristics. 
M ore  i m p orta ntl y, cli nical data  of earl y  i ntr o d ucti o n of a ller ge nic f o o d i n t he diet o f 
se nsitized  i nfa nt/t o d dlers or c o m plete d  a n d o n g oi n g  dese nsitizati o n  st u dies wit h f o o d or 
aer oaller ge ns are e nc o ura gi n g be ca use t he y s u g gest t hat ver y y o u n g c hil dre n  ca n be 
dese nsitize d t o t hese aller ge ns, wit h a hi g her s u ccess as ol der s u bjects. 
Fi nall y,  rece ntl y re p ort e d diffe re n ces i n i m m u ne reacti o ns bet w ee n  a d ults  a n d c hil dre n 
e vi de nci n g i ncrease d i n n ate i m m u nit y i n c hil dre n s ki n, rei nf orce t he c o n ce pt of E PI T as a 
p ote ntial well-t olerate d,  c o n ve nie nt a n d efficie nt a p pr oac h of  i m m u n ot hera p y f or f o o d 
aller gic t o d dler. 
Base d  o n t hese  fi n di n gs, D B V 7 1 2 at 1 0 0 or  2 5 0 µ g  use d  f or E PI T  f or a d urati o n  of  
1 2 m o nt hs  is c o nsi dere d  t o be s uita ble d ose s f or treati n g t o d dlers/ y o u n g c hil dre n wit h 
pe a n ut aller g y i n t his st u d y. 
1. 3  
Ris k - Be nefit Asse ss m e nt 
T he pri mar y safet y c o ncer n f or a n y aller ge n s pecific i m m u n ot hera p y is relate d t o t he ris k 
of i n d uci n g s yste mic,  se vere or  life-t hreate ni n g aller gic reacti o ns. D B V 7 1 2  a p plie d 
e pic uta neo usl y  w as  d e vel o pe d  i n t his se nse, w hic h  is t o  re d uce t he ris k of t hese severe 
s yste mic reacti o ns b y a p pl yi n g t he pea n ut aller ge ns o n t he s ki n a n d reac hi n g t he i m m u ne 
s yste m t hr o u g h t he c uta n e o us La n ger ha ns a n d d e n dritic cells.  
A c o m pre h ensi ve s u m m ar y of t h e safet y an d effi cacy d a ta fr o m n o n-cli ni ca l an d cli nical 
st u dies wit h D B V 7 1 2 is a vaila ble i n t he I B.  
Safet y  i nf or mati o n ori gi nati n g  fr o m cli nical st u dies i ncl u di n g pe diatric s u bjects ha v e 
de m o nstrate d a g o o d s afet y pr ofile f or D B V 7 1 2 u p t o 2 5 0 µ g  i n c hil dre n as of 4 t o 1 1 years 
of a ge.  T he  e x pecte d l ocal s ki n reacti o ns tri g gere d b y D B V 7 1 2  at t he site of patc h 
ap plicati o n, w hic h are pr urit us, er yt he ma, e de ma, a n d urticaria, are i n t he maj orit y of cases 
mil d  or m o derate  a n d m a na ge d  a n d c o ntr olle d satisfact oril y b y t he s u bjects  wit h t o pi cal 
me dicati o ns  c o ntai ni n g c ortic oster oi ds.  As a  c o ns e q ue nce, a ver y  g o o d c o m plia nce  wa s 
s h o w n i n t he st u dies c o n d ucte d s o far. 
F urt her m ore,  es p eciall y i n t he P hase II b VI P E S  st u d y, D B V 7 1 2  2 5 0 µ g  ha s s h o w n a 
statisticall y si g nifica nt effect wit h  u p t o 5 3. 6 %  of  chil dre n  res p o n di n g p ositi vel y  t o t he 
treat me nt vers us  1 9. 4 % f or place b o, as per t he d ose-fi n di n g st u d y pri mar y e n d p oi nt. I n a 
p ost- h oc a n al ysis wit h a hi g her stri n ge nt criteri o n f or t he treat me nt be nefit (t he sa me use d 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
3 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
f or t he pri mar y efficac y e n d p oi nt i n t his P hase  III E PI T O P E st u d y), t he ma g nit u de of effect 
of D B V 7 1 2  2 5 0  µ g w as e ve n hi g her ( 4 6. 5 % res p o nse rat e i n t he acti ve tr eat me nt gr o u p 
vers us  6. 5 % res p o nse rate f or place b o).  T h e effi cac y of D B V 7 1 2  2 5 0  µ g was f urt her 
c o nfir me d i n t he p i v otal P hase III P E PI T E S st u d y, w hic h i ncl u de d 3 5 6 pea n ut-aller gic 
c hil dre n fr o m 4 t o 1 1 years. I n t his st u d y , w hic h use d t he sa me pri mar y effi cac y e n d p oi nt 
t ha n E PI T O P E, D B V 7 1 2  2 5 0  µ g s h o we d a statisticall y si g nifica nt hi g her res p o n der rate 
( 3 5. 3 %) vers us  pla ce b o ( 1 3. 6 %) after 1 2 
m o nt hs of treat me nt ( bet wee n -tr eat me nt 
differe n ce of 2 1. 7 %, p < 0 0 1).  F urt her detail re g ar di n g b ot h VI P E S a n d P E PI T E S  st u dies 
ca n be f o u n d i n t he I B.  
N o partic ular safet y c o ncer n ar ose i n y o u n g c hil dre n prese nti n g wit h fila g gri n def icie nc y 
d uri n g t he cli nical pr o gra m  i n dicati n g a fa v ora bl e safet y pr ofile of t he E PI T t hera p y wit h 
re gar d t o t his ge netic c o n diti o n je o par dizi n g s ki n i nte grit y. T he safet y assess me nt ma de 
d uri n g t he C o F A R 6 st u d y di d n ot e vi de nce a d diti o nal a d verse e v e nts ( A Es) i n t he s u bjects 
prese nti n g wit h at o p y ( 5 1. 4 % of t he o verall st u d y p o p ulati o n).  
O verall, t he a vaila ble i nf or mati o n gat here d fr o m se veral cli nical st u dies c o n d ucte d i n 
c hil dre n wit h D B V 7 1 2  s u g gest t hat D B V 7 1 2  2 5 0  µ g d ose prese nts a fa v ora ble be nefit -ris k 
rati o. 
2  
S T U D Y O B J E C TI V E S  
T he o bjecti ve of t his st u d y is t o verif y t he safet y a n d l ocal t olera nce of t he 2 D B V 7 1 2  
d oses of 1 0 0 a n d 2 5 0 µ g a n d t o assess t he effi cac y a n d safet y of D B V 7 1 2  t o i n d uce 
dese nsitizati o n t o pea n ut i n pea n ut -aller gic s u bjects 1 t o 3  years of a ge after a 1 2 -m o nt h 
treat me nt peri o d b y E PI T.  
3  
O V E R A L L D E SI G N A N D P L A N O F T H E S T U D Y  
3. 1  
O ver vie w  
T his is a 1 2 -m o nt h, d o u ble -bli n d, place b o -c o ntr oll e d, ra n d o mize d p hase III trial t o assess 
t he safet y a n d efficac y of D B V 7 1 2  ( d oses of 1 0 0 μ g or 2 5 0 μ g pea n ut pr otei n per patc h ) 
i n pea n ut-aller gic c hil dre n 1 t o 3 years of a ge.  
T he trial will  be c o n d ucte d i n a p pr o xi matel y  5 0 -7 0  sites i n at least 8  c o u ntries wit h 
I n v esti gat ors a n d staffs trai ne d a n d e x perie nce d i n t he dia g n osis a n d t he ma na ge me nt of 
pea n u t aller g y a n d a na p h yla xis, a n d ca pa ble of perf or mi n g D o u ble -Bli n d, Place b o -
C o ntr olle d F o o d C halle n ge s (D B P C F C s) i n y o u n g c hil dre n.  
Pea n ut aller gic c hil dre n meeti n g t he f oll o wi n g ke y i ncl usi o n criteria will be selecte d : 
•
P h ysicia n -dia g n ose d pea n ut aller g y or hi g h s us pici o n of pea n ut aller g y as assesse d
b y t he p h ysicia n: c hil d prese nti n g si g ns, s y m pt o ms a n d a me dical a n d/ or a fa mil y
hist or y p utti n g hi m/ her at hi g h ris k of ha vi n g a p ea n ut aller g y a n d / or hist or y of
prese nce o f pea n ut-s pecific I g E a n d/ or p ositi ve S P T;
•
S u bject c urre ntl y f oll o wi n g a strict pea n ut -free diet;
•
Prese nce of pea n ut s p ecific I g E >  0. 7  k U / L;
•
P ositi ve S P T  t o pea n ut wit h a lar gest w heal dia meter ≥ 6  m m ;
•
P ositi ve D B P C F C t o pea n ut  wit h s y m pt o ms meeti n g t he c h alle n ge st o p pi n g criteri a
at a n E D ≤ 3 0 0  m g pea n ut pr otei n .

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
3 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
D uri n g t he ma xi m u m 6 -wee k s cree ni n g peri o d, s u bjects will u n der g o a n e ntr y/scree ni n g 
D B P C F C t o pea n ut t o c o nfir m t heir aller g y t o p ea n ut a n d t o d eter mi ne t heir e ntr y or 
scree ni n g p ea n ut E D. T h e starti n g d ose of t he c h alle n ge will be 1  m g pea n ut pr otei n a n d  
will escalate u p t o t he hi g hest d ose of 3 0 0  m g pea n ut pr otei n. S u bjects w h o react at or 
bel o w t he d ose of 3 0 0  m g pea n ut pr otei n are c o nsi dere d eli gi ble.   
A p ost -treat me nt D B P C F C will be p erf or me d at M o nt h 1 2, starti n g at t h e d ose of 1 m g 
pea n ut pr ot ei n a n d pr ocee di n g u p t o t he hi g hest d ose of 2, 0 0 0 m g pea n ut pr otei n. T he 
pri mar y effic ac y e n d p oi nt of t his p hase III st u d y is t he differe nce bet w ee n t he perce nta ge 
of treat me nt res p o n ders i n t he selecte d D B V 7 1 2  d ose gr o u p ( 2 5 0  µ g) c o m pare d t o t he 
place b o gr o u p at 
M o nt h 1 2, deter mi ne d o n t he pea n ut pr otei n E D d uri n g t he f o o d 
c halle n ge.  
Ot her efficac y ass ess me nts at m o nt hs 3, 6 a n d 1 2, i ncl u de i m m u n ol o gical c h a n ges i n 
pea n ut -s pecific I gE  a n d I gG 4  s u bt y pe a n d S P Ts. 
Ke y ass ess me nts of gl o bal safet y will be p erf or me d at eac h st u d y visit i ncl u di n g s ki n 
o bser vati o n of t he patc h areas of a p plicati o n, vital si g ns, p h ysical e xa mi nati o ns, cli nical 
la b orat or y ass ess me nts. At o pic der matitis will als o be assesse d at baseli ne a n d at m o nt hs 
3, 6 a n d 1 2 usi n g t he S C O Rri n g At o pic  Der matitis ( S C O R A D).  
I n bet w ee n visits, occ ure nce of l ocal s ki n reacti o ns will be s pecificall y s olicite d a n d t heir 
se verit y gra d e d o n a dail y basis b y t he pare nts/ g uar dia ns i n a diar y, f or at least 6  m o nt hs 
f or part A s u bjects, a n d d uri n g t he w h ole treat me nt d urati o n f or part B s u bjects (see 
S ecti o ns 3. 1. 1  a n d 3. 1. 2  f or desi g n of Parts A a n d B). A n y ot her A Es (i ncl u di n g l ocal s ki n 
reacti o ns occ urri n g after t he first 6 m o nt hs of treat me nt f or part A s u bjects), a n d a n y 
c o nc o mita nt me dicati o ns will als o be r e p orte d i n t he diar y b y t he pare nts/ g uar dia ns a n d 
t his will be re vie we d b y t he site me dical staff at eac h s u bject visit. 
At scree ni n g , at M o nt h 1 2  a n d at t he e n d of st u d y visit , t he s u bjects’ p are nts/ g uar dia ns will 
c o m plete q ualit y of life q uesti o n naires ( F o o d Aller g y Q ualit y of Life Q uesti o n naire 
[F A Q L Q ] / F o o d Aller g y I n de pe n d e nt Meas ure-pare nt f or m [F AI M ] / E ur o Q ol -5 D -5 L  
(E Q -5 D -5 L ) [ part B o nl y, see S ecti o n 3. 1. 2  f or desi g n of Part B]) t o assess t he i m pact of 
D B V 7 1 2  1 2 -m o nt h treat me nt o n t heir q ualit y of life.  
T he o verall ma xi m u m st u d y d urati o n f or eac h s u bject is a p pr o xi matel y 6 2  wee ks ( 6 -wee k 
scree ni n g 
peri o d, 
1 2-m o nt h treat me nt 
peri o d 
a n d 
4 -wee k f oll o w -u p 
peri o d).  
T he s u bjects will at te n d a t otal of 1 2 st u d y visits:  
•  3 visits d uri n g t he scree ni n g p hase,  
•  8 visits d uri n g t he treat me nt peri o d ( + 1 a d diti o nal Visit  7 bis f or t he s u bjects i n Part 
A  i n t he e ve nt ualit y of d ose s witc hi n g  f or safet y reas o n. After interi m safet y 
anal ysis, b ot h d os es of D B V 7 1 2  were s h o w n t o be safe, a n d n o d ose s witc hi n g is 
re q uire d. As a c o nse q u e n ce, Visit 7 bis will be n ot a p plica ble; see s ecti o n 3. 1. 1 ), 
•  1  visi t at t he e n d of t he f oll o w-u p peri o d.  
I n a d diti o n, 5 tele p h o ne c o ntacts will be ma de d uri n g t he treat me nt peri o d.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
3 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
After c o m pleti o n of t his 1 2 -m o nt h bli n de d st u d y, eli gi ble s u bjects will  be offere d t he 
o p p ort u nit y t o partici pate i n a n e xte nsi o n st u d y t o recei v e treat me nt wit h D B V 7 1 2  2 5 0  µ g 
f or 2 4 a d diti o nal m o nt hs if t he y were i nitiall y ra n d o mize d i n t he D B V 7 1 2  1 0 0  µ g or 
2 5 0  µ g gr o u ps , or f or 3 6 m o nt hs if t he y were ra n d o mize d i n t he place b o gr o u p . 
3. 1. 1  St u dy p art A  
I n t h e first part, t he safet y of 2 d oses of D B V 7 1 2 , 1 0 0 μ g a n d 2 5 0 μ g was e val uate d wit h 
a d o u ble-bli n d place b o -c o ntr olle d desi g n. Fift y s u bjects were t o be ra n d o mize d eit her i n 
t he place b o ar m or i n t he 2  acti ve ar ms, wit h a 1: 2: 2 r ati o, i.e. 1 0  s u bjects i n t he place b o 
ar m a n d 2 0 s u bjects i n eac h of t he 2 acti ve ar ms, D B V 7 1 2  1 0 0 μ g a n d D B V 7 1 2  2 5 0 μ g.  
A safet y a n al ysis was t o be perf or me d after t he first 3 m o nt hs  of treat me nt t o esti mate t he 
safet y pr ofiles of t he 2 st u die d d oses of D B V 7 1 2 . T he safet y a n d t olera bilit y assess me nt 
was t o be assess e d b y a n i n de pe n de nt Dat a a n d Safet y M o nit ori n g B oar d ( D S M B).  
As a res ult of t his t olera bilit y a n d safet y re vie w, 4 sit uati o ns c o ul d ha ve bee n  e nc o u ntere d:  
1.  B ot h d oses are c o nsi dere d well t olerate d wit h a g o o d safet y pr ofile . T h e 2 5 0 μ g 
d ose w o ul d  t he n be selecte d f or t he c o nti n uati o n of t he st u d y i n Part B. I n p arallel, 
all s u bjects still i n Part A at t he m o me nt of t he decisi o n w o ul d  re mai n u n der t he 
treat me nt ar m t he y were u n der u ntil t heir M o nt h 1 2 treat me nt peri o d: s u bjects 
u n der D B V 7 1 2  2 5 0 μ g d ose i n Part A w o ul d  c o nti n ue wit h t he sa me d ose u p t o 
M o nt h 1 2, s u bjects u n d er D B V 7 1 2  1 0 0 μ g d ose i n Part A w o ul d  c o nti n ue wit h t he 
sa me d ose u p t o M o nt h 1 2, a n d s u bjects u n der pla ce b o w o ul d  re mai n u n der place b o 
u p t o M o nt h 1 2 . T here w o ul d  be n o V isit 7 bis  t o perf or m i n t his sit uati o n.  
2.  T he D B V 7 1 2  2 5 0 μ g d ose has a b etter t olera bilit y /safet y pr ofile t ha n t he 1 0 0 μ g 
d ose. T he 2 5 0  μ g d ose w o ul d  t he n be selecte d f or t he c o nti n uati o n of t he st u d y i n 
Part B. I n p arallel, all s u bjects still i n Part A at t he m o me nt of t he decisi o n w o ul d  
c o me f or t he V isit 7 bis  t o recei ve a ne w treat me nt b o x wit h t he ri g ht treat me nt: 
s u bjects u n der D B V 7 1 2  2 5 0 μ g d ose i n Part A (t he safest d ose) w o ul d  recei ve a 
ne w b o x of D B V 7 1 2  2 5 0 µ g s o t hat t h e y c o ul d  c o nti n ue wit h t he s a me s afe d ose 
u p t o M o nt h 1 2 , s u bjects u n der D B V 7 1 2  1 0 0 μ g d ose i n Part A ( d ose c o nsi dere d 
n ot safe) w o ul d  recei ve a ne w b o x of D B V 7 1 2  2 5 0 µ g s o t hat t h e y were  treate d 
wit h a safe d ose u p t o M o nt h 1 2 a n d s u bjects u n d er place b o w o ul d  recei ve a ne w 
b o x wit h place b o u p t o M o nt h 1 2. It w o ul d ha ve bee n  i m p orta nt t hat all s u bjects 
c o me bac k f or t he  V isit 7 bis  t o kee p t he bli n di n g wit h re gar d t o t he s u bjects w h o  
nee d t o c ha n g e t heir tr eat me nt d ose.  
3.  T he hi g hest d ose of D B V 7 1 2  2 5 0 μ g is n ot c o nsi dere d as ha vi n g a n acce pta ble 
safet y pr ofile a n d o nl y t he D B V 7 1 2  1 0 0 μ g d ose  is c o nsi dere d ha vi n g a fa v ora ble 
safet y pr ofile. T he D B V 7 1 2  1 0 0 μ g d ose w o ul d  b e selecte d f or t he c o nti n uati o n of 
t he st u d y i n Part B. I n p arallel, all s u bjects still i n Part A at t he m o me nt of t he 
decisi o n w o ul d  c o me f or t he  V isit 7 bis  t o recei ve a ne w treat me nt b o x wit h t he 
ri g ht treat me nt: s u bjects u n der D B V 7 1 2  2 5 0 μ g d o se i n Part A ( d ose c o nsi dere d 
n ot safe) w o ul d  recei ve a ne w b o x of D B V 7 1 2  1 0 0  µ g s o t hat t he y were  treate d 
wit h a safe d ose u p u ntil M o nt h 1 2; s u bjects u n der D B V 7 1 2  1 0 0  μ g d ose i n Part A 
(t he safe d os e) w o ul d  recei ve a ne w b o x of D B V 7 1 2  1 0 0  µ g s o t hat t he y c o ul d  
c o nti n ue wit h t he sa me safe d ose u p u ntil M o nt h 1 2, a n d s u bjects u n der place b o 
w o ul d  recei ve a ne w b o x wit h place b o u p u ntil M o nt h 1 2. I n t his sit uati o n t o o, it 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
3 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
w o ul d ha ve bee n  i m p orta nt t hat all s u bjects c o me bac k f or t he V isit 7 bis  t o kee p 
t he bli n di n g wit h re gar d t o t he s u bjects w h o nee d t o c ha n ge t heir treat me nt d ose.  
4.  B ot h d oses are c o nsi der e d b y t he D S M B as ha vi n g a n u nfa v ora bl e safet y pr ofile or 
t olera bilit y. T he st u d y w o ul d  t he n be st o p pe d a n d all s u bjects w o ul d  ha ve t o st o p 
a p pl yi n g t he patc hes a n d w o ul d  be wit h dra w n fr o m t he st u d y.  
He nce, t he 5 0 first s u bjects i ncl u de d i n t he 3 i nitial treat me nt ar ms i n Part A were t o 
c o nti n ue bli n dl y t heir assi g ne d treat me nt u ntil t h e e n d of t he st u d y (i.e. 1 2 m o nt hs of 
treat me nt; Sit uati o n n° 1), or were t o st o p t heir treat me nt pre mat urel y ( Sit uati o n n° 4), or 
were t o s witc h t o t he safest D B V 7 1 2  d ose  ( Situati o n n° 2 or n° 3) , acc or di n g t o t he decisi o n 
or rec o m me n d ati o n ma de b y t he D S M B.  
U p o n re vi e w of t he 3 -m o nt h safet y data of t h e 5 1 s u bjects act u all y ra n d o mize d i n p art A, 
t he D S M B ha d n o safet y c o ncer n a n d c o nsi dere d b ot h d oses as well t olerate d wit h a g o o d 
safet y pr ofile (sce n ari o “1 ” as descri be d a b o v e). As a c o nse q u e nce:  
•  
T he d ose sele cte d f or part B is t he 2 5 0-µ g d ose;  
•  
All s u bjects fr o m part A were t o  re mai n i n t h eir i nitial ra n d o mize d tr eat me nt ar m 
u ntil t he e n d of 1 2 -m o nt h treat me nt ( place b o, D B V 7 1 2  1 0 0  µ g or D B V 7 1 2  
2 5 0  µ g).  
After  all s u bjects fr o m Part A c o m plete t he st u d y, Part A data will be u n bli n de d f or 
a nal ysis.  
3. 1. 2  St u dy p art B  
T he sec o n d p art of t he st u d y ai m s t o assess t he safet y a n d efficac y of t he selecte d d ose 
after 1 2 -m o nt h treat me nt vers us  place b o. T his part was t o be  i nitiate d after t he c h oice of 
t he hi g hest safe d ose u p o n t he D S M B meeti n g . As fr o m pr ot oc ol v 6. 0, t he s electe d hi g hest 
safe d ose f or part B u p o n D S M B rec o m me n dati o n is 2 5 0 µ g. A d diti o nal s u bjects will be 
recr uite d i n t he acti ve selecte d d ose ar m a n d i n t he place b o ar m, t o reac h t h e tar gete d t otal 
n u m ber of s u bjects.  
I n acc or da nce wit h t he calc ulate d sa m ple size f or t his st u d y, a t otal of 3 5 0 a d diti o nal 
s u bjects will be ra n d o mize d i n t he sec o n d part (Part B ) of t he st u d y. T hese s u bjects will be 
ra n d o mize d wit h a 2: 1 rati o i n eit her t he acti ve or place b o ar m, 2 3 3 s u bjects i n t he acti ve 
ar m a n d 1 1 7 s u bjects i n t he place b o ar m.  
A n i nteri m a nal ysis t o e vi de nce t he treat me nt acti vit y o n t he i m m u ne s yste m of 1 t o 3  years 
ol d c hil dre n is pla n ne d after t he first 5 0 s u bjects fr o m part B ha ve recei ve d 6 m o nt hs of 
acti ve treat me nt wit h t h e select e d D B V 7 1 2  d os e  of 2 5 0  µ g  ( Visit 8). 
 
 
 
 
 
 
 
 
  
I n t he sit uati o n w here t h e me dia n relati ve c h a n ge fr o m baseli ne of t he pea n ut s pecific I g G 4 
is e q ual or l o wer t ha n t he me dia n relati ve c h a n ge i n t he place b o gr o u p, t he pre mat ure st o p 
C CI

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
3 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
of t he st u d y f or lac k of e vi de nce of t hera pe utic b e nefit will be c o nsi dere d. T his u n bli n d e d 
data re vie w will be c o n d ucte d b y t he D S M B w h o will be res p o nsi ble of iss ui n g t he 
rec o m me n dati o n t o t he s p o ns or. 
3. 2  
St u d y S c he m atic Di a gr a m  
T he Sc he d ule of visits a n d pr oce d ures is prese nt e d i n pa ge 1 5  a n d t he st u d y desi g n is 
prese nte d i n  Fi g ure  1 . 
Fi g ure  1 : St u d y Desi g n  
 
Base d o n t he I nteri m Safet y A nal ysis, t he D B V 7 1 2  Selecte d d ose f or Part B is 2 5 0  µ g, a n d all s u bjects fr o m 
Part  A are t o c o nti n ue t heir treat me nt u ntil t he e n d of t he st u d y  as per t heir i nitiall y ra n d o mize d ar m ( Place b o, 
D B V 7 1 2  1 0 0  µ g or D B V 7 1 2  2 5 0  µ g). As a c o nse q ue nce, t he V isit 7 bis  f or d ose s witc hi n g i n Part A is n ot 
a p plica ble.  
A b bre viati o ns: D = Da y; D B P C F C  =  D o u ble -bli n d, place b o -c o ntr olle d f o o d c halle n ge;  M = 
M o nt h; 
s =  s u bject; V  =  Visit ; w = we e ks.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
3 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
3. 3  
Criteri a f or E v al u ati o n of t he St u d y  
3. 3. 1  Effic acy Criteri a  
3. 3. 1. 1  Pri m ary Effic acy E n d p oi nt  
T he pri mar y effic ac y e n d p oi nt is t he differe nce bet wee n  t he perce nta ge of treat me nt 
res p o n ders i n t he sele cte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g) c o m pare d t o t he place b o gr o u p 
after 1 2 m o nt hs of E PI T treat me nt . A s u bject is defi ne d as a tr eat me nt res p o n der if: 
•  T he i nitial E D was > 1 0  m g pea n ut pr otei n a n d t h e E D is ≥1, 0 0 0  m g p ea n ut pr otei n 
at t he p ost -treat me nt D B P C F C at M o nt h 1 2 or  
•  T he i nitial E D was ≤1 0 m g pea n ut pr otei n a n d t he E D is ≥3 0 0  m g pea n ut pr otei n 
at t he p ost -treat me nt D B P C F C at M o nt h 1 2.  
3. 3. 1. 2  Sec o n d ary Effic acy E n d p oi nt s 
T he f oll o wi n g sec o n dar y effic ac y e n d p oi nts will be a nal yze d:  
•  C ha n ge fr o m bas eli ne t o M o nt h  1 2  i n C u m ulati ve Reacti ve D ose ( C R D ) i n t he 
selecte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g) vers us  t h e place b o gr o u p;  
•  C ha n ge fr o m baseli ne t o M o nt h  1 2  i n E D  i n t he selecte d acti ve D B V 7 1 2  gr o u p  
( 2 5 0 µ g) vers us  t he place b o gr o u p; 
3. 3. 1. 3  Ot her Effic acy E n d p oi nts  
•  T he perce nta g e  of s u bjects reac hi n g a c u m ulati ve d ose ≥1, 4 4 4 m g pea n ut pr otei n 
at t he p ost treat me nt D B P C F C at M o nt h 1 2 i n t he selecte d acti ve D B V 7 1 2  gr o u p  
( 2 5 0 µ g) vers us  t he place b o gr o u p;  
•  T he perce nt a ge  of s u bjects reac hi n g a c u m ulati ve d ose ≥3, 4 4 4  m g pea n ut pr otei n 
at t he p ost -treat me nt D B P C F C at M o nt h 1 2 i n t he select e d acti ve D B V 7 1 2  gr o u p  
( 2 5 0 µ g)  vers us  t he place b o gr o u p; 
•  T he perce nta ge of s u bjects u nres p o nsi ve (t h ose s h o wi n g n o s y m pt o ms lea di n g t o 
D B P C F C st o p) t o t he hi g hest d ose of pea n ut pr ote i n ( 2, 0 0 0 m g of pea n ut pr otei n)  
i n t he selecte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g)  vers us  t he place b o gr o u p.  
•  T he c ha n ge fr o m baseli n e i n pea n ut -s pecific I g E a n d  I g G 4 at m o nt hs 3, 6 a n d  1 2 
i n t he selecte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g)  vers us  t he place b o gr o u p; 
•  T he c ha n ge fr o m baseli ne i n pea n ut -s pecific I g G 4 at m o nt h 6  i n t he selecte d acti ve 
D B V 7 1 2  gr o u p  ( 2 5 0 µ g)  vers us  t he place b o gr o u p will be t he mai n criteria of t he 
i nteri m 6-m o nt h a nal ysis of t he first 5 0  s u bjects treate d wit h t he selecte d d ose of 
D B V 7 1 2 ; 
•  T he c ha n ge fr o m baseli ne i n pea n ut S P T  a vera ge w heal dia meters at m o nt hs  3, 6 
a n d 1 2 i n t he selecte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g)  vers us  t he place b o gr o u p, 
•  Descri pti o n of t he q u alit y of life q uesti o n nair es ( F A Q L Q/ F AI M)  a n d c ha n g e fr o m 
baseli ne i n F A Q L Q / F AI M sc ores at M o nt h 1 2 i n t he selecte d acti ve D B V 7 1 2  
gr o u p  ( 2 5 0 µ g)  vers us  t h e place b o gr o u p (f or t h os e c o u ntries w here t he tra nslate d 
a n d vali date d q uesti o n naires are a vaila bl e a n d use d).  
Details of t he assess me nt of eac h of t he efficac y e n d p oi nts are pr o vi de d i n Secti o n  6. 1  a n d 
details of t he c orres p o n di n g statistical a nal ysis are pr o vi de d i n Secti o n  8. 5 . 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
3 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
3. 3. 2  S afety Criteri a  
T he f oll o wi n g I M P safet y criteria will be e val uate d: 
•  A Es a n d treat me nt -e mer ge nt a d verse e ve nts ( T E A Es) b y S yste m Or ga n Class 
( S O C) a n d Preferre d Ter ms ( P Ts); 
•  T E A Es b y ma xi m u m se verit y a n d rel ate d ness t o D B V 7 1 2 ; 
•  I n ci de nce, d urati o n a n d ma xi m u m se verit y of l ocal c uta ne o us D B V 7 1 2 -i n d uce d 
A Es as assesse d b y t h e s u bject;  
•  I n ci de nce a n d se verit y of l ocal c uta ne o us D B V 7 1 2 -i n d uce d A Es as ass esse d b y t h e 
I n v esti gat or; 
•  L ocal a d v erse e ve nts of s pecial i nterest ( A E SI s) (i.e., reacti o ns at patc h sites 
p ote ntiall y lea di n g t o s ki n barrier disr u pti o n) a n d s yste mic A E SIs (i.e. a na p h yla xis, 
or s yste mic h y p erse nsiti vit y reacti o ns l ea di n g t o e pi ne p hri ne i nta ke), w ha t e ver t he 
ca usal r elati o ns hi p t o t he I M P; 
•  S A Es b y S O C a n d P Ts, a n d relate d ness t o D B V 7 1 2 ;  
•  La b orat or y d ata, p h ysical e xa mi nati o ns a n d vital si g ns;  
I n a d diti o n, t he f oll o wi n g st u d y pr oce d ure safet y criteria will be e val u ate d: 
•  S y m pt o ms elicite d d uri n g t he e ntr y/scree ni n g 
D B P C F C a n d p ost -treat me nt 
D B P C F C at M o nt h  1 2 b y se verit y;  
•  C ha n ge i n se v erit y of s y m pt o ms elicite d d uri n g t he D B P C F C fr o m bas eli ne t o 
M o nt h  1 2 i n t he selecte d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g)  vers us  t he place b o gr o u p; 
•  S A Es elicite d d uri n g t he e n tr y/scree ni n g D B P C F C a n d p ost-treat me nt D B P C F C at 
M o nt h  1 2.  
Details of t he assess me nt of eac h of t he safet y criteria are pr o vi de d i n Secti o n  6. 2  a n d 
details of t he c orres p o n di n g statistical a nal ysis are pr o vi de d i n Secti o n  8. 6 . 
3. 3. 3  E x pl or at ory Criteri a  
T he f oll o wi n g e x pl orat or y criteria will be e val uate d:  
•  T he c ha n ge fr o m baseli n e i n I g E a n d I g G 4 s pecifi c t o pea n ut pr otei n c o m p o ne nts 
at 3 , 6 a n d 1 2 m o nt hs  f or b ot h D B V 7 1 2  gr o u ps vers us  t he place b o gr o u p; 
•  T he c h a n ge fr o m baseli n e i n t otal I g E at 3, 6 a n d 1 2  m o nt hs f or b ot h D B V 7 1 2  
gr o u ps vers us t he place b o gr o u p;  
•  E n u merati o n a n d c haract erizati o n of reacti o ns tri g gere d b y acci de ntal c o ns u m pti o n 
of pea n ut d uri n g t h e st u d y  a n d anal ysis of “ris k -ta ki n g be ha vi or” of pare nts’ 
s u bjects ( v ol u ntar y pea n ut c o ns u m pti o n) d uri n g t he st u d y; 
•  E pi ge netic m o dificati o ns of t he pr o m oters of s o m e s pecific g e nes;  
•  Se nsitizati o n stat us t o s o me ot her aller g e ns a n d t heir e v ol uti o n o v er t h e st u d y 
peri o d;  
•  S C O R A D e v ol uti o n o ver ti me ; 
 
 
•  Q ualit y of Life a n al ysis usi n g t he E Q -5 D -5 L;  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
3 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•
Bas o p hil acti vati o n test ( B A T) a nal ys es ( U S eli gi ble sites o nl y);
•
De tails of t he assess me nt of each o f t he e x pl orator y criteria are pr o vi de d i n Secti o n 6. 4  
an d details of t he corres p o n di n g statistical a nal ysis are pr o v i de d i n Secti o n 8. 7 . 
3. 4  
J u stific ati o n of t he S t u d y Desi g n 
T his st u d y is de si g ne d t o assess t he efficacy a n d safet y of D B V 7 1 2 a t eit her 1 0 0 µ g or 
2 5 0 µ g i n c hil dre n a ge d 1 t hr o u g h 3 yea rs c o m par e d t o place b o.  
Ra n d o mize d, d o u ble- bli n d an d place b o c o ntr olle d desi g n wa s c h os en t o pre ve nt bias i n 
treat me nt all ocati o n a n d i n t he assess me nt of b ot h safet y a n d efficac y.  
T he use of a placeb o gr o u p i n t his st u d y is j ustified t o o btai n reliable scie ntific e vi de nce 
f or t he e v al uati o n of t his ne w me dici nal pr o d u ct.  
T he first p art of t he st u d y ( Part A) is d esi g ne d t o assess t he safet y a n d t olera bilit y of t h e 
t w o d oses of D B V 7 1 2 patc hes, 1 0 0 µ g or 2 5 0 µ g, i n t his pe diatric p o p ulati o n. At t he ti me 
of  i nitiati o n of E PI T O P E  st u d y, these  t w o D B V 7 1 2  d oses  ha d  bee n  pre vi o usl y  tested  i n 
se veral cli nic al st u dies i n ver y y o u n g c hil dre n: P E P 0 1. 0 9 st u d y wit h c hil dre n fr o m 6 years 
of a ge, A R A C HI L D st u d y wit h c hil dre n fr o m 5 years of a ge, P hase II b VI P E S st u d y wit h 
c hil dre n fr o m 6 years of a ge a n d C o F A R 6 st u d y wit h s u bjects fr o m 4 years of a ge ( 3 4 ). 
N o d ose- de pe n d e nt differe nce re gar di n g t he patc hes l ocal t olera nce was i d e ntifie d o n t he 
pea n ut pr ot ei n d oses ra n g e 5 0 t o 2 5 0 µ g. Hi g h i nci de nces of l o cal s ki n reacti o ns fr o m a n y 
gra de  of se v erit y  ( 1 t o 3) are re p orte d: 9 0 %  t o 9 8 %, wit h ver y  l o w i nci dence  lea di n g t o 
treat me nt disc o nti n uati o n  ( 1. 2 % i n VI P E S S t u d y). N o differe nce  i n l ocal t olera nce was 
i de ntifie d bet wee n t h e a g e gr o u ps.  
Si nce n o c hil dre n less t h a n 4 years ol d was tr eate d b y D B V 7 1 2, t w o d oses were selecte d 
f or t his st u d y:  t he 2 5 0 µ g d ose selecte d as t he t hera pe utic d ose f or c hil dre n a ge d fr o m 6 
t o 1 2 years ol d, a n d t he l o wer d ose of 1 0 0 µ g, t o deal wit h p ossi ble p o or t olera nce t o t he 
2 5 0 µ g d ose i n y o u n ger c hil dre n.  
T he  safet y a n d t olera bilit y  e val uati o n a n d d ose  selecti o n was  t o be pe rf or me d aft er 
3 m o nt hs of acti ve treat me nt. I n t he pre vi o us Vias ki n ®  cli nical st u dies, a vast maj orit y of 
t he l ocal t olera n ce iss ues has  e mer g e d wit hi n  t he first m o nt h  of  treat me nt. T he  an al ysis 
after 3 m o nt hs of treat me nt s h o ul d all o w a relia bl e assess me nt of t he l ocal t olera bilit y a n d 
t o c o nfir m t he t olera nce of t he t w o d oses ( U p o n re vie w of t he 3- m o nt h safet y data, b ot h 
d oses were  c o nsi dere d as safe b y t he D S M B, a n d t he hi g hest [ 2 5 0- µ g] d ose was select e d 
f or Part B). 
Pea n ut aller gic c hil dre n will be ra n d o mize d b ase d o n t he f oll o wi n g ke y i n cl usi o n criteria: 
pea n ut aller g y wit h t he prese nce of p ea n ut-s pecifi c I g E > 0. 7 K U/ L a n d a S P T t o pea n ut 
e xtract wit h t he lar gest w heal dia meter ≥ 6 m m a n d a p ositi ve D B P C F C wit h a pea n ut E D 
≤ 3 0 0 m g of pea n ut pr otei n. 
A D B P C F C will be perf or me d as it is t he “ g ol d sta n dar d” t o dia g n ose a n d assess t he f o o d 
aller gies ( 3 5 ). Si nce it carries a ris k of i n d uci n g p ote ntiall y se vere aller gic reacti o ns, 
s u bjects will  be  a p pr o priatel y selecte d a n d ma na ge d  f or t h e c h alle n ges, base d  o n t heir 
cli nical hist or y a n d pea n ut-s pecific I g E t est res ults.  
C CI

