Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Phase: PHASE2
Conditions: Plague, Pneumonic, Plague, Vaccine-Preventable Diseases
Sponsor: Dynavax Technologies Corporation

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 1 of 79 
 
 
Medical Monitor: 
Oliver Medzihradsky , 
MPH 
Dynavax Technologies Corporation 
0
Tel: + (415) 
8063 
mail o edzihradsky @dynavax.com 
Clinical Operations: 
Tammy Boyce, MEd 
Senior Director, Clinical Operations 
Dynavax Technologies Corporation 
3
Tel: +1 (619) 93 7176 
 
 
Protocol Title: 
Phase 2, Randomized, Active-Controlled, Observer-Blinded, 
Multicenter Trial of the Immunogenicity, Safety, and Tolerability of 
rF1V Vaccine with CpG 1018 Compared with rF1V Vaccine in 
Adults 18 to 55 Years of Age 
Protocol No.: 
DV2-PLG-01 
Investigational Product: 
rF1V Vaccine with CpG 1018 
 
Study Phase: 
2 
US IND Number: 
028166 
Sponsor: 
Dynavax Technologies Corporation 
2100 Powell Street, Suite 720 
Emeryville, CA 94608 
U.S.A 
 
Oliver 
, MDMPH MS
Tel: +1 (415) 310 8063 E-mail: 
edzihradsky@dynavax.com 
Tammy Boyce, MEd  
 
Tel: +1 (619) 933 7176 
E-mail: tboyce@dynavax.com 
 
Original Protocol: 
07 March 2022 
Amendment 1: 
11May 2022 
Amendment 2: 
01 June 2022 
Amendment 3: 
06 June 2022 
Amendment 4 
07 December 2022 
Amendment 5 
11 August 2023 
This study will be conducted in accordance with good clinical practice (GCP) as defined in International 
Council for Harmonisation (ICH) Guidelines E6 (R2) and applicable local legal and regulatory 
requirements. 
Clinical Operations: 
Medical Monitor 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 2 of 79 
 
 
PROTOCOL APPROVAL PAGE 
Protocol Title: Phase 2, Randomized, Active-Controlled, Observer-Blinded, 
Multicenter Trial of the Immunogenicity, Safety, and 
Tolerability of rF1V Vaccine with CpG 1018 Compared with 
rF1V Vaccine in Adults 18 to 55 Years of Age 
Protocol No.: DV2-PLG-01 
Amendment 5: 11 August 2023 
Sponsor: Dynavax Technologies Corporation 
2100 Powell Street, Suite 720 Emeryville, CA 94608 
U.S.A. 
 
 
 
 
This protocol has been approved by Dynavax Technologies Corporation. The following 
signature documents this approval. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
15-Aug-2023 I 11:25 PDT 
Ouzama Henry, MD 
Vice President, Clinical Development 
Date 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 3 of 79 
 
 
INVESTIGATOR SIGNATURE PAGE 
Protocol Title: Phase 2, Randomized, Active-Controlled, Observer-Blinded, 
Multicenter Trial of the Immunogenicity, Safety, and 
Tolerability of rF1V Vaccine with CpG 1018 Compared with 
rF1V Vaccine in Adults 18 to 55 Years of Age 
 
 
Protocol No.: DV2-PLG-01 
Amendment 5: 11 August 2023 
Sponsor: Dynavax Technologies Corporation 
2100 Powell Street, Suite 720 
Emeryville, CA 94608 
U.S.A. 
 
 
 
DECLARATION OF INVESTIGATOR 
I confirm that I have read and understood this protocol and agree to conduct the study as 
outlined in the protocol and other information supplied to me. I agree to conduct the study in 
accordance with ICH GCP guidelines, and applicable local legal and regulatory requirements. 
 
