A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of Group B Streptococcus Vaccine (GBS NN/NN2 With Alhydrogel®) in Elderly Participants Aged 55 to 75
Phase: PHASE1
Conditions: Group B Streptococcal Infections
Sponsor: Minervax ApS

TITLE PAGE 
Protocol Title: 
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, 
tolerability and immunogenicity of three doses of Group B Streptococcus vaccine 
(GBS-NN/NN2 with Alhydrogel®) in elderly participants aged 55 to 75. 
Protocol Number: MVX0006 
Amendment Number: Not Applicable 
Compound: Group B Streptococcus Vaccine (GBS-NN/NN2) 
Brief Title: 
Study to evaluate the safety, tolerability and immunogenicity of three doses of Group B 
Streptococcus vaccine in elderly participants 
Study Phase: I 
Sponsor Name: MinervaX ApS 
Legal Registered Address: MinervaX ApS, Ole Maaløes Vej 3, DK-2200 Copenhagen N, 
Denmark 
Regulatory Agency Identifier Number(s): EudraCT number: 2022-003681-20 
Date of Original Protocol: 09 December 2022 
Date of Protocol Amendment 2.0: 03 May 2023 
 
 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
3 of 69 
PROTOCOL AMENDMENT 2.0 (03 MAY 2023) 
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) 
of Directive 2001/20/EC of the European Parliament and the Council of the European Union. 
Overall Rationale for the Amendment: 
This amendment serves to clarify inconsistencies and to provide further guidance for trial 
assessments and procedures per clinical study protocol. 
Section # and 
Name (page #) 
Current Language 
Proposed Language 
(New text will be bolded and 
deleted text will be struck 
through) 
Rationale for Change 
1.1 Synopsis 
(p.17) 
 
Sixty (60) healthy older adult 
participants aged 55 to 
75 years will be randomized 
in two cohorts; 30 obese 
and/or diabetic participants 
aged 55 to 75 years will be 
randomized in two cohorts. 
Sixty (60) healthy older adult 
participants aged 55 to 
75 years at screening will be 
randomized in two cohorts; 
30 obese and/or diabetic 
participants aged 55 to 
75 years at screening will be 
randomized in two cohorts. 
Clarification that eligible 
age is considered at 
screening. 
1.3 Schedule of 
Activities (p.21) 
i Between Day 57 (28 days 
post second injection) to 
Day 168 and from 28 days 
after the third vaccine to 
Day 365 only MAAEs, 
AESIs and SAEs will be 
collected. 
i Solicited AE/SAEs will be 
collected 7 days post each 
vaccination in the eDiary. 
j Between Day 5758 (28 days 
post second 2nd injection) to 
Day 168161 and from 
28 days after the third3rd 
vaccine to Day 365 only 
MAAEs, AESIs, and SAEs 
will be collected. 
k Between Day 1 to Day 57 
and Day 162 to Day 197 all 
CMs will be collected. 
Between Day 58 to Day 161 
and Day 198 to Visit 12 
(Day 365): only CMs taken 
for MAAEs, AESIs, and 
SAEs, which are collected 
within this period will be 
recorded. 
Table flow chart and 
table footnotes edited to 
provide clarity to 
collection of adverse 
events (AEs) and 
concomitant medications 
(CMs). 
5.0 Study 
Population 
(p.30) 
N/A 
Data from screening 
procedures will be used for 
treatment allocation if a 
procedure is not planned or 
repeated at Visit 2. 
Procedures will not be 
repeated at Visit 4 and 
Visit 8. 
Clarification how 
eligibility data should be 
handled if procedure is 
not repeated prior to 1st 
dosing. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
4 of 69 
Section # and 
Name (page #) 
Current Language 
Proposed Language 
(New text will be bolded and 
deleted text will be struck 
through) 
Rationale for Change 
5.0 Study 
Population 
(p.30) 
N/A 
x 
The investigator should 
consider whether a 
participant with BMI 
 WR  NJP2 and 
with prediabetes is 
eligible for Cohort 1 
or 2. This decision can 
be made based on the 
CDC definition of 
prediabetes of an 
HbA1c of 5.7% to 
6.4%. 
x 
If a participant has a 
%0,  WR  NJP2 
and the participant has 
prediabetes, the 
participant would be 
eligible for Cohorts 3 
and 4 as a participant 
who is obese.  
x 
For a participant to be 
included in the 
Cohorts 3 and 4 as a 
participant with 
diabetes (as opposed to 
a participant who is 
obese), a pre-existing 
diagnosis of diabetes, 
documented by the 
general practitioner or 
other treating 
physician, is required. 
x 
If the participant is 
diagnosed with type 2 
diabetes, the 
participant must be on 
treatment for type 2 
diabetes; e.g. 
metformin, 
sulphonylureas, or 
glitazones. The diabetic 
participant is not 
eligible for Cohort 3 
and 4 if not receiving 
treatment for type 2 
diabetes at study 
enrolment. 
Clarification on 
prediabetic conditions 
regarding eligibility for 
Cohorts 1 and 2 and 
clarification of the 
requirements for a 
participant to be 
considered diabetic for 
assessing allocation to 
cohorts. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
5 of 69 
Section # and 
Name (page #) 
Current Language 
Proposed Language 
(New text will be bolded and 
deleted text will be struck 
through) 
Rationale for Change 
5.1 Inclusion 
Criteria (p.30) 
Participant aged 55 to 
75 years. 
Participant aged 55 to 
75 years of age at screening. 
Clarification that eligible 
age is considered at 
screening. 
5.1 Inclusion 
Criteria (p.30) 
%RG\ PDVV LQGH[ %0, 
DQG  NJP2 for healthy 
SDUWLFLSDQWV   WR
 kg/m2 for obese 
SDUWLFLSDQWV DQG  WR
 kg/m2 for type 2 diabetic 
participants. 
%RG\ PDVV LQGH[ %0, 
and 30 kg/m2 for healthy 
SDUWLFLSDQWV   WR
 kg/m2 for obese 
SDUWLFLSDQWV DQG  WR
 kg/m2 for type 2 diabetic 
participants at screening. 
Inconsistency correction, 
it was unclear which 
group a participant with a 
BMI of 30 should be 
enrolled in. 
5.2 Exclusion 
Criteria (p.31) 
NOTE: Patients with type 2 
diabetes are to be recruited 
for Cohort 3 and Cohort 4. 
 
NOTE: Patients with type 2 
diabetes are to be recruited 
for Cohort 3 and Cohort 4. 
The autoimmune skin 
diseases, mild psoriasis and 
vitiligo, will not be 
considered as relevant for 
exclusion. Other 
autoimmune diseases that 
are not stable or are 
progressive/worsening (as 
evaluated by the 
investigator) should lead to 
exclusion. 
While mild psoriasis and 
vitiligo are considered as 
autoimmune diseases, 
they are not considered 
as relevant for eligibility 
assessment of a 
participant. No additional 
risks for participants with 
mild psoriasis or vitiligo 
are expected. 
5.2 Exclusion 
Criteria (p.31) 
Participants who have 
received any vaccine within 
30 days of first IMP 
administration, or who are 
planning to receive any 
vaccine (eg, travel vaccines) 
up to 30 days after each 
vaccination. 
 
Participants who have 
received any vaccine within 
30 days of first 1st IMP 
administration, or who are 
planning to receive any 
vaccine (eg, travel vaccines) 
up to 30 days after each 
vaccination and/or 7 days 
prior to 3rd administration. 
Clarification on time 
window for participants 
receiving other vaccines 
planned around the 3rd 
study dosing. 
6.3.1 Participant 
Identification 
(p.34) 
Participant identification 
numbers will be assigned 
sequentially to the 
participants who have 
consented to participate in 
the study, according to the 
range of participant 
identification numbers 
allocated to the study site. 
Participant identification 
numbers will be assigned 
sequentially to the 
participants who have 
consented to participate in the 
study, according to the range 
of participant identification 
numbers allocated to the 
study site. Re-screening of 
participants will require the 
allocation of a new 
participant identification 
number. 
Clarification regarding 
re-screened participants. 
6.3.2 Treatment 
allocation to the 
Allocation of the participant 
to treatment within a cohort 
Allocation of the participant 
to treatment within a cohort at 
Clarification to ensure 
consistency with actual 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
6 of 69 
Section # and 
Name (page #) 
Current Language 
Proposed Language 
(New text will be bolded and 
deleted text will be struck 
through) 
Rationale for Change 
participant 
(p.34) 
at the study site will be 
performed using a 
randomisation schedule at the 
site after confirming 
eligibility and prior to first 
dosing. 
the study site will be 
performed using a 
randomisation schedule 
module of the electronic 
case report form (eCRF) 
used as Interactive 
Response System (IRS) at 
the site after confirming 
eligibility and prior to first 1st 
dosing. 
setup of the 
randomisation system 
used. 
6.6 Concomitant 
Therapy (p.36) 
Any medication or vaccine 
(including OTC or 
prescription medicines, 
recreational drugs, vitamins, 
and/or herbal supplements) 
that the participant is 
receiving at the time of 
enrolment or receives during 
the study must be recorded 
along with… 
 
Concomitant medications 
(CM) may be recorded on the 
electronic diary (eDiary) of 
the participant. 
Any medication or vaccine 
(including OTC or 
prescription medicines, 
recreational drugs, vitamins, 
and/or herbal supplements) 
that the participant is 
receiving at the time of 
enrolment or receives during 
the study must be recorded 
along with… 
 
Concomitant medications 
(CM) may will be recorded 
on in the electronic diary 
(eDiary) of the participant 
7 days after each 
vaccination. 
 