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
3 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
T he E D of pea n ut pr otei n, t hat is t he d ose of pea n ut pr otei n a d mi nistere d t o s u bjects d uri n g 
t he f o o d c halle n ge pr oce d ure, w hic h tri g gers aller gic reacti o ns lea di n g t he c halle n ge st o p, 
is ca p pe d t o 3 0 0 mg f or t he baseli ne f o o d challe n ge,  wit h t he st arti n g  d ose  of 1 m g. 
Alt h o u g h t he a vera ge a m o u nt of pea n ut c o ns u me d i n a n acci de ntal e x p os ure has n ot bee n 
acc uratel y q ua ntifie d, it is ge nerall y belie ve d t o be n o m ore t ha n 1 t o 2 pea n ut ker nels, or 
t he e q ui vale nt of a p pr o xi matel y 3 0 0 t o 6 0 0 m g of pea n ut pr otei n (2 4 , 3 6 , 3 7 ). T h us, t his 
st u d y will e nr oll s u bjects w h o will react at or bel o w 3 0 0 m g pea n ut pr otei n. 
T he  sec o n d part  of  t he st u d y ( Part B)  is desi g ne d t o assess t he effi cac y, t he safet y a n d 
t olera bilit y of t he selecte d  d ose  of D B V 7 1 2  patc he s, 1 0 0 µ g  or 2 5 0 µ g,  i n t his pe diatric 
p o p ulati o n  (as fr o m pr ot oc ol  v 6. 0, t he sel ecte d d ose  f or part  B  u p o n D S M B 
rec o m me n dati o n is 2 5 0 µ g). T he  pri mar y  efficac y en d p oi nt  will  rel y o n  t he differe n ce 
vers us  place b o i n t he res p o nse t o t he pea n ut D B P C F C after 1 2- m o nt hs of treat me nt. 
T he pri mar y e n d p oi nt will be assesse d at M o nt h 1 2 base d o n p ositi ve res ults of pre vi o us 
cli nical st u dies s h o wi n g e vi de nce of dese nsitizati o n wit h pea n ut E PI T after 1 2 m o nt hs of 
treat me nt. 
A n i nteri m a nal ysi s wil l be c o n d uc te d w he n 5 0 s u bjects fro m Pa rt B will ha ve reac he d 6 
m o nt hs of acti ve treat me nt wit h t he acti ve d ose selecte d i n t he Part A. 
T his i nteri m a nal ysis will assess t he prese n ce of a n i m m u n ol o gical reacti o n t o t he pea n ut 
aller ge n e x p os ure t hr o u g h t he s ki n, e vi de nce d b y a n i ncrease of t he pea n ut s pecific I g G 4. 
I n all pre vi o us cli nical st u dies, t he pea n ut s pecific I g G 4 le vels ha ve c o nsiste ntl y rise n fr o m 
baseli ne  i n t he s u bjects treate d b y  D B V 7 1 2  p a tc hes. We  defi ne d  t his assess me nt as a 
st o p pi n g criteri o n, si nce t he a bse nce of pea n ut s pecific I g G 4 i ncreas e w o ul d be a si g n of a 
lac k of e x p os ur e or a l ac k of res p o nse of t h e c hil dre n’s i m m u ne s yste m, c o m pr o misi n g a 
dese nsitizati o n t o pea n ut. 
T he d osi n g d urati o n escalati o n is i ncrease d i n t his st u d y i n y o u n g c hil dre n fr o m a 2- wee k 
peri o d use d i n t he pre vi o us Vias ki n ®  st u dies t o a 4- wee k treat me nt i nitiati o n peri o d i n t he 
prese nt  st u d y. T his e xte nsi o n  is j ustifie d b y t he hi g her  diffic ult y  t o assess t he l ocal 
t olerance  i n y o u n g c hil dre n. A sl o wer  i ncrease i n t he d urati o n of t he d osi n g  escalati o n 
s h o ul d re d uce t he l o cal disc o mf ort f or t he m ost reacti ve s u bjects. 
T he st u d y desi g n f oll o ws t he I nter nati o nal C o nfere nce o n Har m o nizati o n (I C H) g ui deli ne 
o n ge neral c o nsi derati o ns f or cli nical st u dies (3 8 ). 
4  
S T U D Y P O P U L A TI O N  
T he st u d y p o p ulati o n will c o nsist of c hil dre n 1 t o 3 years of a ge wit h pea n ut aller g y. St u d y 
partici pati o n will re q uire c o nse nt fr o m a le gall y a ut h orize d re prese ntati ve. S u bjects m ust 
meet all t he i ncl usi o n criteria a n d n o n e of t he e xcl usi o n criteria.  
All pare nts / g uar dia ns will c o nti n ue wit h t heir us ual pea n ut -free diet a n d la bel rea di n g of 
f o o d pr o d ucts t o a v oi d as m uc h as p ossi ble a n y acci de nt al pea n ut c o ns u m pti o n f or t he 
d urati o n of t he st u d y.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
3 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
4. 1  
I ncl usi o n Criteri a 
S u bjects will be e nr olle d o nl y if t he y meet all of t he f oll o wi n g criteria:  
1.  Male or fe m ale fr o m 1 -3 years of a ge at Visit  1.  
2.  P h ysicia n -dia g n ose d pea n ut aller g y  or hi g h s us pici o n of pea n ut aller g y as assesse d b y 
t he p h ysicia n: c hil d prese nti n g si g ns, s y m pt o ms a n d a me dical a n d/ or a fa mil y hist or y 
p utti n g hi m/ her at hi g h ris k of ha vi n g a p ea n ut aller g y a n d / or hist or y of prese nce of 
pea n ut -s pecific I g E a n d/ or p ositi ve S P T. 
3.  S u bject c urre ntl y f oll o wi n g a strict pea n ut -free diet. 
4.  Si g ne d i nf or me d c o nse nt of pare nt(s)/ g uar dia n(s) of t he c hil dre n a ge d 1 -3  years.  
5.  Pea n ut -s pecific I g E le vel (I m m u n o C A P s yste m) > 0. 7  k U/ L.  
6.  P ositi ve pea n ut S P T wit h a lar gest w h eal dia meter ≥ 6  m m.  
7.  P ositi ve D B P C F C t o pea n ut, wit h s y m pt o ms  meeti n g t he  c h alle n ge st o p pi n g criteri a at 
a n E D ≤3 0 0  m g pea n ut pr otei n.  
8.  Pare nts/ g uar dia ns a n d s u bjects willi n g t o c o m pl y wit h all st u d y re q uire me nts d uri n g 
t heir partici pati o n i n t he st u d y. 
4. 2  
E xcl usi o n Criteri a  
S u bjects will be e nr olle d o nl y if t he y meet n o ne of t he f oll o wi n g e xcl usi o n criteria:  
1.  Pea n ut aller gic s u bjects prese nti n g a me dical hist or y of se vere a na p h yla xis t o pea n ut 
will be e x cl u de d f or t his st u d y. Se vere a n a p h yla xis is defi ne d b y t he Gra d e 3 of t he  
A na p h yla xis Sta gi n g S yste m  (A P P E N DI X 4 ), i ncl u di n g: 
•  Se vere h y p o xia, persiste nt h y p ote nsi o n or m ore t ha n 2 0 % dr o p i n bl o o d press ure , 
ne ur ol o gical c o m pr o mise, or  
•  C ya n osis or S p O 2 ≤ 9 2 % at a n y sta ge, c o nf usi o n, car di o vas c ular c olla ps e, l oss of 
c o nsci o us ness, bra d y c har dia, car diac arrest.  
2.  Se vere reacti o n d uri n g t he e ntr y/scree ni n g D B P C F C, defi ne d as  a n y of t he f oll o wi n g : 
•   N ee d f or i nt u bati o n  
•  H y p ote nsi o n persisti n g a fter e pi ne p hri ne a d mi nistrati o n  
•  N ee d f or t hree d os es or m ore of s yste mic e pi ne p hri ne.  
3.  S u bject wit h reacti o ns t o t he place b o f or m ula d uri n g t he scree ni n g D B P C F C ( wit h 
reacti o ns dee me d t o st o p pi n g t he c halle n ge).  
4.  S u bject s w h o fail t o c o m plete t he e ntr y f o od c halle n ge d ue t o a n y reas o n i ncl u di n g 
clear a versi o n t o t he f o o d f or m ula matri x ,  
5.  S u bject wit h a n y cli nicall y si g nifica nt a b n or malit y i de ntifie d at t he ti me of scree ni n g 
s uc h as maj or i nfa ntile i nfecti o us diseases ( p o x, m easles) w hic h i n t he j u d g me nt of t he 
I n v esti gat or ca n precl u d e safe p artici pati o n or strict c o m plia nce t o t he pr ot oc ol 
pr oce d ures.  S u bjects ca n be c o nsi dere d f or t he st u d y after rec o ver y fr o m t hese 
diseases.  
6.  Viral u p per res pirat or y i nfecti o n or gastr oe nteritis or a n y se vere di sease wit hi n 7  da ys 
of f o o d c halle n g e (c h alle n ge m ust be resc h e d ule d at least after 7  da ys u p o n rec o ver y).  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
4 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
7.  H y perse nsiti vit y t o a n y of t he Vias ki n ®  patc h c o m p o ne nts (e xce pt t o pea n ut pr otei n), 
i ncl u di n g t he a d hesi ve fil m. 
8.  H y perse nsiti vit y t o a n y c o m p o ne nt of t he f o o d c halle n ge f or m ula (e xce pt t o pea n ut 
pr otei n)  or a k n o w n hist or y of a p ple aller g y . 
9.  I n a bilit y t o disc o nti n ue s h ort-acti n g a nti hista mi nes or l o n g -acti n g a nti hista mi nes f or 
t he mi ni m u m was h-o ut peri o ds re q uir e d ( de pe n di n g o n half-li ves a n d s pecifie d i n 
A P P E N DI X 3 ) pri or t o t he s ki n pric k testi n g or t he f o o d c halle n g es.  
1 0.  Dia g n osis of  ast h ma t hat f ulfills a n y of t he f oll o wi n g criteria: 
•  U n c o ntr olle d ast h ma (as per Gl o bal I nitiati ve f or Ast h ma  [GI N A ] lat est 
g ui deli nes ; see A P P E N DI X 8 )  
•  Ast h ma  re q uiri n g c o ntr oller  treat me nt ste p 3 or hi g her (as per GI N A l atest 
g ui deli nes : eit her m o derate [ d o u ble l o w d ose ] of i n hale d c ortic oster oi d , or 
ass ociati o n of i n hale d c ortic oster oi d wit h le u k otrie ne rece pt or a nt a g o nist  [see 
A P P E N DI X 8 ]. L o n g acti n g beta a g o nist s are n ot rec o m me n de d bel o w 5 years )  
•  H ist or y of 2 or m ore s yste mic c ortic oi d c o urses wit hi n t he 3 pre vi o us m o nt hs 
pri or t o Visit 1 or 1  s yste mic c ortic oi d  c o urse wit hi n t he 4 wee ks pri or t o Visit 
1 f or treati n g a di a g n ose d ast h ma.  
•  Pri or i nt u bati o n/ mec ha nical ve ntilati o n f or ast h ma wit hi n o ne year pri or t o 
Visit  1.  
A st h matic s u bjects wit h t he f oll o wi n g treat me nt o pti o ns  are eli gi ble : 
− N o c o ntr oller treat me nt ( GI N A Ste p 1),   
− C o ntr olle r treat me nt m o n ot hera p y  ( GI N A Ste p 2): 
o   wit h dail y or s h ort -ter m c o urse (i nter mitte nt) l o w d ose i n hale d 
c ortic oster oi d , 
o  or wit h le u k otrie ne rece pt or a nta g o nist. 
1 1.  Prese nce of m ore t h a n 3  e pis o des of w heezi n g i n t he past y ear (eac h lasti n g m ore t h a n 
1 0 c o nsec uti ve da ys , a part fr o m c ol ds ) or prese nce of res pirat or y s y m pt o ms  ( w heezi n g, 
c o u g h, hea v y breat hi n g)  bet wee n t hes e e pis o des, a n d/ or ot her re s pirat or y s y m pt o ms 
s ug gesti n g eit her u n dia g n ose d  ast h ma or ast h ma n ot c o ntr olle d b y ast h ma treat me nt 
(as per GI N A lat est g ui deli nes, see A P P E N DI X 8 ).  
1 2.  Ge neralize d der mat ol o gic disease (e. g. se v ere at o pic der matitis, u nc o ntr olle d 
ge neralize d ecze ma, ic ht h y osis v ul garis) e xte n di n g wi del y o n t he s ki n a n d es peciall y 
o n t he bac k wit h n o i ntact z o nes t o a p pl y t he Vias ki n ®  patc hes.  
1 3.  Dia g n osis of mast cell dis or d ers i ncl u di n g mast oc yt osis or urticaria pi g me nt osa as well 
as here ditar y or i di o pat hi c a n gi oe de m a;  
1 4.  Pri or hist or y of a n y i m m u n ot hera p y t o a n y f o o d (e. g. oral i m m u n ot hera p y, s u bli n g ual 
i m m u n ot hera p y, s pecific oral t olera nce i n d ucti o n). S u bjects w h o recei ve d a pri or oral 
i m m u n ot hera p y of l ess t ha n 1 m o nt h-d urati o n w hic h e n de d at least 3  m o nt hs bef ore 
Visit 1 are eli gi ble f or i n cl usi o n.  
1 5.  S u bject recei vi n g or pl a n ni n g t o recei ve a n y i m m u n ot hera p y (aer oaller ge ns, ve n o ms, 
a nti-i nfecti ve …) d uri n g t heir partici pati o n i n t he st u d y. T hese i m m u n ot hera pies m ust 
be disc o nti n ue d at t he ti me of Visit  1.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
4 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
1 6.  S y m pt o matic seas o nal aller gies t hat ma y i nterfere wit h t he c o n d uct of a D B P C F C. 
T hese s u bjects c o ul d be scree n e d at a ti me w he n s uc h aller gies are as y m pt o matic (f or 
e xa m ple o utsi de of t he c ul prit seas o n) ; 
1 7.  S u bject r ecei vi n g β -bl o c ki n g a ge nts, a n gi ote nsi n -c o n verti n g e nz y me i n hi bit ors, 
a n gi ote nsi n -rece pt or bl o c kers, calci u m c ha n nel bl oc kers or tric yclic a nti de pressa nt 
t hera p y. 
1 8.  S u bject w h o recei ve d a nti -t u m or necr osis fact or dr u gs or a nti -Ig E dr u gs (s uc h as 
o maliz u ma b),  a n y bi ol o gic i m m u n o m o d ulat or y t hera p y , c ycl os p ori n e or ot her 
i m m u n os u p pressi ve dr u gs wit hi n o ne year pri or t o Visit 1 or d uri n g scree ni n g peri o d.  
T o pical calci n e uri n i n hi bit ors are per mitte d.  
1 9.  S u bject w h o recei v e d s yste mic l o n g-acti n g c ortic oster oi ds wit hi n 2  wee ks pri or t o 
Visit  1  ( or wit hi n 4 wee ks pri or t o Visit 1 if us e d f or treati n g ast h ma), a n d/ or s yste mic 
s h ort-acti n g /i nter me diate-acti n g c ortic oster oi ds f or m ore t h a n 3 da ys wit hi n 2  wee ks 
pri or t o Visit  1 or d uri n g scree ni n g ( u nless use d f or D B P C F C s y m pt o ms)  (see list of 
c ortic oster oi ds i n A P P E N DI X 2 ). 
2 0.  A n y dis or der i n w hic h e pi ne p hri ne is c o ntrai n dicate d s uc h as c o n g e nital car diac 
malf or mati o n , u nc o ntr olle d h y perte nsi o n, or seri o us ve ntric ular arr h yt h mias. 
2 1.  C urre nt partici pati o n i n a n ot her cli nical trial or partici pati o n i n a n ot her cli nical trial i n 
t he last 3 m o nt hs pri or t o V isit 1,  
2 2.  S u bjects ha vi n g an y  si bli n g alrea d y ra n d o mize d i n a n y st u d y i n v ol vi n g D B V 7 1 2 , 
i ncl u di n g i n t his E PI T O P E st u d y; 
2 3.  S u bjects or pare nt(s)/ g u ar dia n(s) of s u bjects wit h o b vi o us e xcessi ve a n xiet y a n d 
u nli kel y t o c o pe wit h t he  c o n diti o ns of a f o o d c hall e n ge or u na ble t o f oll o w t he pr ot oc ol 
re q uire me nts. 
2 4.  Past or c urre nt disease(s) w hic h, i n t he o pi ni o n of t he I n v esti gat or or t he S p o ns or ma y 
affect t he s u bject’s partici pati o n i n t his st u d y or place t he s u bject at i ncrease d ris k 
d uri n g partici pati o n i n t h e st u d y, i ncl u di n g b ut n ot li mite d t o past or acti ve e osi n o p hilic 
gastr oi ntesti nal dis or der s, a ut oi m m u ne dis or ders, i m m u n o deficie nc y, mali g na nc y, 
u nc o ntr olle d diseases (e. g. h y perte nsi o n, ps yc hiatric, ne ur ol o gic, car di o vasc ular ), or 
ot her dis or ders (e. g. l i ver, gastr oi ntesti nal, ki d ne y, p ul m o nar y diseas e or bl o o d 
dis or ders).  
2 5.  S u bjects bei n g i n a n y relati o ns hi p or de pe n de nc y wit h t he s p o ns or a n d/ or t he 
i n vesti gat or or t he st u d y staff. 
4. 3  
P atie nt Wit h dr a w al a n d Re pl ace me nt  
4. 3. 1  S u bjects  St o p pi n g R ules  
S u bjects m ust be wit h dra w n fr o m t he st u d y tre at me nt u n der t he f oll o wi n g circ u msta nces:  
•  Se vere a n a p h yla xis ( sta g e 3 a na p h yla xis, see A P P E N DI X 4 ) relate d t o Vias ki n®  
patc h a p plicati o n  (eit her pea n ut or place b o patc h); 
•  M ore t ha n 2  i ntra m usc ular e pi ne p hri n e i njecti o ns f or a n A E relat e d t o Vias ki n®  
patc h a p plicati o n ( eit her pea n ut or place b o patc h ), a n d n ot occ urri n g d uri n g t he 
D B P C F C  n or relate d t o a n acci de nt al f o o d aller ge n c o ns u m pti o n.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
4 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
S u bjects ma y be re q uire d t o be wit h dra w n fr o m t he st u d y treat me nt or st u d y after 
disc ussi o n wit h t he I n vesti gat or a n d/ or S p o ns or f or t he f oll o wi n g reas o ns:  
•  A E(s);  
•  Se vere “ mac ul o -pa p ular ras h” or se v ere  ge n eralize d at o pic  “ der matitis”  o utsi de of 
patc h a p plicati o n area, w hic h  faile d t o b e c o ntr olle d b y a de q uat e correcti ve 
treat me nts (i ncl u di n g t o pical c ortic oster oi ds) a n d i n s pite of se veral st u d y tr eat me nt 
i nterr u pti o ns; 
•  At t he discreti o n of t he I n vesti gat or, if s he/ he deci des t hat it is i n t he s u bject’s best 
i nterest t o be wit h dra w n fr o m t he st u d y; 
•  T he s u bject i s u n willi n g t o c o nti n ue i n t he st u d y (c o nse nt wit h dra wal); 
•  Lac k of c o m plia nce wit h pr ot oc ol re q uire m e nts a n d pr oce d ures;  
•  T he s u bject fails t o ret ur n t o t he cli nic f or sc h e d ul e d visits a n d d oes n ot res p o n d t o 
tele p h o ne or writte n atte m pts at c o ntact (l ost to f oll o w -u p);  
4. 3. 2   St u dy St o p pi n g R ules  
T he safet y of D B V 7 1 2  is c o nti n u o usl y m o nit ore d b y t he D B V me di cal m o nit or a n d t he 
i n de pe n de nt D S M B. H o we ver, t he st u d y will be s us pe n de d pe n di n g a n e x pe dite d safet y 
re vie w b y t he i n de p e n de nt D S M B if a n y of t he f oll o wi n g occ ur:  
1.  A n y deat h rel ate d t o D B V 7 1 2  patc h d osi n g;  
2.  M ore t ha n 3 cas es of s e v ere a na p h yla xis (sta ge  3 a na p h yla xis , see A P P E N DI X 4 ) 
relate d t o D B V 7 1 2  pat c h a p plicati o n ( n ot occ urri n g d uri n g t he D B P C F C);  
3.  M ore t ha n 
5  s u bjects re q uiri n g 
m ore t ha n 2  i njecti o ns of i ntras m usc ular 
e pi ne p hri ne f or a n A E rel ate d t o t he D B V 7 1 2  pat c h a p plicati o n , a n d n ot occ urri n g 
d uri n g t he D B P C F C  n or relate d t o a n acci d e ntal f o o d aller ge n c o ns u m pti o n.  
U p o n safet y r e vie w , t he D S M B will rec o m me n d  1 of t he f oll o wi n g o utc o mes:  
•  T he st u d y ma y c o nti n ue wit h o ut m o dificati o n;  
•  T he st u d y ma y c o nti n ue wit h m o dificati o ns as prescri be d b y t he D S M B;  
•  T he st u d y s h o ul d be disc o nti n ue d.  
T he st u d y will be pre mat urel y st o p pe d if t he S p o ns or, Re g ulat or y A ut h orities, or 
I n d e pe n de nt Et hics C o m mittees (I E Cs)/I nstit uti o nal Re vie w B oar ds (I R Bs) f or a n y reas o n, 
re q uest t o st o p t he st u d y. 
4. 3. 3  Re pl ace me nt of Wit h dr a w n S u bjects  
S u bjects w h o wit h dra w pre mat urel y after ha vi n g b ee n ra n d o mize d a n d h a vi n g recei v e d 
at least o ne  d ose of t h e I M P will n ot be re place d.  
4. 3. 4  D at a C ollecti o n a n d F oll o w -u p after Wit h dr a w al  
If a s u bject is pre m at urel y wit h dra w n fr o m t he I M P f or a n y reas o n b ef ore c o m pleti n g all 
st u d y visits, t he I n vesti gat or m ust ma ke e ver y eff ort t o perf or m t he e val uati o ns descri be d 
f or t he Earl y Ter mi nati o n Visit (see Secti o n 7. 2. 1 2 ). T he I n v esti gat or m ust f urt her m ore 
c o m plete all a p pr o priate s u bject diar y a n d e -C R F p a ges, pr o vi di n g t he date a n d e x pla nati o n 
f or t he s u bject’s wit h dra wal/ disc o nti n uati o n. 
W he n i n dicat e d, t he I n vesti gat or m ust 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
4 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
arra n g e f or a p pr o pri ate f oll o w -u p a n d/ or alter nati ve me dical care of t he disc o nti n ue d 
s u bject. 
If t he s u bject fails t o atte n d a s c he d ule d E n d of St u d y Visit, t here will be at least 
t w o d oc u me nte d atte m pts t o c o ntact t h e s u bject’s pare nts/ g uar di a ns via t ele p h o ne a n d 
writte n c o m m u nicati o n. If n o re pl y is  recei ved , t he s u bject will be c o nsi dere d as l ost t o 
f oll o w-u p.  
4. 4  
Pl a n ne d S a m ple Size a n d N u m ber of St u d y Ce nters  
It is pla n ne d t o ra n d o mize 4 0 0  s u bjects at 5 0  t o 7 0  ce nters i n at least 8  c o u ntries  f or t his 
st u d y. I n t he e v e nt t he sa m ple size w o ul d nee d t o be a dj uste d, t he n u m ber of ce nters w o ul d 
be a da pt e d acc or di n gl y. See Secti o n  8. 1 0  f or a disc ussi o n of sa m ple si ze i ncl u di n g a 
p ote ntial reassess me nt . 
I n t he p art A, 5 0 s u bjects will be ra n d o mize d i n t he 3 tr eat me nt ar ms. I n t he p art B, 
3 5 0  s u bjects will be  ra n d o mize d i n t he 2 treat me nt ar ms. 
4. 5  
S u bject  I de ntific ati o n a n d R a n d o miz ati o n 
4. 5. 1  S u bject  I de ntific ati o n 
At  scree ni n g, eac h s u bject will recei ve a u ni q u e, 4-di git, scree ni n g n u m ber. Scree ne d 
s u bjects w h o dr o p o ut of t he st u d y bef ore ra n d o mizati o n will retai n t heir scree ni n g n u m ber. 
T he scree ni n g n u m ber f or eac h s u bject will be a c o m bi nati o n of t he 2 -di git site n u m ber 
pl us t he 2 -di git n u m ber assi g ne d t o t he s u bject acc or di n g t o her/ his c hr o n ol o gical or der of 
scree ni n g at t hat site. T he scree ni n g n u m ber will be use d as t he s u bject i de ntifier 
t hr o u g h o ut t he st u d y.  
4. 5. 2  R a n d o miz ati o n Sc he me  
A n I nt eracti ve We b Res p o nse Syste m  (I W R S) will ra n d o mize s u bjects a n d assi g n t he 
a p pr o priate tr eat me nt n u m ber or kit n u m ber. I n t he part A of t he st u d y, su bjects will be 
ra n d o mize d o n a 2: 2: 1 rati o t o D B V 7 1 2  1 0 0 µ g , D B V 7 1 2  2 5 0 µ g vers us  place b o.  
I n t he p art B, t he ra n d o mizati o n sc he me will be o n a 2: 1 rati o t o D B V 7 1 2  at t he selecte d 
d ose  ( 2 5 0 µ g) . 
Ra n d o mizati o n will be stratifie d b y ce nter a n d ma na ge d ce ntr all y  f or b ot h parts A a n d B. 
T he ra n d o mizati o n sc he me will e ns ure t hat t he rati o of acti ve treat me nt s t o place b o is 
mai ntai ne d  
T he ra n d o mizati o n c o des will be mai ntai ne d b y I W R S. 
Bli n di n g a n d brea ki n g t he bli n d pr oce d ures are descri be d i n Secti o n 5. 4 . 
4. 5. 3  All oc ati o n/ R a n d o miz ati o n of S u bject s t o Tre at me nt 
Ra n d o mizati o n of s u bjects t o treat me nt will o cc ur at Visit 4  aft er all scree ni n g pr oce d ures 
ha ve bee n perf or me d a n d eli gi bilit y f or t he st u d y c o nfir me d. Eac h ra n d o mize d s u bject will 
be assi g ne d b y t he  I W R S a kit n u m ber base d o n a pre-defi ne d al g orit h m/ pre -defi ne d 
ra n d o mizati o n list.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
4 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
5  
I N V E S TI G A TI O N A L M E DI CI N A L P R O D U C T 
5. 1  
I de ntit y 
B ot h, 
D B V 7 1 2  a n d 
Vias ki n ®  place b o 
will 
be 
ma n ufact ure d 
b y 
 
 a n d la bel e d, pac ka g e d a n d release d f or cli nical use 
b y 
, i n acc or da nce wit h the re q uir e me nts of G o o d 
Ma n ufact uri n g Practices.  
5. 2  
A d mi nistr ati o n  
I n t he part A, su bjects were t o be ra n d o mize d t o recei ve eit her acti ve D B V 7 1 2  
c o ntai ni n g  1 0 0  µ g or 2 5 0  µ g of pea n ut pr otei ns or place b o, i n a 2: 2: 1 rati o vers us  place b o. 
T he recr uit me nt w as  t o b e be s us p e n de d after  t he ra n d o mizati o n of 5 0 s u bjects. Safet y dat a 
was t o be c ollecte d after a 3 -m o nt h treat me nt peri o d a n d e v al uate d b y a D S M B t o c o nfir m 
if t he t w o d os es of D B V 7 1 2  are safe i n c hil d re n 1 t o 3 years of a ge. If t he safet y pr ofile of 
D B V 7 1 2  was c o nfir me d i n c hil dre n 1 t o 3 y ears of a ge, r ecr uit me nt was t o res u me i n part 
B. T he ne w e nr olle d s u bj ects are t o recei v e eit her t he select e d D B V 7 1 2  d os e or place b o  t o 
reac h t he sa m ple size re q uire d f or t he efficac y e val uati o n. As fr o m pr ot oc ol v 6. 0, t he 
selecte d d ose f or part B base d o n D S M B rec o m me n dati o n is 2 5 0  µ g  (see Secti o n 3. 1 ). 
D uri n g t he 1 2 -m o nt h bli n de d tre at me nt p eri o d, e xce pt f or t he first 4  wee ks (see b el o w), 
t he Vias ki n®  patc h will b e a p plie d o n t he s ki n f or 2 4  h o urs ( ± 4 h o urs of all o wa nce) e v er y 
da y a n d re n e we d o n a dail y basis, 1  ne w patc h per da y.  
T he l ocati o n of patc h a p plicati o n is t he i nter -sca p ular area of t he bac k of t he s u bjects. 
T here will be 6  z o nes f or a p pl yi n g t he patc h, 3 o n eac h si de of t he s pi ne (see  Fi g ur e  2 ). 
T he first Vias ki n ®  patc h will be a p plie d o n z o ne  1, t he sec o n d o n z o ne  2 (after re m o val of 
t he first pat c h), a n d s o f ort h, u ntil all 6 z o nes h a ve bee n us e d. After z o ne  6, d osi n g restarts 
wit h z o ne  1 a n d c o nti n ues se q ue ntiall y, as descri b e d.  
C CI
C CI

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
4 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
Fi g ure  2 : Sc he m atic Re prese nt ati o n of Vi as ki n®  P atc h A p plic ati o n o n t he B ac k of t he S u bjects  
T o e ns ure a n e n ha n ce d l o cal t olera n ce at t he i nitiati o n of Vias ki n ®  patc h t reat me nt, t he 
d urati o n of a p plicati o n of t he Vias ki n ®  patc h will be pr o gressi vel y i ncreas e d as f oll o ws: 
•
D uri n g t he first wee k (fr o m Da y  1 t hr o u g h Da y  7), t he patc hes will be a p plie d f or
2  h o urs ( ± 3 0  m in utes ) e ver y da y;
•
D uri n g t he sec o n d w ee k (fr o m Da y  8 t hr o u g h Da y  1 4), t h e patc hes will be
a p plie d f or 4  h o urs ( ± 3 0  m in utes ) e ver y da y;
•
D uri n g t he t hir d wee k (fr o m Da y  1 5  t hr o u g h Da y 2 1 ), t he patc hes will be a p plie d
f or 8  h o urs ( ± 1  h o ur ) e v er y da y;
•
D uri n g t he f o urt h w ee k (fr o m Da y  2 1  t hr o u g h Da y 2 8 ), t he patc hes will be
a p plie d f or 1 2  h o urs ( ± 2  h o urs ) e ver y da y;
•
Fr o m t he fift h w ee k o n war ds ( Da y  2 9 ), t he pat c hes will be a p plie d f or t he e ntire
2 4  h o urs  ( ± 4  h o urs ) e v er y da y.
S o me s u bjects ma y ha ve a hi g her s ki n reacti vit y at t he i nitiati o n of t he treat m e nt, lea di n g 
t o u nc o mf orta ble se nsati o ns or i nte nse pr urit us. T hese l ocal reacti o ns us uall y decrease o v er 
ti me as far as t he tr eat m e nt c o nti n ues. H o we v er, s o me s u bjects ma y ha ve diffic ulties i n 
beari n g t hese u n c o mf orta ble se nsati o ns or i nte nse pr urit us. I n  t hese s u bjects, it is 
rec o m me n de d t o re m o ve t he patc h as s o o n as t he s u bject starts c o m plai ni n g, t o clea n a n d 
t o was h t he s ki n area a n d if necessar y use t o pical c ortic oster oi ds. T he ne xt patc h will b e 
a p plie d t he f oll o wi n g d a y o n t he n e xt s ki n z o n e as s c he d ule d. T h e d urati o n of patc h 
a p plicati o n c o ul d us uall y be i ncrease d wit h ti me, u p t o t he fi nal tar gete d 2 4 h o urs of patc h 
a p plicati o n; t heref ore, t h e tre at me nt i niti ati o n peri o d c o ul d be l o n ger t h a n t he 4  wee ks 
pr o p ose d a b o ve , u ntil t olera nce t o Vias ki n ®  patc h tr eat me nt is ac hie ve d per t he 
I n v esti gat or’s ass ess me nt. 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
4 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
If p ossi ble, t he pare nts or g uar dia ns s h o ul d ta ke a d va nta ge of t he c hil d bat h /s h o wer ti me 
t o c ha n ge t he patc h. T h e pre vi o us Vias ki n®  pat c h s h o ul d be re m o ve d j ust bef ore t he 
bat h /s h o wer, a n d t he ne w Vias ki n®  patc h s h o ul d be a p plie d a fe w mi n utes after t he 
bat h /s h o wer a n d after dr yi n g t he s ki n caref ull y. A p plicati o n of t he Vias ki n ®  patc h at a 
si milar ti me f or eac h dail y a p plicati o n ( m or ni n g or e ve ni n g) is rec o m me n d e d. If t he c hil d 
d oes n o t bat he or s h o wer dail y or at t he sa me ti me dail y, it is rec o m me n de d t hat t he z o ne 
w here t h e patc h will be a p plie d be cl ea ne d wit h a m oist dis p osa ble na p ki n or tiss ue a n d 
drie d pri or t o a p plicati o n.  
I n case t he Vi as ki n®  patc h c o mes off, it s h o ul d be i m me di atel y discar de d  a n d t he s ki n 
clea ne d wit h a m oist dis p osa ble na p ki n or tiss ue . A Vias ki n®  patc h m ust n ot be re -a p plie d.  
A ne w p atc h ca n be a p pli e d t he sa me da y t o re place t he pre vi o us patc h t hat ca me off o nl y 
if t hat patc h ca me off wit hi n 2 h o urs after bei n g a p plie d  ( o nl y o nce). C o nse q ue ntl y , n o 
ne w p atc h s h o ul d be a p plie d t he s a me d a y if t he pre vi o us p atc h c a me off m ore t h a n 
2  h o urs after bei n g a p plie d.  I n t hat case, a ne w p atc h will be a p plie d o n ce 2 4 h o urs ha ve 
passe d si nce t h e i nitial patc h (t he o ne t h a t ca me off) was a p plie d. After t he Vias ki n®  patc h 
c o mes off, or after re m o vi n g a Vias ki n ®  patc h t o a p pl y a ne w o ne, it is rec o m me n de d t hat 
t he s u bjects’ pare nts/ g uar dia ns wi pe  t he z o ne wit h a m oist dis p osa ble na p ki n or a m oist 
dis p osa ble tiss ue a n d t he n was hes h er/ his ha n ds t o pre ve nt acci d e ntal ma n ual tra ns missi o n 
of pea n ut pr otei n.  
T he first a p plicati o n of t he Vias ki n ®  patc h will b e d o ne  i n a h os pital setti n g at t he st u d y 
site, wit h t he a p pr o priate e mer ge n c y treat me nt (e pi ne p hri ne) a n d res uscitati o n e q ui p me nt 
rea dil y a vaila ble. Aft er t he first a p plicati o n of t he Vias ki n ®  patc h at t he st u d y site, all 
s u bjects will be o bser ve d f or at least 3  h o urs  t o c hec k a n d gra de a n y reacti ons u n der or 
ar o u n d t he p atc h bef ore bei n g disc har ge d.  I n case of s yste mic reacti o n or se vere 
a p plicati o n site reacti o n f oll o wi n g t he first patc h a p plicati o n, t he ne xt patc h a p plicati o n 
s h o ul d be p ost p o ne d u ntil t he reacti o n res ol ves a n d s h o ul d be perf or m e d  at t he st u d y site. 
Si milarl y, s u bjects will be o bser ve d f or at least 3 h o urs bef ore bei n g disc h ar ge d.  
O n Da y  4 , Da y  2 2, M o nt h 2 s pecific p h o ne c o nt acts will be ma de t o t he pare nts/ g uar dia ns 
t o assess t he safet y of patc h a p plicati o ns o n t he bac k d uri n g t h e i ncrease weari n g ti me 
peri o d  (4 first wee ks). If re q uire d, t he s u bjects ma y c o me t o t he site s o o ner t ha n pla n ne d 
t o be see n a n d e val uate d b y t he I n vesti gat or. 
Of n ote, t he rec o m me n d e d d urati o n of d ail y D B V 7 1 2  patc h a p plicati o n is 2 4  h o urs of 
a p plicati o n per da y. H o we ver, a n y dail y d urati o n of D B V 7 1 2  patc h a p plicati o n of 
2 4  h o urs  ±  4  h o urs will be all o we d.  
5. 2. 1  A dj ust me nt of Vi as ki n ®  P atc h A p plic ati o n i n C ase of L oc al or Syste mic 
Re acti o ns  
W he n s u bjects are u n a ble t o  a p pl y t he D B V 7 1 2  p atc h f or t he rec o m me n de d d urati o ns as 
descri be d a b o v e beca us e of l ocal i nte nse or se vere reacti o ns, u n der or a dj ace nt t o t he patc h 
site, t he patc h s h o ul d be re m o ve d i m me diatel y, t he site of a p plicati o n wi pe d wit h a m oist 
dis p osa ble tiss u e a n d a t o pical c ortic oster oi d me di cati o n mi g ht be t o picall y a p plie d t o treat 
t he reacti o n. T he pare nts/ g uar dia ns s h o ul d ta ke a p h ot o of t he bac k of t he s u bject t o 
d oc u me nt h o w i nte nse a n d e xte n de d t he l ocal reacti o ns are. I n t he s pecific case of l ocal 
i nte nse or se vere reacti o ns, it is ma n dat or y t hat t he ne xt Vias ki n ®  patc h is a p plie d o nl y t he 
ne xt da y o n t he ne xt z o n e; n o ot her Vias ki n ®  patc h m ust be a p plie d t he sa me da y. I n case 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
4 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
of re -a p peara n ce of t he l ocal i nte nse or se v ere reacti o ns after a p plicati o n of t he ne xt p atc h 
t he f oll o wi n g da y, t he sa me pr ocess is re peate d e v er y da y.  
T he dail y d urati o n of Vias ki n ®  patc h a p plicati o n s h o ul d be a dj uste d/r e d uce d as n ecess ar y, 
a n d s u bjects ma y n ee d m ore t ha n t he 4 wee ks  pre vi o usl y descri be d b ef ore t he y ca n a p pl y 
a n d t olerate t he Vias ki n ®  patc h f or t he f ull 2 4  h o urs dail y.  
I n case of a n y s us p ect e d s yste mic reacti o ns relate d t o patc h a p plicati o n (i ncl u di n g 
c uta ne o us reacti o ns dista nt fr o m t he sites of patc h a p plicati o n), t he Vias ki n ®  patc h s h o ul d 
be  re m o ved i m me diatel y . A treat me nt ca n be gi ve n t o treat t he s yste mic or l ocal reacti o ns: 
t o pical c ortic oster oi ds, a nti hista mi nes , a d diti o nal oral c ortic oster oi ds or si milar a nti -
aller gic dr u gs, as dee me d necessar y b y t he I n vesti gat or. T he ne xt p atc h will o nl y be 
a p plie d t he f oll o wi n g d a y.  
T he s u bject’s pare nts/ g u ar dia ns will be i nstr ucte d t o c o ntact t he I n vesti g at or i n case of 
s yste mic or i nte nse or se v ere l ocal reacti o ns lasti n g f or m ore t h a n 1 da y or a n y u ne x pecte d 
reacti o ns d uri n g t h e treat me nt peri o d, i n partic ular i n case of a p p eara nce of vesicles u n der 
t he Vias ki n®  patc h or cl ose t o t he Vias ki n ®  patc h site a p plicati o n. It is t he n rec o m me n de d 
t hat t he pare nts/ g uar di a n ta ke a p h ot o of t he bac k of t he s u bj ect t o d o c u me nt t hese i nte nse 
or se vere reacti o ns.   
A p pea ra nce of a n y vesicl es ( gra d e 4) or ulcerati ve s ki n lesi o ns or a n y ot her si g nifica nt s ki n 
lesi o n see n u n der t he p at c h w hile t he p atc h is still a p plie d o n t he s ki n or u p o n re m o val of 
t he patc h w hic h c o ul d p ote ntiall y lea d t o s ki n barrier disr u pti o n at sites of Vias ki n ®  patc h 
a p plicati o ns will be ca uti o usl y ma na ge d a n d f oll o w -u p.  
C hil dre n’s pare nts or g uar dia ns will be i nstr ucte d t o ta ke a p h ot o gra p h i n case of 
a p peara nce of a n y vesicl es or ulcerati ve s ki n lesi o ns. I n t hese rare s pecific cases, s u bjects 
s h o uld tra nsie ntl y disc o nti n ue patc h a p plicati o n a n d ret ur n t o t he site f or e val uati o n a n d 
treat me nt of t he w o u n d e d area, as well as f or t h e ne xt p atc h a p plicati o n a n d a d e q uate 
e val uati o n a n d treat me nt of t he w o u n de d z o ne.  
U p o n re -a p plicati o n of t he ne w patc h, t he s u bject s h o ul d re mai n at t he site f or 1 h o ur bef ore 
bei n g disc har ge d. T h e site m ust c o ntact t he s u bject’s pare nts/ g uar dia ns b y p h o ne t he da y 
after t his visit t o e ns ure t hat n o a d diti o nal l ocal blisters or vesicles de vel o pe d a n d t o 
c o nfir m t hat t he trea t me nt ca n c o nti n ue n or mall y. T he z o ne wit h vesicles or se vere lesi o ns 
s h o ul d n ot be use d f or patc h a p plicati o n u ntil it has c o m pletel y heale d.  
5. 2. 2  S afety Prec a uti o n I nf or m ati o n  
A leafl et wit h safet y preca uti o ns f or usi n g t he Vias ki n ®  patc h a n d i nstr ucti o ns t o f oll o w i n 
case of a n y safet y iss ue will be gi ve n t o eac h pare nt’s s u bject. T his safet y leaflet will 
s pecif y at least t he f oll o wi n g i nf or mati o n: 
1.  I nstr u cti o ns a n d pr oce d ures t o a p pl y t he patc h safel y a n d c orrectl y i n t he bac k of 
t he s u bject; 
2.  Necessit y t o cal l t he i n vesti gati ve site staff i n case of i nte ns e or se v ere l ocal 
reacti o ns lasti n g f or m ore t ha n 1 d a y or a n y u ne x pecte d reacti o ns d uri n g t he 
treat me nt peri o d, i n parti c ular a n y a p peara nce of vesicles/ blisters u n der t h e patc h 
or cl ose t o t he area of p atc h  a p plicati o n a n d a rec o m me n dati o n t o ta ke p h ot os of 
t he site of a p plicati o n t o d oc u me nt s uc h a sit uati o n; 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
4 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
3.  Necessit y t o call t he i n vesti gati o n site staff i n case of occ urre n ce of c hic ke n p o x or 
measles. At t he sa me ti m e, i nterr u pti o n of patc h a p plicati o n u n til rec o ver y; 
4.  I n cas e of acti ve ecze ma e xte n di n g o n t he bac k of t he c hil d: st o p a p pl yi n g t he patc h 
u ntil rec o ver y fr o m t he acti ve ecze ma o n t he b ac k;  
5.  A na p h yla xis E mer ge nc y Acti o n Pla n i n case of a s us pecte d a na p h ylactic reacti o n 
a n d h o w t o a d mi nister t he e pi ne p hri ne a ut o -i nject or t o ra pi dl y treat t he reacti o n; 
6.  S u bject st o p pi n g r ules (s u bject are c o nse q u e ntl y wit h dra w n):  
a. Se vere a na p h yla xis (st a ge 3 a n a p h yla xis, see A P P E N DI X 4 ) relate d t o 
Vias ki n ®  patc h a p plicati o n (eit her pea n ut or place b o patc h);  
b.  M ore t ha n 2 i ntra m usc ular e pi ne p hri n e i njecti o n s f or a n A E relat e d t o Vias ki n®  
patc h a p plicati o n (eit her pea n ut or pla ce b o patc h ), a n d n ot occ urri n g d uri n g t he 
D B P C F C  n or relate d t o a n acci de nt al f o o d aller ge n c o ns u m pti o n . 
5. 3  
P ac k a gi n g, L a beli n g a n d St or a ge  
T he I M P, Vias ki n®  patc h (acti ve a n d place b o), is ma n ufact ure d u ntil pri mar y pac ka gi n g 
sta ge ( patc h i n p o uc h) b y  
. Eac h p o u c h will be la bele d a n d pac ka g e d b y 
 i n acc or da n ce wit h G o o d Ma n ufact uri n g Practices a n d 
a p plica ble l ocal re g ulat or y re q uire me nts. T he la bele d treat me nt b o xes will be dis pe nse d t o 
s u bjects at eac h visit, wit h e n o u g h q u a ntit y of Vias ki n®  patc hes t o c o ver t he peri o d 
bet wee n 2  c o nsec uti ve visits.  
T he la bele d a n d pac k a ge d I M P m ust be st ore d i n acc or da nce wit h t he S p o ns or’s 
i nstr ucti o ns (bel o w 2 5° C [ 7 7° F] a n d s h o ul d n ot be fr oze n ). S hi p me nts fr o m de p ots t o 
cli nical sites will be perf or me d at refri gerate d te m perat ure b et wee n 2° C t o 8° C [ 3 6° F t o 
4 6 F] wit h a te m perat ur e m o nit ori n g de vice.  
U p o n recei pt of a s hi p me nt re q uest via I W R S, t he I M P will be s hi p pe d t o t he cli nical site. 
T he site p har m acist or a n y ot her staff me m ber d esi g nate d f or t his tas k will recei ve a n d 
st ore t he I M P u ntil t he ti me of dis pe nsi n g. U ntil dis pe nse d b y t he I n vesti gat or t o t he 
s u bjects, t he I M P will be st ore d i n a s ec urel y l oc ke d area, accessi ble t o a ut h orize d 
pers o n nel o nl y. At t he e n d of t he st u d y, or at ti mes desi g nate d b y t he S p o ns or, a n d aft er 
c o m plete acc o u nta bilit y, t he site p har macist or t he desi g nate d pers o n will be res p o nsi ble 
f or pre pari n g t he ret ur n of t he use d ( partiall y) a n d  u n use d I M P t o t he I M P distri b ut or. 
Destr ucti o n of I M P o n -site is n ot all o we d.  
5. 4  
Bli n di n g a n d Bre a ki n g t he Bli n d  
T he st u d y will be perf or me d i n a d o u ble -bli n d ma n ner. Acti ve a n d place b o D B V 7 1 2  
patc hes will be s u p plie d i n i de ntical p o uc hes a n d will be si milar i n p h ysical a p peara n ce, 
t here b y e n a bli n g d o u ble-bli n d c o n diti o ns.  
T he treat me nt c o des will be i nte grate d t o t he I W R S. I n vesti gat ors h a ve t he p ossi bilit y t o 
u n bli n d a treat me nt via t he I W R S i n s o me s pecific cas es (as det aile d b el o w). F urt her 
i nstr ucti o ns f or e mer g e nc y c o de brea k will be pr o vi de d i n a se parate I W R S User G ui de .  
T he st u d y bli n d s h o ul d n ot be br o ke n e xce pt i n a me dical e mer g e nc y ( w here k n o wle d ge 
of t he I M P recei ve d w o ul d affect t he treat me nt of t he e mer g e nc y) or d ue t o a re g ulat or y 
re q uire me nt (f or e xa m ple f or S us pecte d U ne x pecte d S eri o us A d verse R eacti o ns 
C CI
C CI