 
 
 
Investigator Signature 
Date 
 
 
 
 
 
 
Investigator Name (Print) 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 4 of 79 
 
 
TABLE OF CONTENTS 
LIST OF TABLES ........................................................................................................................ 7 
LIST OF APPENDICES ............................................................................................................... 7 
PROTOCOL SYNOPSIS ..............................................................................................................8 
1 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS .............................. 20 
2 
INTRODUCTION AND RATIONALE ........................................................................ 22 
2.1 
Plague (Yersinia pestis) ......................................................................................... 22 
2.2 
rF1V Vaccine Background .................................................................................... 22 
2.3 
Clinical Experience with rF1V Vaccine ................................................................ 23 
2.3.1 
Effectiveness Data with rF1V Vaccine – Bridge Strategy ................... 23 
2.3.2 
rF1V Mechanism of Action .................................................................. 23 
2.3.3 
Clinical Evaluation of rF1V Plague Vaccine ........................................24 
2.4 
CpG 1018 Background .......................................................................................... 26 
2.4.1 
CpG 1018 Mechanism of Action .......................................................... 26 
2.4.2 
Review of Available Clinical Data Supporting Rationale for CpG 
1018 with rF1V Antigen ....................................................................... 26 
2.5 
Study Rationale and Doses to Be Evaluated ......................................................... 30 
3 
STUDY OBJECTIVES AND ENDPOINTS ................................................................. 31 
4 
INVESTIGATIONAL PLAN ......................................................................................... 36 
4.1 
Study Design ......................................................................................................... 36 
4.2 
Study Duration ...................................................................................................... 37 
4.3 
Randomization and Blinding ..................................................................................37 
4.4 
Appropriateness of Measurements .........................................................................37 
5 
SELECTION OF SUBJECTS ........................................................................................ 38 
5.1 
Inclusion Criteria ................................................................................................... 38 
5.2 
Exclusion Criteria .................................................................................................. 39 
5.3 
Criteria for Discontinuation of Individual Subjects From Receiving Additional 
Study Injections ..................................................................................................... 40 
5.4 
Removal of Subjects From the Study .....................................................................40 
5.5 
Replacement of Subjects ....................................................................................... 41 
5.6 
Study Termination ................................................................................................. 41 
6 
STUDY TREATMENT AND SUPPLIES ..................................................................... 42 
6.1 
Study Treatments ................................................................................................... 42 
6.1.1 
rFIV Vaccine ........................................................................................ 42 
6.1.2 
CpG 1018 ............................................................................................. 42 
6.1.3 
Placebo ..................................................................................................42 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 5 of 79 
 
 
6.2 
Instructions for Preparation and Administration .................................................... 42 
6.2.1 
rFIV vaccine and CpG 1018 Preparation .............................................. 42 
6.2.2 
Study Vaccine Administration ............................................................... 42 
6.3 
Labeling .................................................................................................................. 43 
6.4 
Storage and Handling Instructions ......................................................................... 44 
6.4.1 
rF1V and CpG 1018 .............................................................................. 44 
6.4.2 
Bedside mix of rF1V vaccine and CpG 1018 ........................................ 44 
7 
TREATMENT OF SUBJECTS ...................................................................................... 44 
7.1 
Study Treatments .................................................................................................... 44 
7.2 
Dosage and Dosage Regimen ................................................................................. 45 
7.3 
Treatment Compliance ........................................................................................... 45 
7.4 
Control and Accountability of Investigational Medicinal Product ......................... 46 
7.5 
Concomitant Medications ....................................................................................... 46 
7.5.1 
Prohibited Treatments or Therapies ...................................................... 46 
7.5.2 
Permitted Therapy ................................................................................. 47 
8 
MANAGEMENT OF SUBJECT SAFETY ................................................................... 48 
8.1 
Data Monitoring Committee .................................................................................. 48 
8.2 
Potential Reasons for Stopping the Study .............................................................. 48 
8.3 
Injection Site Reactions .......................................................................................... 48 
8.4 
Observation Period After Study Vaccine Injection ................................................ 48 
8.5 
Other Supportive Care ............................................................................................ 48 
9 
STUDY PROCEDURES .................................................................................................. 50 
9.1 
Informed Consent, Screening, and Eligibility ........................................................ 50 
9.1.1 
Informed Consent .................................................................................. 50 
9.1.2 
Screening and Eligibility ....................................................................... 50 
9.1.3 
Demographics and Medical and Medication History ............................ 50 
9.2 
Study Visits ............................................................................................................ 51 
9.3 
Immunogenicity Assessments ................................................................................ 51 
9.3.1 
Antibodies to rF1V ................................................................................ 51 
9.4 
Safety Assessments ................................................................................................ 51 
9.4.1 
Vital Signs ............................................................................................. 51 
9.4.2 
Physical Examinations ........................................................................... 52 
9.4.3 
Laboratory Assessments. ....................................................................... 52 
9.4.4 
Post-Injection Reaction Assessments .................................................... 52 
9.4.5 
Adverse Events ...................................................................................... 53 
9.4.6 
Concomitant Medications ...................................................................... 54 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 6 of 79 
 