NOTE: The overall 
collection of CMs during the 
study period should be done 
as follows (see Section 8.3.1 
for AE collection details): 
x 
Day 1 – Visit 6 (Day 57): 
All CMs associated with 
an AE. 
x 
Day 58 – Day 161: Only 
CMs taken for MAAEs, 
AESIs, and SAEs, which 
are collected within this 
period. 
x 
Day 162 (7 days prior to 
3rd vaccination at 
Visit 8) – Visit 10 
(Day 197): All CMs 
associated with an AE. 
x 
Day 198 – Visit 12 
(Day 365): Only CMs 
Information regarding the 
use of recreational drugs, 
vitamins, and/or herbal 
supplements would not 
be required to support 
medical overview on 
participant safety nor 
increase the scientific 
value of the trial. 
Therefore, it is 
unnecessary to collect 
information on the use of 
recreational drugs, 
vitamins, and/or herbal 
supplements. 
Furthermore, the 
clarification was added 
that concomitant 
medication between 
28 days post dose 2nd 
investigational medicinal 
product (IMP) 
administration until 3rd 
study IMP administration 
will not be required 
except for MAAEs, 
AESIs, and SAEs. The 
collection of unrelated 
concomitant medication 
during this period does 
not increase the scientific 
value of the study and 
will therefore be limited. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
7 of 69 
Section # and 
Name (page #) 
Current Language 
Proposed Language 
(New text will be bolded and 
deleted text will be struck 
through) 
Rationale for Change 
taken for MAAEs, 
AESIs, and SAEs 
collected within this 
period. 
6.6.1 Permitted 
Concomitant 
Medication 
(p.37) 
Non steroidal 
anti-inflammatory drugs or 
paracetamol at doses of 
 g/day, will be permitted 
for use any time during the 
study for the treatment of 
headache or other symptoms. 
Non-steroidal 
anti-inflammatory drugs or 
paracetamol at doses of 
 g/day, will be permitted 
for use any time during the 
study, except within 
72 hours before each 
vaccination, for the treatment 
of headache or other 
symptoms. 
Clarification to ensure 
consistency with 
exclusion criteria. 
6.6.2 Prohibited 
Concomitant 
Medications 
(p.37) 
Any short-term medications 
including OTC preparations, 
with the exception of 
non-steroidal 
anti-inflammatory drugs or 
paracetamol. 
Any short term medications 
including OTC preparations, 
with the exception of 
non steroidal 
anti inflammatory drugs or 
paracetamol. 
Text deleted to avoid 
confusion. The exclusion 
criteria provide sufficient 
clarity regarding 
prohibited medication. 
6.6.2 Prohibited 
Concomitant 
Medications 
(p.37) 
Vaccines within 30 days of 
first IMP administration or 
planning to receive any 
vaccine up to 30 days after 
each study vaccination, with 
the exception of emergency 
vaccinations or vaccination 
campaigns, which will be 
permitted not less than 7 days 
before and after study 
vaccination. 
 
Vaccines within 30 days of 
first 1st IMP administration or 
planning to receive any 
vaccine and up to 30 days 
after each study vaccination 
and 7 days prior to 3rd IMP 
administration, with the 
with the exception of 
emergency vaccinations or 
vaccination campaigns, which 
will be permitted not less 
than 7 days before and after 
study vaccination. 
Clarification of 
prohibited use of 
vaccines, has been edited 
to specify that vaccines 
are prohibited within 
30 days of 1st IMP 
administration and up to 
30 days after each study 
vaccination and 7 days 
prior to 3rd IMP 
administration. 
8.2.4 Electronic 
Diary (p.43) 
For solicited systemic 
reactions (nausea, vomiting, 
diarrhoea, headache, fatigue, 
myalgia) 
For solicited systemic 
reactions (chills, muscle 
pains/myalgia, malaise, 
nausea, vomiting, diarrhoea, 
headache, and fatigue, 
myalgia) 
Correction of 
inconsistency that was 
present in the protocol. 
8.3.1 Time 
Period and 
Frequency for 
Collecting AE 
and SAE 
Information 
(p.43) 
N/A 
NOTE: The overall 
collection of AEs during the 
study period should be done 
as follows: 
x 
Day 1 – Visit 6 (Day 57): 
All AEs 
Clarification regarding 
overall collection of AEs 
added. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
8 of 69 
Section # and 
Name (page #) 
Current Language 
Proposed Language 
(New text will be bolded and 
deleted text will be struck 
through) 
Rationale for Change 
x 
Day 58 – Day 161: Only 
MAAEs, AESIs, and 
SAEs 
x 
Day 162 – Visit 10 
(Day 197): All AEs 
x 
Day 198 – Visit 12 
(Day 365): Only 
MAAEs, AESIs, and 
SAEs 
10.2 
Appendix 2, 
Clinical 
Laboratory 
Tests, Table 6 
(p.57) 
White blood cell count with 
differential 
White blood cell count with 
differential white blood cell 
(Absolute and percentages): 
Clarification of white 
blood cell parameter 
10.2 
Appendix 2, 
Clinical 
Laboratory 
Tests, Table 6 
(p.57) 
Globulin 
Globulin (Calculated by: 
total protein – albumin) 
Clarification regarding 
how the result of the 
serum globulin will be 
obtained. 
10.2 
Appendix 2, 
Table 6: Clinical 
Laboratory 
Tests (p.57) 
Human immunodeficiency 
virus (HIV) I and II 
Human immunodeficiency 
virus (HIV) I and II 
Local lab is not able to 
distinguish human 
immunodeficiency virus 
(HIV) I versus HIV II, 
therefore, this detail was 
removed. 
10.3 
Appendix 3: 
AEs and SAEs 
(p.59) 
Definition of Unsolicited and 
Solicited AE 
 
An unsolicited adverse event 
is an adverse event that was 
not solicited using a 
participant diary and that is 
communicated by a 
participant who has signed 
the informed consent. 
Unsolicited AEs include 
serious and non-serious AEs. 
Timing for the collection of 
AEs, Ddefinition of 
Unsolicited and Solicited AE 
An unsolicited adverse event 
is an adverse event that was 
not solicited using a 
participant diary and that is 
communicated by a 
participant who has signed 
the informed consent. 
Unsolicited AEs include 
serious and non-serious AEs. 
x 
All AEs, AESIs, and 
SAEs will be collected 
from the 1st IMP 
administration. 
x 
Solicited AEs are 
predefined 
events/symptoms that 
the participant is 
Correction made 
regarding timing for the 
collection of AEs as well 
as clarification of what is 
considered an unsolicited 
AE and what is 
considered a solicited 
AE. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
9 of 69 
Section # and 
Name (page #) 
Current Language 
Proposed Language 
(New text will be bolded and 
deleted text will be struck 
through) 
Rationale for Change 
specifically asked to 
record in the eDiary. 
The predefined solicited 
AEs include: Injection 
site reactions (redness, 
swelling, pain, 
tenderness, and itching) 
and systemic reactions 
(pyrexia, chills, muscle 
pains/myalgia, malaise, 
nausea, vomiting, 
headache, and fatigue). 
x 
An AE reported in 
response to an open 
question e.g., “Did you 
experience any other 
signs/symptoms?”, is an 
unsolicited AE. 
x 
An unsolicited AE is an 
AE reported 
spontaneously by the 
participant. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
10 of 69 
TABLE OF CONTENTS 
TITLE PAGE ........................................................................................................................... 1 
PROTOCOL AMENDMENT 2.0 (03 MAY 2023) ............................................................... 3 
TABLE OF CONTENTS ...................................................................................................... 10 
LIST OF TABLES ................................................................................................................. 14 
LIST OF FIGURES ............................................................................................................... 14 
1.0 
PROTOCOL SUMMARY ........................................................................................ 15 
1.1 
Synopsis .......................................................................................................... 15 
1.2 
Schema ............................................................................................................ 18 
1.3 
Schedule of Activities .................................................................................... 19 
2.0 
INTRODUCTION ..................................................................................................... 22 
2.1 
Background .................................................................................................... 22 
2.2 
Study Rationale .............................................................................................. 23 
2.3 
Benefit/Risk Assessment................................................................................ 23 
2.3.1 
Risk Assessment................................................................................ 23 
2.3.2 
Benefit Assessment ........................................................................... 24 
2.3.3 
Overall Benefit Risk Conclusion ...................................................... 24 
3.0 
OBJECTIVES AND ENDPOINTS .......................................................................... 25 
4.0 
STUDY DESIGN ....................................................................................................... 27 
4.1 
Overall Design ................................................................................................ 27 
4.2 
Scientific Rationale for Study Design .......................................................... 27 
4.3 
Justification for Dose ..................................................................................... 28 
4.4 
End of Study Definition ................................................................................. 28 
4.5 
Dose Escalation .............................................................................................. 28 
4.6 
Study Stopping Criteria ................................................................................ 28 
4.6.1 
Stopping Criteria for Individual Participants .................................... 28 
4.6.2 
Criteria for Stopping Dose Escalation ............................................... 28 
4.6.3 
Criteria for Stopping the Study ......................................................... 28 
5.0 
STUDY POPULATION ............................................................................................ 30 
5.1 
Inclusion Criteria ........................................................................................... 30 
5.2 
Exclusion Criteria .......................................................................................... 30 
5.3 
Lifestyle Considerations ................................................................................ 32 
5.4 
Screen Failures ............................................................................................... 32 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
11 of 69 
5.5 
Criteria for Temporarily Delaying .............................................................. 32 
6.0 
INVESTIGATIONAL MEDICINAL PRODUCT(S) AND 
CONCOMITANT THERAPY ................................................................................. 33 
6.1 
Investigational Medicinal Product(s) Administered .................................. 33 
6.2 
Preparation, Handling, Storage, and Accountability ................................. 34 
6.3 
Measures to Minimise Bias: Randomisation and Blinding ........................ 34 
6.3.1 
Participant Identification ................................................................... 34 
6.3.2 
Treatment Allocation to the Participant ............................................ 34 
6.3.3 
Blinding ............................................................................................. 34 
6.4 
Investigational Medicinal Product Compliance.......................................... 36 
6.5 
Dose Modification .......................................................................................... 36 
6.6 
Concomitant Therapy ................................................................................... 36 
6.6.1 
Permitted Concomitant Medications ................................................. 37 
6.6.2 
Prohibited Concomitant Medications ................................................ 37 
7.0 
DISCONTINUATION OF INVESTIGATIONAL MEDICINAL 
PRODUCT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ................................................................ 38 
7.1 
Discontinuation of Investigational Medicinal Product............................... 38 
7.1.1 
Liver Chemistry Stopping Criteria .................................................... 38 
7.2 
Participant Discontinuation/Withdrawal from the Study ......................... 38 
7.3 
Lost to Follow-up ........................................................................................... 39 
8.0 
STUDY ASSESSMENTS AND PROCEDURES .................................................... 40 
8.1 
Efficacy Assessments ..................................................................................... 40 
8.2 
Safety Assessments ........................................................................................ 40 
8.2.1 
Physical Examinations ...................................................................... 41 
8.2.2 
Vital Signs ......................................................................................... 41 
8.2.3 
Clinical Safety Laboratory Tests ....................................................... 41 
8.2.4 
Electronic Diary ................................................................................ 42 
8.3 
Adverse Events, Serious Adverse Events, and Other Safety 
Reporting ........................................................................................................ 43 
8.3.1 
Time Period and Frequency for Collecting AE and SAE 
Information ........................................................................................ 43 
8.3.2 
Method of Detecting AEs and SAEs ................................................. 44 
8.3.3 
Follow-up of AEs and SAEs ............................................................. 44 
8.3.4 
Regulatory Reporting Requirements for SAEs ................................. 44 
8.3.5 
Solicited Adverse Events .................................................................. 45 
8.3.6 
Adverse Events of Special Interest and Medically 
Attended Adverse Events .................................................................. 45 
8.4 
Pharmacokinetics .......................................................................................... 46 
8.5 
Pharmacodynamics ....................................................................................... 46 
8.6 
Genetics .......................................................................................................... 46 
8.7 
Immunogenicity and Peripheral Blood Mononuclear Cell 
Assessments .................................................................................................... 46 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
12 of 69 
8.7.1 
Immunogenicity Assessments ........................................................... 46 
8.7.2 
 ............................ 46 
8.8 
Biomarkers ..................................................................................................... 46 
8.9 
Health Economics .......................................................................................... 46 
8.10 
Study Procedures During Special Circumstances ...................................... 47 
9.0 
STATISTICAL CONSIDERATIONS ..................................................................... 48 
9.1 
Statistical Hypotheses .................................................................................... 48 
9.2 
Sample Size Determination ........................................................................... 48 
9.3 
Analysis Sets ................................................................................................... 48 
9.4 
Statistical Analyses ........................................................................................ 49 
9.4.1 
Safety Analysis.................................................................................. 50 
9.4.2 
Analysis of Immunogenicity ............................................................. 50 
9.4.3 
Missing Data ..................................................................................... 51 
9.5 
Interim Analysis ............................................................................................. 51 
9.6 
Safety Review Group ..................................................................................... 51 
10.0 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ................................................................................................. 52 
10.1 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations ............................................................................................... 52 
10.1.1 
Regulatory and Ethical Considerations ............................................. 52 
10.1.2 
Adequate Resources .......................................................................... 53 
10.1.3 
Financial Disclosure .......................................................................... 53 
10.1.4 
Insurance ........................................................................................... 53 
10.1.5 
Informed Consent Process................................................................. 53 
10.1.6 
Data Protection .................................................................................. 54 
10.1.7 
Committees Structure ........................................................................ 54 
10.1.8 
Dissemination of Clinical Study Data ............................................... 54 
10.1.9 
Data Quality Assurance ..................................................................... 54 
10.1.10 Source Documents ............................................................................ 55 
10.1.11 Study and Site Start and Closure ....................................................... 55 
10.1.12 Publication Policy ............................................................................. 56 
10.2 
Appendix 2: Clinical Laboratory Tests ....................................................... 57 
10.3 
Appendix 3: AEs and SAEs: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting for 
Investigational Medicinal Product ............................................................... 59 
10.3.1 
Definition of AE ................................................................................ 59 
10.3.2 
Definition of SAE and SUSAR ......................................................... 60 
10.3.3 
Recording and Follow-Up of AE and/or SAE .................................. 61 
10.3.4 
Reporting of SAEs ............................................................................ 63 
10.3.5 
Reporting of SUSARs ....................................................................... 63 
10.4 
Appendix 4: Liver Safety: Suggested Actions and Follow-up 
Assessments .................................................................................................... 65 
10.5 
Appendix 5: Abbreviations ........................................................................... 66 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
13 of 69 
11.0 
REFERENCES .......................................................................................................... 68 
Signature of Investigator........................................................................................... 69 
 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
14 of 69 
LIST OF TABLES 
Table 1 
Schedule of Activities (Refer to Section 8.10 for Study Procedures to be 
Considered During Special Circumstances) ..................................................... 19 
Table 2 
Study Objectives and Corresponding Endpoints .............................................. 25 
Table 3 
Number of tests, volumes of blood per test and total volume of blood ............ 42 
Table 4 
Reactogenicity Assessment: List of solicited adverse events ........................... 45 
Table 5 
Analysis Sets .................................................................................................... 49 
Table 6 
Protocol-required Safety Laboratory Tests....................................................... 57 
 