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
4 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
[ S U S A R]). T he bli n d will o nl y be br o ke n at t he  discreti o n of t he I n vesti gat or. All  
u n bli n di n g e ve nt s will be rec or de d a n d re p orte d b y t he I W R S t o t he Me dical M o nit or a n d 
t he S p o ns or. I n cas e of I W R S fail ure, a bac k u p s yste m is o perate d 2 4 h o urs e ver y da y of 
t he year e na bli n g u n bli n di n g of treat me nt by calli n g t he I W R S h ot li ne ( Please refer t o 
I W R S U ser G ui de) . 
If t he bli n d is br o ke n, t he date, ti me, a n d reas o n m ust be rec or de d i n t he s u bject’s s o urce 
d oc u me nts, i n t he electr o nic Case Re p ort F or m ( e-C R F ) a n d a n y ass ociate d A E m ust be 
re p orte d.  
If a s u bject ( pare nts/ g uar dia ns), is u n bli n de d, t his m ust be liste d as maj or pr ot oc ol 
de viati o n a n d  t he c o n cer ne d s u bject(s)  will be wit h dra w n fr o m t he st u d y.  
Seri o us u ne x pecte d s us p ecte d a d verse reacti o ns, w hic h a re s u bj ect t o e x pe dite d re p orti n g, 
will be u n bli n de d bef ore s u b missi o n t o t he Re g ulat or y A ut h orities.  
T he o verall ra n d o mizati o n c o de will be br o ke n o nl y f or data a nal yses  of st u d y Part A or 
Part B, as f oll o ws : 
•  Part A data will be u n bli n de d w he n t he last s u bject fr o m Part A will ha ve 
c o m plete d t he st u d y, a n d 
•  Part B data will be u n bli n de d w he n t h e last s u bject fr o m Part B will ha ve 
c o m plete d t he st u d y.  
U n bli n di n g will be perf or me d w he n all fi nal cli nical data ha ve bee n e ntere d i nt o t he 
data base a n d all d ata q ueries ha ve bee n res ol ve d, t he e -C R F h as bee n si g n e d a n d l oc ke d, 
a n d t he assi g n me nt of s u bjects t o t he a nal ysis p o p ulati o ns  has bee n c o m plete d.  
5. 5  
Dr u g Acc o u nt a bilit y  
T he I n vesti gat or is res p o nsi ble f or mai ntai ni n g acc urate I M P acc o u nta bilit y rec or ds 
t hr o u g h out t he st u d y. Eac h site will ha ve t o c o m plete a site I M P acc o u nta bilit y l o g a n d a n  
i n di vi d ual I M P acc o u nt a bilit y l o g f or eac h s u bject. T hese rec or ds s h o ul d i ncl u de t he 
a m o u nts a n d dates t hat I M P s u p plies were recei ve d o n-site, dis pe nse d t o t he s u bject, 
retur ne d b y t he s u bject, a n d ret ur ne d t o I M P distri b ut or ( or destr o y e d o n -site, if 
a p plica ble).  
Eac h dis pe nsi n g of I M P will be perf or me d vi a I W R S.  
5. 6  
C o m pli a nce  
It is t he I n v esti gat ors’ res p o nsi bilit y t o e ns ure t hat s u bjects’ pare nts/ g uar di a ns are c orrectl y 
i nstr ucte d o n h o w t o st ore a n d a d mi nister t he I M P. Rec or ds of I M P us e d a n d i nter vals 
bet wee n visits will be ke pt d uri n g t he st u d y. Dr u g acc o u nta bilit y will be m o nit ore d b y 
C R O  site m o nit or d uri n g site m o nit ori n g visits a n d at t he c o m pleti o n of t he st u d y. S u bje cts’ 
pare nts/ g uar dia ns will be as ke d t o ret ur n t heir u n use d I M P ( b o xes a n d patc hes ) w he n t he y 
c o me bac k f or t heir st u d y visits. All u n use d I M P (b o xes a n d patc hes ) s h o ul d be ret ur ne d 
t o t he I M P distri b ut or. T he I M P s h o ul d be dis pe nse d b y t he I n v esti gat or, or b y a q ualifie d 
i n di vi d ual u n der t he I n vesti gat or’s s u per visi o n. A n u p-t o-date dr u g acc o u nta bilit y rec or d  
m ust be mai ntai ne d (see Secti o n 5. 5 ). 
At eac h visit, pri or t o dis pe nsi n g t he I M P, pre vi o usl y dis pe nse d I M P will be retrie ve d b y 
t he I n v esti gat or a n d c o m plia nce assesse d. C o m plia nce at eac h visit is t o be calc ulate d 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
5 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
ta ki n g i nt o acc o u nt t he t otal n u m ber of patc hes a p plie d si nce t he last visit vers us  t he 
n u m ber of da ys i n t hat p eri o d of ti me. S u bjects e x hi biti n g p o or c o m plia nce ( bel o w 8 0 %) 
at a n y s pecific ti me p oi nt d uri n g t he treat me nt peri o d s h o ul d be c o u nsele d o n t he 
i m p orta nce of g o o d c o m plia nce t o t he st u d y d osi n g re gi me n. 
S u bjects w h o are persiste ntl y n o n -c o m plia nt will be wit h dra w n fr o m t he st u d y  (see Secti o n 
4. 3 ). 
5. 7  
Pri or a n d C o nc o mit a nt Me dic at i o n 
A n y me dicati o n ta ke n b y t he s u bject ot her t ha n t he I M P, i ncl u di n g her bal a n d ot her 
n o n -tra diti o nal re me dies, is c o nsi dere d as c o nc o mita nt me dicati o n. A n y me dicati o n use d 
i n t he last 6 m o nt hs or b ei n g a d mi nistere d at t he ti me of scree ni n g is c o nsi dere d as pri or 
me dicati o n.  
At scree ni n g, c hil dre n pare nts or g u ar dia ns will be as ke d w hat m e dicati o ns t he c hil d has 
bee n ta ki n g d uri n g t he l ast 6  m o nt hs. At eac h s u bse q ue nt st u d y visit, c hil dre n pare nts or 
g uar dia ns will be as k e d w hat c o nc o mita nt me dicati o ns t h e c hil d is c urre ntl y ta ki n g. All 
c o nc o mita nt a n d pri or m e dicati o ns m ust be rec or de d i n t he e -C R F.  
T he f oll o wi n g i nf or mati o n m ust be rec or de d i n t he e -C R F f or eac h pri or a n d c o nc o mita nt 
me dicati o n: ge neric na m e, r o ute of a d mi nistrati o n, start date, st o p dat e, d osa ge, t otal dail y 
d ose, a n d i n dicati o n. A n y c ha n ges i n t he d osa ge or re gi me n of a c o n c o mita nt me dicati o n 
m ust be rec or de d i n t he e -C R F . 
Of n ote, pri or or c o nc o mita nt me dicati o n prescri b e d t o a s u bject b ut n ot act uall y ta ke n or 
a d mi nistere d s h o ul d n ot be re p orte d i n t he e-C R F, s uc h as t he e pi ne p hri n e a ut o -i nject or 
prescri be d f or use i n case of a na p h yla xis b ut ne v er i njecte d i ntra m usc ularl y.  
5. 7. 1  Per mitte d C o nc o mit a nt Me dic ati o n  
A p plicati o n of a t o pical c ortic oster oi d t o treat a n y l ocal c o n diti o n ( ecze m at o us lesi o ns, 
pr urit us, e de ma, et c.) is p er mitte d .  
F or l oc al reacti o ns t o t he Vias ki n ®  patc h, a t o pical me dicati o n ( oi nt me nt, gel, crea m) wit h 
0. 5 % t o 1 % h y dr oc ortis o ne or e q ui vale nt will be distri b ute d t o eac h ra n d o mize d s u bject at 
disc har ge o n Da y  1. I n case t he 1 % h y dr oc ortis o ne t o pical me dicati o n is n ot s ufficie nt t o 
treat t he l o cal reacti o n, a t o pical me dicati o n c o nt ai ni n g a m ore p ote nt c ortic oster oi d ca n 
be pres cri be d a n d l oc all y a p plie d  i n acc or da nce t o t he l ocal a p pr o ve d i n dicati o n of eac h 
pr o d uct f or t he s u bject a g e class . 
Oral a nti hista mi nes or oral c ortic oster oi ds are all o we d t o treat c o n diti o ns deter mi ne d as 
bei n g aller gic reacti o ns a n d s h o ul d be rec or de d as c o nc o mita nt me dicati o ns. T hese 
treat me nts s h o ul d be li mite d i n d urati o n a n d st o p pe d as s o o n as t he c o n diti o n has res ol ve d. 
T he I n vesti gat or will deter mi ne t he best c h oice of treat me nt, t he d ose a n d t he re gi me n 
acc or di n g t o t he s u bject’s a ge, a n d t h e t y pe a n d t he de gree of s e verit y of t he reacti o ns. 
Cetirizi ne is rec o m me n d e d as t he  oral a nti hista mi ne of c h oice.  
Oral a nti hista mi nes or oral c ortic oster oi ds m ust be was he d o ut f or t he mi ni m u m peri o d of 
ti me pri or t o t he s ki n pric k testi n g or t o t he f o o d c halle n ges  (see Secti o n 5. 7. 2  f or detail o n 
was h -o ut peri o ds) .  
I ntr a m usc ularl y i njecta bl e e pi ne p hri n e (a ut o-i nject or E pi Pe n ®  or a n y ot h er tra d e na me 
a vaila ble at t he ri g ht d osa ge i n t he differe nt c o u ntries) will be distri b ute d t o eac h pare nt or 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
5 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
g uar dia n at disc har ge o n Da y  1 t o be use d i n case of s y m pt o ms of a n a p h yla xis. T he 
I n v esti gat or will e x plai n t o t he pare nts/ g uar dia ns w he n a n d h o w t o i nject t he e pi ne p hri ne 
acc or di n g t o t he A n a p h yla xis E mer ge nc y Acti o n Pla n. T he i ntra m usc ularl y i njecta ble 
e pi ne p hri ne will be re pl ace d if use d or if it e x pires. A n y use of i njecta bl e e pi ne p hri n e 
s h o ul d be rec or de d as a c o nc o mita nt me dicati o n. 
All ot her treat me nts prescri be d b y t he I n vesti gat or or a n y ot her p h ysicia n t o treat a n y 
c o n diti o ns are als o per mitte d. Me dicati o ns t hat are n ot n ote d i n t he Secti o n  5. 7. 2  are als o 
per mitte d.  
5. 7. 2  Pr o hi bite d Pri or a n d C o nc o mit a nt Me dic ati o n  
Pr o hi bite d pri or a n d c o nc o mita nt me dicati o ns as o utli ne d i n t he e xcl usi o n criteria ( Secti o n 
4. 2 ) are t h e f oll o wi n g: 
•  M o derate dail y d ose of  i n hale d c ortic oster oi d  or hi g her (i.e. ≥2  ti mes “l o w d ose”; 
see A P P E N DI X 8 ), treat me nt wit h a c o m bi nati o n t hera p y of i n hal e d c ortic oster oi d 
wit h a l o n g -acti n g i n hal e d β 2 -a g o nist , or wit h a c o m bi nati o n t hera p y of i n hale d 
c ortic oster oi d a n d le u k otrie ne rece pt or a nta g o nist are pr o hi bite d . Dail y l o w d ose 
of i n hale d c ortic oster oi d , a n d s h ort c o urse of i n hale d c ortic oster oi d i n dicat e d f or 
treati n g eit her i nter m itte nt ast h ma or br o nc hitis are per mitte d , 
•  C ortic oster oi ds pri or t o Visit 1:  
o  T w o or m ore s yste mic c ortic oster oi d c o urses wit hi n 3  m o nt hs pri or t o 
Visit  1  f or a n y i n dicati o n,  
o  1 s yste mic c ortic oster oi d c o urse wit hi n 4 wee ks pri or t o Visit 1 f or treati n g 
a dia g n ose d ast h ma, 
o  A n y s yste mic l o n g -acti n g c ortic oster oi ds wit hi n 2  wee ks pri or t o Visit 1 f or 
a n y i n dicati o n,  
o  A n y s yste mic s h ort -acti n g/i nter me diate -acti n g c ortic oster oi ds f or m ore 
t ha n 3 da ys wit hi n 2 wee ks pri or t o Visit 1 f or a n y i n dicati o n. 
•  β -bl oc ki n g a ge nts, a n gi ot e nsi n -c o n verti n g e nz y me i n hi bit ors, a n gi ote nsi n -rece pt or 
bl oc kers, calci u m c h a n n el bl oc kers or tric y clic a nti de pressa nt t hera p y,  d uri n g t he 
scree ni n g p eri o d or d uri n g st u d y partici pati o n, 
•  A nti -t u m or necr osis fact or dr u gs or a nti-I g E dr u gs (s uc h as o maliz u ma b) or a n y 
bi ol o gic i m m u n o m o d ulat or y t hera p y are pr o hi bite d if ta ke n wit hi n 1 year pri or t o 
Visit  1, d uri n g scree ni n g peri o d or d uri n g st u d y partici pati o n , 
•  C ycl os p ori ne or ot her i m m u n os u p p ressi ve a ge nts are pr o hi bite d if use d wit hi n 
1  year pri or t o Visit  1, d uri n g t he scree ni n g p eri o d or d uri n g t he st u d y partici pati o n. 
T o pical calci n e uri n i n hi bit ors are per mitte d,  
•  A n y pri or or c o n c o mita nt i m m u n ot hera p y a d mi nistere d t o a n y f o o d ( f or e xa m ple 
E PI T or OI T or S LI T or s pecific oral t olera nce i n d ucti o n) . A pri or pre m at urel y 
disc o nti n ue d OI T ( i.e., s u bject treate d less t ha n 1 m o nt h) w hic h e n de d at least 
3  m o nt hs bef ore Visit 1 is per mitte d , 
•  A n y aer oaller ge n i m m u n ot hera p y a d mi nistere d d uri n g st u d y partici pati o n. 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
5 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
Bef ore t he first d a y of D B P C F C : 
T he mi ni mal was h o ut peri o d f or s h ort a n d l o n g acti n g a nti hista mi nes (refer t o 
A P P E N DI X 3 ) a n d l o n g -acti n g 2 -a g o nists ( 3 6 h o urs pri or t o t he D B P C F C) will ha ve 
t o be res p ecte d. R e gar di n g s yste mic c ortic oster oi ds, t he f oll o wi n g mi ni mal was h -o ut 
peri o d  will be a p plie d:  
•
S u bjects 
s h o ul d 
n ot 
ha ve 
recei ve d 
a n y 
c o urse 
of 
s yste mi c 
s h ort-
actin g /i nter me diate-actin g  c ortic oster oi ds of m or e t ha n 3 da y s wit hi n 2  wee ks of
t he D B P C F C, or a n y c o urse of s yste mic l o n g-acti n g c ortic oster oi ds wit hi n 2  wee ks
of t he D B P C F C . I n t his case, t he D B P C F C s h o ul d be dela ye d t o all o w f or 2  wee ks
of c ortic oster oi d w as h -o ut.
•
I n cas e t he s u bject h as recei ve d a s yste mic c ortic oster oi d  f or ast h ma bef ore t he
D B P C F C , t he f o o d c halle n ge s h o ul d be dela ye d  t o all o w f or 4  wee k s of was h -o ut.
•
If a s u bject has a reacti o n d uri n g t he first da y of t he D B P C F C t hat re q uires
treat me nt wit h s yste mic c ortic oster oi ds, t he s u bject has t o wait at least 3 da ys
bef ore p erf or mi n g t he sec o n d da y of t he D B P C F C.
6  
V A RI A B L E S A N D M E T H O D S O F A S S E S S M E N T  
T he efficac y, sa fet y a n d e x pl orat or y e n d p oi nts are liste d i n Secti o n 3. 3 . T he Sc he d ule of 
Pr oce d ures is pr o vi d e d i n pa ge 1 5 . 
6. 1  
Effic ac y V ari a bles  
6. 1. 1  Res p o nse t o Tre at me nt –  D B P C F C t o Pe a n ut  
T he D B P C F C t o pea n ut will be perf or me d at st u d y e ntr y a n d p ost -treat me nt at M o nt h 1 2 
i n or der t o assess t he pri mar y efficac y e n d p oi nt (differe n ce bet wee n perce nt a ge of 
treat me nt res p o n ders i n t he selecte d acti ve D B V 7 1 2  gr o u p  [2 5 0  µ g ] c o m pare d t o t he 
place b o gr o u p), as w ell as t he sec o n dar y a n d ot her efficac y e n d p oi nts  (see Secti o n 3. 3. 1 ). 
T he D B P C F C is t he g ol d sta n dar d t o dia g n ose a n d assess f o o d aller g y. T he c halle n ges will 
be c o n d ucte d  o v er 2  d a ys; t he c hil d will be gra d uall y fe d i n creasi n g a m o u nts of 
sta n dar dize d bli n de d oral f or m ulas c o ntai ni n g eit her pea n ut pr otei n s d uri n g o ne of t he t w o 
da ys of t he c halle n ge, or wit h o ut a n y pea n ut pr ot ei n s d uri n g t he ot her da y of t he c halle n ge, 
or vice vers a. C halle n ges 
m ust ta ke place u n der direct 
me dical s u per visi o n i n a 
h os pital/cli n ic setti n g wit h res uscitati o n e q ui p me nt a n d e mer g e nc y me dicati o ns a n d 
trai ne d staff i m me diatel y a vaila ble. A n i ntra ve n o us (I V) li ne ca n be esta blis he d pri or t o 
t he c halle n ge w he n j u d g e d necessar y b y t he I n v esti gat or. I n t hat case, a l ocal a nest hetic 
crea m c o ul d  be use d pri or t o esta blis hi n g t he I V li ne. If a site prefers t o ha ve t he s u bjects 
c o me t o t he h os pital t he da y bef ore t he c o n d u ct of t he D B P C F C, t o get t he m rea d y f or t he 
f oll o wi n g da y, t his is all o we d a n d will n ot be c o nsi dere d a n S A E. 
If t he s u bject has a c o nc o mita nt disease s uc h as a r hi nitis, br o nc hitis , gastr oi ntesti nal 
i nfecti o n, or ac ute ast h ma flare -u p , w hic h te m p oraril y c o ntra-i n dicates t he perf or ma n ce of 
t he D B P C F C, t he test will be p ost p o ne d u ntil at least 7 da ys after  rec o ver y. 
S u bjects s h o ul d was h o ut a n y a nti hista mi nes f or t he mi ni m u m peri o d of ti me s pecifie d i n 
t he ta ble i n A P P E N DI X 3  pri or  t o perf or mi n g t he D B P C F C. 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
5 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
S u bjects will n ot be all o we d t o use l o n g -acti n g 2 -a g o nists wit hi n 3 6  h o urs pri or t o t he 
D B P C F C. 
S u bjects 
s h o ul d 
n ot 
ha ve 
recei ve d 
a n y 
c o urse 
of 
s yste mic  
s h ort-acti n g/i nter me diate -acti n g c ortic oster oi ds of m ore t ha n 3 da y s wit hi n  2  wee ks of t he 
D B P C F C , or a n y c o urse of s yste mic l o n g-acti n g c ortic oster oi ds  wit hi n 2 wee ks of t he 
D B P C F C . I n t hese cas es, t he D B P C F C s h o ul d be dela ye d t o all o w f or 2 wee ks of was h -o ut  
(i n case t he s u bject has recei ve d a s yste mic l o n g-acti n g c ortic oster oi d f or ast h ma bef ore 
t he D B P C F C, t he f o o d c halle n ge s h o ul d be del a y e d t o all o w f or 4 wee ks of was h-o ut) . If 
a s u bject h as a reacti o n d uri n g t he first d a y of t h e D B P C F C t hat re q uires trea t me nt wit h 
s yste mic c ortic oster oi ds o n t he first da y, t he s u bject has t o wait at least 3  da ys bef ore 
perf or mi n g t he sec o n d da y of t he D B P C F C.  
T he s u bject ma y  ha v e a li g ht brea kfast a n d ma y dri n k water at h o m e at least 2  h o urs bef ore 
starti n g t he D B P C F C at t he site. D uri n g t he c o n d uct of t he c halle n ge, dri n ki n g a si p of 
water t o hel p s wall o w t h e f or m ulas is all o we d , b ut eati n g is n ot all o we d. A p ple sa uce will  
be gi ve n t o t he s u bjects d uri n g t he c halle n g e after eac h d ose fr o m t he t hir d d ose  ( 1 0 m g) 
o n war ds  t o i m pr o ve t he acce pta bilit y of t he f o o d c halle n g e f or m ulas a n d pre ve nt u n d u e 
disc o mf ort d ue t o h u n ger, c o nsi deri n g t he pr ol o n ge d fasti n g re q uire d b y t he pr oce d ure i n 
t hese y o u n g c hil dre n . If a p ple sa uce is n ot gi ve n t o t he s u bjects at scree ni n g, it s h o ul d n ot 
be gi ve n d uri n g t he D B P C F C at M o nt h  1 2 . A defi ne d  a p ple sa uce f or m ulati o n will be us e d 
b y all t he ce nt ers a n d t h e a m o u nt of a p ple sa u ce a d mi nistere d will be  sta n dar dize d a n d 
li mite d s o t hat it d oes  n ot i nterfere wit h t he s u bject’s willi n g ness t o i n gest t he f o o d 
c halle n ge f or m ula. After t he last d ose of t he c halle n ge f or m ula is a d mi nistere d, t he me dical 
staff s h o ul d wait at least 1 h o ur bef ore fee di n g t he s u bject wit h a n y ot her f o o d a n d/ or water. 
T his first fee di n g s h o ul d be li g ht.  
A  detaile d a n d st u d y -s pecific Ma n ual of Pr oce d ures f or t he c o n d uct of t he D B P C F C will 
be pr o vi de d t o t he I n vesti gat ors, t he site staff a n d t he u n bli n de d st u d y -trai ne d pers o n 
res p o nsi ble f or rec o nstit uti n g t he f o o d c halle n ge f or m ulas. Of n ote , t he a m o u nts of a p ple 
sa uce t o be a d mi nistere d are s pecifie d i n t he Ma n u al of Pr oce d ures. W h e n n ee de d, u p d ate d 
versi o ns will be ma de a v aila ble. A n o utli ne of t he pr oce d ures is s pecifie d b el o w.  
6. 1. 1. 1  Pre p ar ati o n of Pe a n ut pr otei n a n d Pl ace b o F or m ul as  
Sta n dar dize d 
f or m ulas, 
ce nt rall y 
pr o d uce d 
b y 
 
 
, a n d pac k e d a n d release d b y 
, 
will be distri b ute d t o all partici pati n g ce nters f or t he D B P C F C. O ne of t he f or m ulas will 
be pea n ut  pr otei n -free ( place b o) a n d t he ot her o ne will c o ntai n pea n ut pr otei n s. A n 
u n bli n de d pers o n i de ntifie d at eac h site b y t h e i n vesti gat or , s pecificall y trai ne d t o 
rec o nstit ute t he f or m ulas i n t he st u d y a n d n ot i n v ol ve d i n t he c halle n ge itself will be 
res p o nsi ble f or t he pre p arati o n, a d e q uate la beli n g a n d bli n di n g of t he p ots c o ntai ni n g t he 
pre pare d/ h y drate d f or m ulas. T he bli n de d p ots will t he n be ha n de d t o t he me dical tea m t o 
perf or m t he c halle n ge.  
6. 1. 1. 2  Ti me I nterv al a n d D oses  
T he or der of t he f or m ulas t o be c o ns u me d d uri n g t he first a n d t he s ec o n d d a y of t he 
D B P C F C will be pre -deter mi ne d at ra n d o m . T he u n bli n de d st u d y -trai ne d pers o n will 
pre pare t he f or m ula usi n g a s pecific ra n d o mizati o n list pr o vi de d t o her/ hi m f or t his 
p ur p ose. Ot her me m b ers of t he site staff ( f or e xa m ple t he I n vesti gat or, st u d y c oor di nat ors, 
a n d st u d y n urses), t he s u bject/ pare nts/ g uar di a ns will re mai n bli n de d t o t he or der of 
C CI
C CI

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
5 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
c o ns u m pti o n u ntil t he e n d of t he sec o n d da y of t he D B P C F C. U p t o 7  da ys ( 1  wee k) 
bet wee n t he 2  da ys of t he D B P C F C will be per mitte d. T he 2  da ys of t he D B P C F C m a y be 
2  c o nsec uti ve da ys, b ut n ot t he sa me da y.  
T he c h alle n ge will c o nsist i n gi vi n g d oses of p ea n ut pr otei n or pl ace b o i n gra d u all y 
i ncreasi n g d oses at 2 0 -mi n ute i nter vals  (refer t o secti o n 6. 1. 1. 3  f or m ore det ails). 
T he starti n g d ose is 1  m g of pea n ut pr otei n f or t h e e ntr y/scree ni n g D B P C F C as well as t he 
p ost -treat me nt D B P C F C; t he 
ma xi m u m d ose is 3 0 0 m g of pea n ut pr otei n f or t he 
e ntr y/scree ni n g D B P C F C a n d 2, 0 0 0 m g f or t he p ost -treat me nt D B P C F C. 
T he pea n ut pr ot ei n d ose i ncre me nts f or t he e ntr y/s cree ni n g D B P C F C are : 
1  m g, 3  m g, 1 0  m g, 3 0  m g, 1 0 0  m g a n d 3 0 0  m g.  
T he e ntr y/scree ni n g D B P C F C c halle n ge is ca p p e d at 3 0 0  m g as t he ma xi m u m  d ose , 
re gar dl ess of w het h er a reacti o n occ urre d or n ot.  
T he pea n ut pr ot ei n d ose i ncre me nts f or t he p ost -tr eat me nt D B P C F C are: 
1  m g, 3  m g, 1 0  m g, 3 0  m g, 1 0 0  m g, 3 0 0  m g, 1, 0 0 0  m g a n d 2, 0 0 0  m g.  
6. 1. 1. 3  E ntry/scree ni n g D B P C F C  
S u bjects w h o ha ve n ot ha d a n I g E -me diat e d reacti o n lea di n g t o st o p pi n g t he D B P C F C at 
≤3 0 0  m g pea n ut pr otei n will be c o nsi dere d n ot se nsiti ve e n o u g h a n d t h us i neli gi ble f or t his 
st u d y. He nce, t he e ntr y/s cree ni n g D B P C F C is st o p pe d after t he 3 0 0 m g d ose of place b o or 
pea n ut has bee n dis pe nse d o n b ot h da ys;  e ve n if t here ha ve bee n n o reacti o ns  meeti n g t he 
c halle n ge st o p pi n g criteria. 
S u bjects will recei ve o ne  f or m ula ( place b o or pea n ut) o n t he first da y a n d t he ot her f or m ula 
( pea n ut or place b o) o n t h e sec o n d da y. All s u bjects will u n der g o b ot h da ys of t he D BP C F C.  
If t he s u bject reacte d se v erel y or seri o usl y d uri n g t he first da y of t he c halle n ge (i.e. nee d 
f or i nt u bati o n, h y p ote nsi o n persisti n g after e pi ne p hri ne a d mi nistrati o n, a n d/ or t he nee d f or 
≥3  d oses  of e pi ne p hri ne ), t he nat ure of t he a d mi nistere d f or m ula will b e hi g hl y s us pecte d 
t o be t he pea n ut-c o ntai ni n g f or m ula . I n t his rare case a n d o nl y i n t his c as e o nl y, the sec o n d 
da y of t he D B P C F C ca n n ot  be perf or me d . T h e bli n d o n t he f or m ula will be o pe ne d  at t he 
e n d of t he first da y t o c o nfir m t hat t he s u bject act uall y recei v e d t he pea n ut f or m ula. 
At t he e n d of t he sec o n d da y of c halle n ge, t he se q ue nce of t he t w o f or m ulas will be 
u n bli n de d a n d re veale d t o t he me dical staff b y t he u n bli n de d pers o n res p o nsi ble f or 
rec o nstit uti n g t he f orm ulas a n d t he res ults of t he c halle n ge will be esta blis he d f oll o wi n g 
t he decisi o n -ma ki n g  al g orit h m bel o w:  
1.  T he s u bject ha d I g E -me diate d s y m pt o ms  meeti n g t he c halle n ge st o p pi n g criteria t o 
t he place b o f or m ula at a n y d ose of t he c h alle n ge. S he/ he ca n n ot b e ran d o mize d i n 
t he st u d y; 
2.  T he s u bject ha d n o I g E -me diate d s y m pt o ms meeti n g t he  c h alle n ge  st o p pi n g criteria 
d uri n g t he 2  da ys of t he D B P C F C, neit her t o t he place b o n or t o t he pea n ut f or m ulas, 
e ve n at t he 3 0 0  m g d ose of pea n ut pr otei n. S he/ he ca n n ot be ra n d o miz e d i n t he 
st u d y; 
3.  T he s u bject ha d n o s y m pt o m  meeti n g t he  c halle n ge st o p pi n g criteri a w he n 
recei vi n g place b o but h a d s y m pt o m s meeti n g t hese criteria at o ne  of t he d oses of 
t he pea n ut f or m ula c o ns u me d bet wee n 1 m g a n d 3 0 0  m g i ncl usi ve.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
5 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
T he f oll o wi n g s h o ul d b e c o nsi dere d t o st o p t he c h alle n ge a n d t o der mi ne t he E D:  
•  O bjecti ve s y m pt o ms 
a n d/ or  
•  M o der ate a b d o mi n al p ai n 
wit h decre ase d acti vit y 
ass oci ate d wit h ot her 
o bjecti ve s y m pt o ms 
acc or di n g t o A P P E N DI X 5  
a n d/ or  
•  Se vere a n d/ or persiste nt 
a b d o mi n al p ai n wit h 
si g nific a nt c h a n ge i n 
be h a vi or  
( ot her s u bjecti ve s y m pt o ms will 
be gra de d b ut will n ot c o u nt i n 
t he st o p pi n g r ules of t he 
c halle n ge)  
+  
Tre at me nt 
re q uire d  
(c h oice of t y pe of 
treat me nt left t o t he 
decisi o n of t he 
I n v esti gat or) 
=  
St o p t he 
c h alle n ge  
T he O ral F o o d C halle n g e  S y m pt o m Sc ore S heet  descri be d i n  A P P E N DI X 5  will be use d 
t o sc ore t he se verit y of eac h pre -s pecifie d o bjecti v e a n d s u bjecti ve s y m pt o ms. T his sc ori n g 
is classifie d u n der t he 5 cate g ories:  
I S ki n ( Pr urit us, Urticaria, A n gi oe de ma, Er yt h e mat o us Ras h)  
II U p per res pir at or y /O cc ular ( S neezi n g/It c hi n g, N asal C o n gesti o n, R hi n orr hea, 
Lar y n geal , C o nj u ncti vitis)  
III L o wer Res pirat or y ( W heezi n g) 
I V Gastr oi ntesti nal ( S u bjecti ve C o m plai nts, O bjecti ve C o m plai nts) 
V Car di o vasc ular/ Ne ur ol o gic  ( h y p ote nsi o n/c olla pse/u n c o nsci o us ness) .  
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
5 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
M ore s pecific all y, t he f o o d c h alle n ge m ust be st o p pe d if  t he f oll o wi n g occ urs a n d 
re q uires tre at me nt: 
 
O nl y 1 o ut of 5 c ate g ori es  h as i ncre ase d  its gr a di n g s y m pt o m  sc ore 
 
≥ 1 -p oi nt rise  f or at le ast 1 
f oll o wi n g s y m pt o m 
(i.e. mil d, m o der ate or se vere) 
O R  
≥ 2 -p oi nt rise  
f or at le ast 1 
f oll o wi n g 
s y m pt o m 
(i.e. m o der ate 
or se vere)  
O R  
3 -p oi nt rise  f or at 
le ast 1 f oll o wi n g 
s y m pt o m 
(i.e. se vere) 
o  Lar y n geal *  
o  W heezi n g  
o  O bjecti ve Gastr oi ntesti nal * *  
o  Car di o vasc ular /ne ur ol o gical * * *  
o  
Urticaria  
o  
A n gi oe de ma   
o  
Ras h  
o  Pr urit us  
o  S neezi n g /Itc hi n g  
o  Nasal C o n gesti o n  
o  R hi n orr hea  
o  C o nj u ncti vitis  
o  A b d o mi nal 
c o m plai nts 
*” Lar y n geal” refers t o lar y n geal oe d e ma s y m pt o ms, a n d m ust be differe nciate d fr o m ot her ca uses of c o u g h 
s uc h as tra nsie nt p har y n geal irritati o n or l o wer res pirat or y s y m pt o m (e. g., c o u g h d ue t o br o nc h os pas m).  
Ca uses of c o u g h ot her t ha n lar y n geal oe d ma s y m pt o ms will be d oc u me nte d as “ ot her s y m pt o m” i n t he 
e C R F, a n d s pecifie d i n t he free te xt b o x. Tra nsie nt lar y n geal irritati o n will n ot be c o nsi dere d as a n o bjecti ve 
O F C s y m pt o m a n d will n ot b e c o nsi dere d i n t he st o p pi n g r ules.  
* * F or e mesis/ v o miti n g, t he s y m pt o ms  ma y res ult fr o m t w o differe nt sit uati o ns: v o miti n g/s pitti n g -u p d uri n g 
t he fee di n g, res ulti n g fr o m s u bjecti ve i nt olera nce t o t he f o o d f or m ula or v o miti n g/e mesis res ulti n g fr o m a 
gastr oi ntesti nal aller gic reacti o n t o t he pea n ut aller ge n, us uall y dela y e d fr o m t he fee di n g. O nl y t he sec o n d 
sit uati o n will be c o nsi dere d as a n o bjecti ve O F C s y m pt o m a n d will be c o nsi dere d f or t he st o p pi n g r ules.  
* * * Car di o vasc ular s y m pt o ms: h y p ote nsi o n or car di o vasc ular fail ure directl y relate d t o t he s yste mic aller gic 
reacti o n. T hey ha ve t o be differe n ciate d fr o m si milar s y m pt o ms relate d t o a n ot her ca use, s uc h as a dizzi n ess 
i n d uce d b y v o miti n g. 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
5 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
2 c ate g ori es ( or m ore) h a ve i ncre ase d t heir gr a di n g s y m pt o m sc ores 
 