 
9.5 
Unscheduled Visit for Safety ................................................................................ 54 
9.6 
Duration of Follow-up ........................................................................................... 54 
9.7 
Early Discontinuation/End of Study ..................................................................... 54 
10 
ADVERSE EVENTS ....................................................................................................... 55 
10.1 
Definition of Adverse Events ................................................................................ 55 
10.2 
Definition of Post-Injection Reactions .................................................................. 56 
10.3 
Overdoses .............................................................................................................. 56 
10.4 
Adverse Events Associated With Cancer .............................................................. 56 
10.5 
Definition of Adverse Reaction ............................................................................. 56 
10.6 
Definition of Suspected Adverse Reaction ........................................................... 56 
10.7 
Definition of Unexpected Adverse Event or Unexpected Suspected Adverse 
Reactions ................................................................................................................57 
10.8 
Definition of Immune-mediated Adverse Event of Special Interest ..................... 57 
10.9 
Serious Adverse Events ......................................................................................... 57 
10.9.1 
Definition of Serious Adverse Events .................................................. 57 
10.9.2 
Serious Adverse Event Reporting Requirements ................................. 58 
10.10 Adverse Event Severity and Relationship to Study Treatment ............................. 59 
10.10.1 
Severity Grading of Adverse Events and Abnormal Laboratory Test 
Results .................................................................................................. 59 
10.10.2 
Relationship of Adverse Events to Study Treatment ............................ 59 
10.11 Reporting and Documentation of Pregnancy and Exposure during 
Breastfeeding ..........................................................................................................60 
11 
STATISTICAL METHODS ............................................................................................62 
11.1 
Sample Size Considerations ...................................................................................62 
11.2 
Study Analysis Populations ................................................................................... 63 
11.3 
Demographics and Baseline Characteristics...........................................................63 
11.4 
Immunogenicity Endpoints ................................................................................... 63 
11.5 
Safety Analyses ..................................................................................................... 64 
11.6 
Interim Analysis .................................................................................................... 65 
12 
DATA QUALITY ASSURANCE ................................................................................... 65 
13 
ETHICS ............................................................................................................................ 65 
13.1 
Ethical Conduct of the Study ................................................................................ 65 
13.2 
Informed Consent .................................................................................................. 65 
13.3 
Subject Confidentiality .......................................................................................... 66 
13.4 
Data Handling and Record Keeping ..................................................................... 66 
13.4.1 
Source Documents .................................................................................66 
13.4.2 
Direct Access to Source Data/Documents ............................................ 67 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 7 of 79 
 
 
13.5 
Case Report Forms ................................................................................................. 67 
13.6 
Data Handling ........................................................................................................ 67 
13.7 
Coding of Adverse Events, Drugs, and Diseases ................................................... 68 
13.8 
Record Retention .................................................................................................... 68 
14 
USE OF INFORMATION AND PUBLICATION ........................................................ 69 
15 
REFERENCES ................................................................................................................. 70 
 
 
LIST OF TABLES 
Table 7-1: 
Study Treatments....................................................................................... 45 
Table 10-1: 
Grading Scale for Adverse Events Not Included in the CBER 
Guidance on Toxicity Grading for Healthy Volunteers in Vaccine 
Clinical Trials ............................................................................................. 59 
Table 10-2: 
Definitions for Relationship of Adverse Events to Study Treatment ........ 60 
Table 11-1: 
Precision Estimate at Various Level of Predicted Protection Using 
Clopper Pearson CI (N=85) ...................................................................... 63 
 
 
LIST OF APPENDICES 
Appendix 1: 
Schedule of Trial Events ........................................................................... 73 
Appendix 2: 
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
Enrolled in Preventive Vaccine Clinical Trials ........................................ 75 
Appendix 3: 
LIST OF AUTOIMMUNE CONDITIONS AND TERMS OF 
SPECIAL INTEREST ............................................................................... 77 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 8 of 79 
 