LIST OF FIGURES 
Figure 1 
Study Schema (Refer to Section 8.10 for Study Procedures to be Considered 
During Special Circumstances) ........................................................................ 18 
 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
17 of 69 
Overall Design: 
This is a Phase I, randomised, double-blind, placebo-controlled, parallel group study. 
Eligible participants will be randomised pre dose on Day 1, once all eligibility criteria have been 
verified. There will be two cohorts comprising 30 healthy older adult participants each and two cohorts 
comprising 15 obese and/or diabetic older adult participants each (see Figure 1): 
x 
Cohort 1 will receive three injections, each consisting of 50 ȝJ RI *%6-NN and 50 ȝJ RI
GBS-NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product [IMP]: 
placebo). 
x 
Cohort 2 will receive three injections, each consisting of 125 ȝJ RI *%6-NN and 125 ȝJ RI
GBS-NN2 bound to aluminium hydroxide in a 4:1 ratio (IMP : placebo). 
x 
Cohort 3 will receive three injections, each consisting of 50 ȝJ RI *%6-NN and 50 ȝJ RI
GBS-NN2 bound to aluminium hydroxide in a 4:1 ratio (IMP : placebo). 
x 
Cohort 4 will receive three injections, each consisting of 125 ȝJ RI *%6-NN and 125 ȝJ RI
GBS-NN2 bound to aluminium hydroxide in a 4:1 ratio (IMP : placebo). 
Number of Participants: 
Approximately 90 participants will be randomised in four cohorts. 
Cohort Groups and Duration: 
Participants will be involved in the study for approximately one year including screening and safety 
follow-up. The start of the study is defined as Day 1 when participants are randomised. Eligible 
participants will be administered a dose of GBS-NN/NN2 or placebo on three occasions: the 1st dose 
will be administered on Day 1, followed by the 2nd and 3rd doses 4 and 24 weeks later, respectively. 
Sixty (60) healthy older adult participants aged 55 to 75 years at screening will be randomised 
in two cohorts; 30 obese and/or diabetic participants aged 55 to 75 years at screening will be 
randomised in two cohorts. 
Progression from Cohort 1 to Cohort 2 and Cohort 3 will only occur after the available 
safety/tolerability data from all participants who completed Visit 3 in Cohort 1 have been assessed by a 
Safety Review Group (SRG). The SRG will review the safety data from all participants who have 
completed Visit 3 in Cohort 2 and Cohort 3 to determine if participants in Cohort 4 could receive the 
IMP. 
During the study, participants will attend study visits as described in the Schedule of Activities (SoA), 
up to safety follow-up visit at month 12. Safety assessments will be performed and immunogenicity 
blood samples will be collected at study visits according to the SoA. 
Safety Review Group: Yes 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
18 of 69 
1.2 
Schema 
Figure 1 
Study Schema (Refer to Section 8.10 for Study Procedures to be Considered During 
Special Circumstances) 
 
 
GBS-NN/NN2: Group B Streptococcus vaccine containing the N-terminal domains of the Rib, Alpha C, 
Alpha 1 and Alpha 2/3 proteins. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
22 of 69 
2.0 INTRODUCTION 
2.1 
Background 
Streptococcus agalactiae or Lancefield’s Group B Streptococcus (GBS) is a common 
commensal in humans, approximately 25% of all adults will be colonised with GBS at any 
given time.1 Invasive GBS disease is normally associated with infection in pregnant women 
and new-born babies; however, invasive GBS disease in adults has been increasing over the 
last 40 years.1,2 The older adult population (>65 years of age) and adults with underlying 
chronic health conditions (diabetes mellitus, cancer, immune suppression, obesity) are at 
particular risk of invasive GBS disease.2,3 
In the United States of America (USA), it has been estimated that the majority of cases of 
invasive GBS occur in adults and are not related to pregnancy. Disease rates increase with age 
and are twice as high in the black population as in the white population. The associated 
mortality rate is approximately 25%.2 The incidence of invasive GBS disease has been 
estimated in Belgium to be 8.2 cases/100,000 inhabitants in 2018. This has increased from 
3.7 cases/100,000 inhabitants in 2009.4 
However, non invasive GBS infections are more common than invasive infections by a factor 
of 3.7.5 McLaughlin and colleagues calculated for cases where GBS was identified an overall 
annual hospitalisation rate of 73 (95% confidence interval [CI], 68–78) per 100,000 adults in 
Louisville, Kentucky USA. The hospitalisation rate varied by age; rates were 68 (95% 
CI, 63-74) and 100 (85–117) per 100,000 in adults 18– DQG  \HDUV RI DJH UHVSHFWLYHO\
The highest rate of GBS-associated hospitalisation was seen among adults <65 years of age 
with diabetes, at 486 (95% CI, 437–540) per 100.000 annually. Overall, 20% of patients 
admitted to hospital were admitted to intensive care unit and an all-cause death rate of 3% was 
reported.5 
Group B Streptococcus disease in non-pregnant adults causes secondary and primary 
bacteraemia, septic arthritis, endocarditis, prosthetic joint infection, and necrotising myositis 
and fasciitis.5 
It is apparent that outside of pregnancy and the neonatal period, GBS infection results in high 
morbidity and mortality rates. There is no preventative treatment, cases are managed with 
antibiotics when an infection is diagnosed. There is a clear unmet medical need for a 
preventative vaccine that could provide protection to all adults but particularly to the older 
adult population or those at risk of infection due to underlying medical or demographic 
conditions. In addition, the incidence is increasing and will probably continue to increase with 
an increasing older adult population and an increase in the prevalence of obesity and 
type 2 diabetes around the world. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
23 of 69 
MinervaX has developed a novel GBS vaccine candidate designated GBS-NN/NN2, based on 
the N-terminal domains of the alpha protein family of GBS surface proteins. The vaccine 
consists of two fusion proteins each containing two N-terminal domains: GBS-NN (containing 
the N-terminal domains of the Rib and Alpha C proteins – RibN and AlpCN) and 
GBS-NN2 (containing the N-terminal domains of the Alpha 1 and Alpha 2/3 proteins – Alp1N 
and Alp2/3N). These alpha-like proteins (Alps) are found on most isolates of capsular 
polysaccharide serotypes Ia, Ib, II, III, IV, V, VI, VII, and VIII. Therefore, it is anticipated 
that the GBS-NN/NN2 vaccine will confer protection against close to 100% of GBS clinical 
isolates. Antibodies directed against the vaccine were found to recognise the vast majority 
of 154 clinical isolates of serotypes Ia, Ib, II, III, and V tested for antibody binding. 
The MinervaX GBS-NN/NN2 vaccine is currently being evaluated for safety and 
immunogenicity of a primary course of two doses of 50 ȝJ RI HDFK IXVLRQ SURWHLQ *%6-NN 
and GBS-11 LQ FRPELQDWLRQ ZLWK  ȝJ $OK\GURJHO®) in pregnant women, administered 
from 22 to 30 weeks gestational age, with a 4- and 8-week interval. 
2.2 
Study Rationale 
In light of the increasing incidence of GBS infection in the older adult population, MinervaX 
wish to explore the safety and immunogenicity in this increasingly at-risk population, 
particularly in adults over 65 years of age. 
The purpose of this planned Phase 1 trial is to study the safety and immunogenicity 
of two dose levels, in an older adult population, with and without underlying medical 
conditions (obesity and/or diabetes type 2), to assess whether the GBS-NN/NN2 vaccine could 
potentially be effective in an older adult population and warrant further development in this 
population. The trial will investigate the safety and immune response to the dose level 
currently under development for use in pregnant women (50 μg of each fusion protein) and a 
higher dose of 125 μg of each fusion protein. 
2.3 
Benefit/Risk Assessment 
2.3.1 
Risk Assessment 
From the data gathered to date administration of GBS-NN/NN2 has been associated with 
mild, self-limiting pain at the injection site. No systemic risks have been identified. There 
have been no reports of significant or persistent reactions at the injection site. 
There is a low risk of anaphylactic reactions after injection of the vaccine. All staff 
administering vaccines will be trained in basic or advanced life support procedure. The 
necessary equipment and medication for treatment would be in place when administering the 
vaccines, such as resuscitation equipment and medication. The participants will be observed 
for 30 minutes post dose. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
24 of 69 
Injection site haemorrhage may occur at the injection site in populations at increased risk of 
haemorrhage, such as those with thrombocytopenia or acquired/hereditary coagulation 
disorders. The Investigators are informed of possible injection site haemorrhage in individuals 
with thrombocytopenia or any coagulation disorder following study treatment administration 
by information included in product labels or Investigator’s Brochure (IB) based on the 
following language in the company Core Safety Information: “As with other vaccines 
administered intramuscularly, all study vaccine should be given with caution to individuals 
with thrombocytopenia or any coagulation disorder since bleeding may occur following an 
IMP administration to these participants.” 
There is a risk from blood sampling associated risk of discomfort, syncope, dizziness, and 
infection at the injection site after or during venepuncture. Blood samples will be obtained by 
a trained professional and medical assistance will be available. 
2.3.2 
Benefit Assessment 
No clear benefits have been identified as efficacy has not been assessed. It is apparent that 
GBS-NN/NN2 induces an immune response but it is not known if the immune response is 
protective, as this has not been studied. The immune response generated has been shown to 
induce immunoglobulin G (IgG) antibodies. 
 