 
F or eac h pea n ut pr otei n d ose ste p,  t he c o ns u m pti o n m ust be carrie d o ut as fast as p ossi ble, 
n ot e xcee di n g 3 0 mi n utes bet wee n t he start a n d e n d of d ose i n gesti o n.   
T he e v al uati o n of pres pecifie d c h alle n ge st o p pi n g criteria m ust b e carrie d o ut i m perati vel y 
wit hi n a 2 0 -mi n utes peri o d after t he d ose has bee n c o m pletel y i n geste d (i.e., 2 0 -mi n ute 
peri o d starti n g fr o m t he e n d of d ose i n gesti o n):  
•  
 If n o s y m pt o ms meeti n g t he st o p pi n g criteria are o bser ve d wit hi n t his 2 0- mi n ute 
peri o d,  t he I n vesti gat or m ust pr ocee d i m me diatel y t o t he a d mi nistrati o n of t he ne xt 
asce n di n g d ose  ( or st o p t he D B P C F C if t he last d ose ste p has bee n reac he d); 
•  
If t here is a d o u bt o n a p ossi ble de vel o p me nt of s y m pt o ms meeti n g st o p pi n g criteria 
at t he e n d of t he 2 0 -mi n ute peri o d, t he I n vesti gat or ma y e xcercise his/ her cli nical 
j u d ge me nt a n d e xte n d t he e v al uati o n peri o d t o a n a d diti o nal 1 0 mi n ut es ( n ot 
e xcee di n g 3 0 -mi n ute e v al uati o n peri o d o verall, starti n g fr o m t he e n d of d ose 
i n gesti o n). If t h e e m er gi n g s y m pt o ms have n ot m et t he st o p pi n g criteria at t he e n d 
of t he a d diti o nal e v al uati o n peri o d, t h e I n v esti gat or 
m ust pr ocee d t o t h e 
a d mi nistrati o n of t he ne xt asce n di n g d ose ( or st o p t he D B P C F C if t he last d ose ste p 
has bee n reac he d). H o we ver, t he a d mi nistrati o n of t he ne xt d ose 
ma y be 
≥ 1 -p oi nt rise f or  at le ast 1 
f oll o wi n g s y m pt o m 
(i.e. mil d, m o der ate or se vere) 
A N D  
≥ 2 -p oi nt rise f or at le ast 1 
f oll o wi n g s y m pt o m 
(i.e. m o der ate or se vere) 
o  
Urticaria  
o  
A n gi oe de ma  
o  
Ras h  
o  
S neezi n g/Itc hi n g  
o  
Nasal C o n gesti o n  
o  
R hi n orr hea  
o  
C o nj u ncti vitis  
o  
A b d o mi nal c o m plai nts 
O R  
≥ 2 -p oi nt rise  
(i.e. m o der ate or se vere) 
A N D  ≥ 2 -p oi nt rise f or at le ast 1 
f oll o wi n g s y m pt o m 
(i.e. m o der ate or se vere) 
o  
Pr urit us  
o  
S neezi n g/Itc hi n g  
o  
Nasal C o n gesti o n  
o  
R hi n orr hea  
o  
C o nj u ncti vitis  
o  
A b d o mi nal c o m plai nts  
O R  
≥ 2 -p oi nt rise  
(i.e. m o der ate or se vere) 
A N D  ≥ 2 -p oi nt rise f or at le ast 1 
f oll o wi n g s y m pt o m 
(i.e. m o der ate or se vere) 
o  
A b d o mi nal c o m plai nts  
o  
S neezi n g/Itc hi n g  
o  
Nasal C o n gesti o n  
o  
R hi n orr hea  
o  
C o nj u ncti vitis  
o  
P r urit us 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
5 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
a d mi nistere d m ore sl o wl y, n ot e xcee di n g 3 0  mi n ute s bet wee n t h e start a n d e n d of 
d ose i n gesti o n.   
•
T he re petiti o n of a sa me d ose ste p will n ot be all o we d d uri n g D B P C F C. If t here
are n o s y m pt o m s meeti n g t he st o p pi n g criteria after a m a xi m u m o f 3 0-mi n ute
e val uati o n, t he I n vesti gat or m ust pr ocee d t o t he ne xt asce n di n g d ose, or m ust st o p
t he F o o d C halle n ge if t h e last d ose ste p has bee n reac h e d.
T he pr oce d ure is sc h e matize d bel o w:  
*  A sl o wer a d mi nistrati o n ( n ot e x cee di n g 3 0 mi n utes) ma y be p ossi ble if e mer gi n g s y m pt o ms ( n ot meeti n g 
st o p pi n g criteria)  occ urre d  at 
t he e n d  of  t he e val uati o n  peri o d  of  t he pre vi o us  d ose. 
* *  I n case of  e m er gi n g  s y m pt o ms at t he e n d  of  t he 2 0- mi n ute  peri o d,  e val uati o n  ca n be  e xte n de d  t o a n 
a d diti onal 1 0 mi n utes ( n ot e xcee di n g 3 0 mi n utes o verall).
F urt her de tails are pr o vi ded i n t he st u d y-s pecific Ma n ual of Pr o ce d ures f or t he D B P C F C 
t hat will be pr o v i de d t o t he sites. 
T he d ose t hat tri g gers s y m pto ms meeti n g t he st o p pi n g r ule s will be co nsi der e d as t h e E D . 
As a safet y preca uti o n, t he s y m pt o ms si g nali n g t he en d of t he D B P C F C will be treate d. 
T he c h oice o f t y pe of me dicati o n t o be use d will be left t o t he I n vesti gat or’s j u d g me nt. 
T he  I n v esti gat or a n d me dical  staff will  use  t heir o w n c li nical j u d g ment  f or t he m ost 
effe cti ve treat me nt c o nsi deri n g t he s u bject’s a g e, t he t y pe of aller gic  reacti o ns a n d t heir 
se verit y. Als o refer t o t he rec o m me n dati o ns 
ma de b y Sa m ps o n et al. f or treati n g 
a na p h yla xis ( 3 9 ). 
S u g ge ste d treat ments f or t he differe nt s y m pt o ms are detaile d i n t he st u d y-s pecific Ma n ual 
of Pr oce d ures f or t he D B P C F C pr o v i de d t o t he sites. 
S h o ul d  e pi ne p hri ne nee d  t o be a d mi nistere d, it s ho ul d  be  i njecte d i ntra m usc ularl y i n t he 
a nter olate ral t hi g h usi n g  a ut o-i nject ors c o m merciall y a vaila bl e i n eac h s pecific 
site/c o u ntr y or usi n g  wei g ht-a p pr o priat e  d oses  of e pi ne p hri ne  i n a sta n dar d s yri n ge. 
Wei g ht -a p pr o priate d oses of e pi ne p hri ne i n a sta n dar d s yri n ge s h o ul d be use d i n c hil dre n 
w h o wei g h  l ess t ha n 1 5 k g. I ntr a ve n o us  e pi ne p hri ne s h o ul d N O T  be  c o nsi dere d at t he 
i n vestigati ve sites t o treat t he reacti o ns.  
S u bjects will be ke pt u n der o bser vati o n f or a n a d diti o nal 3 h o urs after t he i n gesti o n of t he 
last d ose of t h e c h alle n ge f or m ula. Bas e d o n t he I n vesti gat or’s j u d g me nt, t he o bser vati o n 
peri o d  c o ul d  be  e xte n d e d  be y o n d  t he first 3 h o urs  t o e ns ure t hat all s y m pt o ms ha ve 
s u bsi de d be f ore t he s u bject is disc har ge d. F or  i nsta nce, a n o ver ni g ht  sta y ma y be 
c o nsi dere d necessar y  b y t he I n v esti gat or  if t he s y m pt o ms ha ve  n ot c o m pletel y  res ol ved 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
5 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
wit hi n t he 3  h o urs or if t he s y m pt o ms ha ve b ee n se vere or seri o us a n d re q uire l o n ger 
o bser vati o n peri o ds.  
C o m plete i nf or mati o n f or all reacti o ns will be re p orte d first i n s o urce d o c u me nts t he n i n 
t he e-C R F, al o n g wit h F C d oses gi ve n, s y m pt o ms o bser ve d a n d t h eir hi g h est gra d es, ti me 
of a p peara n ce of t he s y m pt o ms a n d I n v esti gat or’s assess me nt of t he E D. 
6. 1. 1. 4  P ost -tre at me nt D B P C F C t o Pe a n ut at M o nt h 1 2 
T he D B P C F C at M o nt h  1 2 is c o n d ucte d f oll o wi n g e xactl y t he sa me pr oce d ures as f or t h e 
e ntr y/scree ni n g D B P C F C  (refer t o t he  Ma n ual of Pr oce d ures f or t he c o n d uc t of t he 
D B P C F C) . H o we ver, it is n ot st o p pe d at t he 3 0 0 m g d ose  b ut  will be c o nti n ue d u p t o t he 
last d ose of 2, 0 0 0 m g pea n ut pr otei n or u ntil reacti o ns lea di n g t o st o p pi n g t he D B P C F C 
occ ur.  
T he patc h s h o ul d be re m o ve d bef ore perf or mi n g t he D B P C F C a n d a ne w patc h s h o ul d be 
a p plie d at t he e n d of t h e D B P C F C  (i.e. at t he e n d of t he 3-h o ur o bser vati o n peri o d) . 
T he sa me i nstr ucti o ns pr o vi de d a b o ve t o st o p t he c halle n ge at t he e ntr y c h alle n ge will b e 
f oll o we d t o st o p t he p ost -treat me nt c halle n g e.  
If t he s u bject was n ot fe d a p ple sa u ce at t he e ntr y/scree ni n g D B P C F C, t h e n a p ple s a uce 
s h o ul d n ot be a d mi nistere d wit h  t his f o o d c halle n ge eit her. 
F o o d C halle n ges t o ot h er f o o d aller ge ns (b esi des pea n ut ) ma y be c o n d ucte d d uri n g t he 
st u d y if me dicall y j ustifie d, a n d o nl y if perf or me d i n t he c o nte xt of a dia g n osis or f or 
c o nfir mi n g a d ese nsitizati o n . W het her t he s u bject’s me dical c o n diti o n is still c o m pati ble 
wit h t heir partici pati o n i n t he st u d y s h o ul d be assesse d b y t he I n vesti gat or a n d t he 
S p o ns or’s me dical m o nit or, bef ore t h e f o o d c halle n ge is perf or me d. If n ot c o m pati ble, t he 
S p o ns or ma y deci de t o  disc o nti n ue t he s u bject fr o m t he st u d y. I m p orta ntl y, t he i nitiati o n 
of i m m u n ot hera p y t o a n y f o o d aller ge n re mai ns pr o hi bite d d uri n g t he partici pati o n i n t he 
st u d y ( See Secti o n 5. 7. 2 ).  T he patc h s h o ul d n ot be a p plie d o n t he da y of a f o o d c halle n ge 
a n d u ntil all pr oce d ures are c o m plete d.  
6. 2  
S afet y V ari a bles  
6. 2. 1  A dverse Eve nts  
C o di n g of A Es will be perf or me d as d escri b e d i n Secti o n  9. 7 . 
6. 2. 1. 1  C ollecti o n of A dverse Eve nts  
It is t he res p o nsi bilit y of t he I n vesti gat or t o c ollect all A Es ( b ot h seri o us a n d n o n-seri o us) 
deri ve d b y s p o nta n e o us, u ns olicite d re p orts of s u bjects, b y o bser vati o n a n d b y r o uti ne o p e n 
q uesti o ni n gs, f or e xa m pl e “H o w h a ve y o u felt si nce I last sa w y o u?”.  A d verse e ve nts will 
als o ha ve t o be rec or de d b y t he pare nts/ g uar dia ns i n t he s u bject diaries (see Secti o n 6. 2. 5 ). 
T he  occ urre n ce of t h e  f oll o wi n g A Es/s y m pt o ms will be s pecificall y s olicite d: 
•  Pre -s pecifi e d s y m pt o ms of l ocal reacti o ns at a p plicati o n site (itc hi n g, re d ness, 
s welli n g), b y mea ns of t he s u bject diaries ( d uri n g t he first 6 m o nt hs f or part A, a n d 
d uri n g t he w h ole treat me nt d urati o n f or part B ; See als o Secti o n 6. 2. 5  re gar di n g t he 
r ules of A Es re p orti n g of t hese pre-s p ecifie d l o cal s y m pt o ms). 

D B V Tec h n ol o gies  
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•  S pecific a p plicati o n site reacti o ns a n d s yste mic  e ve nts of a p ote ntial aller gic nat ure 
(re gar dless of ca usal rel ati o ns hi p wit h t he I M P) will als o be s olicite d at eac h st u d y 
visit  a n d p h o ne c o ntact  f or part B o nl y (see T a ble  1 ). 
 
T a ble  1 : List of S olicite d A d verse E ve nts ( A p plic a ble  f or P art  B O nl y ) 
A p plic ati o n site re acti o ns  
S yste mic e ve nts of a p ote nti al aller gic n at ure  
•  
Pr urit us  
•  
Er yt he ma  
•  
Oe d e ma  
•  
Urticaria  
•  
H y per pi g me ntati o n  
•  
Ecze ma  
•  
E xc oriati o n (er osi o n)  
•  
Ulcerati o n  
•  
Blister ( vesicles)  
•  
Gra d e 4 patc h site reacti o ns (er yt he ma 
wit h vesicles)  
•  
Pai n u n der t he patc h  
•  
Ast h ma a g gra viati o n/e xacer bati o n  
•  
Hi ves  
•  
E yeli d oe de ma  
•  
Aller gic c o ntact c o nj u ncti vitis  
•  
Li p s welli n g  
•  
A n gi oe de ma  
6. 2. 1. 2  Defi niti o ns  
A n A E i s a n y u nt o war d me dical occ urre n ce t hat occ urs i n a s u bject or cli nical i n vesti gati o n 
s u bject a d mi nistere d a p har mace utical pr o d uct, a n d w hic h d oes n ot necessaril y ha ve a 
ca usal rel ati o ns hi p wit h t his treat me nt. A n A E ca n t heref ore b e a n y u nfa v ora bl e a n d 
u n i nte n de d si g n (i ncl u di n g a b n or mal la b orat or y fi n di n g), s y m pt o m, or disease te m p orall y 
ass ociate d wit h t he us e of a n i n vesti gati o nal pr o d uct, w het her or n ot c o nsi dere d relat e d t o 
t he i n vesti gati o nal pr o d uct.  
All A Es, i ncl u di n g i nterc urre nt ill nesses, o cc urri n g d uri n g t he st u d y will b e d oc u me nte d 
i n t he e-C R F. C o nc o mita nt ill nesses, w hic h e xiste d bef ore e ntr y i nt o t he st u d y, will n ot be 
c o nsi dere d A Es u nless t he y w orse n d uri n g t he treat me nt peri o d. All A Es, re gar dless of t he 
s o urce of i de ntificati o n (f or e xa m ple p h ysical e xa mi nati o n, la b orat or y assess me nt, 
electr ocar di o gra m [ E C G], re p orte d b y s u bject), m ust be d oc u me nte d.  
Pre -e xisti n g c o n diti o ns will be rec or de d i n t h e e -C R F o n t he 
Me dical Hist or y or 
a p pr o priate p a ge.  
A d verse e v e nt s d ue t o D BP C F C will als o be rec or de d i n t he e -C R F b ut will be a nal yze d 
se parat el y. 
6. 2. 1. 3  Assess me nt of A dverse E ve nts  
Eac h A E will be assesse d b y t he I n vesti gat or wit h re gar d t o t he f oll o wi n g cate g ories.  
6. 2. 1. 3. 1  Seri o us ness  
A n S A E is defi ne d as a n y u nt o war d me dical o cc urre nce t hat at a n y d os e:  
•  Res ults i n deat h;  
•  Is life-t hreate ni n g; T his mea ns t hat t he s u bject is at ris k of deat h at t he ti me of t he 
e ve nt; it d oes n ot mea n t hat t he e ve nt h y p ot heticall y mi g ht ha ve ca use d deat h if it 
were m or e se vere   

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N ote : W hereas a s yste mic a na p h ylactic reacti o n is ge nerall y c o nsi dere d p ote ntiall y  
life-t hreat e ni n g, n ot all a na p h yla xis p ut t he s u bjects at i m me diate ris k of d eat h, if 
f or e x a m ple a p pr o priate treat me nts lea d t o s y m pt o ms re d ucti o n or disa p p eara nce. 
As per t he A na p h yla xis Sta gi n g S yste m ( A P P E N DI X 4 ), a n a n a p h yla xis assesse d 
as mil d or m o derate s h o ul d n ot be classifie d as life -t hreate ni n g. 
•  Re q uires h os pitalizati o n ( at least o ver ni g ht sta y or i n patie nt h os pital a d missi o n) 
or pr ol o n gati o n of e xisti n g h os pitalizati o n;  
E ve nts ass ociate d wit h h os pit aliz ati o n  f or t he f oll o wi n g reas o ns will n ot  be 
c o nsi dere d as a n S A E:  
1.  E val uati o n or treat me nt of a pre -e xisti n g ( bef ore i nf or me d c o nse nt 
si g nat ure) a n d n o n-e xacer bati n g c o n diti o n:  
a. T he c o n diti o n e xiste d pri or t o t he s u bject’s e ntr y i nt o t he st u d y a n d 
has bee n rec or de d i n t he s u bject’s disease/ me dical hist or y a n d t he e -
C R F A N D  
b.  T he c o n diti o n has n ot w orse ne d i n se verit y or fre q ue nc y d uri n g t he 
s u bject’s e x p os ure t o t he I M P A N D  
c. T he c o n d iti o n has n ot re q uire d a c h a n ge i n treat me nt ma na ge me nt 
d uri n g t he s u bject’s e x p os ure t o t he I M P; 
2.  H os pitalizati o n t he da y pri or t o or after t he da y of D B P C F C f or practical 
reas o ns a n d wit h o ut f ulfilli n g a n y ot her seri o us ness criteri o n. 
•  Res ults i n persiste n t or si g nifica nt disa bilit y or i nca pacit y (a n A E is i n ca pacitati n g 
or disa bli n g if it res ults i n a s u bsta ntial a n d/ or per ma ne nt disr u pti o n of t he 
s u bject’s a bilit y t o carr y o ut n or mal life f u ncti o ns).; 
•  Is a c o n ge nital a n o mal y or birt h defect; 
•  Is a n i m p orta nt me dical e ve nt t hat ma y n ot be i m me diatel y life-t hreat e ni n g or res ult 
i n deat h or h os pitalizati o n b ut t hat 
ma y je o par dize t h e s u bject or re q uir e 
i nter ve nti o n t o pre ve nt o ne of t he a b o ve o utc o mes. E xa m ples of s uc h e ve nts are 
i nte nsi ve treat ment i n a n e mer ge nc y r o o m or at h o me f or aller gic br o nc h os pas m; 
bl o o d d yscrasias or c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n; or 
de vel o p me nt of dr u g d e p e n de nc y or dr u g a b us e.  
o  A n a na p h yla ctic reacti o n classifie d as s e vere usi n g t he A na p h yla xis Sta gi n g 
S yste m i n A P P E N DI X 4  (i.e., a na p h ylactic reacti o n wit h c ya n osis or 
S p O 2  ≤9 2 %, h y p ote nsi o n wit h > 2 0 % dr o p i n bl o o d press ur e, c o nf usi o n, 
c olla pse, l os s of c o nsci o us ness) or re q uiri n g 3 or m ore e pi ne p hri ne i nta kes 
s h o ul d be re p orte d at least wit h t he seri o us ness criteri o n “i m p orta nt me dical 
e ve nt”;  

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o  I n t he c o nte xt of t he D B P C F C, i n a d diti o n t o t he se vere a na p h yla xis, t he 
occ urre nce of:  
▪ Br o nc h os pas m/a u di bl e w heezi n g wit h use of access or y m uscles,  
▪ Se vere a n gi o e de ma  
▪ A d missi o n i n I nte nsi ve Care U nit a n d/ or re q uir e me nt of o x y ge n 
t hera p y 
▪ I nta k e of 3 or m ore d oses of e pi ne p hri ne 
s h o ul d be c o nsi dere d as meeti n g t he seri o us ness criteri o n of “i m p orta nt 
me dical e ve nt ”  
Me dical a n d scie ntific j u d g me nt s h o ul d be e xercis e d i n deci di n g w het her a case is seri o us 
a n d w het her e x pe dite d re p orti n g is a p pr o priate.  
6. 2. 1. 3. 2  Se verit y  
T he se verit y of eac h A E m ust be assesse d b y t he I n vesti gat or usi n g 1  of t he f oll o wi n g 
cate g ories, a n d rec or d e d i n t he e -C R F:  
•  Mil d: T he A E was tra nsi e nt a n d easil y t olerate d b y t he s u bject;  
•  M o derate: T h e A E ca use d disc o mf ort a n d i nterfere nce wit h t he s u bject ’s g e neral 
c o n diti o n;  
•  Se vere: T he A E ca us e d c o nsi dera ble i nterfere nce wit h t he s u bject ’s ge neral 
c o n diti o n  a n d ma y ha ve bee n i nca p acitati n g.  
A na p h yla xis (i ncl u di n g t h ose re p orte d as part of Me dical Hist or y) will be gra de d i n 
acc or da nce t o t he A na p h yla xis Sta gi n g S yste m ( A P P E N DI X 4 ). 
6. 2. 1. 3. 3  Ca usalit y  
T he I n v esti gat or will ass ess t he ca usalit y/relati o ns hi p bet wee n t he I M P a n d t he A E a n d 
rec or d t h at assess me nt i n t he s o urce d o c u me nts a n d i n t he e-C R F.  
T he m ost li kel y ca use of a n A E/ S A E ( f or e x a m ple disease u n der treat me nt, c o nc o mita nt 
disease, c o nc o mita nt me dicati o n, ot her) will be i n dicate d i n t he e -C R F wit h details of t he 
c o nc o mita nt disease or m e dicati o n or ot her ca use.  
T he ca us al relati o ns hi p of t he A E t o I M P will be descri be d i n ter ms of:  
•  Relate d: t he A E:  
o  F oll o ws a cle ar te m p or al se q ue nce fr o m a p plicati o n  of t he I M P. 
o  Has n o ot her p ossi ble e x pla nati o ns, s uc h as t he s u bject’s cli nical stat e, 
e n vir o n me ntal or t o xic fact ors  or ot h er t hera pies a d mi nistere d t o t h e 
s u bject. 
o  Disa p pears or decreas es o n cessati o n or re d ucti o n i n d ose of t he I M P. 
o  F oll o ws a cle ar patter n of res p o nse t o t he I M P. 
o  Rea p pears or w ors e ns u p o n rec halle n g e.  
 

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•  Pr o ba ble: t he A E:  
o  F oll o ws a reas o na ble te m p oral s e q ue n ce fr o m a p plicati o n  of t he I M P. 
o  C o ul d n ot be reas o na bl y e x plai ne d b y t he s u bject’s cli nical state, 
e n vir o n me ntal or t o xic fact ors or ot her t hera pi es a d mi nistrate d t o t he 
s u bject. 
o  Disa p pears or decreas es o n cessati o n or re d ucti o n i n d ose of t he I M P. 
o  F o ll o ws a k n o w n patter n of res p o nse t o t he I M P. 
o  Rea p pears or w ors e ns u p o n rec halle n g e.  
•  P ossi ble: t he A E:  
o  F oll o ws a reas o na ble te m p oral se q ue n ce fr o m a p plicati o n  of t he I M P. 
o  C o ul d be reas o na bl y e x pl ai ne d b y t he s u bject’s cli nical state, e n vir o n me ntal 
or t o xic  fact ors or ot her t hera pies a d mi nistrate d t o t he s u bject. 
o  F oll o ws a k n o w n patter n of res p o nse t o t he I M P. 
•  U nli kel y: t he A E  
o  D oes n ot f oll o w a reas o na ble te m p oral se q ue nce fr o m a p plicati o n  of t he 
I M P. 
o  C o ul d be reas o na bl y e x pl ai ne d b y t he s u bject’s cli nical s tate, e n vir o n me ntal 
or t o xic fact ors or ot her t hera pies a d mi nistrate d t o t he s u bject.  
o  D oes n ot f oll o w a k n o w n patter n of res p o nse t o t he I M P. 
o  D oes n ot rea p p ear or w orse n u p o n rec h alle n ge.  
•  N ot relate d:  
o  T he A E d oes n ot meet t h e a b o ve criteria.  
o  T here is s ufficie nt i nf or mati o n t hat t he eti ol o g y of t he A E is n ot relate d t o 
t he I M P. 
All S A Es assesse d as rel ate d, pr o ba bl y relate d, a n d p ossi bl y relate d will be c o nsi dere d as 
relate d f or e x pe dite d re p orti n g (see Secti o n 6. 2. 1. 5 ). 
T he st u d y c o n d uct rel ate d ness f or S A Es will als o be assesse d a n d d oc u me nte d.  
6. 2. 1. 3. 4  L ocal S ki n Reacti o ns  
T he i nci de n ce, d urati o n a n d ma xi m u m se verit y of s ki n reacti o ns i n d uce d b y t he I M P will 
be re p orte d b y t he s u bj ect’  pare nts/ g uar dia ns i n t he diar y. P h ot os of t hes e l ocal reacti o ns 
s h o ul d be ta ke n at h o me b y t he pare nts/ g uar dia ns. A d diti o nall y, t he I n v esti gat or or 
dele gate d trai n e d staff, i n cl u di n g b ut n ot li mite d st u d y n urses a n d p h ysicia n as sista nts, will 
assess t he se verit y of l oc al s ki n reacti o ns i n d uce d b y t he I M P at eac h site visit d uri n g t he 
p h ysical e xa mi nati o n a n d p h ot os s h o ul d be ta ke n d uri n g t he site visits b y t he me dical staff 
t o d oc u me nt t hese l ocal s ki n reacti o ns (see Secti o ns 6. 2. 4  a n d 6. 2. 6 ). 
I n a d diti o n, a n y occ urre nce of s pecific a p plicati o n  site reacti o n will als o be s olicite d at 
eac h st u d y visit a n d p h o ne c o ntact a m o n g a pre -s pecifie d list of s y m pt o ms (see Secti o n 
6. 2. 1. 1 ). 
6. 2. 1. 3. 5  A d verse E v e nts of S peci al I nt erest  
A d verse E v e nts of S peci al I nt erest  ( A E SI) t o t he S p o ns or are defi ned  as f oll o ws: 

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L oc al A E SI:  A n y reacti o n at patc h a p plicati o n site w hic h c o ul d p ote ntiall y lea d t o a s ki n 
barrier disr u pti o n, s uc h as b ut n ot li mite d t o, blister, vesicle, ul cerati ve s ki n lesi o n, 
blee di n g or a n y G ra de 4 patc h site reacti o n. 
S ki n reacti o ns will be e xa mi ne d at t he ti me  p oi nts s pecifie d i n t he Sc he d ule of Pr oce d ures 
(pa ge 1 5 ) acc or di n g t o gra di n g i n Ta ble  3  ( Secti o n 6. 2. 6 ). S u bject’s pare nts/ g uar dia ns will 
be i nstr ucte d t o ta ke a p h ot o gra p h i n case of a p peara nce of a n y vesicles or ulcerati ve s ki n 
lesi o ns. I n t hese rare s pecific cas es, s u bjects s h o ul d tra nsie ntl y disc o nti n ue patc h 
a p plicati o n a n d ret ur n t o t he site f or e val uati o n a n d treat me nt of t h e w o u n de d area, as well 
as f or t he ne xt patc h a p plicati o n a n d a de q uate e v al uati o n a n d treat me nt of t he w o u n de d 
z o ne.  
U p o n re -a p plicati o n of t h e ne w patc h, t h e s u bject  s h o ul d re mai n at t h e site f or 1 h o ur b ef ore 
bei n g disc har ge d. T h e site m ust c o ntact t he s u bject’s pare nts/ g uar dia ns b y p h o ne t he da y 
after t his visit t o e ns ure t hat n o a d diti o nal l ocal blisters or vesicles de vel o pe d a n d t o 
c o nfir m t hat t he treat me nt ca n c o nti n ue n or mall y.  T he z o ne wit h vesicles or se vere lesi o ns 
s h o ul d n ot be use d f or patc h a p plicati o n u ntil it has c o m pletel y heale d.  
L oc al A E SI s h o ul d N O T  be re p orte d o n t he s pecific A E SI f or m of t he e C R F . T his 
s pecific A E SI f or m is o nl y t o be use d f or s yste mic A E SI (see b el o w).  
S yste mic A E SI : A n y ac ute s yste mic i m me diate aller gic reacti o ns (ra pi d o nset) after 
e x p os ure t o a k n o w n or s us pecte d aller ge n re gar dless of t he ca usal relati o ns hi p t o t he I M P, 
a n d occ urri n g o utsi de t he D B P C F Cs : 
1.  A na p h ylactic reacti o n:  
o  A n y A E dia g n ose d b y p h ysicia n as a n a na p h ylactic reacti o n, re g ar dless of 
t he se verit y a n d ca usal r elati o ns hi p t o t he I M P.  
o  A na p h ylactic reacti o n defi ne d as t he occ urre nce of t he f oll o wi n g aller gic  
s y m pt o ms:  
− Maj or ac ute aller gic reacti o n (ass ociate d or n ot wit h ot her s y m pt o ms): 
ac ute h y p ote nsi o n ( > 2 0 % dr o p i n  bl o o d press ure) or ass oci ate d 
car di o vas c ular s y m pt o ms ( h y p ot o nia, c o nf usi o n, l oss of c o ns ci o us ness, 
c olla pse, s y nc o p e, i n c o nti ne nce); 
− 2 or m ore c o nc o mita nt  ac ute aller gic s y m pt o ms fr o m at least 2 differe nt 
or ga n s yste ms s uc h as, b ut n ot li mite d t o:  
▪ U p per air wa y or res pirat or y s y m pt o ms ( d ys p nea, 
w heeze -
br o nc h os pas m, stri d or, h y p o xe mia, decreas e d Sa O 2) 
▪ A c ute a n d p ersiste nt gastr o -i ntesti nal s y m pt o ms (a b d o mi nal pai n, 
cra m ps, v o miti n g ) 
▪ Ac ute s ki n or m uc osal tiss ue s y m pt o ms (a n gi oe de ma, urticaria, 
pr urit us, fl us h, s w olle n li ps -t o n g ue-u v ul a) 
▪ A c ute car di o v asc ular s y m pt o ms ( h y p ot o nia, re d u ce d bl o o d 
press ure ) 
2.  A n y s yste mic h y perse nsiti vit y reacti o n  lea di n g t o e pi ne p hri ne i nta ke 
A n y A E f ulfilli n g t he a b o ve defi niti o n m ust be tic ke d as a n A E SI i n t he A E f or m of t he 
e C R F. I n a d diti o n, t hes e A E SI m ust be d oc u me nte d a n d re p orte d o n a s p ecific s yste mic 
A E SI f or m b y th e In v esti gat or o n a n  o n g oi n g basis (g ui da nce a n d precis i o ns will be gi ve n 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
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i n t he e C R F Co m pleti o n G ui deli nes ). T hese s pecific s yste mic A E SI f or ms m ust be 
c o m plete d a n d se nt b y t he i n vesti gat or wit hi n 2 4 h o urs of t h e site b ec o mi n g a ware of t he 
e ve nt.  
P ote ntial a na p h ylactic reacti o ns  will be i de ntifie d b y d e dicate d Sta n dar di ze d Me d D R A 
Q ueries ( S M Q) al g orit h ms. Cases retrie ve d b y t he al g orit h m will t he n be c o nfir me d b y 
me dical re vie w.  
6. 2. 1. 3. 6  S y m pt o ms d uri n g t o t he D o u ble -bli n d, Place b o -C o ntr olle d F o o d C halle n ge  
T he se verit y of t he o bj ecti ve a n d s u bjecti ve s y m pt o ms e licite d d uri n g t he e ntr y a n d 
p ost -treat me nt D B P C F C will be ass esse d b y t he I n vesti gat or. T hes e o bjecti ve a n d 
s u bjecti ve s y m pt o ms assesse d b y t he I n vesti gat or 
will n ot be re p orte d as si n gle 
i n de pe n de nt A E i n t he A E pa ges of t he e-C R F. C o m plete i nf or mati o n f or all t hese 
s y m pt o ms will be re p orte d i n t he D B P C F C pa ges of t he e-C R F, al o n g wit h all pea n ut 
pr otei n d oses gi ve n, t he s y m pt o ms o bser ve d, t he ti me of a p peara nce of t he s y m pt o ms a n d 
t heir s pecifi c gra des, t he ti me of gra de c ha n g e of eac h s y m pt o m , t he d oses of e pi ne p hri ne 
gi ve n, t he d oses of c ortic oster oi ds a n d a nti hista mi nes gi ve n a n d t he I n vesti gat or’s 
assess me nt of t he pea n ut E D as well as t he pea n ut c u m ulati ve d ose. If, as per t h e 
I n v esti gat or’s j u d g me nt, t he c o m bi nati o n of all t hese s y m pt o ms res ulte d i n a n a na p h yla xis 
re q uiri n g a pr ol o n ge d ( mi ni mall y o ver ni g ht) h os pitalizati o n, t he n t his will be c o nsi dere d 
a n S A E. A n y s uc h S A E wit h its s pecific ver bati m  (e. g. ‘ d uri n g f o o d c halle n ge’ or ‘ d ue t o 
f o o d c halle n ge’) m ust be re p orte d i n t he A E p a ges of t he e -C R F.  
6. 2. 1. 4  Rec or di n g A dvers e Eve nts  
A d verse e v e nt re p orti n g will start at t he si g nat ure of t he i nf or me d c o nse nt f or m (I C F) a n d 
e n d after t he 2 -w ee k f oll o w -u p peri o d ( V isit 1 2: E n d of St u d y Visit).  
D uri n g t he scree ni n g peri o d (t hat is, fr o m t he ti me of I C F si g nat ur e t hr o u g h Da y -1), o nl y 
S A Es will be rec or de d i n t he e -C R F; a n d  A E s t hat d o n ot meet a n y s eri o us n ess criteri a will 
o nl y be d oc u me nte d i n t h e s u bject’s s o urce d oc u m e nts.  
A d verse e ve nts occ urri n g after t h e e n d of t he st u d y s h o ul d be re p orte d t o t he S p o ns or b y  
t he I n v esti gat or if t he I n vesti gat or c o nsi ders t hat t here is a ca us al relati o ns hi p wit h t he 
I M P.  
A d verse e ve nts still o n g oi n g at t he ti me of t h e E n d of St u d y Visit will be f oll o we d u p f or 
a n a d diti o nal 3 0 da ys, or u ntil t he y res ol ve or sta bilize, w hic he v er c o mes first.  
All A E s occ urri n g o n or after t he da y of t he first d ose of I M P, re g ar dless of t he relati o ns hi p 
t o t he I M P, will be rec or de d i n t he e-C R F.  
All A E re p orts i n t he e -C R F s h o ul d c o ntai n t he f oll o wi n g i nf or mati o n of t he e ve nt: dat e 
a n d ti me of o n set, date a n d ti me of res ol uti o n, se verit y, treat me nt re q uir e d, relati o ns hi p t o 
I M P, acti o n ta ke n wit h t he I M P, o utc o me, a n d w het her t he e ve nt is classifie d as seri o us or 
n ot.  
6. 2. 1. 5  Re p orti n g Seri o us A dverse Eve nts  a n d A E SI of all er gic syste mic r e acti o n  
•  All S A Es m ust be re p orte d wit hi n 2 4 h o urs of t he site bec o mi n g a ware of t he e ve nt 
b y filli n g i n t he S A E pa ges i n t he e -C R F. I n cas e of tec h nical iss ues wit h t he e -
C R F, t he re p orti n g ca n b e d o ne b y se n di n g a c o m plete d  S A E Re p ort F or m t o t he 
D B V Gl o bal Safet y a n d P har mac o vi gila nce tea m  at t he e mail a d dress  i n dicate d o n 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
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t he S A E Re p ort : 
 T his mail b o x is 
m o nit ore d f or a n y i nc o mi n g S A E re p ort. 
T he mi ni m u m i nf or mati o n re q uire d f or a n i nitial re p ort is: 
•
Na me of pers o n se n di n g t he re p ort (t hat is na me a n d a d dress of
I n v esti gat or);
•
S u bject i de ntificati o n (scree ni n g n u m ber, N O T t h e s u bject’s na me);
•
Pr ot oc ol n u m ber;
•
Descri pti o n of t he S A E i ncl u di n g a c o m pre h e nsi ve ver bati m ter m;
•
Ca usalit y assess me nt.
H o we ver, as far as p ossi ble all p oi nts i n t he S A E pa ges i n t he e -C R F ( or o n t he 
S A E Re p ort F or m, i n case of tec h nical iss ues wit h t he e -C R F) s h o ul d be c o vere d 
i n t he i nitial re p ort. If a n S A E occ urs d uri n g t he D B P C F C, t he ver bati m of t he S A E 
m ust s pecif y “ d uri n g t he D B P C F C” or “ d ue t o t he D B P C F C” b ot h o n t he S A E 
Re p ort F or m a n d i n t he S A E pa ges of t h e e -C R F.  
•
T reat me nt e mer g e nt s yste mic A E SIs defi n e d i n t he e -C R F C o m pleti o n G ui deli ne s
pr o vi de d t o t he I n vesti gat or a n d re g ar dless of t heir ca usal relati o ns hi p t o t he I M P
m ust als o be re p orte d wit hi n 2 4 h o urs of t he site b ec o mi n g a ware of t he e v e nt , b y
filli n g t he s yste mic A E SI s pecifi c re p ort f or m i n t he e-C R F. I n cas e a s yste mic
aller gic reacti o n is ass oci ate d wit h a seri o us n ess criteria, a n S A E re p ort f or m m ust
be c o m plete d i nstea d.
S p o ns or will eit her directl y or t hr o u g h c o ntracte d ser vice pr o vi ders s u b mit e x pe dite d a n d 
peri o dic re p orts t o b ot h C o m pete nt A ut h orities  a n d Et hics C o m mittee s as per re g ulati o ns 
a n d pr oce d ures i n f orce, t a ki n g i nt o acc o u nt l ocal s pecific re q uire me nts.  
S A Es t hat are b ot h relate d (acc or di n g t o t he s p o ns or a n d/or  t he i n vesti gat or) t o 
i n vesti gati o nal me dici nal pr o d uct a n d u ne x p ecte d (acc or di n g t o s p o ns or a n d base d o n t he 
i n vesti gati o nal pr o d uct Refere n ce Safet y I nf or m ati o n i n use) will us uall y be assesse d as 
re p orta ble b y t h e S p o ns or t o C o m pete nt A ut h orities. 
W ai ver t o e x pe dite d re p orti n g: 
I n case a n a na p h yla ctic reacti o n is e x perie nce d d uri n g t he D B P C F C a n d assesse d as seri o us 
b y t he i n vesti gat or, t his e ve nt s h o ul d be re p orte d wit hi n 2 4 h o urs of a ware ness b y t he 
i n vesti gati o nal site as f or ot her S A Es. Aller gi c reacti o ns are v ol u ntaril y tri g gere d b y a n 
“aller ge n ” pr ot ei n matri x ( place b o matri x or “aller ge n” pr otei n matri x) d uri n g t he 
D B P C F C pr oce d ures a n d a na p h yla xis are  elicite d e ve nts . T hese a na p h yl actic reacti o ns 
will be c o nsi dere d as e x pecte d, if n ot lea di n g t o deat h ( See A P P E N DI X 9  f or Refere nce 
Safet y I nf or mati o n relat e d t o D B P C F C pea n ut pr otei n matri x). Seri o us a na p h ylactic 
reacti o ns ass esse d as rel ate d t o t he D B P C F C will n ot be s u bject t o e x pe dite d re p orti n g, 
u nless t he y lea d t o deat h.  
6. 2. 1. 6  F oll o w -u p of A dverse Eve nts  
All A Es e x perie nce d b y a s u bject, irres pecti ve of t h e s us pect e d ca us alit y, will be m o nit ore d 
u ntil t he A E has res ol ve d, a n y a b n or mal la b orat or y val ues ha ve ret ur ne d t o baseli ne or 
sta bilize d at a le vel acce pta ble t o t he I n v esti gat or a n d Me dical M o nit or, u ntil t here is a 
C CI