 
Bridge ELIS
Bridge ELISA 
Bridge ELISA 
Bridge ELISA t 
Bridge ELISA 
57 Week 8
1
Week 30
PROTOCOL SYNOPSIS 
Protocol Title: 
Phase 2, Randomized, Active-Controlled, Observer- 
Blinded, Multicenter Trial of the Immunogenicity, 
Safety, and Tolerability of rF1V Vaccine with CpG 
1018 Compared with rF1V Vaccine in Adults 18 to 55 
Years of Age 
Study Objectives and Endpoints: 
Objectives 
Endpoints 
PART 1 
Primary 
• 
To select one of the two methods of 
administration of rF1V vaccine with 
CpG 1018 for Part 2 by comparing 
humoral immunization response 28 
days after the second dose of vaccine 
• 
Ratio of geometric mean ELISA 
concentration (GMC) between rF1V 
vaccine with CpG 1018 and rF1V 
vaccine 
Secondary 
• 
To assess the safety and tolerability of 
rF1V vaccine with CpG 1018 compared 
with rF1V vaccine 
• 
Rate of reactogenicity: solicited local 
and systemic post-injection reactions 
• 
Rate of adverse events (AEs), severe 
AEs, serious adverse events (SAEs), 
immune-mediated adverse events of 
special interest (AESI), and deaths 
PART 2 
Primary 
• 
To assess the utility of a 2-dose 
schedule of rF1V vaccine with CpG 
1018 as measured by reduction in time 
to onset of predicted rF1V protection 
• 
To assess the serum  
 
antibody concentration to rF1V with 
CpG 1018 compared with rF1V vaccine 
28 days after the second dose of vaccine 
• 
Predicted protection (percentage of 
subjects reaching the 
threshold that corresponds to 50% 
predicted vaccine efficacy) after 2 doses 
of rF1V vaccine with CpG 1018 
compared to that of 3 doses of rF1V 
vaccine 
Criterion for evaluation: Similar 
percentage of subjects reaching the 
hreshold that corresponds 
to 50% predicted vaccine efficacy after 2 
doses of rF1V vaccine with CpG 1018 at 
Day 
Week 8) compared to that after 
3 doses of rF1V vaccine at Day 211 
(Week 30) 
• 
Ratio of geometric mean ELISA 
concentration (GMC) between rF1V 
vaccine with CpG 1018 and rF1V 
vaccine 28 days after the second dose 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 9 of 79 
 
 
Bridge ELISA 
Bridge ELISA 
Bridge ELISA 
5
Week 8
Week 0/baseline: prior to the first 
injection 
Week 4: prior to the second 
injection: 4 weeks after the first 
injection for each vaccine group. 
Week 8
weeks after the second
injection for each vaccine group 
Week 12 8 
after the second 
injection for each vaccine group 
Week 16 12 
after the second
injection for each vaccine group 
Week 30 4 weeks after third 
injection for Group 3 26 
aft e second dose of CpG 1018 
vaccin for Groups 1 or 2 
Week 38 12 weeks after the third 
injection for Group 3 / 34 
after the second injection for Groups 
1 or 
Week 50 24 weeks after the third 
injection for Group 3 / 46 
after the second injection for Group 
1 or 
 
Criterion for evaluation: 2-times 
increase in Bridge ELISA GMC point 
estimate after the second dose of rF1V 
vaccine with CpG 1018 to that after the 
second dose of rF1V vaccine at Day 57 
(Week 8) 
Secondary 
• 
To assess the safety and tolerability of 
rF1V vaccine with CpG 1018 compared 
with rF1V vaccine 
• 
Rate of reactogenicity: solicited local 
and systemic post-injection reactions 
• 
Rate of AEs, severe AEs, SAEs, AESIs, 
and deaths 
• 
To assess the serum Bridge ELISA 
• 
GMC and seroconversion rate of serum 
rF1V Bridge ELISA titers at the 
following selected time points after each 
dose of vaccine: 
• 
Week 0/baseline 
injection 
• 
Week 4 prior to the second 
injection: 4 weeks after the first 
injection for each vaccine group. 
• 
Week 8: 4 weeks after the second 
injection for each vaccine group 
• 
Week 12: 8 weeks after the second 
injection for each vaccine group 
• 
Week 16: 12 weeks after the second 
injection for each vaccine group 
• 
Week 30: 4 weeks after third 
i 
3 / 26 weeks 
aft 
vaccine f 
• 
Week 38: 12 weeks after the third 
i 
34 weeks 
a 
1 or 2 
• 
Week 50: 24 weeks after the third 
injection for Group 3 / 46 weeks 
a 
1 or 2 
Seroconversion is defined as the 
presence of detectable antibody in 
subjects who had no detectable antibody 
levels at Day l, or a 2' 2--fold increase in 
antibody level in subjects who had 
detectable antibody levels at Day 1 
Criterion for evaluation: GMC and 
seroconversion rate point estimates from 
concentration to rF1V with CpG 1018 at 
selected time points after each dose 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 10 of 79 
 