 
 
 
2.3.3 
Overall Benefit Risk Conclusion 
Considering the measures taken to minimise risk to participants participating in this study, the 
potential risks identified in association with GBS-NN/NN2 with Alhydrogel® are justified by 
the anticipated benefits that may be afforded to older adult participants at high risk of 
contracting GBS infection. 
The Sponsor will immediately notify the Principal Investigator if any additional safety or 
toxicology information becomes available during the study. 
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events (AEs) of GBS-NN/NN2 Recombinant Alhydrogel® may be found in 
the IB. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
27 of 69 
4.0 STUDY DESIGN 
4.1 
Overall Design 
This is a phase I, randomised, double-blind, placebo-controlled, parallel group, single centre 
study. 
A schema of the trial design is shown in Section 1.2. 
Eligible participants will be randomised pre dose on Day 1, once all eligibility criteria have 
been verified. 
There will be 2 cohorts comprising 30 healthy older adult participants each and two cohorts 
comprising 15 obese and/or diabetic older adult participants each (see Figure 1): 
x Cohort 1 will receive three injections, each consisting of 50 ȝJ RI *%6-NN and 50 ȝJ RI
GBS-NN2 bound to aluminium hydroxide in a 4:1 ratio (IMP : placebo). 
x Cohort 2 will receive three injections, each consisting of 125 ȝJ RI *%6-NN and 125 ȝJ
of GBS-NN2 bound to aluminium hydroxide in a 4:1 ratio (IMP : placebo). 
x Cohort 3 will receive three injections, each consisting of 50 ȝJ RI *%6-NN and 50 ȝJ RI
GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (IMP : placebo). 
x Cohort 4 will receive three injections, each consisting of 125 ȝJ RI *%6-NN and 125 ȝJ
of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (IMP : placebo). 
Eligible participants will be administered a dose of GBS-NN/NN2 or placebo 
on three occasions: the 1st dose will be administered on Day 1, followed by the second and 3rd 
doses 4 and 24 weeks later, respectively. Participants will be involved in the study for 
approximately one year including screening and safety follow-up. The start of the study is 
defined as Day 1 when participants are randomised. 
Dose escalation will be managed as described in Section 4.5. 
4.2 
Scientific Rationale for Study Design 
This study is designed as randomised, double-blind, and placebo-controlled to distinguish the 
effect of the IMP from other influences such as placebo effect or biased observation. 
Group B Streptococcus is also associated with disease in adults particularly in the older adult 
and adults who are immunosuppressed. In the current study, GBS-NN/NN2 vaccine will be 
administered for the first time in an older adult population with and without underlying 
medical conditions (obesity and/or diabetes type 2) to assess whether the GBS-NN/NN2 could 
potentially be effective in an older adult population and warrant further development in this 
population. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
28 of 69 
4.3 
Justification for Dose 
The study will investigate the safety and immune response to the dose level currently under 
development for use in pregnant women (50 μg of each fusion protein) as well as a higher 
dose of 125 μg of each fusion protein. In the initial trial with GBS-NN alone, doses of 250 μg 
of the single fusion protein were administered to healthy non pregnant women. No safety 
concerns were reported with the maximum dose of 250 μg. Older adult participants, in whom 
the immune system is ageing may need a higher dose or more doses to achieve the same 
immune response. Hence, this study will explore the higher dose of 125 μg and a three-dose 
administration regimen. 
4.4 
End of Study Definition 
The end of the study is defined as the date of the last visit of the last participant in the study. 
A participant is considered to have completed the study if he/she has completed all periods of 
the study including the last safety follow-up visit. 
See Section 10.1.11 for information on early study and/or site termination. 
4.5 
Dose Escalation  
Progression from Cohort 1 to Cohort 2 and Cohort 3 will only occur after the available 
safety/tolerability data from all participants who completed Visit 3 (Day 8) in Cohort 1 have 
been assessed by a Safety Review Group (SRG). Please see Section 9.6 for further details. 
The SRG will review the safety data from all participants who have completed Visit 3 in 
Cohort 2 and Cohort 3 to determine if participants in Cohort 4 could receive the IMP (see 
Figure 1). 
4.6 
Study Stopping Criteria 
4.6.1 
Stopping Criteria for Individual Participants 
Individual participants may be withdrawn for any of the reasons outlined in Section 7.0. 
4.6.2 
Criteria for Stopping Dose Escalation 
Dose escalation will be stopped if any of the study stopping rules are met (see Section 4.6.3). 
4.6.3 
Criteria for Stopping the Study 
The study will be discontinued if any unacceptable safety findings are identified. This 
decision will be made jointly by the Principal Investigator (or deputy) and the Sponsor. A 
written document signed by the Principal Investigator (or deputy) and Sponsor will be 
produced ratifying the decision. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
29 of 69 
A safety review meeting will be convened to determine the progression of the study if any of 
the following scenarios occur: 
x If more than 20% of the participants in a cohort experience a severe site reaction related to 
the GBS-NN/NN2 vaccine (IMP administration). 
x If more than 20% of the participants in a cohort experience a severe systemic reaction 
related to the IMP administration. 
x If more than 20% of the participants in a cohort experience a persistent febrile reaction 
!& IRU  hours) related to IMP administration. 
x If one or more participants experience a serious AE (SAE) related to the IMP 
administration. 
x If two or more participants in the same cohort, experience 'severe' non serious adverse 
reactions (ie, severe non serious adverse events, independent of system-organ-class, 
considered at least possibly related, to the IMP administration). 
If the study is temporarily halted for any reason including the circumstance where any of the 
above stopping criteria are fulfilled, the study will only proceed and restart once an 
appropriate substantial amendment has been submitted and receives regulatory approval from 
the Medicines and Healthcare products regulatory agency and approval from the Research 
Ethics Committees associated with the study. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
30 of 69 
5.0 STUDY POPULATION 
Data from screening procedures will be used for treatment allocation if a procedure is not 
planned or repeated at Visit 2. Procedures will not be repeated at Visit 4 and Visit 8. 
x The investigators should consider whether a participant with BMI  WR  kg/m2 
and with prediabetes is eligible for Cohort 1 or 2. This decision can be made based on 
the CDC definition of prediabetes of an HbA1c of 5.7% to 6.4%. 
x If a participant has a %0,  WR  kg/m2 and the participant has prediabetes, the 
participant would be eligible for Cohorts 3 and 4 as a participant who is obese. 
o For a participant to be included in Cohorts 3 and 4 as a participant with 
diabetes (as opposed to a participant who is obese), a pre-existing diagnosis of 
diabetes, documented by the general practitioner or other treating physician, is 
required. 
o If the participant is diagnosed with type 2 diabetes, the participant must be on 
treatment for type 2 diabetes; e.g. metformin, sulphonylureas or glitazones. The 
diabetic participant is not eligible for Cohort 3 and 4 if not receiving treatment 
for type 2 diabetes at study enrolment. 
5.1 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Participants aged 55 to 75 years at screening. 
2. %RG\ PDVV LQGH[ %0,  DQG <30 kg/m2 for healthy participants, 30 WR  kg/m2 for 
obese participants DQG 18 WR  kg/m2 for type 2 diabetic participants at screening. 
3. Able to voluntarily provide written informed consent to participate in the study. 
4. Female participants must be post-menopausal. 
5. Participants capable and willing to follow trial schedule and procedures. 
5.2 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Participants who have received a GBS vaccine previously. 
2. Participants with history or presence of significant (as evaluated by the investigator) 
cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, 
haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, 
psychiatric, autoimmune disease, or current infection. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
31 of 69 
NOTE: Patients with type 2 diabetes are to be recruited for Cohort 3 and Cohort 4. 
The autoimmune skin diseases, mild psoriasis and vitiligo, will not be considered as 
relevant for exclusion. 
Other autoimmune diseases that are not stable or are progressive/worsening (as evaluated 
by the investigator) should lead to exclusion. 
3. Laboratory values at screening which are deemed by the investigator to be clinically 
significantly abnormal. 
4. Current or history of drug or alcohol abuse per investigator judgement. 
5. Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. 
6. Participants currently participating in a clinical trial. 
7. Participants receiving an investigational drug, vaccine or device during the 90 days 
preceding the initial dose in this study. 
8. Any significant illness during the 4 weeks preceding the vaccination visit, per investigator 
judgement. 
9. Participants with a history of severe allergic reactions after previous vaccination. 
10. Participants who have received any vaccine within 30 days of 1st IMP administration, or 
who are planning to receive any vaccine (eg, travel vaccines) up to 30 days after each 
vaccination and/or 7 days prior to 3rd administration. 
NOTE: Exceptions could be made for emergency vaccinations (eg, tetanus) or vaccination 
campaigns (eg, SARS, CoV-2 or influenza) which will be permitted not less than 7 days 
before or after study vaccination. 
11. Participants receiving immunosuppressive therapy or immunoglobulins in the 6 months 
prior to screening. 
12. Participants within a 7-day period after an acute infection in the 7 days preceding 
vaccination, as per investigator judgement, or with fever (oral temperature >37.9°C) in 
the 72 hours preceding vaccination. 
13. Participants who have received antipyretics/analgesics treatment within 72-hours prior to 
dosing. 
14. Participants on chronic medications that are likely to affect the assessments specified in 
the protocol (eg, anticoagulant therapy, systemic steroids). 
NOTE: Chronic medications such as antihypertensives, bronchodilators or statins that do 
not affect the immune system, will be permitted and allowed to continue during the study 
at the discretion of the investigator. Treatment for diabetes will be continued as required 
for the diabetic participants recruited. Non-steroidal anti-inflammatory drugs or 
paracetamol will be permitted for the treatment of headache or other symptoms during the 
study. Use of over the counter (OTC) vitamins and dietary supplements is allowed. 
15. Participants with skin defects and/or tattoos at the proposed site of vaccine administration. 
16. Donation of blood or blood products within 90 days prior to 1st study vaccination. 
17. Participants who, in the opinion of the Investigator, are unsuitable for participation in the 
study. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
32 of 69 
18. Involvement in the planning and/or conduct of the study (applies to both Sponsor 
personnel and/or personnel at the study centre or Clinical Research Organisation [CRO]). 
 