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
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satisfact or y e x pla n ati o n f or t he c ha n ges o bserve d, u ntil t he s u bject is l ost t o f oll o w -u p, or 
u ntil t he s u bject has die d.  
6. 2. 1. 7  Tre at me nt of Over d ose of St u dy Me dic ati o n  
O ver d ose is defi ne d as t he c o nc o mit a nt a p plic ati o n of 2  Vias ki n ® patc hes or m ore o n t he 
s ki n of t he s u bject, w hate ver t he d urati o n of t h e c o nc o mita nce of t he m ulti ple patc h 
a p plicati o n.  
O ne pat c h a p plie d t he sa me da y after t he pre vi o us patc h was re m o ve d or has falle n off is 
N O T a n o ver d ose.  
N o s pecific tr eat me nt f or o ver d osi n g is k n o w n. T he first acti o n will be t o re m o ve a n y 
a d diti o nal patc h  fr o m t he s ki n, lea vi n g o nl y 1 patc h o n t he s ki n . Treat m e nt gi ve n t o a 
s u bject i n case of o ver d osi n g s h o ul d be s y m pt o matic a n d s u p p orti ve.  
All o ver d ose cases s h o ul d be re p ort e d i n t he s u bject’s e -C R F.  
A n y case of o ver d ose , e v e n if it is n ot ass ociate d wit h  a n y A E , s h o ul d be rec or de d i n t he 
A E secti o n of t he e -C R F. A n y A Es / S A Es ass ociate d wit h t he o ver d ose s h o ul d be re p orte d 
i n t he c orres p o n di n g e -C R F  secti o n. 
6. 2. 2  L a b or at ory V ari a bles  
La b orat or y assess me nts will be perf or me d b y a ce ntral la b orat or y, as i de ntifie d i n t he List 
of St u d y Pers o n nel.  
Ve n o us bl o o d sa m ples will be ta ke n f or he m at ol o g y a n d bi oc he mistr y testi n g.  
T he f oll o wi n g la b orat or y varia bles will be deter mi ne d i n acc or da n ce wit h t he Sc he d ule of 
Pr oce d ures  (pa ge 1 5 ): 
•  He mat ol o g y: C o m plete bl o o d c o u nt: he m o gl o bi n, he mat ocrit, platelets, re d bl o o d 
cells, w hite bl o o d cells wit h differe ntial cell c o u nt;  
•  Bi oc he mistr y: ala ni ne a mi n otra nsferase, as p artate a mi n ot ra nsferase, t otal bilir u bi n, 
t otal pr otei n, bl o o d urea nitr o ge n, creati ni ne; 
Details of t he pr oce d ures t o be f oll o we d f or sa m ple c ollecti o n, st ora ge, a n d s hi p me nt will 
be d oc u me nte d i n t he L a b orat or y Ma n u al.  
Cli nicall y si g nifica nt c ha n ges (a b n or malities) i n la b orat or y para m eters, i n t he j u d g me nt of 
t he I n v esti gat or, will be rec or de d as A Es a n d a p pr o priate c o u nter meas ures ta ke n. 
I n t he e ve nt of u ne x plai ne d a b n or mal la b orat or y test val ues of cli nical si g nifica nce, t he 
tests s h o ul d be re peate d at a reas o na bl e ti me p oi nt a n d f oll o we d u p u ntil t he y ha ve ret ur n e d 
t o t he n or mal ra n ge a n d/ or a n a de q u ate e x pl a nati o n of t he a b n or malit y is f o u n d. 
T he bl o o d v ol u me dra w n f or all t he bl o o d a nal yses ( he mat ol o g y, bi oc he mistr y, 
i m m u n ol o gical mar kers, e pi ge netic a nal yses  a n d B A T ) e q uals t o 7. 5  m L  ( 8. 5 m L i n U S 
sites eli gi ble f or B A T) f or eac h of t he 4 bl o o d s a m pli n gs ta ke n al o n g t he st u d y. T he t otal 
bl o o d v ol u me f or t he 1 2 -m o nt h d urati o n of t he st u d y is 3 0  m L  ( 3 4 m L f or U S sites eli gi ble 
f or B A T). A d diti o nal a n d re peat la b orat or y safet y testi n g o utsi de t he st u d y ma y be 
perf or me d at t he discreti o n of t he I n vesti gat or.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
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6. 2. 3  Vit al Si g ns  
T he f oll o wi n g vital si g ns will be assesse d i n acc or da nce wit h t he Sc he d ule  of Pr oce d ures 
(pa ge 1 5 ): 
•  Bl o o d press ure (s yst olic a n d diast olic; m m H g),  
•  Heart rate ( b eats per mi n ute),  
•  Res pirati o n rate ( breat hs per mi n ute).  
S yst olic bl o o d press ure a n d diast olic bl o o d press ure will b e meas ure d i n sitti n g p ositi o n 
o n t he sa me ar m after t h e s u bject has bee n resti n g.  
Heart rate will be rec or de d si m ulta ne o usl y wit h bl o o d press ure meas ure me nts, f oll o we d 
b y res pirat or y rate.  
D uri n g  t he st u d y, t he meas ure me nt of vital si g ns ma y be re p eate d at t he discreti o n of t he 
I n v esti gat or f or s afet y reas o ns. Cli nicall y rele va nt a b n or mal fi n di n gs will be re p ort e d as 
A Es.  
Vital si g ns m ust be assesse d bef ore t he D B P C F C. A d diti o nal assess me nts ca n b e re peate d 
d uri n g t he D B P C F C pr oce d ure o n b ot h da ys at a n y ti me if j u d ge d n ecessar y b y t he 
I n v esti gat or. 
6. 2. 4  P hysic al E x a mi n ati o ns  
P h ysical e xa mi nati o ns will be perf or me d i n acc or da nce wit h t he Sc he d ule of Pr oce d ures 
(pa ge 1 5 ).  
P h ysical e xa mi nati o ns will be perf or me d b y a p h ysicia n or dele gate d staff pr o perl y trai ne d 
t o perf or m s uc h e x a mi nati o n, i ncl u di n g b ut n ot li mite d t o st u d y n urses a n d p h ysicia n 
assista nts , a n d wil l i ncl u de t he f oll o wi n g:  
•  Ge neral a p peara n ce,  
•  Hea d, ears, e y es, n ose a n d t hr oat,  
•  Nec k,  
•  C o m plete s ki n e xa mi nati o n,  
•  Car di o vasc ular s yste m,  
•  Res pirat or y s yste m,  
•  A b d o mi nal s yste m,  
•  Ner v o us s yste m,  
•  B o d y wei g ht ( k g),  
•  Hei g ht (c m).  
B o d y wei g ht will be meas ure d wit h o ut s h oes, jac ket, or dia per a n d per Sc he d ule of 
Pr oce d ures a n d as fre q ue ntl y as necessar y.  
Hei g ht will be meas ure d wit h o ut s h oes a n d per Sc he d ule of Pr oce d ures a n d as fre q u e ntl y 
as necess ar y f or t his p o p ulati o n of s u bjects i n acti ve gr o wt h.  
F or eac h b o d y s yste m, a n assess me nt of n or mal or a b n or mal will be rec or de d i n t he e -C R F 
at scree ni n g a n d t he a b n or malit y will be d oc u me nte d. Besi des, t he s ki n as pect will be 
gra de d f or t he sites of pat c h a p plicati o n (see Secti o n  6. 2. 6 ). 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
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P h ysical e xa mi nati o ns m ust be perf or me d bef ore t he D B P C F C. A d diti o nal assess me nts 
ca n be re p eate d d uri n g t he D B P C F C pr oce d ure o n b ot h da ys at a n y ti me j u d ge d necess ar y  
b y t he I n vesti gat or.  
Cli nicall y si g nifica nt c ha n ges (a b n or malities) i n p h ysical e x a mi nati o n fi n di n gs, i n t he 
j u d g me nt of t he I n vesti g at or, will be rec or de d as A Es a n d a p pr o priate c o u nter meas ures 
ta ke n. 
6. 2. 5  S u bject Di aries  
S u bject diaries will be pr o vi de d t o e ac h s u bject’s pare nt/ g uar dia n  t o re p ort s pecific 
i nf or mati o n bet wee n visits as f oll o ws: s u bjects’ p are nts/ g uar dia ns will be as ke d t o rec or d 
o n a d ail y basis i n t he diaries t he ti me of a p plicati o n a n d re m o val of eac h Vias ki n ®  patc h, 
al o n g wit h t he reas o n f or a n y earl y re m o val (s h o ul d t hat occ ur). T he y will als o rec or d t he 
gra de of a n y o bser ve d l oc al s ki n reacti o ns t o t he Vias ki n ®  patc h ( gra di n g scale 0 t o 3, n o ne, 
mil d, m o derate or se vere).  
Defi niti o ns of t he gra di n g of eac h s y m pt o m are pr o vi de d i n t he diar y  as prese nte d i n Ta ble 
2 . 
T a ble 2 : Gr a di n g of L oc al S ki n Re acti o ns b y t he P are nts/ G u ar di a ns 
Gr a de L oc al  
Itc hi n g L oc al 
Re d ness L oc al  
S welli n g  
1 = Mil d  
Itc hi n g easil y beara ble, 
pai nless, occasi o nal 
scratc hi n g l ocalize d u n der 
t he Vias ki n®  patc h areas.  
Mil d re d ness ( pale pi n k) 
l ocalize d u n der t he 
Vias ki n ®  patc h areas.  
S welli n g l ocalize d u n der 
t he 
Vias ki n ®  patc h areas.  
2 = M o derate  
Itc hi n g wit h i nter mitte nt 
scratc hi n g, possi bl y u p t o 2 
mi n utes  eac h l ocalize d 
u n der t he Vias ki n ®  patc h 
areas.  
Re d ness m ore i nte nse 
( bri g hter pi n k t o re d), 
a n d/ or re d ness e xte n di n g 
be y o n d t he Vias ki n ®  
patc h areas.  
S welli n g e xte n di n g be y o n d 
t he Vias ki n®  patc h areas.  
3 = Se vere  
S prea di n g i nte nse itc hi n g 
res ultin g i n c o nti n u o us 
scratc hi n g u n beara ble, 
i nterferi n g wit h dail y 
acti vities. Re q uiri n g 
treat me nt. 
Ver y i nte nse re d ness/ras h 
a n d/ or re d ness lar gel y 
e xte n di n g be y o n d t he 
Vias ki n ®  patc h areas.  
Lar ge s welli n g area 
e xte n di n g be y o n d t he 
Vias ki n ®  patc h areas.  
T hese t hree  pre -s pecifie d s y m pt o ms at patc h a p pli cati o n sites  (itc hi n g, re d n ess, s welli n g) 
will be gra de d o n a d ail y basis i n t he diaries , d uri n g t he first 6 m o nt hs f or part A s u bjects, 
a n d d uri n g t he w h ole tr eat me nt d urati o n f or p ar t B s u bjects. S u bjects’ pare nts/ g uar dia ns 
will als o be i nstr ucte d t o rec or d i n t he diaries a n y ot her A Es (i ncl u di n g a n y l ocal s ki n 
reacti o ns ot her t ha n t he 3 pre -s pecifie d o n es at a n y ti me of t he st u d y, a n d a n y pre-s p ecifie d 
l ocal s ki n reacti o ns occ urri n g after t h e i nitial 6  m o nt hs of treat me nt  f or part A s u bjects), 
a n d a n y c o n c o mita nt me dicati o n or treat me nt ta k e n f or a n y t y p e of A Es . 
T he site me dical staff will re vie w t he s u bject’s diar y at eac h s u bject visit.  
•  F or part A s u bjects : the 3 pre -s p ecifie d s y m pt o ms s olicite d d uri n g t he first 
6  m o nt hs  will n ot be re p orte d b y t he In vesti gat ors i n t he A E pa ges of t he e -C R F, 
e xce pt if t hese s y m pt o ms are p art of a n ot her c o nc o mita nt disease or if t hese 
s y m pt o ms are lea di n g t o t he s u bject’s st u d y disc o nti n uati o n or seri o us A Es.  A n y 
ot her l ocal s ki n reacti o ns or a n y ot her t y pe of a d verse e ve nts s p o nta n e o usl y 
re p orte d i n t he diaries will be re p orte d b y t he In vesti gat ors i n t he A E e -C R F f or m. 
After m o nt h 6, a n y A E, i ncl u di n g t he 3 a b o ve s y m pt o ms, ot her l ocal s ki n reacti o ns 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
7 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
or a n y ot her t y pe of A E will be re p orte d i n t he de dicate d secti o n of t he diaries. 
T hese A Es will be re p ort e d b y t he In vesti gat ors i n t he e -C R F.  
•
F or part B s u bjects:  t he 3 pre -s pecifie d s y m pt o ms s olicite d d uri n g t he w h ole
treat me nt d urati o n will be re p orte d b y t he I n v esti gat ors as A Es i n t he e -C R F,
re gar dl ess of t heir se verit y ( mil d, m o derate or se vere) or seri o us ness. T he diaries
will  be als o use d t o s u p ple me nt  a d diti o nal s p o nta ne o usl y re p orte d e ve nts b y t he
pare nts w hic h will be re vie we d a n d assesse d  at eac h visit b y t he I n v esti gat ors  or
dele gate d tr ai ne d staff , i ncl u di n g b ut n ot li mite d t o st u d y n urses a n d p h ysicia n
assista nts .
S u bjects’ pa re nts/ g uar dia ns m ust bri n g bac k t he di ar y t o t he I n v esti gat or at eac h visit, a n d 
t he I n vesti gat or m ust  c h ec k t he di ar y f or  c o m plete ness an d  acc urac y. It  is t h e I n v esti gat ors’ 
res p o nsi bilit y t o i nstr uct t he s u bjects’ pare nts/ g uar dia ns a b o ut t he use of t he diar y, a n d t o 
e ns ure t hat it is acc urat el y c o m plete d. A n y pr o ble ms  wit h c o m pleti n g  t he diary  will  be 
a d dresse d wit h t he s u bjects’ pare nts/ g uar dia ns. All diaries m ust be ret ur ne d t o t he site at 
c o m pleti o n of t he st u d y, or if t he s u bject disc o nti n ues. 
6. 2. 6  S ki n R e acti o n a n d P h ot o gr a p hy 
L oca l s ki n reactio ns u n de r t he Vias ki n ®  pa tc h or o n an y of t he pre vi o us site s of patc h 
a p plicatio n will be a s a w h ole at each visi t acc or di n g t o t he rec o m me n datio ns of t he 
E ur o pea n Aca de m y of Aller g ol o g y a n d Cli nical I m m u n ol o g y ( E A A CI) a n d t he Gl o bal 
Aller g y a n d Ast h ma E ur o pea n Net w or k ( G A 2L E N) ( 4 0 ), a n d m o difie d as f oll o ws: 
T a ble 3: S ki n Re acti o n Gr a di n g S yste m 
S ki n Re acti o n 
Gr a de if l oc alize d 
u n der t he p atc h 
Gr a de if e xte n di n g 
be y o n d t he p atc h  
Ne g ati ve  
Gra de 0  
Gra de 0  
O nl y er yt he ma, or er yt he ma a n d i nfiltrati o n 
Gra de 1 A  
Gra de 1 B  
Er yt he ma  a n d  fe w pa p ules 
Gra de 2 A  
Gra de 2 B  
Er yt he ma  a n d  ma n y or s prea di n g pa p ules  
Gra de 3 A  
Gra de 3 B  
Er yt he ma  a n d  vesicles  
Gra de 4 A  
Gra de 4 B  
T he Vias ki n ®  patc h is tr a ns pare nt a n d t h e de gree of t he l ocal reacti o ns u n der t he Vias ki n ®  
patc h ca n be easil y see n t hr o u g h t he patc h. Gra di n g of t he l ocal s ki n reacti o ns o n t he bac k 
will start bei n g rec or de d at Visit  4 ri g ht after t he Vi as ki n ®  patc h h as bee n a p plie d a n d w hile 
t he s u bject is k e pt at site u n der o bser vati o n a n d s u bse q ue ntl y w he n s u bjects ret ur n at site 
f or t heir visits.  
D uri n g Visit  4, t he first Vias ki n ®  patc h will be a p plie d at t he st u d y site f or 2 h o urs. T he 
p atc h will t he n be re m o v e d after 2 h o urs a n d all s u bjects will be o bser ve d f or 1 a d diti o nal 
h o ur bef ore bei n g disc har ge d. T he reacti o ns u n der or ar o u n d t he patc h will be c hec k e d a n d 
gra de d : bef ore a p plicati o n, at 3 0  m in utes , 1 h o ur, 2 h o urs d uri n g patc h a p plicati o n  a n d 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
7 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
t he n 1 h o ur after t he pat c h re m o val, bef ore s u bject disc har ge. P h ot o gra p hs will be ta ke n at 
eac h gra di n g ti me p oi nt.  
A p peara nce of a n y vesicl es ( gra d e  4) or ulcerati ve s ki n lesi o ns or a n y ot her si g nifica nt s ki n 
lesi o n see n u n der t he pat c h w hile t he p atc h is still a p plie d o n t he s ki n or u p o n re m o val of 
t he patc h w hic h c o ul d p ote ntiall y lea d t o s ki n barrier disr u pti o n at sites of Vias ki n®  patc h 
a p plicati o ns will be ca uti o usl y ma na ge d a n d f oll o w -u p.  
C hil dre n’s pare nts or g uar dia ns will b e i nstr ucte d t o ta ke a p h ot o gra p h of t he patc h s ki n 
area at h o me i n case of a p peara n ce of a n y vesicles or ulcerati ve s ki n lesi o ns. I n t hese rare 
cases, s u bjects s h o ul d tra nsie ntl y disc o nti n ue  t he patc h a p plicati o n s a n d ret ur n t o t he site 
f or e val uati o n a n d tr eat m e nt of t he w o u n de d area, as well as f or t he n e xt patc h a p plicati o n 
a n d a de q u ate e v al uati o n a n d treat me nt of t h e w o u n de d z o ne.  
U p o n re -a p plicati o n of t he ne w patc h, t he s u bject s h o ul d re mai n at t he site f or 1  h o ur bef ore 
bei n g disc har ge d. T h e a p plica ti o n d urati o n ma y be te m p oraril y a da pt e d if deeme d 
necessar y. T he site m ust c o ntact t he s u bject’s pare nts/ g uar dia ns b y p h o ne t h e da y after t his 
visit t o e ns ure t hat n o a d diti o nal l ocal blisters or vesicles de vel o pe d a n d t o c o nfir m t hat 
t he treat me nt ca n c onti n ue n or mall y.  T h e z o ne wit h vesicles or  se vere lesi o ns s h o ul d n ot 
be use d f or p atc h a p plicati o n u ntil it has c o m pletel y heale d.  
P h ot o gra p hic rec or ds of t he a p plicati o n sites of t he Vias ki n ®  p atc h will be ta ke n a n d 
d oc u me nte d  as  me dical rec or ds or s o urc e d oc u m e nts. T he s u bject’s face will n ot, at a n y 
ti me, be ca pt ure d i n t h e p h ot o gra p h. Ca mera or a s pecifi c d e vice a n d ph ot o gra p h y 
ac q uisiti o n g ui deli nes will be pr o vi de d t o t he sites, s o t hat p h ot o gra p h y pr ocess ca n be 
sta n dar dize d as m uc h as p ossi ble. All t he p h ot o gra p hs will be d o w nl oa de d b y t he site staff 
o nt o a de dicate d sec ure d ser ver wit h a restricti ve access t o t he site staff me m bers, t he 
S p o ns or me m bers a n d S p o ns or re prese ntati ves.  
P h ot o gra p hic rec or ds will be ma de a v aila ble t o t he D S M B me m bers u p o n re q uest.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
7 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
T he f oll o wi n g i nf or mati o n will be s yste maticall y c ollecte d d uri n g t he visits:  
•  T he ea s e of re m o val of t he patc h ( v er y eas y/ eas y / diffic ult / ver y diffic ult);  
•  T he gra di n g w het her t he re m o val of t he patc h was pai nf ul ( ver y pai nf ul / pai nf ul / 
n ot pai nf ul);  
•  T o s pecif y w h et her t he patc h re m o val ca use d s ki n i nj ur y ( yes / n o);  
•  T he s us pecte d ca use of a d hesi o n iss ue s, if a n y. 
T he d urati o n of a p plicati o n of t he assesse d Vias ki n ®  patc h m ust be n ote d, a n d t he 
assess me nt b y t he site staff will use t he sa me sc ori n g s yste m as a b o ve.  
6. 3  
De m o gr a p hics a n d B aseli ne C h ar acteristics  
De m o gra p hics a n d bas eli ne c haracteristics c o nsist of t h ose varia bles t hat are assesse d o nl y 
at scree ni n g/ baseli ne. 
6. 3. 1  P atie nt De m o gr a p hy  
Patie nt de m o gra p h y c o nsists of:  
•  A ge a n d dat e of birt h at s cree ni n g Visit 1,  
•  Race , w he n e ver t he c ollecti o n is all o we d b y l ocal re g ulati o n, 
•  Se x.  
6. 3. 2  Dise ase Hist ory a n d Me dic al Hist ory  
Hist or y a n d d urati o n of pea n ut aller g y  wit h well -d oc u me nte d I g E -me di ate d s y m pt o ms 
after i n gesti o n of p ea n ut m ust be re p orte d i n t he disease hist or y f or m i n t he e -C R F.  
T he d oc u me ntati o n of t h e c o m plete me dical hist or y will i ncl u de hist or y a n d d urati o n of 
a n y ot her aller gies a n d c urre nt me dical c o n diti o ns, a n y aller gic reacti o ns ( ot her t ha n p ea n ut 
I g E-me diate d s y m pt o ms) i n t he pre vi o us 1 2 m o nt hs, past or prese nt car di o vasc ular, 
res pirat or y (i ncl u di n g ast h ma), gastr oi ntesti nal, re nal, he patic, ne ur ol o gical, e n d ocri ne, 
l y m p hatic, he mat ol o gic, i m m u nol o gic, der mat ol o gical (i ncl u di n g at o p y), ps yc hiatric, 
de vel o p me ntal, a n d ge nit o uri nar y dis or ders, dr u g a n d s ur gical hist or y a n d a n y ot h er 
diseases or dis or ders.  
T he disease a n d 
me dical hist ories will be o btai ne d b y i nter vie wi n g t he s u bject’s 
pare nts/ g uar dia ns a n d/or b y i ns pecti n g her/ his me dical rec or ds.  
F or c o di n g of dis ease/ me dical hist or y, see Secti o n  9. 7 . 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
7 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
6. 3. 3  Pri or a n d C o nc o mit a nt Me dic ati o ns  
Pre vi o us a n d c o nc o mita nt me dicati o ns will be d oc u me nte d as descri be d i n Secti o n  5. 7 . 
6. 4  
E x pl or at or y V ari a bles  
6. 4. 1  I m m u n ol o gic al M ar kers 
Ve n o us bl o o d sa m ples will be dra w n t o as sess t he i m m u n ol o gical mar kers (p ea n ut -s pecific 
I g E a n d I g G 4; I g E a n d I g G 4 s pecifi c t o eac h of t he f oll o wi n g pea n ut pr ot ei n c o m p o ne nt : 
Ara  h  1, Ara  h  2  a n d Ara  h  3 ; a n d t otal I g E  [t otal I g E: f or Part B s u bjects o nl y] ) at t he visits 
s pecifie d i n t he Sc he d ul e of Pr oce d ures (pa g e 1 5 ).  
T he f oll o wi n g i m m u n ol o gical mar kers will als o be assesse d at s pecific ti me p oi nts  
( Visits 1 a n d 1 0) : I g E s p ecific t o c o w’s mil k, e g g, h o use d ust mites, a n d grass p olle n. 
A nal ysis of sa m ples will be c o n d uct e d b y a ce ntr al  la b orat or y a n d t he res ults at a n y ti me 
p oi nt after b aseli ne will be bli n de d u ntil t he data are u n bli n de d at t he st u d y e n d. F urt her 
details of t he pr oce d ures t o be f oll o we d f or sa m pl e c ollecti o n, st or a ge, a n d s hi p me nt will 
be d oc u me nte d i n t he L a b orat or y Ma n u al.  
6. 4. 2  S ki n Pric k Test  
Pea n ut e xtract pl us ne gati ve sali ne c o ntr ol a n d p ositi ve hista mi ne c o ntr ol will be use d f or 
s ki n pric k testi n g. All materials ( S ol u Pric k ®  s ol uti o ns a n d a ncillar y materials, C E mar ke d) 
will be pr o vi de d free of c har ge ce ntrall y t o all sites b y t he S p o ns or, i ncl u di n g a detaile d 
pr oce d ure f or c o n d ucti n g t he S P Ts.  
T he s u bjects s h o ul d w as h o ut a n y a nti hista mi nes f or t he mi ni m u m peri o d of ti me (s pecifie d 
i n t he ta ble i n A P P E N DI X 3 ) pri or t o p erf or mi n g t he test. Briefl y, a s ki n D u oti p II®  test is 
presse d t hr o u g h a s m all dr o p of t he c o m mercial e xtract of pea n ut or p ositi ve a n d ne g ati ve 
c o ntr ols i nt o t he e pi der mis of t he v olar s urface of t he f orear m .  
After 1 5  mi n utes t he area will be meas ure d b y t he l o n gest w heal dia meter ( D 1) a n d t he 
l o n gest per pe n dic ular dia meter ( d 2). T h e A vera ge w heal dia meter = ( D 1 + d 2) / 2. 
e. g. 
D 1: size of t he l o n gest di a meter i n m m  
d 2: size of t he l o n gest per pe n dic ular di a meter t o D 1 i n m m  
 
 
 
 
A traci n g s h o ul d be o bt ai ne d b y usi n g a fi ne ball p oi nt pe n. T he traci n g will be perf or me d 
at t he de marcati o n li ne f or t he w heal as t he s ki n dr o ps bac k t o fl us h. Sc otc h or a clear 
tra ns p ort ta pe s h o ul d be use d t o lift t h e tr aci n g; t he ta pe traci n g s h o ul d be place d o n a 
s pecific f or m a n d file d as part of t he s u bject’s s o urce d oc u me nt ati o n.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
7 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
6. 4. 3  Q u alit y of Life Q uesti o n n aire s 
6. 4. 3. 1  F o o d Aller gy Q u alit y of Life Q ue sti o n n aires / F o o d Aller gy I n depe n d e nt 
Me as ure 
T he F A Q L Qs are dise ase-s pecific healt h-relate d q ualit y of life q uesti o n nair es f or s u bjects 
wit h f o o d aller g y. T he y are c o nsi dere d relia ble a n d vali d i nstr u me nts t o meas ure t he 
i m pact of f o o d aller g y o n healt h-relate d q ualit y of life (4 1 ). T he F AI M q uesti o n naires 
ca pt ure t he s u bjects’ e x pectati o n of s o met hi n g ha p pe ni n g beca use of her/ his f o o d aller g y 
(4 2 ). 
At scree ni n g, at M o nt h 1 2  a n d at t he e n d of st u d y visit, t he s u bjects’ pare nts/ g uar dia ns 
will c o m plete t he F A Q L Q/ F AI M q uesti o n naires (i n c o u ntries w here t he tra nslate d 
a n d vali date d q uesti o n naires are a vaila ble a n d use d).  
T he differe nt versi o ns of t he F A Q L Q/ F AI M q uesti o n naire t o be use d b ot h at scree ni n g 
a n d 
M o nt h 1 2 f or eit her s u bjects fr o m Part 
A or s u bjects fr o m Part 
B are 
pr o vi de d i n A P P E N DI X 6 . 
6. 4. 3. 2  Ge neric Q u ality of Life Q uesti o n n aire: E Q- 5 D- 5 L 
At scree ni n g at at M o nt h 1 2, t he s u bjects’ pare nts/ g uar dia ns will c o m plete t he E Q - 5 D- 5 L 
q uesti o n naire. T he q uesti o n naire will be c o m plete d f or s u bjects ra n d o mize d i n Part B 
o nl y. 
T he te m plate q uesti o n naire is pr o vi de d i n A P P E N DI X 1 0 . 
6. 4. 4  Acci de nt al C o ns u m pti o n of Pe a n uts 
S pecific reacti o ns tri g gere d b y acci de ntal c o ns u m pti o n of pea n ut a n d t he c o n diti o ns 
ar o u n d t hat c o ns u m pti o n will be c ollecte d wit h as m uc h detaile d i nf or mati o n as p ossi ble, 
i n partic ular wit h re gar d t o t he nat ure of t he f o o d a n d t he q ua ntit y c o ns u me d. T he 
s u bjects’ pare nts/ g uar dia ns will be as ke d t o clarif y w het her a n y pea n ut c o ns u m pti o n was 
acci de ntal or n ot. T he A Es i n d uce d b y t he c o ns u m pti o n will be classifie d a n d a nal yze d 
se paratel y. 
As far as p ossi ble, a sa m ple of t he f o o d ha vi n g tri g gere d t he reacti o ns will be c ollecte d 
a n d se nt f or a nal ysis of its pea n ut c o nte nt t o a s pecialize d la b orat or y. A s pecific 
pr oce d ure t o or ga nize t he c ollecti o n a n d t he s hi p me nt of t hese sa m ples will be pr o vi de d 
t o t he ce nters a n d t he s u bjects’ pare nts/ g uar dia ns. 
6. 4. 5  E pi ge netic a n alyses 
Ve n o us bl o o d sa m ples will be dra w n t o assess t he e pi ge netic m o dificati o ns i n d uce d b y 
t he E PI T treat me nt wit h D B V 7 1 2 o n t he pr o m oter re gi o ns of ke y ge nes c o di n g f or 
se veral aller g y-s pecific pr otei ns. T he tests will be ma na ge d ce ntrall y a n d t he res ults at 
a n y ti me p oi nt after baseli ne will be bli n de d u ntil t he data are u n bli n de d at t he st u d y e n d. 
Detaile d pr oce d ures t o be f oll o we d f or sa m ple c ollecti o n, st ora ge a n d s hi p me nt will be 
d oc u me nte d i n a s pecific Ma n ual pr o vi de d t o t he sites.  
6. 4. 6  Sc ori n g At o pic Der m atitis 
T he S C O R A D, a sc ori n g i n de x of at o pic der matitis de vel o pe d b y t he E ur o pea n Tas k 
F orce o n At o pic Der matitis ( 4 3 ) will be assesse d as s pecifie d i n t he Sc he d ule of 
Pr oce d ures ( pa ge 1 5 ). 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
7 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
Secti o ns A a n d B m ust be assesse d a n d c o m plet e d b y t he In vesti gat or  or d ele gate d trai ne d 
staff, w hile secti o n C is assesse d b y t he s u bject’s pare nts/ g uar dia ns. Dele gate d staff 
i ncl u des b ut is n ot li mite d t o st u d y n urses a n d p h ysicia n assista nts. 
T he S C O R A D is pr o vi de d i n A P P E N DI X 7 . 
6. 4. 7  B as o p hil Activ ati o n Test  ( Unite d S t ates eli gi ble sites o nly)  
V e n o us bl o o d sa m ples will be dra w n at t he visits s pecifie d i n t he Sc he d ule of Pr oce d ures 
(pa ge 1 5 ) t o assess t he acti vati o n of bas o p hils after  i nc u bati o n of bl o o d  sa m ples wit h 
pea n ut aller ge n  i n vitr o. 
T his test will be c o n d ucte d i n all s u bjects e nr olle d at eli gi ble sites of  t he U S o nl y. 
A nal yses of sa m ples  will be c o n d ucte d  b y a ce ntral la b orat or y , a n d t he res ults at a n y ti me 
p oi nt after b aseli ne will be bli n de d u ntil t he data are u n bli n de d at t he st u d y e n d . F urt her 
details re gar di n g c ollecti o n a n d l ocal pr ocessi n g of sa m ples, sa m ples st ora ge, a n d sa m ples 
s hi p me nt t o t he ce ntral la b orat or y will be pr o vi de d i n a de dicate d La b orat or y Ma n ual.   
6. 4. 8  Ot her C a n di d ate E x pl or at ory Bi o m ar kers  
7  
S T U D Y C O N D U C T  
7. 1  
Sc he d ule of Pr oce d ures  
T he Sc he d ule of Pr oce d u res is prese nte d i n pa ge 1 5 . 
C CI

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
7 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
7. 2  
Pr oce d ures b y Visit  
Visits s h o ul d occ ur wit hi n t he ti me wi n d o ws i n dicate d i n t he Sc he d ule of Pr oce d ures  
( pa ge 1 5 ). All ti mes s h o ul d be rec or de d usi n g t h e 2 4 -h o ur cl oc k ( f or e xa m ple 2 3: 2 0, n ot 
1 1: 2 0  p m).  
7. 2. 1  Visit 1, Scree ni n g ( D ay -4 2 / D-3 ) 
T he first scree ni n g Visit ( Visit  1) wil l ta ke place wit hi n 4 2 da ys pri or t o t he start of t he 
treat me nt peri o d. T heref ore, t he d urati o n of t he scree ni n g peri o d c o ul d be less t ha n 
4 2  da ys.  
T he f oll o wi n g assess me nts will be perf or me d at t his visit:  
•  Writte n i nf or me d c o nse nt , i ncl u di n g s pecific c o nse nt f or p artici pati o n i n t he 
o pti o nal bi ore p osit or y ; 
•  C hec k i ncl usi o n/e xcl usi o n criteri a, e xce pt f or t h ose criteria t h at de p e n d o n t he 
res ults of t he p ea n ut-s pecific I g E assess me nt a n d o n t he o ut c o me of t he 
e ntr y/scree ni n g D B P C F C;  
•  Disease/ Me dical hist or y (see Secti o n 6. 3. 2 );  
•  Pare ntal (fat h er a n d/ or m ot her) me dical hist or y of at o p y (a n y aller gies, ast h ma 
c o n diti o ns, ecze ma/ at o pic der matitis);  
•  De m o gra p hics (see Secti o n  6. 3. 1 ); 
•  P h ysical e xa mi nati o n (i ncl u di n g a c o m plete s ki n e xa mi nati o n; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (see Secti o n 6. 2. 3 ); 
•  S C O R A D (see Secti o n 6. 4. 6 ); 
•  S P T (see Secti o n 6. 4. 2 ); 
•  I m m u n ol o gical mar kers (see Secti o n 6. 4. 1 );  
•  La b orat or y tests (see Secti o n 6. 2. 2 ); if a p plica ble, s u bjects 
wit h a b n or mal 
la borat or y assess me nts d ue t o a c o nc o mita nt tra nsie nt disease (fl u, viral ill ness, 
etc.) ca n re p eat t heir l a b orat or y assess me nts or be res c he d ule d f or la b orat or y 
assess me nt at t he discreti o n of t he I n vesti gat or;  
•  F A Q L Q/ F AI M (see Secti o n 6. 4. 3. 1 ); 
•  E Q -5 D -5 L ( part B o nl y) (see Secti o n 6. 4. 3. 2 ); 
•  C ollect bl o o d sa m ple f or e pi ge netic a n a l yses (see Secti o n 6. 4. 5 );  
•  U S eli gi ble site s o nl y: c ollect bl o o d sa m p le f or B A T (see Secti o n 6. 4. 7 ); 
•  A Es r ec or di n g (i ncl u di n g v ol u nteere d or s olicite d A E s a n d A E SI); 
•  C o nc o mita nt me dicati o ns (see Secti o n 5. 7 ); 
•  Dis pe nse s u bject partici pati o n car d; 
•  Sc he d ule Visit  2.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
7 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
7. 2. 2  Visit  2, Scree ni n g (t hr o u g h D ay  -2)  
Visit  2 c orres p o n ds t o t h e first da y of t he e ntr y/s cree ni n g D B P C F C. T his visit ca n ta ke 
place a n y ti me t hr o u g h Da y  -2, as s o o n as t he pea n ut -s pecific I g E res ults f or t he s u bject 
are o btai ne d b y t h e site  fr o m t he ce ntr al la b orat or y. If t he s u bject f ulfills all i ncl usi o n 
criteria i ncl u di n g t he pea n ut -s pecific I g E v al ue ( > 0. 7 k U/ L), t he n Visit 2 ma y pr ocee d.  
T he f oll o wi n g assess me nts will be perf or me d at t his visit:  
•  P h ysical e xa mi nati o n (i n cl u di n g a c o m plet e s ki n e xa mi nati o n; t o ta ke pl ace bef ore 
D B P C F C; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (t o ta ke place bef ore D B P C F C;  see Secti o n 6. 2. 3 ); 
•  E ntr y/scree ni n g D B P C F C (first da y) (see Secti o n  6 . 1. 1. 3) 
•  A Es rec or di n g (i ncl u di n g v ol u nteere d or s olicite d A Es, A E SIs a n d rec or di n g of 
A Es/aller gies i n res p o nse t o t he D B P C F C);  
•  C o nc o mita nt me dicati o ns (i ncl u di n g a n y me dicati o ns gi ve n t o treat aller gic 
s y m pt o ms; see Secti o n 5. 7 ); 
•  Sc he d ule Visit 3.  
P h ysical e xa mi nati o ns a n d assess me nt of vit al si g ns ca n be re p eate d d uri n g t he D B P C F C 
as dee me d n ecess ar y b y t he I n vesti gat or.  
T he s u bject ma y be disc har ge d after a mi ni m u m o bser vati o n peri o d of 3  h o urs after t he 
last d ose of t h e c h alle n ge f or m ula i n geste d. T h e o bser vati o n peri o d ca n be e xt e n de d 
be y o n d 3  h o urs if dee me d necessar y b y t he I n v esti gat or.  
7. 2. 3  Visit 3, Scree ni n g ( wit hi n 1 wee k of Visit 2 a n d t hr o u g h D ay  -1)  
Visit 3 c orres p o n ds t o t he sec o n d da y of t he e ntr y/scree ni n g D B P C F C. It ta kes place wit hi n 
a wee k f oll o wi n g Visit  2 (t he first da y of t he  e ntr y/scree ni n g D B P C F C). Visit  3 c o ul d ta ke 
place 1  da y pri or t o Visit  4.  
T he f oll o wi n g assess me nts will be perf or me d at t his visit:  
•  P h ysical e xa mi nati o n (i n cl u di n g a c o m plete s ki n e xa mi nati o n; t o ta ke pl ace bef ore 
D B P C F C; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (t o ta ke place bef ore D B P C F C;  see Secti o n 6. 2. 3 ); 
•  E ntr y/scree ni n g D B P C F C (sec o n d da y) (see Secti o n 6. 1. 1. 3 ) 
•  A Es rec or di n g (i ncl u di n g v ol u nteere d or s olicite d A Es, A E SIs a n d rec or di n g of 
A Es/aller gies i n res p o nse t o t he D B P C F C);  
•  C o nc o mita nt me dicati o ns (i ncl u di n g a n y me dicati o ns gi ve n t o treat alle r gic 
s y m pt o ms; see Secti o n 5. 7 ); 
•  Sc he d ule Visit 4.  
P h ysical e xa mi nati o ns a n d assess me nt of vital si g ns ca n be re p eate d d uri n g t he D B P C F C 
as dee me d n ecess ar y b y t he I n vesti gat or.  
T he s u bject ma y be disc har ge d after a mi ni m u m o bser vati o n peri o d of 3  h o urs after t he 
last d ose of t h e c h alle n ge f or m ula i n geste d. T h e o bser vati o n peri o d ca n be e xt e n de d 
be y o n d 3  h o urs if dee me d necessar y b y t he I n v esti gat or.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
7 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
7. 2. 4  Visit 4 ( D ay 1), First D ay of Tre at me nt  
All scree ni n g ass ess me nts m ust be c o m plet e d a n d s u bject eli gi bilit y m ust be c h ec k e d 
bef ore e ntr y i nt o t he d o u ble -bli n d treat me nt peri o d . I n s o me s pecific cases, a s u bject ma y 
nee d t o be re -s cree ne d t o be a ble t o e nter t he d o u ble-bli n d treat me nt peri o d . T hese 
sit uati o ns will be disc usse d wit h t he S p o ns or’s me dical m o nit or o n a cas e -b y -case b asis.  
After t h e scree ni n g peri o d is c o m plete d , dates of all st u d y visits will be sc h e d ule d relati ve 
t o t he date of Visit 4. Visit 4 will ta ke place at a ma xi m u m of 4 2  da ys after Visit  1 a n d 
mi g ht occ ur e ve n cl oser t o Visit  1 pr o vi de d t hat Visit  2 a n d Visit  3 ha ve bee n perf or me d 
i n bet wee n. I deall y, it will ta ke place 1 d a y after Visit  3 a n d it ma y ta ke place u p t o se v eral 
wee ks after  Visit  3, res pecti n g t he ma xi m u m i nter val of 4 2  da ys after Visit  1. Visit  4 ma y 
ta ke place t he sa m e da y as Visit 3 f or t h ose I n vesti gat ors willi n g t o c o m bi ne t he 2  visits, 
u n der t he c o n diti o n t hat all pr oce d ures of b ot h visits a n d t heir s pecific d urati o ns are 
res pect e d. 
T he f oll o wi n g assess me nts will be perf or me d at t his visit:  
•  P h ysical e xa mi nati o n (i ncl u di n g a c o m plete s ki n e xa mi nati o n; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (see Secti o n 6. 2. 3 ); 
•  C o nfir m eli gi bilit y of s u bject a n d perf or m r a n d o mizati o n;  
•  A Es rec or di n g (i ncl u di n g v ol u nteere d or s olicite d A Es a n d A E SI);  
•  C o nc o mit a nt me dicati o ns (see Secti o n 5. 7 ); 
•  Dis pe nse first b o x of I M P (i nstr uct s u bjects ’ pare nts/ g uar dia ns o n t he pr o per 
a p plicati o n, ti mi n g a n d st ora ge);  
•  A p pl y t he first Vias ki n ®  patc h t o t he s u bject f or a t otal d urati o n of 2 h o urs. Stic k 
t he peal -off part of t he p o uc h la bel i n t he a p pr o priate secti o n of t he s u bject diar y . 
After 2 h o urs t he p atc h will be re m o ve d a n d t he s u bject will be o bser ve d f or 1 
a d diti o nal h o ur bef ore bei n g disc har ge d.  
•  C hec k s ki n reacti o n u n d er or ar o u n d t he patc h wit h o ut re m o vi n g it a n d gra d e 
se verit y (see Ta ble  3 , Secti o n 6. 2. 6 ) at t he f oll o wi n g ti me p oi nts:  
o  bef ore a p plicati o n  
o  3 0  m in utes   
o  1 h o ur  
o  2 h o urs d uri n g patc h a p plicati o n  
o  a n d t he n 1 h o ur after t he patc h re m o val, b ef ore s u bject disc har ge  
•  Wit h o ut re m o vi n g t he p atc h, ta ke a p h ot o gr a p h of t he site of a p plicati o n of t he 
Vias ki n ®  patc h at t he sa me ti me p oi n t t ha n t he s ki n reacti o n gra di n g. T hese 
p h ot o gra p hs will be l oa de d o nt o t he st u d y-s pecific ser ver ( descri be d i n secti o n 
6. 2. 6 ) a n d kep t it i n t he su bject’s me dical r ec or ds or s o urce d o c u me nts;  
•  Patc h a d hesi o n I n vesti gat or’s assess me nt:  I n vesti g at or assess es t he a d hesi o n of t he 
patc h t o t he s ki n as w ell as t he occl usi o n of t he patc h c ha m ber ri g ht aft er first 
a p plicati o n a n d aft er 2 h o urs pri or t o disc har ge;  
•  Dis pe nse s u bject diar y a n d i nstr uct pare nts/ g uar dia ns o n t he use (see Secti o n 6. 2. 5 );  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
7 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  Dis pe nse t he ca mera 
a n d t he car d 
wit h its la n yar d or t he d e vice t o t he 
pare nts/ g uar dia ns a n d i nstr uct t he m w he n a n d h o w t o use it;  
•  Dis pe nse t he s u bject safet y leaflet;  
•  Dis pe nse  t he kit a n d i nstr ucti o ns f or t he acci d e ntal pea n ut c o ns u m pti o n f o o d 
sa m pli n g. 
•  Dis pe nse a n a ut o -i nject or of e pi ne p hri ne a n d e x plai n i n detail t he a na p h yla xis 
e mer ge n c y acti o n pla n t o t he pare nts/ g uar di a ns bef ore disc har ge;  
•  Dis pe nse 1 % h y dr o c ortis o ne oi nt m e nt; 
•  Sc he d ule t he Da y  4 p h o n e c o ntact a n d Visit  5.  
T he s u bject s h o ul d be dis c har ge d 3 h o urs aft er t he Vias ki n ®  first patc h a p plicati o n. 
7. 2. 5  P h o ne C o nt acts ( D ay 4 ± 2  d ays a n d D ay 2 2 ± 2  d ays), Tre at me nt Peri o d  
At Da y  4 af ter t he patc h s h o ul d ha ve b ee n a p plie d 2  h o urs dail y f or 3  da ys, a n d at Da y  2 2 
( Wee k 3 of treat me nt), t h e patc h s h o ul d ha v e starte d t o be a p plie d 1 2  h o urs dail y, s pecific 
p h o ne c o ntacts will be ma de t o t he pare nts/ g uar dia ns t o assess t he safet y of pat c h 
a p plicati o ns o n t he bac k. D uri n g t he p h o ne c o nt acts, t he site staff c o ul d as k t o be pr o vi de d 
wit h p h ot os of t he bac k of t he s u bject t o assess t he l ocal s ki n reacti o ns. If re q uire d, t h e 
s u bjects ma y be see n earlier b y t he I n vesti gat or. 
T he f oll o wi n g assess me nts will be perf or me d d uri n g t he p h o ne c o nta ct: 
•  A Es rec or di n g (i ncl u di n g v ol u nteere d or s olicite d A Es a n d A E SI);  
•  C o nc o mita nt me dicati o ns (see Secti o n 5. 7 ); 
•  C hec k f or a n y acci de ntal pea n ut c o ns u m pti o n (see Secti o n 6. 4. 4 ); 
•  C hec k wit h t he pare nts/ g uar dia ns t o e ns ure t hat t he diar y has bee n c o m plete d 
acc uratel y a n d t hat t he pare nts/ g uar dia ns is/are c o mf orta ble wit h usi n g t he diar y;  
•  Re mi n d of Visit  5 a n d Visit  6 , res pecti vel y. 
 