 
Exploratory 
To assess long term clinical benefit 
Risk ratio of subjects with 2' 6 months 
from rF1V vaccine with CpG 1018 
clinical benefit between rF1V vaccine 
compared with rF1V vaccine 
with CpG 1018 and rF1V vaccine 
Criterion for evaluation 
6 
clinical benefi t is defined as retaining the 
predicted protection antibody level a
months 26 weeks for rF1V vaccine with 
CpG 1018 at Week 30 and 24 
for
rF1V vaccine at Week 50 after the 
complete series . Previous rF1V vaccine 
data showed a small percentage o
ubjects who received 3 doses of rF1V 
vaccine had 
months clinic al 
Similar levels are expected for those who 
received rF1V vaccine with CpG 1018 a
Day 211 Week 
To assess the utility of a 2 dose
Predicted protection using p eak 
schedule of rF1V vaccine with CpG 
rF1V Bridge ELISA concentration after 
1018 
measured by reduction in time 
2 doses of rF1V vaccine with CpG 1018 
to onset of predicted rF1V 
compare
t that a 28 days after 3 
protection using peak serum Bridge 
of rF1V vaccine 
ELISA concentration 
Criterion for evaluation : Similar 
percentage of subjects reaching the 
Bridge ELISA t hreshold that corresponds 
to 50% predicted vaccine efficacy after 2 
doses of rF1V vaccine with CpG 1018 at 
To assess the peak serum bridge ELISA 
peak Days 57, 85, 113 / Weeks 8, 12, 
concentration from rF1V with CpG 
1 ) as compared to that after 3 doses of 
1018 compared with rF1V vaccine 2
rF1V vaccine at Day 1
Week 
days after the complete series 
Ratio of GMCs and seroconversion r ate
betwee
rF1V Bridge E LISA serum 
concentration at peak in rF1V vaccine
with CpG 1018 group and a 28 days i
rF1V vaccine group after the complet 
serie
Criterion for evaluation Similar GMC 
and seroconversion rate after 2 doses of 
rF1V vaccine with CpG 1018 at peak 
(Days 57, 85, 113 / Weeks 8, 12, 16 ) 
compared to that after 3 doses of rF1V 
vaccine at Day 211 Week 
To assess the serum Bridge ELISA 
GMC and seroconversion rate of serum 
concentration to rF1 and rV with CpG 
rF1, and rV Bridge ELISA titers at the 
To assess the utility of a 2-dose 
 s 
1018 as 
 
t 
 
 
protection 
 
 EL
from rF1V vaccine 
compared with rF1V vaccine 
Exploratory 
rF1V vaccine with CpG 1018 to meet or 
exceed results from rF1V vaccine at 
relevant visits 
 
• 
• 
clinical benefit between rF1V vaccine 
with CpG 1018 and rF1V vaccine 
• 
Criterion for evaluation: 2' 6 months 
clinical benefit 
at 6 
months (26 weeks for rF1V vaccine with 
CpG 1018 at Week 30 and 24 weeks for 
rF1V vaccine at Week 50) after the 
complete series Previous rF1V vaccine 
data showed 
of 
subjects who received 3 doses of rF1V 
vaccine had 2' 6 months clinical benefit. 
S 
at 
Day 211 (Week 30). 
• 
• 
Predicted protection using peak serum 
concentration after 
2 doses of rF1V vaccine with CpG 1018 
c 
to that at 
after 3 doses 
of rF1V vaccine 
Criterion for evaluation Similar 
percentage of subjects reaching the 
hreshold 
 
• 
 
 
1018 c 
rF1V vaccine 28 
days after the complete series 
peak (Days 57, 85, 113 / Weeks 8, 12, 
16 
211 (Week 30) 
• 
Ratio of GMCs and seroconversion rates 
between r 
 LISA 
r 
concentration at peak in rF1V vaccine 
with CpG 1018 
and 
28 days in 
e 
series 
Criterion for evaluation: Similar GMC 
and seroconversion rate after 2 doses of 
rF1V vaccine with CpG 1018 at peak 
(Days 57, 85, 113 / Weeks 8, 12, 16) 
 