5.3 
Lifestyle Considerations 
No restrictions pertaining to lifestyle and/or diet beyond the details indicated in Section 5.2. 
5.4 
Screen Failures 
A screen failure occurs when a participant who consents to participate in the clinical study is 
not subsequently randomly assigned to IMP. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants to meet the Consolidated 
Standards of Reporting Trials publishing requirements and to respond to queries from 
regulatory authorities. Minimal information includes demography, screen failure details and 
eligibility criteria. 
If the investigator believes there is a reasonable justification to do so, screening procedures 
may be repeated (maximum one rescreening per participant is allowed). 
Only laboratory results from the rescreening visit, if it occurs, will be taken into consideration 
and recorded in the electronic case report form (eCRF). Medical history (MH), physical 
examination and review of inclusion/exclusion criteria must be repeated if a rescreening visit 
occurs. The participant can only be randomised once the investigator receives the results and 
confirms the eligibility criteria. 
5.5 
Criteria for Temporarily Delaying 
Vaccination may be postponed within the allowed time interval until any transient 
circumstances have been resolved. 
A temporary contraindication (pausing rule) is defined as an event experienced by a study 
participant that leads to the conclusion that no investigational product can be administered to 
the study participant until the event has resolved. 
The investigator must postpone the vaccination of an individual participant in case of: 
x Acute infection in the 7 days before the vaccination, per investigator judgement. 
x Fever (oral temperature >37.9°C) in the 72 hours preceding vaccination. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
33 of 69 
6.0 INVESTIGATIONAL MEDICINAL PRODUCT(S) AND 
CONCOMITANT THERAPY 
6.1 
Investigational Medicinal Product(s) Administered 
The GBS-NN/NN2 vaccine will be supplied as two sterile solutions (GBS-NN and GBS-NN2) 
to be mixed with a sterile dilution buffer and adsorbed to Alhydrogel® adjuvant. The placebo 
vaccine will be 0.9% saline for injection. 
Administration will be by intramuscular injection, preferably into the non-dominant arm. The 
dominant arm may be used if it is not possible to administer into the non-dominant arm (eg, 
due to an ongoing injection site reaction, or tattoo), or the participant prefers to receive the 
vaccine in the dominant arm. 
The procedure for the assembly of both dose levels for the study is described in detail in the 
IMP handling Manual. 
Individual participant treatments will be reconstituted and dispensed by the investigator or 
designee. 
The following dosing strategy will be employed: 
Cohort 
Population 
Dose scheduled 
Dose level GBS-NN/NN2 or placebo 
1 
Healthy older adult 
participants 
Visit 2 
Visit 4 
Visit 8 
50 μg of each protein or placebo 
2 
Healthy older adult 
participants 
Visit 2 
Visit 4 
Visit 8 
125 μg of each protein or placebo 
3 
Obese and/or diabetic older 
adult participants 
Visit 2 
Visit 4 
Visit 8 
50 μg of each protein or placebo 
4 
Obese and/or diabetic older 
adult participants 
Visit 2 
Visit 4 
Visit 8 
125 μg of each protein or placebo 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
34 of 69 
6.2 
Preparation, Handling, Storage, and Accountability 
Refer to IMP Handling Manual for details regarding preparation, handling, storage, and 
accountability of IMP. 
Only participants enrolled in the study may receive IMP, and only authorised unblinded study 
site staff may supply and/or administer IMP. All IMP must be stored in a secure, 
environmentally controlled, and monitored (manual or automated) area in accordance with the 
labelled storage conditions with access limited to the unblinded authorised study site staff. 
The unblinded study team (where applicable) is responsible for IMP accountability, 
reconciliation, and record maintenance (ie, receipt, reconciliation, and final disposition 
records). 
The unblinded study staff must maintain an adequate record of the receipt and distribution of 
all IMPs using the Drug Accountability Form. These forms must be available for inspection at 
any time. 
At the end of the study, following IMP reconciliation, unused medication will be returned to 
the Sponsor or destroyed locally, if destroyed locally a destruction certificate is required. 
6.3 
Measures to Minimise Bias: Randomisation and Blinding 
6.3.1 
Participant Identification 
Participant identification numbers will be assigned sequentially to the participants who have 
consented to participate in the study, according to the range of participant identification 
numbers allocated to the study site. Re-screening of participants will require the allocation of 
a new participant identification number. 
6.3.2 
Treatment Allocation to the Participant 
Allocation of the participant to treatment within a cohort at the study site will be performed 
using a randomisation module of the electronic case report form (eCRF) used as Interactive 
Response System (IRS) at the site after confirming eligibility and prior to 1st dosing. The 
following series of randomisation numbers will be used for the four cohorts: 1001 to 1030, 
2001 to 2030, 3001 to 3015, and 4001 to 4015. 
6.3.3 
Blinding 
Data will be collected in a double-blind manner. The study participant and those responsible 
for the evaluation of any study endpoint (eg, safety and immunogenicity) will all be unaware 
of which IMP was administered. To do so, IMP preparation and administration will be done 
by authorised personnel who will not participate in any of the study clinical evaluations. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
35 of 69 
The laboratory conducting the laboratory testing will be blinded to the treatment, and codes 
will be used to link the participant and study (without any link to the treatment attributed to 
the participant). 
In case of an emergency or any finding that requires unblinding to determine the identification 
of the treatment administered for the appropriate management of a participant on the study, 
the investigator may break the blinding code for an individual participant. If the blind is 
broken the investigator will inform the Sponsor within 24 hours of breaking the blind, that the 
blind has been broken and the reason for breaking the blind (but not necessarily the outcome 
of the breaking of the blind) and record the date/time and reason for breaking the blind. 
The randomisation list will be prepared by a statistician who will not, in any way, participate 
in the data management or the statistical analysis of the data from the clinical study before the 
database has been released for analysis. 
The randomisation list will be generated by a validated statistical analysis system (SAS) 
programme and kept in a restricted access folder and will subsequently be integrated in the 
eCRF. 
The randomisation (ie, group assignment) of a new participant at the investigational site will 
take place using the eCRF. Only unblinded site staff and the unblinded monitor have access to 
the unblinded randomisation module. Unblinded study team members may not reveal any 
unblinded information to any blinded study team members and must keep the unblinded 
randomisation documents in a secure place. 
6.3.3.1 
Emergency Unblinding 
The site Principal Investigator (PI; or delegate) will be able to unblind an individual 
participant. The blinding should only be broken in case of an emergency, and only if the 
knowledge obtained through the unblinding, is assessed to be needed for the proper treatment 
or continued safety of the participant experiencing the emergency. 
The pharmacovigilance responsible CRO will be able to unblind an individual participant 
prior to submitting an expedited report of a suspected unexpected serious adverse reaction 
(SUSAR) to a competent authority (CA) or independent ethics committee (IEC), if unblinding 
is required by the CA or IEC. 
Whenever possible, the Sponsor should be consulted before the blind is broken by the site. 
The unblinding of a participant by the site PI or the pharmacovigilance responsible CRO takes 
place through the unblinding module in the eCRF, to which the applicable parties will be 
given access. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
36 of 69 
If unblinding of a participant has taken place (intentionally or unintentionally), the Sponsor 
must be informed immediately, and be provided with an explanation, and it must be 
considered to withdraw the unblinded participant from the study. 
The information in this section will, if applicable, be described in more detail in a study 
specific blinding manual. 
Participants may continue their participation in the study even if their treatment assignment is 
unblinded. 
6.4 
Investigational Medicinal Product Compliance 
The IMP is administered by health care professionals; therefore, participant compliance with 
dosing will not be an issue. During the clinical study, the unblinded monitor will check IMP 
administration documentation to check that the IMP is being administered correctly. 
6.5 
Dose Modification 
Dose modifications are not planned or allowed in this study. 
6.6 
Concomitant Therapy 
Any medication or vaccine (including OTC or prescription medicines) that the participant is 
receiving at the time of enrolment or receives during the study must be recorded along with: 
x Reason for use 
x Dates of administration including start and end dates 
x Dosage information including dose and frequency 
Concomitant medications (CM) will be recorded in the electronic diary (eDiary) of the 
participant 7 days after each vaccination. Study staff will review the eDiary and transfer 
relevant AEs and CM data into the eCRF. 
NOTE: The overall collection of CMs during the study period should be done as follows (see 
Section 8.3.1 for AE collection details): 
x Day 1 – Visit 6 (Day 57): All CMs associated with an AE. 
x Day 58 – Day 161: Only CMs taken for MAAEs, AESIs, and SAEs, which are collected 
within this period. 
x Day 162 (7 days prior to 3rd vaccination at Visit 8) – Visit 10 (Day 197): All CMs 
associated with an AE. 
x Day 198 – Visit 12 (Day 365): Only CMs taken for MAAEs, AESIs, and SAEs collected 
within this period. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
37 of 69 
6.6.1 
Permitted Concomitant Medications 
Participants may take concomitant chronic medications such as antihypertensives, 
bronchodilators or statins that do not affect the immune system during the study at the 
discretion of the investigator. Treatment for diabetes will be continued as required for the 
diabetic participants recruited. Non-steroidal anti-inflammatory drugs or paracetamol at doses 
of d4 g/day, will be permitted for use any time during the study, except within 72 hours before 
each vaccination, for the treatment of headache or other symptoms. 
6.6.2 
Prohibited Concomitant Medications 
The following medications are prohibited, as defined by the exclusion criteria (Section 5.2): 
x Immunosuppressive therapy or immunoglobulins in the 6 months prior to screening. 
x Chronic medications that are likely to affect the assessments specified in the protocol 
(eg, anticoagulant therapy, systemic steroids). 
x Vaccines within 30 days of 1st IMP administration and up to 30 days after each study 
vaccination and 7 days prior to 3rd IMP administration, with the exception of 
emergency vaccinations or vaccination campaigns, which will be permitted not less 
than 7 days before and after study vaccination. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
38 of 69 
7.0 DISCONTINUATION OF INVESTIGATIONAL 
MEDICINAL PRODUCT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 
Discontinuation of Investigational Medicinal Product 
If IMP is permanently discontinued, the participant will remain in the study to be evaluated 
for safety. See the Schedule of Activities (SoA) in Section 1.3 for data to be collected at the 
time of discontinuation of IMP and follow-up and for any further evaluations that need to be 
completed. The primary reason for the investigator’s decision, must be specified in the end of 
study form in the eCRF. 
If a participant who does not meet enrolment criteria is inadvertently enrolled, that participant 
should be discontinued from IMP and the Sponsor, or Sponsor designee, must be contacted. 
An exception may be granted in rare circumstances, and in these rare cases, the investigator 
must obtain documented approval from the Sponsor, or Sponsor designee, to allow the 
participant to continue in the study. 
Participants who discontinue prior to 1st IMP administration will be replaced. Vaccinated 
participants will not be replaced unless enrolled in error. 
7.1.1 
Liver Chemistry Stopping Criteria 
Discontinuation of investigational product for abnormal liver tests is required by the 
investigator when a participant meets one of the conditions outlined in Hy’s Law or in the 
presence of abnormal liver chemistries not meeting protocol-specified stopping rules if the 
investigator believes that it is in best interest of the participant (see Section 10.4). 
7.2 
Participant Discontinuation/Withdrawal from the Study 
Dosing for any individual participant will be stopped if the participant experiences a serious 
adverse event (SAE) or a clinically significant possibly drug-related related AE, which in the 
opinion of the study physician, Principal Investigator, or Sponsor’s medical representative, 
warrants discontinuation of the study for that participant’s wellbeing. 
A participant is free to leave the study at any time without giving reason for this according to 
the Declaration of Helsinki. 
Should a participant want to withdraw from the study after he/she has been vaccinated, all 
efforts must be made to complete and report the observations as thoroughly as possible up to 
the date of withdrawal. Participants withdrawing due to an AE should be followed up 
according to the follow-up visit schedule (see SoA [Section 1.3]). 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
39 of 69 
7.3 
Lost to Follow-up 
A participant will be considered lost to follow-up if he/she fails to return for a scheduled visit 
and is unable to be contacted by the study site after at least three attempts. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
x The study site must attempt to contact the participant and reschedule the missed visit as 
soon as possible, counsel the participant on the importance of maintaining the assigned 
visit schedule and ascertain whether the participant wishes to and/or should continue in the 
study. 
x Before a participant is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the participant (where possible, three telephone calls, 
and if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
clinical report form. 
x Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
40 of 69 
8.0 STUDY ASSESSMENTS AND PROCEDURES 
Study procedures and their timing are summarised in the SoA (Section 1.3). Adherence to the 
study design requirements, including those specified in the SoA (Section 1.3), is essential and 
required for study conduct. 
Immediate safety concerns should be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
investigational product. 
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
Safety/laboratory results that could unblind the study will not be reported to study sites or 
other blinded personnel until the study has been unblinded. 
The maximum amount of blood collected from each participant over the duration of the study, 
including any extra assessments that may be required, will not exceed 500 mL. 
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with 
the samples. 
The order of each procedure will be determined by the study site. However, when multiple 
procedures are scheduled at the same day, they all need to be performed before the 
administration of the IMP takes place. 
During special circumstances (eg, a pandemic), the specific guidance from local public health 
and other competent authorities regarding the protection of participants’ welfare must be 
applied. In such special circumstances, certain study procedures may be implemented for 
enrolled participants (refer to Section 8.10 for further details). 
8.1 
Efficacy Assessments 
Not applicable. 
8.2 
Safety Assessments 
The safety of the GBS-NN/NN2 vaccine will be assessed through collection of solicited AEs 
in electronic diaries up to 7 days following each administered vaccination, as well as through 
laboratory safety tests, physical examinations and vital signs performed at the study visits. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
41 of 69 
The description of safety assessments is given below, and the timings of these assessments is 
given in the SoA (Section 1.3). Unscheduled assessments may be performed at the discretion 
of the Investigator. 
8.2.1 
Physical Examinations 
Full physical examinations will be performed at screening and safety follow-up. 
A full physical examination will include, at a minimum, assessments of the cardiovascular, 
respiratory, gastrointestinal, and neurological systems. Height, weight and BMI will also be 
measured and recorded at screening. 
Physical examination abnormalities noted at the screening visit should be recorded in the 
participant’s MH. 
A brief physical examination will be performed at dosing visits prior to study vaccination, and 
it will include a symptom directed examination to confirm eligibility for discharge at 
least 30 minutes post dose. 
Investigators should pay special attention to clinical signs related to previous serious illnesses. 
8.2.2 
Vital Signs 
Vital signs measurements will be performed at time points indicated in the SoA (see 
Section 1.3). 
Vital signs will be measured in a sitting position after 5 minutes rest and will include oral 
temperature, systolic and diastolic blood pressure, and pulse rate. 
Vital signs at dosing visits will be recorded pre dose and at least 30 minutes post dose. 
8.2.3 
Clinical Safety Laboratory Tests 
See Section 10.2 for the list of clinical laboratory tests to be performed and the SoA 
(Section 1.3) for the timing and frequency.  
Table 3 presents number of tests, volumes of blood per test and total volume of blood. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
42 of 69 
Table 3 
Number of tests, volumes of blood per test and total volume of blood 
 