7. 2. 6  Visit 5 ( D ay 8 ± 3  d ays), Visit 6 ( M o nt h 1 ± 3  d ays)  a n d Visit 9  ( M o nt h 9 ± 7  d ays), 
Tre at me nt Peri o d  
T he f oll o wi n g assess m e nts will be perf or me d at t hese visits:  
•  P h ysical e xa mi nati o n (i ncl u di n g a c o m plete s ki n e xa mi nati o n; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (see Secti o n 6. 2. 3 ); 
•  A Es rec or di n g (i ncl u di n g v ol u nteere d or s olicite d A Es a n d A E SI);  
•  C o nc o mita nt me dicati o ns (see Secti o n 5. 7 ); 
•  C hec k f or a n y acci de ntal pea n ut c o ns u m pti o n (see Secti o n 6. 4. 4 );  
•  C hec k t hat t he s u bject di ar y has bee n c o m plete d acc urat el y a n d e ns ure t hat t he 
pare nts/ g uar dia ns is/are c o mf orta ble wit h usi n g t he diar y;  
•  Dis pe nse s u bject diar y (re -i nstr uct pare nts/ g uar di a ns o n t he use, if necess ar y; see 
Secti o n 6. 2. 5 );  
•  C ollect t he treat me nt b o x dis pe nse d at t he pre vi o us visit, c hec k t he u n use d 
me dicati o n a n d asses s m e dicati o n c o m plia nce; 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  Dis pe nse a ne w b o x of 
I M P (re-i nstr uct pare nts/ g uar dia ns o n t he pr o per 
a p plicati o n, ti mi n g a n d st ora ge, if n ecess ar y);  
•  Patc h a d hesi o n I n v esti gat or’s assess me nt : 
wit h t he patc h still a p plie d, t he 
I n v esti gat or assess es t he a d here n ce of t he pat c h t o t he s ki n as well as t he o ccl usi o n 
of t he patc h c ha m b er . T his assess me nt will o nl y be ma de if t he s u bject is weari n g 
t he patc h at t he ti me of t he visit. 
A n y iss ues re p orte d b y t he s u bjects’ 
pare nts/ g uar dia ns relate d t o t he patc hes a p plicati o n or re m o val will als o be 
re p orte d; 
•  C hec k s ki n reacti o ns u n der or ar o u n d t he p atc h ( if t he p atc h is still w or n b y t h e 
su bject at t he ti me of t h e visit  b ut wit h o ut re m o vi n g it ) a n d all ot her z o nes of 
a p plicati o n a n d gra d e se v erit y of t he s ki n reacti o ns (see  Ta bl e  3 , Secti o n 6. 2. 6 );  
•  Ta ke a p h ot o gra p h of t he sites of a p plicati o n of t he Vias ki n ®  patc h, l oa d it o nt o t he 
st u d y ser ver ( descri be d i n secti o n 6. 2. 6 ) a n d kee p it i n t he s u bject’s me dical rec ords 
or s o urce d oc u me nts; d o w nl oa d t he p h ot o gr a p hs t a ke n b y t h e pare nts’ s u bj ect fr o m 
t he ca mera m e m or y car d or t he de vi ce , if a n y p h ot os were ta ke n si nce t h e pre vi o us 
visit a n d re vie w t he m;  
•  Re vie w t he use of t he a ut o -i nject or of e pi ne p hri ne a n d t he a na p h ylaxis e mer ge nc y 
acti o n pla n;  
•  Sc he d ule ne xt p h o ne c o ntact a n d Visit 6, Visit 7, a n d Visit 9  res pecti vel y. 
7. 2. 7  P h o ne C o nt acts ( M o nt h 2 ± 3  d ays , M o nt h 4 . 5 ± 7 d ays  a n d  M o nt h 7. 5 ± 7  d ays), 
Tre at me nt Peri o d  
T he pare nts/ g uar dia ns of t he s u bject will b e calle d t o assess t he s u bject’s c o n diti o n si nce 
t he last Visit. 
T he f oll o wi n g assess me nts will be perf or me d d uri n g t he p h o ne c o ntact:  
•  A Es rec or di n g (i ncl u di n g v ol u nteere d or s olicite d A Es a n d A E SI);  
•  C o nc o mita nt me dicati o ns (see Secti o n 5. 7 ); 
•  C hec k f or a n y acci de ntal or pea n ut c o ns u m pti o n (see Secti o n 6. 4. 4 );  
•  C hec k wit h t he pare nts/ g uar dia ns t o e ns ure t hat t he diar y has bee n c o m plete d 
acc uratel y;  
•  Re mi n d of Visit 7, t he p ossi bilit y of Visit 7 bis, Visit 8 a n d Visit 9 res pecti vel y.  
7. 2. 8  Visit 7 ( M o nt h 3 ± 7  d ays) , Visit 7 bis  ( bet wee n M o nt h 3 a n d 1 2  –  de pe n di n g o n 
t he i ncl usi o n d ur ati o n) a n d Visit 8  ( M o nt h 6 ± 7 d ays), Tre at me nt Peri o d  
F or Part A, t h e V isit 7 aft er 3 m o nt hs of treat me nt was t o be t he last visit bef ore t he pla n ne d 
i nteri m safet y a n al ysis f or t he d oses selecti o n. T his i nteri m a nal ysis was t o be perf or me d 
o nce  t he last s u bjects of Part A will h a ve  h a d  t heir Visit 7. T he first ra n d o mize d s u bject 
sh o ul d ha ve n ot yet reac he d t he 1 2 -m o nt h treat me nt, de pe n di n g o n t he act ual recr uit me nt 
d urati o n of t he first 5 0 s u bjects of t he Part A.  
Visit 7 bis  ( O nl y f or p art A s u bjects): 
De pe n di n g o n t he D S M B rec o m me n dati o n  (see Secti o n 3. 1 ), s u bjects i ncl u de d i n t he P art 
A ma y  nee d t o recei ve a ne w tr eat me nt b o x. I n t hese sit uati o ns, the tr eat me nt was  t o b e 
bli n dl y assi g ne d b y t he I W R S  d uri n g Visit 7 bis , e ns uri n g t he st u d y bli n d. T he d ose of t he 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
D B V 7 1 2  gr o u ps w as eit her t o b e k e pt u nc h a n ge d  (i.e., n o Visit 7 bis nee de d), re d u ce d or 
i ncreas e d. T he pla ce b o gr o u p will c o nti n ue wit h Vias ki n®  place b o treat me nt.  
After t he i nteri m safet y a nal ysis, b ot h d oses of D B V 7 1 2  were s h o w n t o be safe , a n d n o 
d ose s witc hi n g is re q uire d (see Secti o n 3. 1 ). As a c o nse q ue nce, Visit 7 bis will be n ot 
a p plica ble.  
Visit 7 a n d Visit 8 : 
B ot h visits are ma d e of t he sa me assess m e nts:  
T he f oll o wi n g assess me nts will be perf or me d at t hese visits:  
•  P h ysical e xa mi nati o n (i ncl u di n g a c o m plete s ki n e xa mi nati o n; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (see Secti o n 6. 2. 3 ); 
•  S C O R A D (see Secti o n 6. 4. 6 ); 
•  S P T (see Secti o n 6. 4. 2 ); 
•  I m m u n ol o gical mar kers (see Secti o n 6. 4. 1 );  
•  La b orat or y tests (s ee Secti o n 6. 2. 2 ); 
•  C ollect bl o o d sa m ples f or e pi ge netic a nal yses (s ee Secti o n  6. 4. 5 );  
•  U S eli gi ble site s o nl y: c ollect bl o o d sa m ple f or B A T (see Secti o n 6. 4. 7 ); 
•  A E s rec or di n g (i ncl u di n g v ol u nteere d or s olicite d A E s a n d A E SI); 
•  C o nc o mita nt me dicati o ns (see Secti o n 5. 7 ); 
•  C hec k f or a n y acci de ntal pea n ut c o ns u m pti o n (see Secti o n 6. 4. 4 );  
•  C hec k t hat t he s u bject di ar y has bee n c o m plete d acc urat el y a n d e ns ure t hat t he 
pare nts/ g uar dia ns are c o mf orta ble wit h usi n g t he diar y;  
•  Dis pe nse s u bject diar y (re -i nstr uct pare nts/ g uar di a ns o n t he use, if necess ar y; see 
Secti o n 6. 2. 5 );  
•  C ollect t he treat me nt b o x dis pe nse d at t he pre vi o us visit, c hec k t he u n use d 
me dicati o n a n d assess m e dicati o n c o m plia nce;  
•  Dis pe nse a ne w b o x of 
I M P (re-i nstr uct pare nts/ g uar dia ns o n t he pr o per 
a p plicati o n, ti mi n g a n d st ora ge, if n ecess ar y);  
•  Patc h a d hesi o n I n vesti gat or’s assess me nt:  m a de wit h t he patc h still a p plie d, t h e 
I n v esti gat or assess es t he a d here n ce of t he pat c h t o t he s ki n as well as t he o ccl u si o n 
of t he patc h c ha m ber. A n y iss ues re p orte d b y t he s u bjects’ pare nts/ g uar dia ns 
relate d t o t he pat c hes a p plicati o n or re m o val will als o be re p orte d; 
•  C hec k s ki n reacti o ns u n d er or ar o u n d t he c urre nt patc h ( d o n ot re m o ve p atc h) a n d 
all ot her z o nes of a p pli cati o n a n d gra de se verit y of t he s ki n reacti o ns (see T a ble  3 , 
Secti o n 6. 2. 6 );  
•  Ta ke a p h ot o gra p h of t he sites of a p plicati o n of t he Vias ki n ®  patc h, l oa d it o nt o t he 
st u d y ser ver ( des cri be d i n S ecti o n 6. 2. 6 ) a n d kee p it i n t he s u bject’s me dical rec or ds 
or s o urce d o c u me nts; d o w nl oa d t he p h ot o gra p hs t a ke n b y t he p are nts’ s u bjectfr o m 
t he ca mera m e m or y car d or t he de vi ce , if a n y p h ot os were ta ke n since t h e pre vi o us 
visit a n d re vie w t he m;  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  Re vie w t he use of t he a ut o -i nject or of e pi ne p hri ne a n d t he a na p h yla xis e mer ge nc y 
acti o n pla n;  
•  Sc he d ule ne xt p h o ne c o ntact a n d Visit.  
7. 2. 9  Visit 1 0  ( M o nt h 1 2 ± 7 d ays), Tre at me nt Peri o d  
Visit 1 0  c orres p o n ds t o t he first da y  of t he p ost -tr eat me nt D B P C F C.  
T he f oll o wi n g assess me nts will be perf or me d at t his visit:  
•  P h ysical e xa mi nati o n (i n cl u di n g a c o m plete s ki n e xa mi nati o n; t o ta ke pl ace bef ore 
D B P C F C; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (t o ta ke place bef ore D B P C F C; see Secti o n 6. 2. 3 ); 
•  S C O R A D (see Secti o n 6. 4. 6 ); 
•  S P T (see Secti o n 6. 4. 2 ); 
•  I m m u n ol o gical mar kers (see Secti o n 6. 4. 1 );  
•  La b orat or y tests (s ee Secti o n 6. 2. 2 ); 
•  F A Q L Q/ F AI M (see Secti o n 6. 4. 3. 1 ); 
•  E Q -5 D -5 L ( part B o nl y) (see Secti o n  6. 4. 3. 2 ); 
•  C ollect bl o o d sa m ple f or e pi ge netic a n al yses (see Secti o n  6. 4. 5 );  
•  U S eli gi ble sites o nl y: c ollect bl o o d sa m ple f or B A T (see Secti o n 6. 4. 7 ); 
•  P ost -treat me nt D B P C F C (first da y) (see Secti o n 6. 1. 1. 4 ); t he p atc h s h o ul d be 
re m o ve d bef ore perf or mi n g t he D B P C F C a n d a ne w patc h  s h o ul d be a p plie d at t he 
e n d of t he D B P C F C  (i.e. at t he e n d of t he 3-h o ur o bser vati o n peri o d) ; 
•  A E s rec or di n g (i ncl u di n g v ol u nteere d or s olicite d AE s, A E SIs a n d rec or di n g of 
A E s/aller gies i n res p o nse t o t he D B P C F C); 
•  C o nc o mita nt 
me dicati o ns (i ncl u di n g a n y 
me dicati o ns gi ve n t o treat aller gic 
s y m pt o ms) (see Secti o n 5. 7 ); 
•  C hec k f or a n y acci de ntal pea n ut c o ns u m pti o n (see Secti o n 6. 4. 4 );  
•  C hec k t hat t he s u bject di ar y has bee n c o m plete d acc urat el y;  
•  Dis pe nse s u bject diar y (re -i nstr uct pare nts/ g uar di a ns o n t he use, if necess ar y; see 
Secti o n 6. 2. 5 ); 
•  C ollect t he treat me nt b o x dis pe nse d at t he pre v i o us visit, c hec k t he u n use d 
me dicati o n a n d assess m e dicati o n c o m plia nce;  
•  D is pe nse t he treat me nt b o x t o t he s u bject’s pare nts/ g uar dia ns f or a p plicati o n u ntil 
t he 2n d da y of t he c halle n ge (re -i nstr uct pare nts/ g uar dia ns o n t he pr o per a p plicati o n, 
ti mi n g a n d st ora ge, if necessar y); 
•  Patc h a d hesi o n I n vesti gat or’s assess me nt:  m a de wit h t he patc h still a p plie d, t h e 
I n v esti gat or assess es t he a d here n ce of t he pat c h t o t he s ki n as well as t he o ccl usi o n 
of t he patc h c ha m ber. A n y iss ues re p orte d b y t he s u bjects’ pare nt s/ g uar dia ns 
relate d t o t he pat c hes a p plicati o n or re m o val will als o be re p orte d; 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  C hec k s ki n reacti o ns u n d er or ar o u n d t he c urre nt patc h ( wit h o ut re m o vi n g it) a n d 
all ot her z o nes of a p plicati o n a n d gra de se verit y of t he s ki n reacti o ns (see T a ble  3 , 
Secti o n 6. 2. 6 );  
•  Ta ke a p h ot o gra p h of t he sites of a p plicati o n of t he Vias ki n ®  patc h, l oa d it o nt o t he 
st u d y ser ver ( des cri be d i n S ecti o n 6. 2. 6 ) a n d kee p it i n t he s u bject’s me dical rec or ds 
or s o urce d oc u m e nts; d o w nl oa d t he p h ot o gr a p hs t a ke n b y t h e pare nts’ s u bj ect  fr o m 
t he ca mera m e m or y car d or t he de vi ce , if a n y p h ot os were ta ke n si nce t h e pre vi o us 
visit a n d re vie w t he m;  
•  Re vie w t he use of t he a ut o -i nject or of e pi ne p hri ne a n d t he a na p h yla xis e mer ge nc y 
actio n pla n;  
•  Sc he d ule Visit 1 1 . 
P h ysical e xa mi nati o ns a n d assess me nt of vital si g ns ca n be re p eate d d uri n g t he D B P C F C 
as dee me d n ecess ar y b y t he I n vesti gat or.  
T he s u bject ma y be disc har ge d after a mi ni m u m o bser vati o n peri o d of 3  h o urs after t he 
last d ose of the c halle n ge f or m ula is i n geste d. T he o bser vati o n peri o d ca n be e xte n de d 
be y o n d 3  h o urs if dee me d necessar y b y t he I n v esti gat or.  
7. 2. 1 0  Visit 1 1  ( ≤1 wee k after Visit 1 0 ), E n d of Tre at me nt Peri o d 
Visit 1 1  c orres p o n ds t o t he e n d of t he 1 2 -m o nt h treat me nt peri o d. Pa tc h a p plicati o n e n ds 
at t his visit. T he patc h w or n b y t he s u bject w he n s he/ he arri ves t o t his visit is re m o ve d a n d 
t here will be n o f urt h er p atc hes a p plie d b e y o n d Visit 1 1 .  
F or t he s u bjects w h o will acce pt t o partici pate i n  t he e xte nsi o n st u d y, t he Visit 1 2  will be 
ca ncelle d. T he i ncl usi o n i n t he st u d y e xte nsi o n will occ ur at t he e n d of t he Visit 1 1 . 
Visit 1 1  c orres p o n ds t o t he sec o n d da y of t h e p ost -treat me nt D B P C F C after 1 2 m o nt hs of 
treatme nt. It ta kes pla ce wit hi n a wee k f oll o wi n g t he first da y of t he p ost -treat me nt 
D B P C F C.  
T he f oll o wi n g assess me nts will be perf or me d at t his visit:  
•  P h ysical e xa mi nati o n (i n cl u di n g a c o m plete s ki n e xa mi nati o n; t o ta ke pl ace bef ore 
D B P C F C; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (t o ta ke place bef ore D B P C F C; see Secti o n 6. 2. 3 ); 
•  P ost -treat me nt D B P C F C (sec o n d d a y) (see Secti o n 6. 1. 1 ); t he patc h s h o ul d be 
re m o ve d bef ore p erf or mi n g t he D B P C F C; 
•  A E s rec or di n g (i ncl u di n g v ol u nteere d or s olicite d AE s, A E SIs a n d rec or di n g of 
A E s/aller gies i n res p o nse t o t he D B P C F C); 
•  C o nc o mita nt  me dicati o ns (i ncl u di n g a n y 
me dicati o ns gi ve n t o treat aller gic 
s y m pt o ms) (see Secti o n 5. 7 ); 
•  C hec k f or a n y acci de ntal pea n ut c o ns u m pti o n (see Secti o n 6. 4. 4 );  
•  C ollect a n d c hec k t h at t he s u bject diar y has bee n c o m plete d acc urat el y . T he diar y 
will n ot be gi ve n bac k t o t he s u bject ;  
•  C ollect t he treat me nt b o x dis pe nse d at t he Visit 1 0  ( M o nt h 1 2 visit), c hec k t he 
u n use d me dicati o n a n d assess me dicati o n c o m plia nce;  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  Patc h a d hesi o n I n vesti gat or’s assess me nt:  m a de wit h t he patc h still a p plie d, t h e 
I n v esti gat or assess es t he a d here n ce of t he pat c h t o t he s ki n as well as t he  o ccl usi o n 
of t he patc h c ha m ber. A n y iss ues re p orte d b y t he s u bjects’ pare nts/ g uar dia ns 
relate d t o t he pat c hes a p plicati o n or re m o val will als o be re p orte d; 
•  C hec k s ki n reacti o ns u n d er or ar o u n d t he c urre nt p atc h ( wit h o ut re m o vi n g it) a n d 
all ot her z o nes of a p plicati o n a n d gra de se verit y of t he s ki n reacti o ns (see T a ble  3 , 
Secti o n 6. 2. 6 );  
•  Ta ke a p h ot o gra p h of t he sites of a p plicati o n of t he Vias ki n ®  patc h, l oa d it o nt o t he 
st u d y ser ver ( descri be d i n secti o n 6. 2. 6 ) a n d kee p it i n t he s u bject’s me dical rec or ds 
or s o urce d oc u me nts; d o w nl oa d t he p h ot o gr a p hs t a ke n b y t h e pare nts’ s u bj ect fr o m 
t he ca mera m e m or y car d or t he de vi ce , if a n y p h ot os were ta ke n si nce t h e pre vi o us 
visit a n d re vie w t he m;  
•  Sc he d ule Visit 1 2 . 
P h ysical e xa mi nati o ns a n d assess me nt of vital si g ns ca n be re p eate d d uri n g t he D B P C F C 
as dee me d n ecess ar y b y t he I n vesti gat or.  
T he s u bject ma y be disc har ge d after a mi ni m u m o bser vati o n peri o d of 3  h o ur s after t he 
last d ose of t h e c h alle n ge f or m ula i n geste d. T h e o bser vati o n peri o d ca n be e xt e n de d 
be y o n d 3  h o urs if dee me d necessar y b y t he I n v esti gat or.  
7. 2. 1 1  Visit 1 2  (4  wee ks after Visit 1 1 ), E n d of St u dy Peri o d 
T he f oll o wi n g assess me nts will be perf or me d at t h is visit: 
•  P h ysical e xa mi nati o n (i ncl u di n g a c o m plete s ki n e xa mi nati o n; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (see Secti o n 6. 2. 3 ); 
•  F A Q L Q/ F AI M (see Secti o n 6. 4. 3. 1 ); 
•  E Q -5 D -5 L ( part B o nl y) (see Secti o n 6. 4. 3. 2 ); 
•  A E s rec or di n g (i ncl u di n g v ol u nteere d or s olicite d AE s a n d A E SI); 
•  C hec k f or a n y acci de ntal pea n ut c o ns u m pti o n (see Secti o n 6. 4. 4 );  
•  C o nc o mita nt me dicati o ns (see Secti o n 5. 7 ); 
T his visit will n ot be perf or me d b y t he s u bjects w h o will be i ncl u de d i n t he e xte nsi o n 
f oll o w-u p st u d y.  
7. 2. 1 2  E arly Ter mi n ati o n Visit  
S u bjects w h o disc o nti n ue earl y fr o m t he st u d y s h o ul d  ha ve , if p ossi ble, a n Earl y 
Ter mi nati o n Visit. T his visit s h o ul d ta ke place as s o o n as p ossi ble after t he s u bject st o ps 
a p pl yi n g  t he I M P). 
T he f oll o wi n g assess me nts will be perf or me d at t hese visits:  
•  P h ysical e xa mi nati o n (i ncl u di n g a c o m plete s ki n e xa mi nati o n; see  Secti o n 6. 2. 4 ); 
•  Vital si g ns (see Secti o n 6. 2. 3 ); 
•  S P T (see Secti o n 6. 4. 2 ); 
•  I m m u n ol o gical mar kers (see Secti o n 6. 4. 1 );  
•  La b orat or y tests ( Se cti o n 6. 2. 2 ); 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  U S eli gi ble sites o nl y: c ol lect bl o o d sa m ple f or B A T (see Secti o n 6. 4. 7 ); 
•  A Es rec or di n g (i ncl u di n g v ol u nteere d or s olicite d A Es a n d A E SI);  
•  C o nc o mita nt me dicati o ns (see Secti o n  5. 7 ); 
•  C hec k f or a n y acci de ntal pea n ut c o ns u m pti o n (see Secti o n 6. 4. 4 );  
•  C hec k s u bject diar y;  
•  C hec k u n use d me dicati o n a n d assess me dicati o n c o m plia nce;  
•  Patc h a d hesi o n I n vesti gat or’s assess me nt : m a de wit h t he patc h still a p plie d, t h e 
I n v esti gat or assess es t he ad here n ce of t he pat c h t o t he s ki n as well as t he o ccl usi o n 
of t he patc h c ha m b er. T his assess me nt will o nl y be ma de if t he s u bject is weari n g 
t he patc h at t he ti me of t he visit. 
A n y iss ues re p orte d b y t he s u bjects’ 
pare nts/ g uar dia ns relate d t o t he patc hes a p plicati o n or re m o val will als o be 
re p orte d; 
•  C hec k s ki n reacti o ns a n d gra de se v erit y (see Ta bl e  3 , Secti o n 6. 2. 6 );  
•  Ta ke a p h ot o gra p h of t he sites of a p plicati o n of t he Vias ki n ®  patc h, l oa d it o nt o t he 
st u d y ser ver ( des cri be d i n S ecti o n 6. 2. 6 ) a n d kee p it i n t he s u bject’s me dical rec or ds 
or s o urce d oc u me nts; d o w nl oa d t he p h ot o gr a p hs t a ke n b y t h e pare nts’ s u bj ect fr o m 
t he ca mera m e m or y car d or t he de vi ce , if a n y p h ot os were ta ke n si nce t h e pre vi o us 
visit a n d re vie w t he m.  
7. 2. 1 3  U nsc he d ule d Visit  
S u bjects ma y c o me t o t he site f or visits o utsi de of t he sc he d ule d visits i n case of A Es, 
Vias ki n ®  patc h a d hesi o n pr o ble ms, etc.  
T he f oll o wi n g assess me nts will be perf or me d at t hese visits, at t he d iscreti o n of t he 
I n v esti gat or: 
•  P h ysical e xa mi nati o n (i ncl u di n g a c o m plete s ki n e xa mi nati o n; see Secti o n 6. 2. 4 ); 
•  Vital si g ns (see Secti o n 6. 2. 3 ); 
•  La b orat or y tests ( Se cti o n 6. 2. 2 ); 
•  A E s rec or di n g (i ncl u di n g v ol u nteere d or s olicite d AE s a n d A E SI); 
•  C o nc o mita nt me dicati o ns (see Secti o n 5. 7 ); 
•  C hec k f or a n y acci de ntal pea n ut c o ns u m pti o n  (see Secti o n 6. 4. 4 );  
•  
C hec k s u bject diar y;  
•  If necess ar y dis pe nse a ne w b o x of I M P (re-i nstr uct pare nts/ g uar dia ns o n t he pr o per 
a p plicati o n, ti mi n g a n d st ora ge);  
•  C hec k u n use d me dicati o n a n d assess me dicati o n c o m plia nce;  
•  Patc h a d hesi o n I n vesti gat or’s assess me nt:  m a de wit h t he patc h still a p plie d, t h e 
I n v esti gat or assess es t he a d here n ce of t he pat c h t o t he s ki n as well as t he o ccl usi o n 
of t he patc h c h a m ber. A n y iss ues re p orte d b y t he s u bjects’ pare nts/ g uar dia ns 
relate d t o t he pat c hes a p plicati o n or re m o val will als o be re p orte d; 
•  C hec k s ki n reacti o ns u n d er or ar o u n d t he c urre nt patc h ( wit h o ut re m o vi n g it) a n d 
all ot her z o nes of a p plicati o n a n d gra de se v erit y of t he s ki n reacti o ns (see T a ble  3 , 
Secti o n 6. 2. 6 );  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  Ta ke a p h ot o gra p h of t he sites of a p plicati o n of t he Vias ki n ®  patc h, l oa d it o nt o t he 
st u d y ser ver ( des cri be d i n S ecti o n 6. 2. 6 ) a n d kee p it i n t he s u bject’s me dical rec or ds 
or s o urce d oc u me nts; d o w nl oa d t he p h ot o gr a p hs t a ke n b y t h e pare nts’ s u bj ect fr o m 
t he ca mera m e m or y car d or t he de vi ce , if a n y p h ot os were ta ke n si nce t h e pre vi o us 
visit a n d re vie w  t he m. 
8  
S T A TI S TI C A L M E T H O D S  
T he statistical c o nsi derati o ns s u m marize d i n t his secti o n o utli ne t he pla n f or data a nal ysis 
of t his st u d y.  
A se parate detaile d S tatistical A nal ysis P la n ( S A P) pr o vi di n g detaile d met h o ds f or t he 
a nal yses o utli ne d bel o w will be pre pare d b ef ore first s u bject i ncl usi o n a n d fi nalize d bef ore 
u n bli n di n g.  
A n y de viati o ns fr o m t he pla n ne d a n al yses will be descri b e d a n d j ustifie d i n t he fi nal 
i nte grate d st u d y rep ort.  
8. 1  
St u d y S u bjects  
8. 1. 1  A n alysis P o p ul ati o ns  
All a nal ysis p o p ulati o ns will be i de ntifie d a n d fi n alize d i n t he S A P.  Data fr o m Part A is 
pla n ne d t o b e assesse d s e paratel y fr o m Part B, pri or t o t he c o m pleti o n of Part B. H o we v er, 
data fr o m Part A will b e assess e d  wit h Part B as a si n gle p o ole d  s u p p orti ve a n al ysis, 
descri be d i n t his d oc u me nt . 
8. 1. 1. 1  S afety P o p ul ati o n  
T he Safet y p o p ulati o n will be c o m prise d of all s u bjects w h o are ra n d o mize d a n d ha v e 
recei v e d at le ast 1 d ose of I M P i n Part B . T his  p o p ulati o n will be use d t o assess 
c o m parati ve s afet y i nf or mati o n. I n cas e t he wr o n g I M P is dis pe nse d, t he s u bject will be 
a nal yze d acc or di n g t o t he I M P recei ve d f or t he l o n gest peri o d of ti me. 
8. 1. 1. 2  I nte nt-t o-tre at P o p ul ati o n 
T he I nte nt-t o-tr eat (I T T) p o p ulati o n will be c o m prise d of all  s u bjects w h o are ra n d o mize d 
i n Part B . S u bjects will be a nal yze d acc or di n g t o t he treat me nt t he y ha v e bee n ra n d o mize d 
t o.  
8. 1. 1. 3  Per -pr ot oc ol P o p ul ati o n  
T he Per -Pr ot oc ol ( P P ) p o p ulati o n will i ncl u de all s u bjects fr o m t he I T T p o p ulati o n w h o 
d o n ot ha ve maj or de viati o ns fr o m t he pr ot oc ol t hat ma y affect t he pri mar y efficac y 
e n d p oi nt (f or i nsta nce, s u bjects w h o ha ve n ot perf or me d  a de q u atel y t he p ost -treat me nt 
D B P C F C at M o nt h  1 2, s u bjects wit h a gl o bal treat me nt c o m plia nce bel o w 8 0 %, etc.). T h e 
de viati o ns t o c o nsi der will be liste d m ore e x h a usti vel y  d uri n g t he bli n de d data re vie w 
meeti n g  T he P P p o p ulati o n will be use d t o prese nt r o b ust ness  a nal yses of t he pri mar y a n d 
sec o n dar y efficac y e val u ati o ns.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
8. 1. 1. 4  P art A P o p ul ati o n  
T he Part A p o p ul ati o n will be c o m prise d of all s u bjects w h o are ra n d o mize d i n Part A. 
S u bjects will be a nal yze d acc or di n g t o t he treat me nt t he y ha ve bee n ra n d o mize d t o . T his 
p o p ulati o n will be use d f or descri pti ve  efficac y a n d safet y a n al yses,  as d etaile d i n t he S A P.  
8. 1. 2  Dis p ositi o n of S u bjects  
S u bject dis p ositi o n will be s u m marize d f or t he I T T p o p ulati o n. T he n u m ber a n d perce nta ge 
of s u bjects ra n d o mize d, s u bjects i n eac h st u d y p o p ulati o n ( Safet y, I T T, P P), a n d s u bj ects 
w h o c o m plete d t h e st u d y, w h o disc o nti n ue d t he st u d y, a n d t he pri m ar y reas o n f or 
disc o nti n uati o n fr o m t he d o u ble -bli n d peri o d will be ta b ulate d b y treat m e nt gr o u p a n d 
o verall.  
A n e nr oll me nt s u m mar y will be prese nte d o verall a n d b y site, s h o wi n g t he first date of  
c o nse nt, a n d t he last st u d y visit e xit date a m o n g e nr olle d s u bjects, d urati o n (i n da ys)  w hic h 
is calc ulate d as last st u d y visit e xit date –  first d ate of c o nse nt + 1, n u m b er of s u bjects 
e nr olle d, ra n d o mize d a n d c o m plete d. T he n u m ber a n d perce nta ge of s u bje cts e nr olle d i n 
t otal a n d b y site will be s u m marize d f or eac h treat me nt gr o u p a n d o verall. 
8. 1. 3  Pr ot oc ol Devi ati o ns  
De viati o ns fr o m t he pr ot oc ol i ncl u di n g vi olati o ns of i ncl usi o n/e xcl usi o n criteria will be 
assesse d as “ mi n or” or “ maj or” pri or t o u n bli n di n g. Maj or de viati o ns fr o m t he pr ot oc ol 
t hat i m pact t he pri mar y efficac y e val uati o n will lea d t o t he e xcl usi o n of a s u bject fr o m t he 
P P p o p ulati o n.  
8. 2  
Ge ner al C o nsi der ati o ns  
8. 2. 1  St atistic al Met h o ds  
T he statistical a nal yses f or t he e ntire st u d y as f urt her o utli ne d i n t he S A P will be i ncl u de d 
i n t he C li nical S t u d y R e p ort ( C S R) f or t his pr ot oc ol. T he S A P will gi ve a d etaile d 
descri pti o n of t he s u m maries a n d a nal yses ( pri mar y a n d sec o n dar y) t hat will be perf or me d 
a n d cle arl y d escri b e w h e n t hese a nal yses will ta ke place. T h e S A P will b e pre p are d aft er 
t he fi nal pr ot oc ol a n d fi nalize d well a hea d of t he data base l oc k t o e ns ure t he i nte grit y of 
t he statistical a nal ysis a n d st u d y c o ncl usi o ns. 
All pre -defi ne d statistical a nal yses will be perf or me d after t h e data base is releas e d f or 
u n bli n di n g. Statistical a nal yses will be per f or me d usi n g S A S®  Versi o n 9. 3 or hi g her ( S A S 
I nstit ute, Car y, N C, U S A). 
Cate g orical varia bl es will be s u m marize d usi n g n u m ber of o bser vati o ns a n d perce nta ges. 
T he de n o mi nat or f or p erce nta ges will be t he n u m b er of s u bjects i n t he p o p ulati o n wit h data 
a vailable u nl ess ot her wise state d. C o nti n u o us varia bles will be s u m marize d usi n g 
descri pti ve statistics ( n u m ber of o bs er vati o ns [ n], mea n, sta n dar d de viati o n, mi ni m u m, 
first q uartile [ Q 1], m e dia n, t hir d q uartile [ Q 3], a n d ma xi m u m). 
8. 2. 2  A n alysis a n d D at a C o nve nti o ns  
8. 2. 2. 1  Defi niti o n of B aseli ne  
T he baseli ne assess me nt will be t he latest, vali d pre -d ose ass ess me nt a vaila ble.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
8 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
8. 2. 2. 2  Visit Wi n d o ws  
Assess me nts o utsi de of pr ot oc ol all o wa ble ti me wi n d o ws will be ta ke n i nt o acc o u nt i n t he 
a nal ysis  acc or di n g t o t he visit i n w hic h t he data  are e ntere d . 
8. 2. 2. 3  U nsc he d ule d Assess m e nts  
E xtra assess me nts (la b orat or y data or vital si g ns ass ociate d wit h n o n -pr ot oc ol cli nical 
visits or o btai ne d i n t he c o urse of i n vesti gati n g or ma na gi n g A E s) will be i ncl u de d i n 
listi n gs, b ut n ot s u m maries. If m ore t h a n 1 la b orat or y val ue is a vaila bl e f or a gi ve n visit, 
t he first vali d o bser vati o n will be use d i n s u m maries a n d all o bser vati o ns will be pres e nte d 
i n listi n gs. It is n ote d t hat i n vali d la b orat or y data ma y n ot be use d (fr o m he m ol yze d 
sa m ples, mis ha n dle d s a m ples, q ua ntit y n ot s ufficie nt, or ot her c o n diti o ns t hat w o ul d re n der 
t he val ues i n vali d).  
8. 2. 2. 4  Missi n g D at a C o nve nti o ns  
E ver y atte m pt m ust be ma de b y t he I n vesti gat or t o pr o vi de c o m plete d ata. T he h a n dli n g of 
missi n g data will be detaile d i n t he S A P.  
8. 2. 2. 5  P o oli n g of Ce nters  
C o nsi deri n g t he e x pecte d s mall n u m ber of s u bjects t o be ra n d o mize d b y ce nter, t he ce nter 
effect will n ot be i n vesti gate d. Ne vert hel ess, t he re gi o n ( A ustralia/ E ur o pe/ N ort h A merica) 
effect will be e x pl ore d f or t he pri mar y efficac y e n d p oi nt  i n t he I T T p o p ulati o n.  
8. 3  
De m o gr a p hics, Dise ase a n d Me dic al Hist ories, B aseli ne C h ar acteristics, a n d 
C o nc o mit a nt Me dic ati o ns  
Descri pti ve statistics 
will be pr o d uce d f or c o nti n u o us de m o gra p hic a n d baseli ne 
c haracteristics (i ncl u di n g a ge, h ei g ht, wei g ht, b o d y m ass in de x , p ea n ut -s p ecific I g E a n d 
pea n ut -s pecific I g G 4) f or eac h treat me nt gr o u p a n d o verall. T h e n u m ber a n d perce nt of 
s u bjects i n eac h gr o u p of t he cate g ori cal de m o gra p hic a n d baseli ne c haracteristics 
(i ncl u di n g a ge, race, m e dical hist or y, a n d S P T) will be ta b ulate d b y treat me nt gr o u p a n d 
o verall.  
C o nc o mita nt me dicati o ns will be c o de d usi n g t h e latest a v aila ble versi o n of t he W orl d 
Healt h Or ga niz ati o n ( W H O) Dr u g Dicti o nar y. A s u m mar y of c o nc o mita nt me dicati o ns 
will be pr o d uce d b y preferre d dr u g na me a n d treat me nt 
gr o u p. 
All c o nc o mita nt 
me dicati o ns will be liste d.  
Me dical hist or y will be re p orte d b y S O C a n d P T a n d c o de d usi n g t h e l atest a vaila bl e 
versi o n of t he 
Me dical Dicti o nar y f or Re g ulat or y Acti vities ( Me d D R A) dicti o nar y. 
Disease hist or y will als o be descri b e d, i ncl u di n g  
•  a ge at ti me of dia g n osis,  
•  ti me fr o m dia g n osis t o st u d y e nr ol me nt, 
•  p h ysicia n cate g or y w h o ma de t he dia g n osis,  
•  mai n reas o n ha vi n g le d t o t he dia g n osis (reacti o n after i n gesti o n, pare ntal/si bli n g 
hist or y of at o p y, ot her ris k fact ors)  
•  dia g n osis criteria ( S P T, I g E, p ositi ve f o o d c halle n ge, pea n ut aller gic reacti o n)  
•  M ost rece nt r es ults of pea n ut aller g y dia g n ostic tests perf or me d,  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
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•  Descri pti o n of aller gic reacti o ns ( n u m b er of reacti o ns per s u bject, n u m ber of 
reacti o n i n t he pre vi o us year …). 
All i n di vi d ual s u bject de m o gra p hic a n d bas eli ne c haract eristic data will be liste d.  
8. 4  
Tre at me nt C o m pli a nce a n d E x p os ure  
Treat me nt c o m plia nce (s ee Secti o n 5. 6 ), e xte nt of e x p os ure ( da ys), a n d t otal d ose of pea n ut 
pr otei n recei ve d d uri n g t he st u d y ( m g)  will be s u m marize d f or eac h treat me nt gr o u p b y 
mea ns of descri pti ve statistics  ( details will be pro vi de d i n t he S A P).  
8. 5  
Effic ac y A n al yses  
8. 5. 1  Pri m ary Effic acy A n alysis  
T he pri mar y effic ac y e n d p oi nt is t he differe nce bet wee n t he perce nta ge of treat me nt 
res p o n ders i n t he s electe d acti ve D B V 7 1 2  gr o u p  ( 2 5 0 µ g)  c o m pare d t o t he place b o gr o u p 
after 1 2 m o nt hs of E PI T treat me nt.  
A s u bject is defi ne d as a treat me nt res p o n d er  if: 
•  T he i nitial E D was > 1 0 m g pea n ut pr otei n a n d t he E D is ≥1, 0 0 0 m g pea n ut pr otei n 
at t he p ost -treat me nt D B P C F C at M o nt h 1 2, 
O R  
•  T he i nitial E D was ≤1 0 m g pea n ut pr otei n a n d t he E D is ≥3 0 0 m g pea n ut pr otei n 
at t he p ost -treat me nt D B P C F C at M o nt h 1 2. 
8. 5. 1. 1  St atistic al Met h o ds  
T he pri mar y effic ac y a nal ysis 
will be perf or me d o n t he I T T p o p ulati o n, usi n g 
missi n g =fail ure i m p utati o n met h o d ( w hic h mea ns t hat s u bjects wit h missi n g D B P C F C 
pea n ut E D  val ue at M o nt h  1 2 will be c o nsi dere d as n o n -res p o n ders).  
T he pri mar y meas ur e of treat me nt effect will be t he differe n ce i n res p o nse rates b et wee n 
acti ve a n d pla ce b o tr eat me nt gr o u ps. T he pri mar y a nal ysis will a p pl y a Wal d test at a 
2 -si de d 5 % si g nifica nce le vel t o e val u ate a n ull h y p ot hesis of n o differe n ce, a n d 2 -si de d 
9 5 % Ne w c o m be c o nfi de nce i nter val ( CI) f or t he differe nce i n res p o ns e rates will be 
calc ulate d. T h e pre -s pecifie d t hres h ol d f or t he pri mar y a nal ysis will be defi ne d b y a ≥1 5 % 
l o wer CI  b o u n d, a n d t his c o n diti o n will deter mi ne w het her t he pri mar y o bj ecti ve has bee n 
s uccessf ull y met. 
8. 5. 1. 2  S u p p ortive A n alys is 
A s u p p orti ve a nal ysis will be perf or me d i n s u bjects ra n d o mize d i n part s A a n d B. T his 
a nal ysis will a p pl y t he sa me statisti cal met h o d as f or t he pri mar y a n al ysis.  
8. 5. 1. 3  S u b gr o u p A n alyses  
Res p o nse rates b y  treat m e nt gr o u ps a n d tr eat me nt effect will be pr o vi de d o n t he f oll o wi n g 
s u b gr o u ps: 
•  Scree ni n g E D s u b gr o u p ( Scree ni n g E D > 1 0 m g, Scree ni n g E D ≤ 1 0 m g)  
•  Re gi o n ( N ort h A meric a, E ur o pe,  A ustralia)  
•  Ge n der ( Male/ Fe male)  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
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•  Race ( W hite/ Blac k or Africa n A merica n/ Asia n/ Ot her)  
•  S u bjects wit h / wit h o ut hist or y of ast h ma  
•  S u bjects wit h / wit h o ut hist or y of f o o d aller g y ot h er t ha n pea n ut  
•  S u bjects wit h / wit h o ut hist or y of at o pic der matitis or ecze ma.  
A nal ysis will be perf or m e d o nl y o n s u b gr o u ps c o ntai ni n g  at least 1 5 s u bjects i ncl u de d.  
8. 5. 2  Sec o n d ary Effic acy A n alyses  
T he c ha n ge fr o m baseli ne t o M o nt h 1 2 i n pea n ut pr otei n C R D  a n d i n pea n ut pr otei n E D 
will be s u m marize d descri pti vel y b y treat me nt gr o u p f or t he I T T p o p ulati o n usi n g Baseli ne 
O bser vati o n Carrie d F or war d  i m p utati o n met h o d , as well as f or t h e P P p o p ulati o n.  
I n a d diti o n, t he pea n ut pr otei n C R D  a n d t he E D i n eac h treat me nt g r o u p at M o nt h 1 2 will 
be c o m pare d  i n t he sele cte d acti ve D B V 7 1 2  gr o u p ( 2 5 0 µ g) vers us  t he place b o gr o u p. 
8. 5. 3  Pre -defi ne d Hier arc hic al Or der f or t he A n alysis of Effic acy E n d p oi nts  
I n or der t o ha n dle m ulti ple c o m paris o ns vers us  place b o, t he o verall t y pe -I err or will be 
c o ntr olle d at a l e vel of 5 % ( 2 -si de d) b y t he us e of a hi erarc hical i nfere ntial a p pr oac h. T he 
pri mar y a n al ysis i n t he o verall p o p ulati o n m ust be p ositi ve acc or di n g t o t he s uccess 
criteri o n ( pre -s p ecifie d t hres h ol d descri b e d i n Secti o n 8. 5. 1. 1 ). T he first sec o n dar y 
effic ac y a nal ysis ( differe nce i n C R D ) m ust meet its s uccess criteri o n bef ore dra wi n g a n 
i nfere ntial c o n cl usi o n a b o ut t he ne xt sec o ndar y c o m paris o n ( differe nce i n pea n ut pr otei n 
E D). T he pre -defi ne d hierarc hi cal or der a n d s uccess criteria are s u m marize d i n  Ta ble  4 . 
 