Number of tests 
Volume of blood per test, mL 
Total blood volume, mL 
Biochemistry 
7 
10 
70 
Haematology 
7 
5 
35 
HIV, Hepatitis B, and C 
1 
10 
10 
Immunogenicity 
6 
15 
90 
 
 
Total blood volume, mL 
 
 
445 
HIV = human immunodeficiency virus; 
 
The maximum amount of blood collected from each participant over the duration of the study, 
including any extra assessments that may be required, will not exceed 500 mL. 
The investigator must review the laboratory report, document this review, and record any 
clinically significant changes occurring during the study as an AE. The laboratory reports 
must be filed with the source documents. 
All laboratory tests with values considered clinically significantly abnormal during 
participation in the study should be repeated until the values return to normal or baseline or 
are no longer considered clinically significant by the investigator or medical monitor. If 
clinically significant values do not return to normal/baseline within a period of time judged 
reasonable by the investigator, the aetiology should be identified. 
All protocol-required laboratory tests, as defined in Section 10.2, must be conducted in 
accordance with the laboratory manual and the SoA (Section 1.3). 
If laboratory values from non protocol-specified laboratory tests performed at the institution’s 
local laboratory require a change in participant management or are considered clinically 
significant by the investigator (eg, SAE or AE or dose modification), then the results must be 
recorded as an unscheduled visit. 
8.2.4 
Electronic Diary 
The participant will get access to an eDiary at Visit 2, when vaccine/placebo is administered. 
In the eDiary, the participant is asked to record details of solicited local and systemic reactions 
for 7 days after each of the vaccinations (the day of the vaccination and the following 6 days). 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
43 of 69 
For solicited local injection site reactions (redness, swelling, pain, tenderness, itching) and 
pyrexia (oral temperature >37.9°C), the diameters and temperatures will be measured by the 
participant, by use of rulers and thermometers, and recorded in the eDiary. 
For solicited systemic reactions (chills, muscle pains/myalgia, malaise, nausea, vomiting, 
headache, and fatigue), intensities (mild, moderate, or severe) should be recorded in the 
eDiary by the participant. In addition, other AEs, ie, unsolicited AEs, including medically 
attended AEs (MAAEs), SAEs, CM and/or vaccines should also be recorded and assessed in 
the eDiary. 
The solicited local and systemic reactions, and CMs recorded in the eDiary, will be assessed 
by the site staff. 
If serious, the SAEs will undergo evaluation as per the current reference safety information of 
the IB, as described in Section 6.0. 
8.3 
Adverse Events, Serious Adverse Events, and Other Safety Reporting 
The definitions of AEs and SAEs can be found in Section 10.3. 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver or 
surrogate). 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible for 
following up all AEs. 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 10.3. 
8.3.1 
Time Period and Frequency for Collecting AE and SAE Information 
All AEs and SAEs will be collected from the 1st IMP administration until the follow-up visit 
at the time points specified in the SoA (Section 1.3). 
NOTE: The overall collection of AEs during the study period should be done as follows: 
x Day 1 – Visit 6 (Day 57): All AEs 
x Day 58 – Day 161: Only MAAEs, AESIs, and SAEs 
x Day 162 – Visit 10 (Day 197): All AEs 
x Day 198 – Visit 12 (Day 365): Only MAAEs, AESIs, and SAEs 
Medical occurrences that begin before the start of IMP administration but after obtaining 
informed consent will be recorded as MH, not as AEs. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
44 of 69 
All SAEs will be recorded and reported to the Sponsor or designee immediately and under no 
circumstance should this exceed 24 hours of the investigator’s awareness of the event, as 
indicated in Section 10.3. The investigator will submit any updated SAE data to the Sponsor 
or designee within 24 hours of their awareness of the updated information. 
Investigators are not obligated to actively seek information on AEs or SAEs after conclusion 
of the study participation. However, if the investigator learns of any SAE, including a death, at 
any time after a participant has been discharged from the study, and he/she considers the 
event/cause of death to be reasonably related to the investigational product or study 
participation, the investigator must promptly notify the Sponsor or designee. 
The method of recording, evaluating, and assessing causality of AE and SAE and the 
procedures for completing and transmitting safety reports are provided in Section 10.3. 
8.3.2 
Method of Detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about AE 
occurrences. 
8.3.3 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. All adverse reactions (ARs) and SAEs will be 
followed until resolution, stabilisation, the event is otherwise explained, or the participant is 
lost to follow-up (as defined in Section 7.3). Further information on follow-up procedures is 
provided in Section 10.3. 
8.3.4 
Regulatory Reporting Requirements for SAEs 
Prompt notification by the investigator to the Sponsor or designee of an SAE is essential so 
that legal obligations and ethical responsibilities toward the safety of participants and the 
safety of an IMP under clinical investigation are met. 
The Sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of an IMP under clinical investigation. The Sponsor will 
comply with country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, EU Eudravigilance Database (as applicable), IRBs/IECs, and 
Investigators. 
An investigator who receives an investigator safety report describing an SAE or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will review and then 
file it along with the IB and will notify the IRB/IEC, if appropriate according to local 
requirements. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
45 of 69 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and Sponsor policy and forwarded to Investigators as necessary. 
8.3.5 
Solicited Adverse Events 
Local and systemic predefined solicited AEs for reactogenicity assessment will be collected 
by the participant in a solicited AE eDiary for 7 days following each study vaccination. The 
set of solicited AEs associated with reactogenicity are presented in Table 4. 
Table 4 
Reactogenicity Assessment: List of solicited adverse events 
Local 
Systemic 
Pain at the site of injection 
Fever (>100°F [>37.9°C])a 
Erythema/redness at the site of injection 
Chills 
Tenderness 
Muscle pains 
Induration/swelling at the site of injection 
Fatigue 
Itching 
Headache 
 