T a ble  4 : Pre-defi ne d Hier a rc hic al Or der f or A n al ysis of Effic ac y E n d p oi nts  —  I T T p o p ul ati o n 
Or der  
Effic ac y e n d p oi nts ( at M o nt h  1 2)  
S uccess criteri o n  
Hier a rc hic al Testi n g 
t hresh ol d  
1  
Perce nta ges of treat me nt res p o n ders  
9 5 % CI l o wer 
b o u n d  ≥1 5 %  
- 
2  
C ha n ge i n pea n ut pr otei n E D  fr o m baseli ne 
- 
p ≤0. 0 5  
3  
C ha n ge i n pea n ut pr otei n C R D  fr o m baseli ne 
- 
p ≤0. 0 5  
A b bre viati o ns: CI = C o nfi de nce inter val ; C R D = C u m ulati ve reacti ve d ose; E D  =  Eliciti n g d ose; 
I T T =   I nte nt-t o-treat. 
8. 5. 4  Ot her Effic acy A n alyses  
T he perce nta ge of s u bjects reac hi n g a c u m ulati ve d ose ≥1, 4 4 4 m g pea n ut pr otei n at M o nt h 
1 2, t he perce nta g e of s u bjects reac hi n g a c u m ulati ve d ose ≥3, 4 4 4  m g pea n ut pr otei n at 
M o nt h 1 2, a n d t he perce nta ge of s u bjects u nres p o nsi ve (i.e, s h o wi n g n o s y m pt o ms lea di n g 
t o st o p t he D B P C F C) t o t he hi g hest d ose ( 2, 0 0 0 m g pea n ut pr otei n)  at M o nt h 1 2 will be 
s u m marize d descri pti vel y b y treat me nt gr o u p f or t he I T T p o p ulati o n usi n g missi n g =fail ure 
i m p utati o n met h o d, as well as f or t he P P p o p ulati o n. 
N o f urt her a dj ust me nts will be ma de f or t he ot h er efficac y e n d p oi nts f or w hic h p -val ues 
will be pr o vi de d f or des cri pti ve p ur p ose o nl y. T he f oll o wi n g efficac y a n al yses will be 
perf or me d usi n g o bs er ve d data ( n o i m p utati o n will be d o ne).  
•  P ea n ut -s pecific I g E a n d I g G 4 a nal ysis o ver ti me: p ea n ut-s pecifi c I g E a n d I g G 4 
le vels at bas eli ne a n d c ha n ges fr o m bas eli ne t o 
M o nt hs 3, 6 a n d  1 2 will be 
s u m marize d des cri pti vel y b y treat me nt gr o u p o n t he I T T p o p ulati o n, usi n g 
o bser ve d dat a.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
9 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
T he mea n c ha n ge  fr o m Baseli ne of t he pea n ut-s pecific I g E a n d I g G 4 will be 
c o m pare d . 
•  S ki n Pric k Test a nal ysis: T he mea n  c ha n ge fr o m baseli ne at M o nt hs  3, 6 a n d  1 2 i n 
mea n w heal dia met er will be e val uate d f or eac h treat me nt gr o u p o n t he I T T 
p o p ulati o n usi n g o bser ve d data.  
•  A q ualit y of life sc ore fr o m t he F A Q L Q/ F AI M Pare nt F or m will be s u m marize d at 
M o nt h 1 2 a n d c o m pare d t o baseli ne f or b ot h treat me nt gr o u ps f or t he o verall I T T 
p o p ulati o n, 
usi n g 
o bser ve d 
dat a. 
F A Q L Q -P are ntal 
F or m 
( F A Q L Q -P F ) 
q uesti o n naires will als o be s u m marize d b y mai n d o mai ns of q ualit y of life usi n g 
s pecific sc ores: 
o  E m oti o nal i m pact,  
o  F o o d -relate d a n xi et y, 
o  S ocial a n d Dietar y li mitati o ns.  
T he relati o ns hi p bet wee n F A Q L Q -P F sc ores a n d treat me nt res p o nse will als o be 
st u die d. 
8. 6  
S afet y A n al yses  
Safet y e n d p oi nts will be e val uate d f or t he Safet y p o p ulati o n (all s u bjects w h o recei ve d at 
least 1 d ose of I M P). 
F or all safet y a n al yses, d ata will be s u m marize d f or acti ve D B V 7 1 2  gr o u p vers us  place b o  
gr o u p . 
8. 6. 1  A dverse Eve nts  
Treat me nt -e mer ge n t AE s will be defi ne d as a n y AE s, re gar dless of relati o ns hi p t o I M P, 
w hic h occ ur d uri n g or after t he i nitial Vias ki n ®  patc h a p plicati o n or a n y e ve nt alrea d y 
prese nt t hat w orse ns i n eit her se verit y or rel ati o ns hi p t o I M P f oll o wi n g e x p os ure t o 
Vias ki n ® patc h es.  
All A E s will be re p orte d b y S O C a n d P T a n d c o de d usi n g t he latest a vaila ble versi o n of 
t he Me d D R A dicti o nar y.  
A n o verall s u m mar y of T E A Es will be pr o vi d e d s h o wi n g t he n u m ber a n d perce nta ge of 
s u bjects i n eac h treat me nt gr o u p wit h a n y T E A Es, a n y p ote ntiall y dr u g-relate d T E A Es, 
a n y D B V 7 1 2 -i n d uc e d l o cal T E A E, a n y s e vere D B V 7 1 2 -i n d uce d l ocal T E A E, a n y s e vere 
T E A Es, a n y se v ere p ote ntiall y I M P-rel ate d T E A Es, a n y seri o us T E A Es, a n y p ote ntiall y 
I M P-relate d seri o us T E A Es, a n y T E A Es lea di n g t o disc o nti n uati o n, a n y T E A Es lea di n g t o 
e pi ne p hri ne i nta k e a n d a n y T E A Es lea di n g t o d eat h. T he n u m ber of e ve nts will als o be 
prese nte d.  
T he n u m ber of e ve nts as well as t h e n u m ber a n d p erce nt a ge of s u bjects w h o e x perie nce d 
at least o n e e v e nt will be s u m marize d b y S O C, P T a n d tr eat me nt gr o u p. T he i nci de n ce of 
t he f oll o wi n g e ve nts will be s u m marize d: 
•  T E A Es ( disti n g uis he d fr o m s y m pt o ms/reacti o ns elicite d d uri n g t he D B P C F Cs): 
i nci de nce, ma xi m u m se v erit y a n d d urati o n; 
•  L ocal s ki n t olera nce at sites of Vias ki n ®  patc h a p plicati o n as assesse d b y t he 
s u bjects (i nci de nce, d urati o n a n d se verit y) (s ee Secti o n 8. 6. 5 ); 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
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•  L ocal s ki n t olera nce at sites of Vias ki n ®  pat c h a p plicati o n as assesse d b y t he 
I n v esti gat or (se v erit y) (s ee Secti o n 8. 6. 6 ); 
•  S A Es, seri o us T E A Es a n d seri o us p ote ntiall y I M P-relate d T E A Es; 
•  P ote nt iall y I M P-relat e d T E A Es; 
•  T E A Es lea di n g t o st u d y treat me nt disc o nti n uati o n  a n d T E A Es lea di n g t o 
e pi ne p hri ne i nta ke ; 
•  L ocal A E SI s a n d s yste mi c A E SIs (see Secti o n 6. 2. 1. 3. 5 ) . 
A d diti o nall y, t he pr o p or ti o ns of patc hes d uri n g t he o ne-year e x p os ure peri o d t hat le d t o 
mil d, m o derate or se vere T E A E c o nsi dere d rel ate d t o I M P will be s u m mari ze d.  
All A E s will be liste d. S A E a n d T E A E lea di n g t o a n e pi ne p hri ne i nta ke will als o be liste d 
se parat el y. 
T he reacti o ns a p peari n g d uri n g a D B P C F C (as t he y are e x pressl y pr o v o ke d) will be 
differe ntiat e d fr o m t h ose A E s occ urri n g o utsi de of t he D B P C F C. O bjecti ve a n d s u bjecti ve 
s y m pt o ms/reacti o ns elicite d d uri n g t he D B P C F Cs i n t he differe nt t reat me nt gr o u ps (see 
Secti o n  6. 1. 1  f or f ull details) will be s u m marize d se parat el y. 
8. 6. 2  L a b or at ory Assess me nts  
Descri pti ve statistics will be calc ulate d  f or cli nical la b orat or y tests ( he mat ol o g y a n d 
bi oc he mistr y) perf or me d at Visit  1 ( Da y  -4 2), Visit  7 ( M o nt h  3), Visit  8 ( M o nt h  6) a n d 
Visit  1 0  ( M o nt h 1 2). 
Cate g orical varia bles 
will be s u m marize d b y fre q ue nc y a n d 
perce nt a ges of s u bjects i n c orres p o n di n g ca te g ori es. 
C ha n ges i n la b orat or y d ata fr o m baseli ne will als o be prese nt e d.  
I n a d diti o n, s u m maries of la b orat or y v al ues cate g orize d b ase d o n C o m m o n T o xicit y 
Criteria f or A d v erse E v e nts ( C T C A E) gra de will als o be prese nt e d.  
S hift ta bles of test a b n or maliti es will be ge nerat e d t o c o m pare b aseli ne v al ues t o t he val ues 
c ollecte d at ot her ti me p oi nts.  
All la b orat or y d ata will be liste d. Listi n g of val u es t hat are o ut of n or mal ra n ge will be 
fla g ge d i n t he data listi n gs. 
8. 6. 3  Vit al Si g ns  
O bser ve d vital si g n val ues a n d c ha n ges fr o m baseli ne will be descri pti vel y s u m marize d b y 
visit a n d treat me nt gr o u p. All vital si g ns data will be liste d.  
T he a nal ysis of vital si g ns will f oc us o n t he i nci de nce of cli nicall y rele va nt a b n or malities. 
T he n u m ber of s u bjects e val ua te d a n d t he n u m ber a n d perce nt a ge of s u bjects wit h 
cli nicall y rele va nt p ost -b aseli ne a b n or m alities at eac h visit will be pres e nte d. T he criteria 
f or cli nicall y rel e va nt p ost-baseli ne a b n or m alities are s h o w n i n T a ble  5 . 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
9 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
T a ble  5 : Criteri a t o Assess  Cli nic all y Rele v a nt A b n or m alities i n Vit al Si g ns  
Vit al Si g n Criteri a 
f or A b n or m alities 
Criteri a f or A b n or m alities  
P ulse  
> 1 6 5  beats per mi n ute or a n i ncrease fr o m pre -d osi n g of > 2 0 beats per mi n ute,
or
< 8 5  beats per mi n ute or a decrease fr o m pre -d osi n g of > 2 0 beats per mi n ute
S yst olic bl o o d 
press ure  
> 1 2 0 m m H g or a n i ncrease fr o m pre -d osi n g of > 3 0 m m H g, or
< 7 5  m m H g or a decreas e fr o m pre -d osi n g of > 2 0 m m H g
Diast olic bl o o d 
press ure  
> 8 0  m m H g or a n i ncrease fr o m pre -d osi n g of > 2 5  m m H g, or
< 4 5 m m H g or a decrease fr o m pre -d osi n g of > 1 5  m m H g
8. 6. 4  P hysic al E x a mi n ati o n  
P h ysical e xa mi nati o n data will be s u m marize d b y visit a n d treat me nt gr o u p a n d liste d. 
C ha n ges i n p h ysical e xa mi nati o n data fr o m baseli ne will be prese nte d. S ki n reacti o ns 
o bser ve d d uri n g t he p h ysical e xa mi nati o ns will als o be re p ort e d a n d t he c orres p o n di n g 
data will be ta b ulate d se p aratel y (s ee Secti o n  8. 6. 6 ). 
8. 6. 5  S u bject Di aries  
S u bject diar y data will be s u m marize d w here a p pr o priate a n d liste d.  
T he n u m ber of da ys of i tc hi n g, re d ness a n d s welli n g of Gra de 1, 2, or 3 will be s u m marize d 
se parat el y b y treat me nt gr o u p a n d o verall ( d uri n g t he first 6 m o nt hs f or part A, a n d d uri n g 
t he w h ole treat me nt d urati o n f or part B). 
T he m ost se vere gra des of itc hi n g, re d ness a n d s welli n g, d oc u me nte d i n t he diar y, will als o 
be s u m marize d. T h e m a xi m u m gra de of l o cal reacti o ns re p orte d (itc hi n g, re d ness or 
s welli n g) will als o be ta b ulate d. 
8. 6. 6  S ki n Re acti o ns  
Vias ki n ®  patc h site e xa mi nati o n data will be s u m marize d w here a p pr o pri ate a n d liste d. 
E xa mi nati o n of t he s ki n at t he site of patc h a p plicati o n will be gra de d b y t he I n v esti gat ors  
or dele gate d trai ne d staff o n a scale of Gra de  0 ( ne gati ve) t o Gra d e  4 (er yt h e ma, vesicles). 
L ocalizati o n of t he s ki n reacti o n ( u n der t he pat c h/ be y o n d t he p atc h) w ill als o be c ollecte d. 
T hese res ults will be s u m marize d usi n g descri pti ve statistics a n d prese nte d b y visit a n d 
treat me nt gr o u p, re g ar dless of t he l ocalizati o n as well as f or eac h t y pe of l ocalizati o n. T he 
w orst gra de re p ort e d will als o be ta b ulate d.  
8. 6. 7  Sy m p t o m atic Re acti o ns d uri n g t he D B P C F C 
T he i nci de nce of o bje cti ve a n d s u bjecti ve s y m pt o ms/reacti o ns elicite d d uri n g t he 
D B P C F Cs will be s u m marize d. A  se v erit y sc ore b ase d o n t h e gra des of s y m pt o ms elicite d 
d uri n g t he D B P C F Cs will be descri be d at bas eli ne a n d at M o nt h  1 2. T he c ha n ge i n t he 
se verit y sc ore fr o m bas eli ne will als o be prese nte d. 
8. 7  
E x pl or at or y A n al yses  
T here will be n o a dj ust me nts f or m ulti pli cit y f or a n y of t he f oll o wi n g e x pl orat or y a nal yses. 
T he f oll o wi n g e x pl orat or y a nal yses will be perf or me d  i n t he Safet y P o p ulati o n: 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
9 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  A nal ysis of I g E a n d I g G 4 s pecific t o pea n ut pr otei n c o m p o ne nts: des cri pti ve 
a nal ysis will be c o n d ucte d f or I g E a n d I g G 4 s pecific t o pea n ut pr otei n c o m p o ne nts 
usi n g o bser ve d data ; 
•  A nal ysis of t otal I g E, usi n g t he sa me statistical met h o d as descri be d f or I g E  a n d 
I g G 4 s pecific t o p ea n ut pr otei n c o m p o ne nts; 
•  Fre q u e nc y of acci de ntal pea n ut c o ns u m pti o ns, c o n diti o ns ar o u n d t he acci de ntal 
c o ns u m pti o ns (i ncl u di n g t he fre q ue n c y of deli berate c o ns u m pti o n t o e val uate ris k -
ta ki n g be ha vi ors), esti mate d q ua ntit y c o ns u me d at eac h occ urre n ce, a n d ass ociate d 
reacti o ns a n d s e verit y of reacti o ns will be st u die d o n t he Safet y p o p ulati o n; 
•  Descri pti ve a nal yses of e pi ge netic m o dificati o ns of s o me s pecific ge nes i n b ot h 
treat me nt gr o u ps usi n g o bser ve d dat a; 
•  Descri pti ve a n al ysis will be c o n d ucte d f or eac h of t he ot her aller ge n -s pecifi c I g E 
a nal yze d (c o w’s mil k, e g g, h o use d ust mites, grass p olle n) a n d t he c h a n ge fr o m 
baseli ne will be ta b ulate d  usi n g o bser ve d data;  
•  S C O R A D c ha n ge fr o m b aseli ne at M o nt hs  3, 6 a n d  1 2 will be prese nte d usi n g 
o bser ve d dat a;  
•  Q ualit y of Life a n al ysis usi n g t he E Q -5 D -5 L;  
•  A nal yses of bas o p hil acti vati o n: c ha n ges fr o m b aseli ne o ver ti me will be prese nte d 
a n d c orrelati o n wit h D B P C F C o utc o mes will be e x pl ore d ; 
•  
. 
C CI

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
9 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
8. 9  
I nteri m A n al yses 
8. 9. 1  E n d of P art A –  3 -m o nt h  S afety a n alysis  
A safet y a nal ysis was t o be c o n d ucte d w he n t he first 5 0 s u bjects ra n d o mize d i n t he st u d y 
ha ve reac he d 3  m o nt hs  of patc h a p plicati o n. T h ese safet y dat a were t o be re vie we d 
u n bli n dl y b y t he D S M B f or f or mi n g t heir rec o m me n dati o n o n t he hi g hest safe d ose t o b e 
selecte d f or t he re mai ni n g s u bject i ncl usi o ns ( Part B). After re vie w of t he 3 -m o nt h safet y 
data of t he 5 1 act uall y ra n d o mize d s u bjects i n p art A, t he D S M B ha d n o s afet y c o ncer n 
a n d c o nsi dere d b ot h d os es as well t olerate d wit h a g o o d safet y pr ofile. T h e 2 5 0 -µ g d ose 
was select e d f or p art B.  
F or t h e s u bject s of t h e P art A, de pe n di n g o n t he D S M B rec o m me n dati o n, t he d ose of t he 
D B V 7 1 2  gr o u ps was t o be ke pt eit her u nc ha n g e d,  re d u ce d or i ncrease d . U p o n D S M B 
rec o m me n dati o ns, all s u bjects fr o m Part A we re t o re mai n i n t heir i nitiall y ra n d o mize d 
treat me nt ar m ( d os es u nc ha n ge d). 
8. 9. 2  I nteri m a n alysis of i m m u n ol o gic al activity 
A n a nal ysis will be c o n d ucte d w he n 5 0 s u bjects fr o m Part B will ha ve reac he d 6  m o nt hs 
of acti ve D B V 7 1 2  treat me nt 
wit h t he d ose selecte d fr o m t he Part 
A ( 2 5 0 µ g) . 
I m m u n ol o gical para meters ( pea n ut-s p ecific I g E a n d pea n ut-s pecific I g G 4), S P T a n d mai n 
safet y data will be prese nte d.  
A s pecific f utilit y a nal ysis will be c o n d ucte d o n t he pea n ut -s pecific I g G 4 meas ure me nts . 
T he relati ve c ha n ge fr o m baseli ne [cal c ulate d as ( M o nt h 6 val ue –  bas eli ne val ue) / 
Baseli ne val ue] of t he pea n ut -s pecific I g G 4 le vels i n t he selecte d acti ve treat me nt gr o u p 
( 2 5 0 µ g) will be n u mericall y c o m pare d t o t he c ha n ge i n t he place b o gr o u p. T he me dia n of 
t he acti ve gr o u p is e x pecte d t o be greater t ha n t he place b o gr o u p me di a n t o e vi de nce a 
treat me nt acti vit y o n t he 1 -3 year  c hil dre n’s i m m u ne s yste m.  
I n t he sit uati o n w h ere t he me dia n rel ati ve c h a n ge fr o m baseli ne of t he p ea n ut-s pecific I g G 4 
is e q ual or l o wer t ha n t he me dia n relati ve c h a n ge i n t he place b o gr o u p, t h e pre mat ure st o p 
of t he st u d y f or lac k of e vi de nce of t hera pe utic b e nefit will be c o nsi d ere d. T his u n bli n d e d 
data re vi e w will be c o n d ucte d b y t he D S M B w h o will be res p o nsi ble of iss ui n g t he 
rec o m me n dati o n t o t he s p o ns or. 
8. 9. 3  P art A a n alysis  
A n a nal ysis will be c o n d ucte d after t he last s u bject fr o m Part A will ha ve c o m plete d  t he 
st u d y. T he ai m is t o d es cri be t he efficac y a n d safet y data a m o n g all s u bjects e nr olle d i n 
Part A. All a nal yses will be detaile d i n a se p arat e i nteri m S A P . 
8. 1 0  Deter mi n ati o n of S a m ple Size  
T he t otal n u m ber of s u bjects t o ra n d o mize i n E PI T O P E will be a p pr o x i matel y 4 0 0, as 
prese nte d i n Ta bl e 6 . 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
9 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
T a ble 6 : R a n d o mize d S u bje cts  
R a n d o mize d s u bjects  
D B V 7 1 2  
1 0 0  µ g  
D B V 7 1 2  
2 5 0  µ g  
Pl ace b o  
T ot al  
Part A  
2 0  
2 0  
1 0  
5 0  
Part B  
0  
2 3 3  
1 1 7  
3 5 0  
I n t his a ge p o p ulati o n, t he esti mate d scree n fail ure rate c o ul d be as hi g h as 6 0 % base d o n 
o ur pre vi o us e x perie n ce i n 4 t o 1 1 years ol d s u bject p o p ulati o n. As a c o nse q ue nce, 
a p pr o xi matel y 1, 0 0 0 pea n ut -aller gic c hil dre n 1 t o 3 years ma y nee d t o be scree n e d t o get 
t he 4 0 0 ra n d o mize d s u bj ects. 
Details f or Part A a n d Part B  are prese nte d bel o w.  
P art A  
D uri n g t he first safet y part of t he st u d y ( Part A), 5 0 s u bjects ( 1 0 place b o s u bjects, 
2 0  s u bjects at t he 1 0 0 µ g D B V 7 1 2  d ose, 2 0 s u bjects at t he 2 5 0 µ g D B V 7 1 2  d ose) w ill be 
ra n d o mize d. T he 2 0 s u bjects i nitiall y ra n d o mize d at t he d ose of D B V 7 1 2  n ot retai ne d will 
c o nti n ue at t hat d ose u p t o M o nt h  1 2 if t here are n o safet y c o ncer ns re gar di n g t his d ose . 
After t he 3 -m o nt h safet y D S M B a nal ysis , 2 5 0  µ g was select e d as t he hi g hest safe d ose. 
P art B  
T he o bjecti ve of t h e E PI T O P E  st u d y is t o assess t he efficac y a n d safet y of D B V 7 1 2  t o 
i n d uce dese nsitizati o n t o pea n ut i n pea n ut-aller gi c c hil dre n 1 t o 3 year s after a 1 2-m o nt h 
treat me nt peri o d of E PI T. T his will be e val uate d b y assessi n g t he perce nta ge of treat me nt 
res p o n ders i n t he acti ve D B V 7 1 2  gr o u p selecte d f or Part B  ( 2 5 0 µ g)  c o m pare d t o t he 
place b o gr o u p.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
9 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
P ote nti al s a m ple size reesti m ati o n  f or P art B 
T he a n al ysis of Part A s h o ul d pr o vi de a m or e acc urate  assess me nt of w het her t he sa m pl e 
size f or Part B is a p pr o priate or w het h er  it n ee ds t o be a dj uste d.  T he c urre nt sa m ple siz e 
calc ulati o n was d o ne at a ti me w he n n o data i n 1 -3 year -ol d s u bjects e xiste d f or D B V 7 1 2. 
T heref ore, t he u n bli n de d data fr o m Part A is esse ntial i n refi ni n g t he c urre nt sa m ple size 
calc ulati o n f or Part B.  
Sa m ple size a dj ust me nt c o ul d be pr o p ose d base d o n a c o m bi nati o n of ( b ut n ot li mite d t o):  
•
a f or mal c o m p utati o n of pr o ba bilit y of s uccess ( 4 5 ).
•
a reeasse me nt of place b o res p o nse rate ass u m pti o n. 
If, f or i nsta nce, t he e x act o bser ve d perce nta ges of res p o n ders i n P art A are belie ve d t o be 
t he “tr ue” rates i n t he p o p ulati o n, t he n a hi g her place b o rate c o ul d re q uir e a greater sa m ple 
size, as s h o w n i n Ta ble 7  bel o w.  
T a ble 7 : E x a m ples of E x act O bser ve d P erce nt a ges of R es p o n ders i n P art A 
Pl ace b o res p o n der r ate  
D B V 7 1 2  2 5 0  µ g res p o n der r ate  
T ot al S a m ple Size  
1 0 %  
4 0 %  
3 5 0  
2 0 %  
5 0 %  
4 6 2  
3 0 %  
6 0 %  
5 1 9  
Re g ulat ors a n d I R Bs will be i nf or me d if a n y s a m ple size a dj ust me nts are nee de d.  
9  
E T HI C A L, L E G A L, A N D A D MI NI S T R A TI V E A S P E C T S  
9. 1  
I nf or me d C o nse nt 
T he I n vesti gat or is res p o nsi ble f or a n d will o bt ai n a si g ne d I C F fr o m eac h s u bject’s 
pare nts/ g uar dia ns, bef ore eac h s u bject is a d mitte d  t o t he st u d y, i n acc or da nce wit h t he 
I C H-G o o d Cli nical Practice ( G C P ) G ui deli nes, t he Declarati o n of Helsi n ki, a n d l ocal 
a p plica ble re g ulat or y re q uire me nts.  
T his c o nse nt f or m m ust be date d, si g ne d a n d ret ai ne d b y t he I n vesti gat or as part of t he 
st u d y rec or ds. T he I n vesti gat or will n ot u n derta ke a n y i n vesti gati o n s pecificall y re q uire d 
o nl y f or t he cli nic al st u d y u ntil vali d c o nse nt has bee n o btai ne d. T he ter ms of t he c o ns e nt 
a n d w he n it was o btai ne d m ust be d oc u me nte d i n t he s u bject’s me dical rec or ds a n d t h e 
e-C R F.
S u bjects’ pare nts/ g uar dia ns will be i nf or me d of t he nat ure of t he st u d y, its ai m, its p ossi ble 
ris ks c o nstrai nts, its e x pecte d be nefits, its d urati o n, a n d t he c o m pe nsati o n t hat t he y mi g ht 
recei v e. T he pr ot o c ol will be e x plai ne d d uri n g a meeti n g pri or t o st u d y e nr oll me nt, a n d 
eac h s u bj ect/ pare nts/ g uar dia ns m ust be i nf or me d t hat partici pati o n i n t he st u d y is v ol u ntar y 
a n d t hat t he s u bject ma y wit h dra w fr o m t h e st u d y at a n y ti me. T h e pare nts/ g uar dia ns 
s h o ul d rea d t he I C F bef ore si g ni n g a n d dati n g it an d a c o p y of t he si g ne d d oc u me nt s h o ul d 
be gi ve n t o t he pare nts/ g uar dia ns. N o s u bject ca n e nter t he st u d y bef ore i nf or me d c o nse nt 
has bee n o btai ne d fr o m h er/ his pare nts/ g uar di a ns.  
If a pr ot oc ol a me n d me nt is re q uire d, t he I C F ma y nee d t o be re vise d t o reflect t he c ha n ges 
t o t he pr ot oc ol. If t he c o nse nt f or m is re vise d, it m ust be re vie we d a n d a p pr o ve d b y t he 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
9 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
a p pr o priate I E C/I R B, a n d si g ne d b y t he p are nts/ g uar dia ns of all s u bjects s u bse q ue ntl y 
e nr olle d i n t he st u d y as well as t h ose c urre ntl y e nr olle d i n t he st u d y. 
T he I n v esti gat or s h o ul d i nf or m t he s u bject’s pri m ar y p h ysicia n a b o ut p artici pati o n i n t he 
cli nical st u d y w here v er re q uire d.  
9. 2  
D at a Q u alit y Ass ur a nce  
T he S p o ns or  or S p o ns or’s desi g nee  will c o n d u ct a site visit or a site p h o n e c o ntact , i n cas e 
t he i n vesti gat or a n d t he ce nter are alr ea d y k n o w n fr o m D B V, t o v erif y t he q ualificati o ns 
of eac h I n v esti gat or, i ns pect t he site facilities, i nf or m t he I n vesti gat or of his/ her 
res p o nsi bilities a n d t he re q uire d pr oce d ures f or e ns uri n g a de q uate site selecti o n a n d pr o p er  
d oc u me ntati o n.  
9. 3  
D at a b ase M a n a ge me nt a n d Q u alit y C o ntr ol  
All data ge nerate d b y t he site pers o n nel will be ca pt ure d electr o nicall y at eac h st u d y ce nte r 
usi n g e-C R F s. Data fr o m e xter nal s o urces (s uc h as la b orat or y data a n d e x pl orat or y B A T ) 
will be i m p orte d i nt o t he ce ntral dat a base.  
O nce cli nical dat a are e ntere d a n d vali date d  i n t he e-C R F , t he y are tra ns mitte d a n d 
rec or de d b y t h e ce ntral s er ver i n t he ce ntr al data base. C o m p uterize d e dit -c hec ks will b e 
de vel o pe d i n a d diti o n t o ma n ual re vie w t o detect a n y discre p a ncies a n d t o e ns ure 
c o nsiste nc y of t he d ata. T he a p pr o priate staff at t he st u d y site will a ns wer q ueries se nt t o 
t he I n vesti gat or. T h e reas o n f or c ha n g e s, t he n a me of t h e pers o n w h o perf or me d t he 
c ha n ges, t o get h er wit h t he ti me a n d date will be a ut o maticall y rec or d b y t he Electr o nic 
Data Ca pt ur e ( E D C) . A n electr o nic a u dit tr ail s yste m will be us e d t o tr ac k all data c ha n ges 
i n t he data base s u bse q u e nt t o t he first data e ntr y 
If a d diti o nal c orrecti o ns are n ee d e d, t he res p o nsi ble m o nit or or data m a n ager or t he 
S p o ns or will raise a q uer y i n t he E D C a p plicati o n. A p pr o priate fee d b ac k t o t he st u d y staff 
or ot her c orrecti ve meas ures will be u n dert a ke n if a n y missi n g data, i nc o nsiste nt data, 
o utlier data a n d p ote ntial pr ot oc ol de viati o ns are i d e ntifie d d uri n g r o uti ne re m ote dat a 
re vie w. 
O nce all s o urce d ata v erificati o n is c o m plet e a n d all q ueries are cl ose d, t h e m o nit or will 
freeze t he e-C R F  pa g e.  
T he s pecific pr oce d ures t o be use d f or data e ntr y a n d q uer y res ol uti o n usi n g t he E D C 
s yste m/e-C R F  will be pr o vi de d t o st u d y sites i n a trai ni n g ma n ual. I n a d diti o n, site 
pers o n nel will recei ve trai ni n g o n t he E D C s yste m/ e-C R F . 
9. 4  
S o urce D oc u me nt ati o n  
All s o urce d o c u me nts fr o m w hic h e-C R F  e ntries are deri v e d s h o ul d be ke pt  i n t he s u bject’s 
me d ical rec or ds.  
F or all e -C R F e ntries, f or eac h s u bject, it m ust be p ossi ble t o c hec k t hese a gai nst s o urce 
d oc u me nts at t he st u d y site , e xce pte d f or t he data ge nerate d f or t h e st u d y a n d rec or de d 
directl y i n t he e -C R F .  
As a mi ni m u m re q uire me nt, t he f oll o wi n g data m ust be s o urce d ata verifia ble i n t he 
s u bject’s s o urce d oc u me ntati o n ot her t ha n t he e-C R F:  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
9 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
•  I d e ntificati o n of s u bject (s u bject i de ntifier: s u bject na me , se x a n d d ate of birt h)  
•  C o nfir mati o n of partici pati o n i n t he st u d y (st u d y i de ntificati o n, s u bject 
i de ntificati o n n u m ber a n d si g ne d a n d date d i nf or me d c o nse nt); 
•  Dia g n osis/i n dicati o n u n der i n vesti gati o n ; 
•  Rele va nt me dical hist or y, c o nc o mita nt ill ness;  
•  Visit dates ; 
•  Data rel ate d t o t he a d v erse e ve nts;  
•  Reas o n f or s u bject e xcl usi o n d uri n g t he selecti o n or wit h dra wal  fr o m t he st u d y; 
T he I n v esti gat or will recei ve t he la b orat or y re p orts fr o m t he ce ntr al la b orat or y. T h e 
I n v esti gat or m ust re vie w, si g n a n d date t he la b orat or y re p orts o n t he da y of e val uati o n. 
T he si g ne d la b orat or y re p orts m ust be retai ne d b y t he site as s o urce d o c u m e ntati o n.  
Data t hat will be e ntere d directl y i nt o t he e-C R F  (t h ose f or w hic h t here is n o pri or writte n 
or electr o nic rec or d of d ata) are c o nsi dere d t o be s o urce d ata.  T hes e data will be defi ne d 
i n t he m o nit ori n g g ui deli nes.  
T he pre -s pecifie d e-C R F  e ntries, d e pe n di n g o n t h e pre-s pecifie d s o urce verifie d dat a, f or 
eac h s u bject s h o ul d be c hec k e d a gai nst s o urce d oc u me nts at t he st u d y site b y t he site 
m o nit or. 
 I nsta nces of 
missi n g or u ni nter preta ble data will be disc usse d wit h t he 
I n v esti gat or f or res ol uti o n.  
9. 5  
D at a C ollecti o n / ele ctr o nic C ase Re p ort F o r m  (e-C R F)  
T he In vesti gat ors (a n d a p pr o priatel y a ut h orize d staff) will be gi ve n access t o a n o nli ne 
we b - base d E D C /e-C R F  s yste m, w hic h is 
F o o d a n d 
Dr u g A d mi nistrati o n  ( F D A) 
2 1  C F R  Part  1 1 c o m plia nt. T his s yste m is s pecificall y desi g ne d f or t he c ollecti o n of t he 
cli nical data i n electr o nic f or mat. Access a n d ri g ht s t o t he E D C s yste m will be c o ntr olle d 
a n d c o nfi g ure d acc or di n g t o eac h i n di vi d ual’s r ol e t hr o u g h o ut t he st u d y. I n ge neral, o nl y 
t he In vesti gat or a n d a ut h orize d staff will be a ble t o e nter d ata a n d ma ke c orrecti o ns i n t h e 
e-C R F s. 
T he s pecific pr oce d ures t o be use d f or d ata e ntr y a n d q uer y res ol uti o n usi n g t he e -C R F 
will be pr o vi de d t o st u d y sites i n a tr ai ni n g ma n ual. I n a d diti o n, site pers o n nel will be 
trai ne d o n t he e -C R F  s yste m. 
T he e -C R F  s h o ul d be pr o m ptl y c o m plete d f or eac h s u bject f orm  w h o m a n I C F was 
o btai ne d  a n d s h o ul d reflect t he latest o bser vati o ns o n t he s u bject partici p ati n g i n t he st u d y . 
T heref ore, t he e-C R F s are t o be c o m plete d as s o o n as p ossi ble d uri n g or i m me diatel y after 
t he s u bject’s visit or ass ess me nt. T he In v esti gat or m ust verif y t hat all dat a e ntries i n t h e 
e-C R F  are acc urate a n d c orrect. If s o me ass ess me nts ca n n ot be d o ne, or if cert ai n 
i nf or mati o n is u na vaila ble, n ot a p plica ble or u n k n o w n, t he In v esti gat or s h o ul d i n dicate it 
i n t he e-C R F .  
C o m p uteri ze d data-c hec k pr o gra ms a n d ma n ual c hec ks will i de ntif y a n y cli n ical data 
discre pa n cies f or res ol uti o n. C orres p o n di n g q ueries will be l oa de d i nt o t he s yste m a n d t he 
site will be i nf or me d a b o ut ne w iss ues t o be res ol ve d o n-li ne. All discre pa ncies will be 
s ol ve d o n-li ne directl y b y t he In vesti gat or or b y a ut h ori ze d staff. Off-li ne e dit c hec ks will 
be d o ne t o e xa mi ne relati o ns hi ps o ver ti me a n d acr oss pa nels t o facilitate q ualit y data.   