Malaise 
 
Nausea 
 
Vomiting 
a Fever measured orally. Investigators who consider a temperature lower than this cutoff as a 
fever or a ‘fever’ reported by participants without documentation by a thermometer should 
record the event as ‘elevated body temperature’. 
8.3.6 
Adverse Events of Special Interest and Medically Attended Adverse Events 
Adverse events will be monitored throughout the study to identify any event of interest that 
may indicate a trend or risk to participants. The following are considered adverse events of 
special interest (AESI): 
x Development of autoimmune diseases 
x GBS infections 
x Symptomatic GBS urinary tract infections 
A MAAE is an AE that leads to an unscheduled visit to a health care provider. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
46 of 69 
8.4 
Pharmacokinetics 
Pharmacokinetic parameters are not evaluated in this study. 
8.5 
Pharmacodynamics 
Pharmacodynamic parameters are not evaluated in this study. 
8.6 
Genetics 
Genetics are not evaluated in this study. 
8.7 
Immunogenicity and Peripheral Blood Mononuclear Cell Assessments 
Instructions for the collection, labelling and handling of biological samples will be provided 
by the Sponsor in the sample handling manual. 
8.7.1 
Immunogenicity Assessments 
Serum samples for immunogenicity assessments will be collected according to the SoA 
(Section 1.3). Samples will be collected, labelled, stored, and shipped as detailed in the sample 
handling manual. Results for exploratory immunogenicity analyses may be reported separately 
from the clinical study report (CSR). 
8.7.2 
 
 
 
8.8 
Biomarkers 
Serum samples will be assayed in a validated enzyme-linked immunosorbent assay (ELISA) 
to measure the concentrations of IgG specific for the four Alps (Alp 1, Alp 2/3, AlpC, and 
Rib). Potentially anomalous results will be discussed with the Sponsor, without revealing the 
identity of the participants. 
8.9 
Health Economics 
Health economics parameters are not evaluated in this study. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
47 of 69 
8.10 Study Procedures During Special Circumstances 
During special circumstances (eg, a pandemic), the specific guidance from local public health 
and other competent authorities regarding the protection of participants’ welfare must be 
applied. For the duration of such special circumstances, the following measures may be 
implemented for enrolled participants: 
x 
Safety follow-up may be made by a telephone call, other means of virtual contact, or 
home visit, if appropriate. 
x 
Biological samples may be collected at the participant’s home. Biological samples should 
not be collected if they cannot be processed in a timely manner or appropriately stored 
until the intended use. 
x 
If, despite best efforts, it is not possible to collect blood samples within the interval 
predefined in the protocol, then the interval for blood sampling may be extended up to a 
maximum length of 30 days before the next blood sampling. Impact on the per-protocol 
set for analysis of immunogenicity will be determined on a case-by-case basis. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
48 of 69 
9.0 STATISTICAL CONSIDERATIONS 
9.1 
Statistical Hypotheses 
No formal statistical hypotheses are to be tested. 
9.2 
Sample Size Determination 
A total of 90 participants are planned. There will be two cohorts comprising 30 healthy older 
adult participants each and two cohorts comprising 15 obese and/or diabetic older adult 
participants each &RKRUW  ZLOO UHFHLYH WKUHH LQMHFWLRQV HDFK FRQVLVWLQJ RI  ȝJ RI *%6-NN 
and 50 ȝJ RI *%6-NN2 bound to aluminium hydroxide (24 healthy older adult participants) or 
placebo (6 healthy older adult participants). Cohort 2 will receive three injections, each 
consisting of 125 ȝJ RI *%6-NN and 125 ȝJ RI *%6-NN2 bound to aluminium hydroxide 
(24 participants) or placebo (6 healthy older adult participants). Cohort 3 will receive three 
LQMHFWLRQV HDFK FRQVLVWLQJ RI  ȝJ RI *%6-11 DQG  ȝJ RI *%6 11 ERXQG WR DOXPLQLXP
hydroxide (12 obese and/or diabetic older adult participants) or placebo (3 obese and/or 
diabetic older adult participants). Cohort 4 will receive three injections, each consisting of 
125 ȝJ RI *%6-NN and 125 ȝJ RI *%6-NN2 bound to aluminium hydroxide (12 obese and/or 
diabetic older adult participants) or placebo (3 obese and/or diabetic older adult participants). 
Sample size has been selected to provide a preliminary assessment of vaccine safety and 
tolerability by cohort, as well as to provide a preliminary assessment of immunogenicity. 
The sample size is not based on statistical considerations but is typical for studies of this 
nature and is considered adequate to characterise the distribution of the planned endpoints. 
Any statistical testing will be considered exploratory and descriptive. 
9.3 
Analysis Sets 
The analysis sets are defined in Table 5. 
 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
49 of 69 
Table 5 
Analysis Sets 
Analysis Set 
Description 
Entered Analysis Set 
All participants who sign the ICF. 
Enrolled Analysis Set 
All participants who have met all eligibility criteria. 
Safety Analysis Set 
All participants randomly assigned to study treatment and who 
take at least one dose of the IMP. Participants will be analysed 
according to the treatment they actually received. 
 
Immunogenicity Analysis Set 
All participants in the Safety Analysis Set with at least one post 
dose blood sample collected and analysed for immunogenicity. 
Participants will be summarised according to treatment 
received. 
Per-protocol Set 
All participants who receive all three doses of the study vaccine 
and provide evaluable samples for analysis of the principal 
immunological endpoint without any protocol deviation that 
could lead to its exclusion. 
The primary and secondary safety analyses will be performed on the safety analysis set. The secondary 
immunological analyses will be performed on the immunogenicity analysis set. The “principal” immunological 
analysis will also be performed on the per-protocol set if the number of participants in the per-protocol set differs 
by more than 5% from the number of participants in the safety analysis set. 
9.4 
Statistical Analyses 
The statistical analysis plan (SAP) will be developed and finalised before database lock and 
will describe the participant analysis sets to be included in the analyses, and procedures for 
accounting for missing, unused, and spurious data. This section is a summary of the planned 
statistical analyses of the primary and secondary endpoints. 
All analyses, summaries, and listings will be performed using the SAS® software 
(version 9.4 or higher). 
The following descriptive statistics will be used as applicable to summarise the study data 
unless otherwise specified: 
x Continuous variables: sample size [n], mean, standard deviation [SD], median, 
minimum [min], and maximum [max]. 
x Categorical variables: frequencies and percentages. 
Individual participant data will be presented in listings. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
50 of 69 
9.4.1 
Safety Analysis 
The percentage of participants with at least one solicited AE (local and systemic), with at least 
one unsolicited AE, and with any AE during the 7-day or the 28-day follow-up period will be 
tabulated after each vaccination and overall. Similar tabulation will be done for 
Grade 3 events, any AESIs, any MAAEs, any AEs considered related to the vaccination and 
any Grade 3 AEs considered related to vaccination. 
The percentage of participants reporting each individual solicited local and general AE during 
the 7-day follow-up period will be tabulated over the three doses. 
The percentage of participants with unsolicited AEs, including AESIs, MAAEs and SAEs 
within 28 days after any doses will be tabulated by treatment and by Medical Dictionary for 
Regulatory Activities (MedDRA) preferred term. Similar tabulation will be done for 
Grade 3 unsolicited AEs and for Grade 3 and causally related unsolicited AEs and for 
unsolicited AEs causally related to vaccination. 
The number of participants who experienced at least one SAE during the entire study period 
will be reported. The number and percentage of participants with AESIs, MAAEs, AEs/SAEs, 
and ARs/SARs leading to withdrawal from the study or discontinuation of the treatment will 
be tabulated. 
The number and percentage of participants with any SAE, AESIs, MAAEs, ARs/SARs 
leading to withdrawal from the study between Day 57 (28 days post second injection) to Day 
168 and from 28 days after 3rd vaccination up to Day 365 will also be summarised by 
treatment group. 
All laboratory test results, and vital signs measurements will be summarised for each 
treatment group using descriptive statistics at each visit for observed and change from baseline 
values. The incidence of treatment-emergent abnormal laboratory values will also be 
summarised using descriptive statistics. 
Further details will be provided in the SAP. 
9.4.2 
Analysis of Immunogenicity 
Geometric mean concentrations and their 95% CIs will be presented for each treatment and at 
each timepoint that blood samples are collected for antibody response specific for the four 
Alps (Alp1, Alp2/3, AlpC and Rib). Fold-change from baseline values specific for the four 
Alps (Alp1, Alp2/3, AlpC and Rib) will be summarised similarly (data permitting). 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
51 of 69 
Proportion of participants with a four-fold increase (seroconversion) above baseline (pre dose 
concentration) at each time point post vaccination will be summarised. Number and 
proportion of participants achieving antibody concentrations above a specific threshold 
(1, 2, 4, and 8 μg/mL) at each timepoint will also be tabulated similarly. 
Exploratory comparisons between the four Alps (Alp1, Alp2/3, AlpC and Rib) and placebo 
within healthy older adult and obese/type 2 diabetic older adult participants may be performed 
using linear mixed models. Model may include age, gender, or other covariates, as relevant. 
More details will be provided in the SAP. 
9.4.3 
Missing Data 
Missing data will not be imputed. 
9.5 
Interim Analysis 
No interim analysis is planned. 
9.6 
Safety Review Group 
An SRG is responsible for ongoing safety monitoring for the clinical conduct of the study and 
meets on a regular basis. 
The SRG will be responsible to assess safety after all participants have completed 
Visit 3 (Day 8) for Cohort 1, at which point the decision will be made as to whether 
proceeding with administration of the doses in Cohorts 2 and 3 is appropriate. Safety in 
Cohorts 2 and 3 will be assessed by the SRG after all participants have completed Visit 3 at 
which point the decision will be made by the SRG as to whether proceeding to Cohort 4 is 
appropriate. 
Details of the compositions and responsibilities of the SRG will be provided in the SRG 
charter. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
52 of 69 
10.0 SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1 Appendix 1: Regulatory, Ethical, and Study Oversight Considerations 
10.1.1 
Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with the following: 
x Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organisations of Medical Sciences 
international ethical guidelines. 
x Applicable International Conference on Harmonisation (ICH) Good Clinical Practices 
(GCP) guidelines. 
x Applicable laws and regulations. 
The protocol, protocol amendments, ICF, IB, and other relevant documents (eg, 
advertisements) must be submitted to an IRB/IEC by the investigator and reviewed and 
approved by the IRB/IEC before the study is initiated. 
Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants. 
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard to 
study participants. 
The investigator will be responsible for the following: 
x Providing written summaries of the status of the study to the IRB/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/IEC 
x Notifying the IRB/IEC of SAEs, or other significant safety findings as required by 
IRB/IEC procedures 
x Providing oversight of the conduct of the study at the study site and adherence to 
requirements of 21 Code of Federal Regulations (CFR), ICH guidelines, the IRB/IEC, 
European regulation 536/2014 for clinical studies (if applicable), European Medical 
Device Regulation 2017/745 for clinical device research (if applicable), and all other 
applicable local regulations. 
After reading the protocol, each investigator will sign the protocol signature page and send a 
copy of the signed page to the Sponsor or representative. The study will not start at site if the 
investigator has not signed the protocol. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
53 of 69 
10.1.2 
Adequate Resources 
The investigator is responsible for supervising any individual or party to whom the 
investigator delegates study-related duties and functions conducted at the study site. 
If the investigator/institution retains the services of any individual or party to perform study-
related duties and functions, the investigator/institution should ensure this individual, or party 
is qualified to perform those study-related duties and functions and should implement 
procedures to ensure the integrity of the study-related duties and functions performed and any 
data generated. 
10.1.3 
Financial Disclosure 
Investigators and subinvestigators will provide the Sponsor with sufficient, accurate financial 
information as requested to allow the Sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study. 
10.1.4 
Insurance 
Sponsor will provide insurance in accordance with local guidelines and requirements as a 
minimum for the participants in this study. The terms of the insurance will be kept in the study 
files. 
10.1.5 
Informed Consent Process 
The investigator or his/her representative will explain the nature of the study, including the 
risks and benefits, to the participant and answer all questions regarding the study. 
Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH GCP guidelines, privacy, and data protection requirements, where 
applicable, and the IRB/IEC or study site. 
The clinical report form must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was obtained. 
The authorised person obtaining the informed consent must also sign the ICF. 
Participants must be reconsented to the most current version of the ICF during their 
participation in the study. 
A copy of the ICF must be provided to the participant. 
A participant who is rescreened is not required to sign another ICF if the rescreening occurs 
within 60 days from the previous ICF signature date. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
54 of 69 
10.1.6 
Data Protection 
x Participants will be assigned a unique identifier by the Sponsor or designee. Any 
participant records or datasets that are transferred to the Sponsor will contain the identifier 
only; participant names or any information which would make the participant identifiable 
will not be transferred. 
x The participant must be informed that his/her personal study-related data will be used by 
the Sponsor in accordance with local data protection law and the General Data Protection 
Regulation (GDPR, Ref. 3). The level of disclosure must also be explained to the 
participant who will be required to give consent for their data to be used as described in 
the informed consent. 
x The participant must be informed that his/her clinical report forms may be examined by 
Clinical Quality Assurance auditors or other authorised personnel appointed by the 
Sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory authorities. 
10.1.7 
Committees Structure 
This study does not have an independent safety monitoring committee. 
10.1.8 
Dissemination of Clinical Study Data 
The results of the study should be reported within 1 year from the end of the clinical study. 
Irrespective of the outcome, the Sponsor will submit to any relevant database a summary of 
the results of the clinical study within 1 year from the end of the global clinical study. It shall 
be accompanied by a summary written in a manner that is understandable to laypersons. 
10.1.9 
Data Quality Assurance 
x All participant data relating to the study will be recorded on eCRFs unless transmitted to 
the Sponsor or designee electronically (eg, laboratory data). The investigator is responsible 
for verifying that data entries are accurate and correct by electronically signing the CRF. 
x Guidance on eCRF will be provided to the investigator in a separate document. 
x The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents. 
x Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques 
(central, remote, or on-site monitoring) are provided in the Study Monitoring Plan. 
x Details of study monitoring, including action required due to SARS-CoV-2 (COVID-19), 
will be included in a separate Study Monitoring Plan. 
x The Sponsor or designee is responsible for the data management of this study, including 
quality checking of the data. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
55 of 69 
x The Sponsor assumes accountability for actions delegated to other individuals (eg, 
contract research organisations). 
x Records and documents, including signed ICFs, pertaining to the conduct of this study 
must be retained by the investigator for at least 25 years after study completion unless 
local regulations or institutional policies require a longer retention period. No records may 
be destroyed during the retention period without the written approval of the Sponsor. No 
records may be transferred to another location or party without written notification to the 
Sponsor. 
10.1.10 
Source Documents 
The investigator/institution should maintain adequate and accurate source documents and 
study records that include all pertinent observations on each of the study site’s participants. 
Source data should be attributable, legible, contemporaneous, original, accurate, and 
complete. Changes to source data should be traceable, should not obscure the original entry, 
and should be explained if necessary (eg, via an audit trail). 
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator’s site. 
Data entered in the eCRF that are transcribed from source documents must be consistent with 
the source documents or the discrepancies must be explained. The investigator may need to 
request previous clinical report forms or transfer records, depending on the study. Also, 
current clinical report forms must be available. 
Definition of what constitutes source data and its origin can be found in source data 
identification log. 
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. 
Study monitors will perform ongoing source data verification to confirm that data entered into 
the CRF by authorised study site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements. 
10.1.11 
Study and Site Start and Closure 
First Act of Recruitment 
The study start date is the date on which the clinical study will be open for recruitment of 
participants. 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
56 of 69 
Study/Site Termination 
The Sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the Sponsor. 
Reasons for the early closure of a study site by the Sponsor or investigator may include but are 
not limited to: 
For study termination: 
x Discontinuation of further IMP development. 
For study site termination: 
x Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC or 
local health authorities, the Sponsor’s procedures, or GCP guidelines. 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
Investigators, the IECs/IRBs, the regulatory authorities, and any contract research 
organisation(s) used in the study of the reason for termination or suspension, as specified by 
the applicable regulatory requirements. The investigator shall promptly inform the participant 
and should assure appropriate participant therapy and/or follow-up. 
Study sites will be closed upon study completion. A study site is considered closed when all 
required documents and study supplies have been collected and a study site closure visit has 
been performed. Refer to Section 4.4 for the End of Study definition. 
10.1.12 
Publication Policy 
The data generated by this study are confidential information of the Sponsor. The Sponsor will 
make the results of the study publicly available. The publication policy with respect to the 
investigator and study site will be set forth in the Clinical Trial Agreement. 
No data from the clinical study, unless approved by MinervaX in writing, may be published, 
presented or communicated, except to CA(s) or EC(s), prior to being published. 
 