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
I nf or mati o n c o ncer ni n g I M P dis pe nsati o n  t o t he s u bject will be trac ke d i n t h e e-C R F . Aft er 
c o m pleti o n, t he I n vesti g at or will be re q uire d t o vali date a n d electr o ni call y si g n -off t he 
cli nical data rec or de d i n eac h e -C R F.  
9. 6  
Access t o S o urce D at a  
9. 6. 1  R o uti ne M o nit ori n g  
D uri n g t he st u d y, a C o ntract Res earc h Or ga nizati o n  (C R O ) site m o nit or will ma ke sit e 
visits t o re vie w pr ot oc ol c o m plia nce, c o m pare e-C R F  e ntries  a n d i n di vi d ual s u bject’s 
me dical rec or ds, assess dr u g acc o u nta bilit y, a n d e ns ure t hat t he st u d y is bei n g c o n d ucte d 
acc or di n g t o  et hical a n d  perti ne nt re g ulat or y re q uire me nts. T he e-C R F  e ntries will be 
verifie d wit h s o urce d o c u me ntati o n. T he re vie w of me dical rec or ds will be perf or me d i n a 
ma n ner t o e ns ur e t hat s u bject c o nfi de ntialit y is mai ntai ne d.  
C hec ki n g of t he e-C R F  e ntries f or c o m plete ness a n d clarit y, a n d cr oss-c hec ki n g wit h 
so urce d oc u me nts, will be re q uire d t o m o nit or t he pr o gress of t he st u d y. Direct access t o 
s o urce dat a will be re q uir e d f or t he m o nit ori n g acti vities. 
9. 6. 2  I ns pecti o ns a n d A u diti n g Pr oce d ures 
T he S p o ns or or its re pres e ntati ve ma y c o n d uct a u dits at t he i n vesti gati ve sites i ncl u di n g, 
b ut n ot li mite d t o, dr u g s u p pl y, prese nce of re q uire d d oc u me nts, t he i nf or me d c o nse nt 
pr ocess, a n d c o m paris o n of e-C R F s wit h s o urce d o c u me nts. All me dical rec or ds ( pr o gress 
n otes) m ust be a vaila bl e f or a u dit. T h e I n vesti gat or a grees t o partici pate i n a u dits 
c o n d ucte d at a c o n ve ni e nt ti me i n a reas o na ble ma n ner.  
M ore o ver, Re g ulat or y A ut h ori ties of certai n c o u ntries, I R Bs a n d I E Cs ma y wis h t o carr y 
o ut s uc h s o urce d ata c h ec ks a n d/ or o n -site a u dit i ns pecti o ns. Direct access t o s o urce dat a 
will be re q uire d f or t hese i ns pecti o ns a n d a u dits; t he y will be carrie d o ut gi vi n g d ue 
c o nsi derati o n t o d ata pr otecti o n a n d m e dical c o nfi d e ntialit y. T he I n v esti gat or ass ur es C R O  
a n d t he S p o ns or of t he necessar y s u p p ort at all ti mes.  
T he p ur p ose of a n a u dit is t o assess w het her et hi cs, re g ulat or y a n d q u alit y re q uire me nts 
are f ulfille d.  
9. 7  
D at a Pr ocessi n g  
All data will be e ntere d b y site pers o n nel i nt o t he e-C R F  (as d etaile d i n Secti o n 9. 3 ). 
T he data -re vie w a n d data-ha n dli n g d oc u me nt, t o be de vel o pe d d uri n g t he i nitiati o n p hase 
of t he st u d y, will i ncl u de s pecificati o ns f or c o m p uterize d e dit -c h ec ks: c o nsi ste nc y a n d 
pla usi bilit y c hec ks o n data a n d will als o i ncl u de data -ha n dli n g r ules f or o b vi o us data 
err ors. Q uer y/c orrecti o n f or u nres ol v e d q ueri es will be  a ut o maticall y  se nt f or res ol uti o n 
wit h t he I n vesti gat or. T he data base will be a ut o maticall y u p date d after c orrecti o ns  are 
ma de b y t he i n vesti gat or’s staff .  
Pre vi o us a n d c o nc o mita nt me dicati o ns will be c o de d usi n g t he W H O  Dr u g Refere n ce List, 
w hic h e m pl o ys t he A nat o mical T hera p e utical C he mical ( A T C ) classifi cati o n s yste m. 
Disease a n d Me dic al hist or ies/c urre nt me dical c o n diti o ns a n d A Es  will be c o de d usi n g t he 
Me d D R A  ter mi n ol o g y. 
T he act ual v ersi o ns of t h e c o di n g dicti o naries will be pr o vi de d i n t he C S R . 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
9. 8  
Arc hi vi n g St u d y Rec or ds  
All data deri v e d fr o m t he st u d y will re mai n t he pr o pert y of t he S p o ns or. R ec or ds m ust b e 
retai ne d i n acc or da n ce wit h t he c urre nt I C H G ui deli nes o n G C P . All esse ntial st u d y 
d oc u me nts i ncl u di n g rec or ds of s u bjects, s o urce d oc u me nts, e-C R F s a n d I M P i n ve nt or y 
m ust be ke pt i n a st u d y-s pecific file. 
Trial d oc u me nts s h o ul d be retai ne d u ntil at least 2 years after t he last a p pr o val of a 
mar keti n g a p plicati o n i n a n I C H re gi o n a n d u ntil t here are n o pe n di n g or pla n ne d 
mar keti n g a p plicati o ns i n a n I C H re gi o n or at least 2  years ha v e ela ps e d si nce t he f or mal 
disc o nti n uati o n of cli nical de vel o p me nt of t he pr o d uct.  
F or t his st u d y, t he I n vesti gat or site files rec or ds m ust be retai ne d b y t he I n v esti gat or  at 
least 1 5 years after t he c o m pleti o n of t he trial, or l o n ger if re q uire d b y t heir nati o nal 
re g ulati o n.  
S u bjects’ me dical rec or ds m ust be ke pt f or t he ma xi m u m peri o d per mitte d b y t he h os pital, 
i nstit uti o n or pri vate practice. 
T he I n vesti gat or will n ot discar d  a n y rel e va nt rec or ds t o t his st u d y wit h o ut pri or writ te n 
per missi o n fr o m t he S p o ns or.  T he I n vesti gat or s h all n otif y t he S p o ns or i n writi n g of t heir 
i nte nt t o destr o y all s uc h material. T he S p o ns or s hall ha ve 3 0 da ys t o res p o n d t o t he 
I n v esti gat or’s n otice, a n d t he S p o ns or s hall ha ve a f urt her o p p ort u nit y t o retai n s uc h 
materials at t he S p o ns or’s e x pe nse.  
T he I n v es ti gat or s hall ta k e res p o nsi bilit y f or m ai ntai ni n g a de q uat e a n d acc urate h ar d c o p y 
s o urce d oc u me nts of all o bser vati o ns a n d data ge nerate d d uri n g t his st u d y. S uc h 
d oc u me ntati o n is s u bject t o i ns pecti o n b y t he S p o ns or, its re pres e ntati ves a n d R e g ulat or y 
A ut h orities. If a n I n v est i gat or 
m o ves, 
wit h dra ws fr o m t he st u d y or retires, t he 
res p o nsi bilit y f or mai ntai ni n g t he rec or ds ma y b e tra nsferre d t o a n ot her p ers o n w h o will 
acce pt res p o nsi bilit y. N otice of tra nsfer m ust be ma de t o a n d a gree d b y t h e S p o ns or.  
9. 9  
G o o d C li nic al Pr actice 
T he pr oce d ures set o ut i n t his st u d y pr ot oc ol are desi g ne d t o e ns ure t hat t he S p o ns or a n d 
I n v esti gat or a bi de b y t he pri nci ples of t he I C H-G C P G ui deli nes , a n d of t h e Declarati o n of 
Helsi n ki ( A P P E N DI X 1 ). T he st u d y als o will be carri e d o ut i n kee pi n g wit h l ocal le gal 
re q uire me nts.  
9. 1 0  Pr ot oc ol A p pr o v al a n d A me n d me nt  
Bef ore t he start of t he st u d y, t he st u d y pr ot oc ol a n d/ or ot her rele va nt d o c u me nts will be 
re vie we d a n d a p pr o ve d b y t he I E C/I R B/ Re g ulat or y  A ut h orities, i n acc or da nce wit h l ocal 
le gal re q uire me nts. T he S p o ns or m ust e ns ure t hat all et hical a n d le gal re q uire ments ha ve 
bee n met bef ore t he first s u bject is e nr olle d i n t he st u d y. 
T his pr ot oc ol is t o be f oll o we d e xactl y. A n y c ha n ge t o t he pr ot oc ol m ust be ha n dle d as a 
pr ot oc ol a me n d m e nt. A n y p ote ntial a me n d m e nt m ust be a p pr o ve d b y t he S p o ns or. A 
writte n a me n d me nt m ust be s u b mitte d t o t he a p pr o priate R e g ulat or y A ut h orities a n d t o t he 
I R B/I E Cs ass u mi n g t his res p o nsi bilit y. T he I n v esti gat or m ust a wait I R B/I E C a p pr o val of 
s u bsta ntial pr ot oc ol a me n d me nts bef ore i m ple me nti n g t he c ha n ges, e xce pt 
w here 
necessar y t o eli mi nat e a p pare nt i m me diate hazar d t o s u bjects.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
All s u bsta ntial a me n d me nts t o t he pr ot oc ol m ust be a p pr o ve d i n writi n g b y b ot h t he 
a p pr o priate R e g ulat or y A ut h orities a n d t he I R B/I E C, e xce pt f or a d mi nistrati ve 
a me n d me nts, w hic h re q uire n otificati o n b ut n ot writte n a p pr o val. O nce a p pr o ve d, t he 
pr ot oc ol a me n d me nt will be distri b ute d t o all reci pie nts of t he ori gi nal pr ot oc ol, wit h 
i nstr ucti o ns t o a p pe n d t he a me n d me nt t o t he pr ot oc ol. If, i n t he j u d g me nt of t he l ocal 
I R B/I E C, t he I n v esti gat or a n d/ or S p o ns or, t he pr otoc ol a me n d me nt alters t he st u d y desi g n, 
pr oce d ures a n d/ or i ncreas es t he p ote ntial ris k t o t he s u bject, t he c urre ntl y a p pr o ve d writte n 
I C F will re q uir e m o dificati o ns. T he m o difie d I C F m ust als o be re vie we d a n d a p pr o ve d b y 
t he S p o ns or, a p pr o priate R e g ulat or y  A ut h orities, a n d t he I R B/I E C. I n s uc h cases, re p eat 
i nf or me d c o ns e nt m ust b e o btai ne d fr o m t he e nr olle d s u bjects’ pare nts/ g u ar dia ns b ef ore 
partici pati o n c o nti n ues.  
9. 1 1  D at a a n d S afet y M o nit o ri n g B o ar d  
A D S M B c o m p ose d of e x perts i n f o o d aller g y a n d i n t he met h o d ol o g y of cli nical st u dies 
will be esta blis he d i n d ue ti me f or t he first data re vie w. T his D S M B will be i n de pe n de nt 
of t he S p o ns or a n d will re vie w safet y data fr o m t he st u d y at s pecifie d i nter vals d uri n g t he 
st u d y a n d o n a n a d h oc basis as dee me d n ecess ary b y t he D S M B C hair p ers o n or w he n 
c o n ve ye d b y t he S p o ns or.  
T he D S M B me m bers will re vie w bli n de d dat a, b ut ma y ha ve access t o u n bli n de d data as 
dee me d n ecessar y d uri n g t he cl ose d re vie w meeti n gs. D uri n g t hes e re vie w meeti n gs, t he 
D S M B will assess w het her t he nat ure, fre q ue n c y, a n d se verit y of t he A Es ass ociate d wit h 
t he st u d y treat me nt warra nt a n y rec o m me n dati o ns or c orrecti ve acti o ns of t he st u d y 
c o n d uct i n t he best i nterest of t he s u bjects.  
A s pecific D S M B meeti n g will re vie w t he safet y a nal ysis o n t he i nitial 5 0 first s u bjects 
i ncl u de d i n t he 3 treat me nt ar ms of t he Part A, D B V 7 1 2  1 0 0 μ g a n d 2 5 0 μ g a n d place b o 
w he n t he y will reac h 3  m o nt hs of patc h a p plicati o n. T hese safet y data will be re vi e we d 
u n bli n dl y be t he D S M B f or f or mi n g t heir rec o m me n dati o n o n t he d ose selecti o n f or t he 
st u d y part B.  
A n ot her  s pecifi c D S M B meeti n g will be c o n d uct e d o n t he f utilit y a nal ysis base d o n 
pea n ut -s pecific I g G 4 me as ure me nts a n d t he safet y data w he n all t he s u bjects of t he Part B 
will reac h 6 m o nt hs of tr eat me nt . T hese d ata w ill be re vie we d u n bli n dl y b y t he D S M B f or 
f or mi n g t heir rec o m me n dati o n o n t he c o nti n uati o n of t he st u d y.  
T he r oles, res p o nsi bilities, c o nstit uti o n, a n d o perati o ns of t he D S M B will be descri be d i n 
t he D S M B C harter, w hic h will be re vie we d a n d si g ne d b y eac h me m ber bef ore t he first 
s u bject is e nr olle d i n t he st u d y. 
9. 1 2  D ur ati o n of t he St u d y  
F or a n i n di vi d ual s u bject, t he ma xi m u m d urati o n of st u d y partici pati o n  w ill be u p t o 
6 2  wee ks (i ncl u di n g u p t o 6  wee ks f or scree ni n g, 1 2  m o nt hs of treat me nt a n d u p t o 4  wee ks 
f or f oll o w-u p). T he pla n ne d o verall st u d y d urati o n is e x pecte d t o be a p pr o xi matel y of 
3 0  m o nt hs. T he date of t he st u d y start will be d efi ne d as t he d ate of t he first visit of t he 
first s u bject a n d t he st u d y e n d will be defi ne d as t he last visit of t he last s u bject. 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
9. 1 3  Pre m at ure Ter mi n ati o n of t he St u d y  
If t he I n vesti gat or, t h e S p o ns or, or t he Me dical M o nit or bec o mes a ware of c o n diti o ns or 
e ve nts t hat s u g gest a p ossi ble hazar d t o s u bjects if t he st u d y c o nti n ues, t he st u d y ma y be 
ter mi nate d after a p pr o pri ate c o ns ultati o n bet wee n t he rele va nt parties. T he st u d y ma y als o 
be ter mi nate d earl y at t he S p o ns or’s discreti o n i n t he a bse nce of s uc h a fi n di n g.  
C o n diti o ns t hat ma y warra nt ter mi nati o n i ncl u de, b ut are n ot li mite d t o:  
•  T he disc o ver y of a n u ne x pecte d, si g nifica nt, or u nacce pta ble ris k t o t he s u bjects 
e nr olle d i n t he st u d y;  
•  Fail ure t o e nr oll s u bjects at a n acce pta ble rate;  
•  A decisi o n o n t he part of t he S p o ns or t o s us pe n d or disc o nti n ue de vel o p me nt of t he  
dr u g;  
•  A decisi o n fr o m t he Re g ulat or y A ut h orities t o s us pe n d or disc o nti n ue t he st u d y ; 
•  Lac k of e vi de nce of t hera pe utic be nefit acc or di n g t o t he i nteri m f utilit y a nal ysis . 
I n t er mi nati n g t he st u d y, t he S p o ns or a n d t he I n v esti gat or will e ns ure t hat a de q u ate 
c o nsi derati o n is gi ve n t o t he pr otecti o n of t he s u bj ects’ i nterests.  
9. 1 4  C o nfi de nti alit y  
All i nf or mati o n i ncl u di n g t he s ki n p h ot os, o btai ne d d uri n g t he c o n d uct of t he st u d y wit h 
res pect t o t he s u bj ect’s state of healt h will be re g ar de d as c o nfi de ntial. F or discl os ure of 
a n y s uc h i nf or mati o n, a n a gree me nt will be o btai ne d i n writi n g. T he I n vesti gat or m ust 
e ns ure t h at eac h s u bj ect’s a n o n y mit y is mai ntai ne d. O n e -C R Fs, t he ot her d oc u me nts a n d 
t he s ki n p h ot os tra ns mitte d t o t he S p o ns or or its re prese ntati ves, s u bjects m ust n ot be 
i de ntifie d b y na me. I nste a d, s u bjects will o nl y be k n o w n b y t he u ni q ue s u bject scree ni n g 
n u m ber all ocat e d t o t he m i n or der t o e ns ure c o nfi de ntialit y o n all st u d y d oc u me ntati o n. 
S u bjects will re tai n t his u ni q ue n u m ber t hr o u g h o ut t he st u d y. T he I n vesti gat or will kee p a 
se parat e l o g of t hese c o d es. 
I n or der t o c o m pl y wit h g o ver n me nt re g ulat or y g ui deli nes a n d t o e ns ure s u bject safet y, it 
ma y be n ecessar y f or t he S p o ns or a n d its re pres e ntati ve s, t he I E C/I R B, or Re g ulat or y 
A ut h orit y t o re vie w s u bjects’ me dical rec or ds as t h e y relate t o t his st u d y. O nl y t he s u bject’s 
u ni q ue n u m ber i n t he e -C R Fs will i de ntif y her/ hi m, b ut t heir f ull na mes ma y be ma de 
k n o w n t o a Re g ulat or y A ut h orit y or ot her a ut h ori ze d g o ver n me nt or healt h care offici als, 
if necessar y, a n d t o pers o n nel desi g nate d b y t he S p o ns or. 
D oc u me nts t hat are n ot f or s u b missi o n t o t he S p o ns or ( f or e x a m ple c o nse nt f or ms) will be 
mai ntai ne d b y t he I n v esti gat or i n strict c o nfi de nce, e xce pt t o t he e xte nt necessar y t o all o w 
m o nit ori n g b y t he S p o ns or a n d its re prese ntati ves, a n d a u diti n g b y re g ulat or y a ut h orities. 
N o d oc u me nts i d e ntif yi n g s u bjects b y na me will lea ve t h e i n vesti gati ve site a n d s u bject 
i de ntit y will re mai n c o nfi de ntial i n all p u blicati o ns relate d t o t he st u d y. 
9. 1 5  C o ntr act u al a n d Fi n a nci al Det ails  
T he I n v esti gat or (a n d/ or, as a p pr o priate, t he h os pital a d mi nistrati ve re prese ntati ve) a n d t he 
S p o ns or will si g n a cli nical st u d y a gree me nt pri or t o t he start of t he st u d y, o utli ni n g o verall 
S p o ns or a n d I n vesti gat or res p o nsi bilities i n relati o n t o t he st u d y. T he c o ntract s h o ul d 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
descri be w het her c osts f or p har mac y, la b orat or y a n d ot her pr ot oc ol -re q uir e d ser vices are 
bei n g pai d directl y or i n directl y.  
Fi na ncial Discl os ur e State me nts will nee d t o be c o m plete d,  as re q ueste d b y F D A C F R 2 1 
part 5 4.  
9. 1 6  Li a bilit y a n d I ns ur a nce  
T he S p o ns or will ta ke o ut reas o na ble t hir d -p art y lia bilit y i ns ura nce c o ver a g e i n acc or da n ce 
wit h all l ocal le gal re q uire me nts. T he ci vil lia bilit y of t he I n vesti gat or, t he pers o ns 
i nstr ucte d b y her / hi m a n d t he h os pital, practice , or i nstit ute i n w hic h t he y are e m pl o ye d 
a n d t he lia bilit y of t he S p o ns or wit h res pect t o fi na ncial l oss d ue t o pers o nal i nj ur y a n d 
ot her da ma ge t hat ma y arise as a res ult of t he carr yi n g o ut of t his st u d y are g o ver ne d b y  
t he a p plica ble la w. 
De viati o ns fr o m t he st u d y pr ot oc ol, es peciall y t he prescri pti o n of a d ose ot her t ha n t hat 
sc he d ule d i n t he st u d y pr ot oc ol, ot her m o des of a d mi nistrati o n, ot her i n dicati o ns, a n d 
l o n ger treat me nt peri o ds, are n ot per mitte d a n d s hall n ot be c o vere d b y t he stat ut or y s u bject 
i ns ura nce sc h e me. 
T he S p o ns or will arra n g e f or s u bjects partici pati n g i n t his st u d y t o be i ns ure d a gai nst 
fi na ncial l oss d ue t o pers o nal i nj ur y ca use d b y t he p har mace utical pr o d ucts bei n g teste d or 
b y me dical ste ps t a ke n i n t he c o urse of t h e st u d y.  
9. 1 7  P u blic ati o n P olic y  
B y si g ni n g t he st u d y pr ot oc ol, t he I n v esti gat or a grees wit h t he use of res ults of t he st u d y 
f or t he p ur p os es of nati o nal a n d i nter nati o nal re gistrati o n, p u blicati o n a n d i nf or mati o n f or 
me dical a n d p har mace utical pr ofessi o nals. If necessar y, Re g ulat or y A ut h orities  will be 
n otifie d of t he I n vesti gat or's na me, a d dress, q ualificati o ns a n d e xte nt of i n v ol ve me nt.  
A n I n v esti gat or s hall n ot p u blis h a n y data ( p oster, a bstract, pa per, etc.) wit h o ut ha vi n g 
c o ns ulte d wit h t he S p o ns or i n a d va nce  a n d ha vi n g recei ve d a writte n a p pr o val f or s uc h a 
p u blicati o n . Details are pr o vi de d i n a se parate d oc u me nt.  
9. 1 8  St u d y Ce nter File M a n a ge me nt  
T he I n vesti gat or is res p o nsi ble f or ass uri n g t hat t he St u d y Ce nter File is mai ntai ne d. T he 
St u d y Ce nter File will c o ntai n, b ut will n ot be li mite d t o, t he i nf or mati o n liste d bel o w:  
•  I B; 
•  C urre nt, si g ne d versi o n of t he pr ot oc ol a n d a n y pre vi o us versi o ns of t he pr ot oc ol;  
•  Pr ot oc ol a me n d me nts (if a p plica ble);  
•  O perati o ns Ma n u al (if a p plica ble);  
•  C urre nt I C F ( bl a n k) a n d a n y pre vi o us versi o ns of t he I C F;  
•  C urric ula Vitae of I n vesti gat or(s) a n d s u b -i n v esti gat or(s) a n d p h ot o c o p y of t heir 
res pecti ve lice nse(s) w here re q uir e d b y la w; Ori gi nal U S F D A F or m 1 5 7 2 (f or all 
st u dies c o n d ucte d u n der U S I n v esti gati o nal Ne w Dr u g [I N D] re g ulati o ns), si g ne d b y 
all Pri nci pal I n v esti gat ors. T he na mes of a n y s u b -i n vesti gators m ust a p pear o n t his 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
f or m. I n vesti gat ors m ust als o c o m plete all re g ulat or y d oc u me ntati o n as re q uire d t he 
I C H G C P a n d b y l oc al or nati o nal re g ulati o ns; 
•  D oc u me ntati o n of I R B/I E C a p pr o val of t he pr ot o c ol, t he I C F, a n y pr ot oc ol 
a me n d me nts, a n d a n y I C F re vis i o ns; 
•  All c orres p o n d e nce b et w ee n t he I n v esti gat or, I R B/I E C, a n d t he S p o ns or/  C R O  
relati n g t o st u d y c o n d uct; 
•  La b orat or y M a n ual a n d certificati o n(s);  
•  M o nit ori n g l o g;  
•  I M P acc o u nta bilit y f or ms ; 
•  Si g nat ure list of all staff c o m pleti n g e-C R F s;  
•  Si g nat ure list of all staff c o m pleti n g dr u g acc o u nt a bilit y s u m maries; a n d  
•  Dele gati o n l o g.  
9. 1 9  Cli nic al St u d y Re p ort  
A fi nal C S R  will be pre pare d acc or di n g t o t he I C H  E 3  g ui deli ne o n Str uct ure a n d C o nte nts 
of C S Rs . A fi nal C S R  will be pre pare d re gar dl ess of w het her t he st u d y is c o m plete d or 
pre mat urel y ter mi nate d. T he S p o ns or will pr o vi d e eac h I n vesti gat or wit h a c o p y of t he 
fi nal re p ort or s y n o psis  f or rete nti o n. 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
1 0 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
1 0  Liter at ure Cite d  
1. B oc k S A, M u n oz -F url o n g A, Sa m ps o n H A. F urt her fatalities ca use d b y a na p h ylactic
reacti o ns t o f o o d, 2 0 0 1-2 0 0 6. J. Aller g y Cli n. I m m u n ol. 2 0 0 7; 1 1 9( 4): 1 0 1 6 – 8.
2. B oc k S A, M u n oz -F url o n g A, Sa m ps o n H A. Fat alities d ue t o a na p h ylacti c reacti o ns t o
f o o ds. J. Aller g y Cli n. I m m u n ol. 2 0 0 1; 1 0 7( 1): 1 9 1– 3.
3. Sic herer S H, M u n oz -F ur l o n g A, G o d b ol d J H, Sa m ps o n H A. U S pre val e nce of self-
re p orte d p ea n ut, tree n ut, a n d sesa me aller g y: 1 1-y ear f oll o w -u p. J. Aller g y Cli n.
I m m u n ol. 2 0 1 0; 1 2 5( 6): 1 3 2 2– 6.
4. Sic herer S H, M u n oz -F url o n g A, Sa m ps o n H A. Pre vale nce of pea n ut a n d tree n ut
aller g y i n t he U nite d States deter mi ne d b y mea ns of a ra n d o m di git dial tele p h o ne
s ur ve y: a 5-year f oll o w -u p st u d y. J. Aller g y Cli n. I m m u n ol. 2 0 0 3; 1 1 2( 6): 1 2 0 3 – 7.
5. Gr u n d y J, Matt he ws S, Bate ma n B, Dea n T, Ars ha d S H. Risi n g pre vale nce of aller g y
t o pea n ut i n c hil dre n: dat a fr o m 2 se q u e ntial c o h orts. J. Aller g y Cli n. I m m u n ol. 2 0 0 2;
1 1 0( 5): 7 8 4 – 9.
6. Peters R L, Alle n KJ, D har ma ge S C, K o pli n JJ, Da n g T, Til br o o k K P et al. Nat ural
hist or y of pea n ut aller g y a n d pre dict ors of res ol uti o n i n t he first 4 years of li fe: a
p o p ulati o n -base d assess me nt. J. Aller g y Cli n. I m m u n ol. 2 0 1 5; 1 3 5( 5): 1 2 5 7 – 6 6.
7. H o M H, W o n g W H, H ei ne R G, H os ki n g C S, Hill DJ, Alle n KJ. Earl y cli nical
pre dict ors of re missi o n of pea n ut aller g y i n c hil dre n. J. Aller g y Cli n. I m m u n ol. 2 0 0 8;
1 2 1( 3): 7 3 1 – 6.
8. Fleisc her D M, C o n o ver -Wal k er M K, C hristie L, B ur ks A W, W o o d R A. T he nat ural
pr o gressi o n of pea n ut aller g y: res ol uti o n a n d t he p ossi bilit y of rec urre n ce. J. Aller g y
Cli n. I m m u n ol. 2 0 0 3; 1 1 2( 1): 1 8 3 – 9.
9. H o uri ha ne J O, R o berts S A, War ner J O. Res ol uti o n of pea n ut aller g y: cas e -c o ntr ol
st u d y. B MJ 1 9 9 8; 3 1 6( 7 1 4 0): 1 2 7 1 – 5.
1 0. D u T oit G, R o berts G, Sa yre P H, Ba h ns o n H T, Ra d ul o vic S, Sa nt os A F et al.
Ra n d o mize d trial of pea n ut c o ns u m pti o n i n i nfa nts at ris k f or pea n ut aller g y. N. E n gl. J.
Me d. 2 0 1 5; 3 7 2( 9): 8 0 3 – 1 3.
1 1. Ei ge n ma n n P A, Be yer K, Wesle y B A, L ac k G, Liac o uras C A, H o uri ha n e J O et al.
Ne w visi o ns f or f o o d aller g y: a n i P A C s u m mar y a n d f ut ure tre n ds. Pe diatr. Aller g y
I m m u n ol. 2 0 0 8; 1 9 S u p pl 1 9: 2 6– 3 9.
1 2. Sa m ps o n H A. F o o d aller g y -acc urat el y i de ntif yi n g cli nical reacti vit y. Aller g y 2 0 0 5;
6 0 S u p pl 7 9: 1 9 – 2 4.
1 3. Sa m ps o n H A, M u ñ oz -F url o n g A, Ca m p b ell R L, A d ki ns o n N F, Jr., B oc k S A, Bra n u m
A M et al. Sec o n d s y m p osi u m o n t he defi niti o n a n d ma na ge me nt of a na p h yla xis:
s u m mar y re p ort– – sec o n d Nati o nal I nstit ute of Aller g y a n d I nfecti o us Disease/ F o o d
Aller g y a n d A n a p h yla xis Net w or k s y m p osi u m. A n n. E mer g. Me d. 2 0 0 6; 4 7( 4): 3 7 3 – 8 0.
1 4. B ur ks A W. Pea n ut aller g y. La ncet 2 0 0 8; 3 7 1( 9 6 2 3): 1 5 3 8 – 4 6.
1 5. Ei ge n ma n n P A. Mec ha nis ms of f o o d aller g y. Pe diatr. Aller g y I m m u n ol. 2 0 0 9;
2 0( 1 ): 5– 1 1.

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
1 6. Ots u K, Dres ki n S C. Pea n ut aller g y: a n e v ol vi n g cli nical c halle n ge. Disc o v Me d 
2 0 1 1; 1 2( 6 5): 3 1 9 – 2 8.  
1 7. Sic herer S H, F url o n g TJ, M u n oz -F url o n g A, B ur ks A W, Sa m ps o n H A. A v ol u ntar y 
re gistr y f or pea n ut a n d tree n ut aller g y: c haracteristics of t he first 5 1 4 9 re gistra nts. J. 
Aller g y Cli n. I m m u n ol. 2 0 0 1; 1 0 8( 1): 1 2 8 – 3 2.  
1 8. Ke m p S F, L oc k e y R F, Si m o ns F E. E pi ne p hri ne: t he dr u g of c h oi ce f or a na p h yla xis: 
A state me nt of t he W orl d Aller g y Or ga ni zati o n. Aller g y 2 0 0 8; 6 3( 8): 1 0 6 1 – 7 0.  
1 9. Le u n g D Y, Sa m ps o n H A , Y u n gi n ger J W, B ur ks, A. W., Jr., Sc h nei der L C, W ortel 
C H et al. Effect of a nti -I g E t hera p y i n patie nts wit h pea n ut aller g y. N. E n gl. J. Me d. 
2 0 0 3; 3 4 8( 1 1): 9 8 6 – 9 3.  
2 0. Sa m ps o n H A, Le u n g D Y, B ur ks A W, Lac k G, Ba h na S L, J o nes S M et al. A p hase II, 
ra n d o mize d, d o u ble bli n d, parallel gr o u p, place b o c o ntr olle d oral f o o d c halle n ge trial of 
X olair ( o maliz u ma b) i n p ea n ut aller g y. J. Aller g y Cli n. I m m u n ol. 2 0 1 1; 1 2 7( 5): 1 3 0 9 – 1 0.  
2 1. J o nes S M, B ur ks A W, D u p o nt C. State of t he art o n f o o d aller ge n i m m u n ot hera p y: 
oral, s u bli n g ual, a n d e pic uta ne o us. J. Aller g y Cli n. I m m u n ol. 2 0 1 4; 1 3 3( 2): 3 1 8– 2 3.  
2 2. Le u n g D Y. F o o d aller g y: are we getti n g cl oser t o a c ure? J. Aller g y Cli n. I m m u n ol. 
2 0 1 1; 1 2 7( 3): 5 5 5 – 7.  
2 3. A na g n ost o u K, Isla m S, Ki n g Y, F ole y L, Pas ea L, B o n d S et al. Asses si n g t he 
effic ac y of oral i m m u n ot hera p y f or t he des e nsitisati o n of pea n ut aller g y i n c hil dre n 
( S T O P II): a p has e 2 ra n d o mise d c o ntr olle d trial. La ncet 2 0 1 4; 3 8 3( 9 9 2 5): 1 2 9 7– 3 0 4.  
2 4. Ki m E H, Bir d J A, K ulis M, La u bac h S, P o ns L, S hreffler W et al. S u bli n g ual 
i m m u n ot hera p y f or pea n ut aller g y: cli nical a n d i m m u n ol o gic e vi de nce of dese nsitizati o n. 
J. Aller g y Cli n. I m m u n ol. 2 0 1 1; 1 2 7( 3): 6 4 0– 6.  
2 5. Vars h ne y P, J o nes S M, Sc url oc k A M, Perr y T T, Ke m per A, Steele P et al. A 
ra n d o mize d c o ntr olle d st u d y of pea n ut or al i mm u n ot hera p y ( OI T): cli nical 
dese nsitizati o n a n d m o d ulati o n of t he aller gic res p o nse. J. Aller g y Cli n. I m m u n ol. 2 0 1 1; 
1 2 7( 3): 6 5 4 – 6 0.  
2 6. J o nes S M, P o ns L, R o berts J L, Sc url oc k A M, Perr y T T, K ulis M et al. Cli nical 
effic ac y a n d i m m u ne re g ulati o n wit h pea n ut oral i m m u n ot hera p y. J. Aller g y Cli n. 
I m m u n ol. 2 0 0 9; 1 2 4( 2): 2 9 2-3 0 0, 3 0 0.  
2 7. Bl u mc he n K, Ul bric ht H, Sta de n U, D o b berstei n K, Besc h or ner J, Oli veira L C de et 
al. Oral pe a n ut i m m u n ot hera p y i n c hil dr e n wit h pea n ut a na p h yl a xis. J. Aller g y Cli n. 
I m m u n ol. 2 0 1 0; 1 2 6( 1): 8 3 – 9 1.  
2 8. Vic ker y B P, Sc url oc k A M, Steele P H, Ka milaris J S, Hie gel A M, Carlisle S K et al. 
Earl y a n d persiste nt gastr oi ntesti nal si de effects pr e dict wit h dra wal fr o m pea n ut oral 
i m m u n ot hera p y ( OI T). J. Aller g y Cli n. I m m u n ol. 2 0 1 1; 1 2 7( 2): A B 2 6. 
2 9. Wasser ma n R L, Fact or J M, Ba ker J W, M a nsfi el d L E, Katz Y, Ha g ue A R et al. Oral 
i m m u n ot hera p y f or pea n ut aller g y: m ulti practice e x perie n ce wit h e pi ne p hri ne-treat e d 
reacti o ns. J. Aller g y Cli n. I m m u n ol. Pract. 2 0 1 4; 2( 1): 9 1– 6.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
3 0. Wasser ma n R L, S u ger ma n R W, Mi re k u-A k o mea h N, Gall ucci A R, Pe n ce D M, L o n g 
N A. Pea n ut oral i m m u n ot hera p y ( OI T) of f o o d all er g y ( F A) carries a si g nifica nt ris k of 
e osi n o p hilic es o p ha gitis ( E o E). J. Aller g y Cli n. I m m u n ol. 2 0 1 1; 1 2 7( 2): A B 2 8.  
3 1. Hsie h F H. Oral f o o d i m m u n ot hera p y a n d iatr o g e nic e osi n o p hilic es o p h a gitis: a n 
acce pta ble le vel of ris k? A n n. Aller g y Ast h ma I m m u n ol. 2 0 1 4; 1 1 3( 6): 5 8 1 – 2.  
3 2. L uce n d o AJ, Arias A, Te nias J M. Relati o n bet wee n e osi n o p hilic es o p h a gitis a n d oral 
i m m u n ot hera p y f or f o o d aller g y: a s yste matic re vie w wit h meta-a n al ysis. A n n. Aller g y 
Ast h ma I m m u n ol. 2 0 1 4; 1 1 3( 6): 6 2 4 – 9.  
3 3. Fairle y J A, R as m usse n J E. C o m paris o n of strat u m c or ne u m t hic k ness i n c hil dre n a n d 
a d ults. J. A m. Aca d. Der mat ol. 1 9 8 3; 8( 5): 6 5 2 – 4.  
3 4. I n v esti gat or's Br oc h ure Vias ki n Pea n ut ( D B V 7 1 2): E diti o n N u m ber 1 0. A u g ust 2 0 1 8. 
3 5. Ni g ge ma n n B, Be yer K. Dia g n osis of f o o d aller g y i n c hil dre n: t o war d a 
sta n dar dizati o n of f o o d c halle n ge. J. Pe diatr. Gastr oe nter ol. N utr. 2 0 0 7; 4 5( 4): 3 9 9 – 4 0 4.  
3 6. K ulis M, Vic ker y B P, B ur ks A W. Pi o neeri n g i m m u n ot hera p y f or f o o d aller g y: 
cli nical o utc o mes a n d m o d ulati o n of t he i m m u ne res p o nse. I m m u n ol. Res. 2 0 1 1; 4 9( 1 -
3): 2 1 6 – 2 6.  
3 7. Ta yl or S L, M o neret -Va utri n D A, Cre v el R W, S heffiel d D, M orisset M, D u m o nt P et 
al. T hres h ol d d ose f or pea n ut: Ris k c haracterizati o n base d u p o n dia g n ostic oral c halle n g e 
of a series of 2 8 6 pea n ut -aller gic i n di vi d uals. F o o d C he m. T o xic ol. 2 0 1 0; 4 8( 3): 8 1 4 – 9.  
3 8. I C H E x p ert W or ki n g Gr o u p. I C H Har m o nise d Tri partite G ui deli ne: Ge n eral 
C o nsi derati o ns f or Cli nical Trials –  E 8. Versi o n d ate d [ 1 7 J ul y] 1 9 9 7. A vaila ble fr o m: 
U R L: 
htt p:// w w w.ic h. or g/filea d mi n/ P u blic _ We b _ Site/I C H _ Pr o d ucts/ G ui deli nes/ Efficac y/ E 8/ St
e p 4/ E 8 _ G ui deli ne. p df.  
3 9. Sa m ps o n H A, M u ñ oz -F url o n g A, Ca m p b ell R L, A d ki ns o n N F, Jr., B oc k S A, Bra n u m 
A M et al. Sec o n d s y m p osi u m o n t he de fi niti o n a n d ma na ge me nt of a na p h yla xis: 
s u m mar y re p ort– sec o n d Nati o nal I nstit ute of Aller g y a n d I nfecti o us Diseas e/ F o o d 
Aller g y a n d A n a p h yla xis Net w or k. J. Aller g y Cli n. I m m u n ol. 2 0 0 6; 1 1 7( 2): 3 9 1 – 7.  
4 0. T urja n maa K, Dars o w U, Ni g ge ma n n B, Ra n ce F, Va nt o T,  Werfel T. 
E A A CI/ G A 2 L E N p ositi o n pa per: prese nt stat us of t he at o p y patc h test. Aller g y 2 0 0 6; 
6 1( 1 2): 1 3 7 7 – 8 4.  
4 1. G o osse ns NJ, Fl o kstra -de Bl o k B M, va n der Me ule n G N, Ar nli n d M H, Aser o R, 
Barreal es L et al. H ealt h -relate d q ualit y of life i n f o o d-aller gic ad ults fr o m ei g ht 
E ur o pea n c o u ntries. A n n. Aller g y Ast h ma I m m u n ol. 2 0 1 4; 1 1 3( 1): 6 3 – 8.  
4 2. va n der Vel de J L, Fl o kstra -de Bl o k B M, Vlie g -B oerstra BJ, O u de El b eri n k J N, 
D u n n Gal vi n A, H o uri ha n e J O et al. De vel o p me nt, vali dit y a n d relia bilit y of t he f o o d 
aller g y i n de pe n d e nt meas ure ( F AI M). Aller g y 2 0 1 0; 6 5( 5): 6 3 0– 5.  
4 3. K u nz B, Ora nje A P, La breze L, Stal der J F, Ri n g J, Taie b A. Cli nical vali dati o n a n d 
g ui deli nes f or t he S C O R A D i n de x: c o nse ns us r e p ort of t he E ur o pea n Tas k F orce o n 
At o pic Der matitis. Der m at ol o g y ( B asel) 1 9 9 7; 1 9 5( 1): 1 0 – 9.  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 0 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
4 4. Ne wc o m be R G. I nter val esti mati o n f or t he differe nce bet w ee n i n de pe n d e nt 
pr o p orti o ns: C o m paris o n of ele ve n met h o ds. Statist. Me d. 1 9 9 8; 1 7( 8): 8 7 3 – 9 0.  
4 5. O' Ha ga n A, Ste v e ns J W, Ca m p bell MJ. Ass ura nce i n cli nical tri al desi g n. 
P h ar mace utical Statistics 2 0 0 5; 4( 3): 1 8 7 – 2 0 1.  
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
1 1  A P P E N DI C E S  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
A P P E N DI X 1  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 
 
 
  
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
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D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
A P P E N DI X 2  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 1 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
A P P E N DI X 3  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 2 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
A P P E N DI X 4  
 
1Sa m ps o n, H u g h A. ( 2 0 0 8) A na p h yla xis a n d F o o d Aller g y. I n : Dea n D. Metcalfe, c o or d.: F o o d aller g y. 
A d verse reacti o ns t o f o o ds a n d f o o d a d diti ves. 4t h e d. Mal de n, Mass: Blac k well P u blis hi n g, p. 1 5 7 -1 7 0  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 2 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
A P P E N DI X 5   

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
1 2 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 2 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 2 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
A P P E N DI X 6  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 2 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 2 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 2 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
1 2 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 2 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3 6  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3 7  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 3 8  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
 
 

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
1 3 9  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
A P P E N DI X 7  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
1 4 0  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
A P P E N DI X 8  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
1 4 1  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4) 
C O N FI D E N TI A L  
Pr ot oc ol Versi o n 7. 0  
1 4 2  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
A P P E N DI X 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 4 3  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  
A P P E N DI X 1 0  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 4 4  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9  

D B V Tec h n ol o gies  
Cli nical St u d y Pr ot oc ol  
E PI T O P E St u d y ( V 7 1 2 -3 0 4)  
C O N FI D E N TI A L  
 
Pr ot oc ol Versi o n 7. 0  
1 4 5  of 1 4 5  
 1 5 N o ve m ber 2 0 1 9