 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
64 of 69 
x 
The Sponsor shall ensure that a SUSAR which is not fatal or life-threatening is reported as 
soon as possible and, in any event, not later than 15 days after the Sponsor is first aware of 
the reaction. 
The contact details of the pharmacovigilance provider are as follows: 
ProPharma Group 
Olliver 
Aske 
Richmond 
North Yorkshire 
DL10 5HX 
Tel: 00 44 (0) 1279 406759 
Fax: 00 44 (0) 1279 418964 
Email: pvservices@propharmagroup.com 
 
 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
65 of 69 
10.4 Appendix 4: Liver Safety: Suggested Actions and Follow-up 
Assessments 
Cases where a participant shows elevations in liver biochemistry may require further 
evaluation. Any occurrences of AST or alanine aminotransferase (ALT)  × ULN together 
with total bilirubin (TBL)  × ULN and confirmed as a Hy's Law case should be reported as 
an SAE. 
Hy’s Law 
$67 RU $/7  × ULN together with TBL  × ULN, where no other reason, other than the 
IMP, can be found to explain the combination of increases, eg, elevated alkaline phosphatase 
indicating cholestasis, viral hepatitis, another drug. The elevation in transaminases must 
precede or be coincident with (ie, on the same day) the elevation in TBL, but there is no 
specified timeframe within which the elevations in transaminases and TBL must occur. 
 
 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
66 of 69 
10.5 Appendix 5: Abbreviations 
Abbreviation 
Definition 
AE 
Adverse event 
AESI 
Adverse event of special interest 
Alps 
Alpha-like proteins 
ALT 
Alanine aminotransferase 
AR 
Adverse Reaction 
AST 
Aspartate aminotransferase 
BMI 
Body mass index 
CA 
Competent authority 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CM 
Concomitant medication(s) 
COVID-19 
Coronavirus disease 2019 
CRO 
Clinical research organisation 
CSR 
Clinical study report 
eCRF 
Electronic case report form 
eDiary 
Electronic diary 
GBS 
Group B Streptococcus  
GCP 
Good clinical practices 
HIV 
Human immunodeficiency virus 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use 
IEC 
Independent Ethics Committee 
IgG 
Immunoglobulin G 
IMP 
Investigational medicinal product 
INR 
International normalised ratio 
IRT 
Interactive response technology 
MAAE 
Medically attended adverse events 
MedDRA 
Medical Dictionary for Regulatory Activities 
MH 
Medical history 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
67 of 69 
Abbreviation 
Definition 
OTC 
Over the counter 
 
  
PI 
Principal investigator 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SAR 
Serious adverse reaction 
SARS-CoV-2 
Severe acute respiratory syndrome coronavirus 2 
SAS 
Statistical analysis system 
SD 
Standard deviation 
SoA 
Schedule of activities 
SRG 
Safety review group 
SUSAR 
Suspected unexpected serious adverse reaction 
TBL 
Total bilirubin 
ULN 
Upper limit of normal 
USA 
United States of America 
 
 
 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
68 of 69 
11.0 REFERENCES 
1. Edwards MS, Baker CJ. Group B streptococcal infections in elderly adults. Clin Infect Dis. 
2005;41(6):839-847. 
2. Farley MM. Group B streptococcal disease in nonpregnant adults. Clin Infect Dis. 
2001;33(4):556-561. 
3. Sendi P, Johansson L, Norrby-Teglund A. Invasive group B Streptococcal disease in non-
pregnant adults: a review with emphasis on skin and soft-tissue infections. Infection. 
2008;36(2):100-111. 
4. Graux E, Hites M, Martiny D, et al. Invasive group B Streptococcus among non-pregnant 
adults in Brussels-Capital Region, 2005-2019. Eur J Clin Microbiol Infect Dis. 
2021;40(3):515-523. 
5. McLaughlin JM, Peyrani P, Furmanek S, et al. Burden of Adults Hospitalized With Group 
B Streptococcal Infection. J Infect Dis. 2021;224(7):1170-1178. 
 

CONFIDENTIAL 
Protocol MVX0006, Version 3.0 
 
 
 
Signature of Investigator 
PROTOCOL TITLE: A randomised, double-blind, placebo-controlled, parallel group study to 
evaluate the safety, tolerability and immunogenicity of three doses of Group B Streptococcus 
vaccine (GBS-NN/NN2 with Alhydrogel®) in elderly participants aged 55 to 75. 
PROTOCOL NO: 
MVX0006 
VERSION:  
 
2.0,  19 January 2023 
This protocol is a confidential communication of MinervaX. I confirm that I have read this 
protocol, I understand it, and I will work according to this protocol. I will also work 
consistently with the ethical principles that have their origin in the Declaration of Helsinki and 
that are consistent with Good Clinical Practices and the applicable laws and regulations. 
Acceptance of this document constitutes my agreement that no unpublished information 
contained herein will be published or disclosed without prior written approval from the 
Sponsor. 
Instructions to the investigator: Please SIGN and DATE this signature page. PRINT your name, title, and the name of the 
study centre in which the study will be conducted. Return the signed copy to Sponsor or CRO. 
 
I have read this protocol in its entirety and agree to conduct the study accordingly: 
 
Signature of Investigator:      __________________________            Date:  ________ 
Printed Name:                                ___________________________ 
Investigator Title:                           ___________________________ 
 
Name/Address of Centre:               
___________________________ 
 
 
 
 
 
___________________________ 
 
 
 
 
 
___________________________