 
• 
To assess the serum Bridge ELISA 
concentration to rF1 and rV with CpG 
vaccine at Day 211 (Week 30) 
• 
GMC and seroconversion rate of 
rF1, and rV Bridge ELISA titers at the 
concentration from rF1V with CpG 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 11 of 79 
 
 
1018 at selected time points after each 
following selected time points after each 
dose 
dose of vaccine: 
Week 0/baseline: prior to the first 
injection 
Week 4: prior to the second 
injection: 4 weeks after the first 
injection for each vaccine group. 
Week 8: 4 weeks after the second 
injection for each vaccine group 
Week 12: 8 weeks after th e 
injection for each vaccine group 
Week 16: 12 weeks after the second 
injection for each vaccine group 
Week 30: 4 weeks after third 
injection for Group 3 / 26 weeks 
after second dose of CpG 1018 
vaccine for Groups 1 or 2 
Week 38: 12 weeks after the third 
injection for Group 3 / 34 weeks 
after the second injection for Groups 
1 or 
Week 50: 24 weeks after the third 
injection for Group 3 / 46 weeks 
after the second injection for Group 
1 or 
Seroconversion is defined as the 
presence of detectable a ntibody in 
subjects who had no detectable antibody 
-
levels at Day l, or a 2' 2 fold increase in 
antibody level in subjects who had 
detectable antibody levels at Day 1 
Criterion for evaluation GMC and 
seroconversion rate point estimates from 
rF1V vaccine wi th CpG 1018 to meet or
exceed results from rF1V vaccine a
relevant visits 
and 29 (and placebo at Day 183 
, 2
and 183 
1 and 29 (and placebo at Day 183) 
 
dose 
f 
each 
dose of vaccine 
• 
injection 
• 
Week 4: prior to the second 
injection: 4 weeks after the first 
injection for each vaccine group. 
• 
Week 8: 4 weeks after the second 
injection for each vaccine group 
• 
Week 12: 8 weeks after the second 
injection for each vaccine group 
• 
Week 16: 12 weeks after the second 
injection for each vaccine group 
• 
Week 30: 4 weeks after third 
a 
vaccine for Groups 1 or 2 
• 
Week 38: 12 weeks after the third 
i 
a 
1 or 2 
• 
Week 50: 24 weeks after the third 
injection for Group 3 / 46 weeks 
a 
1 or 2 
Seroconversion is defined as the 
presence of detectable antibody in 
subjects who had no detectable antibody 
l 
fold increase in 
antibody level in subjects who had 
detectable antibody levels at Day 1 
Criterion for evaluation: GMC and 
 
 
 
 
 
Study Design: 
rF1V vaccine with CpG 1018 to eet or 
exceed results from rF1V vaccine at 
relevant visits 
This is a phase 2, randomized, active-controlled, observer- 
blinded, multicenter trial of the immunogenicity, safety, and 
tolerability of rF1V vaccine with CpG 1018 compared with rF1V 
vaccine alone in adults. Approximately two hundred healthy 
adults 18 to 55 years of age will be enrolled to compare a two- 
dose regimen of rF1V with CpG 1018 administered on study 
Days 
with a three-dose 
regimen of rF1V vaccine alone administered on study Days 1 29, 
. 
The study will be conducted in 2 parts (Part 1 and Part 2). The 
table below outlines study drug administration in both parts. 
and 183 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 12 of 79 
 
 
and 
; and 2 injections of placebo will be administered on 
Day 183 
and 29 and 2 separate injections of 
placebo will be administered on Day 183 
, 2
and 183 
Day
5
29 
When investigational product is co-administered as 2 separate 
injections, the injections should be administered in close physical 
proximity to each other (within approximately 1 inch). 
Injections will be administered by unblinded study personnel not 
otherwise involved in the subjects’ safety evaluation. Recording 
and evaluation of safety information and laboratory data will be 
performed by observers blinded to the subjects’ treatment 
assignment. 
Part 1: 
There will be 2 administration methods of rF1V vaccine with 
CpG 1018: 
• 
Group 1 (N = approximately 20): rF1V vaccine and CpG 
1018 will be co-administered as 2 separate injections on Days 
1 and 29; 
Day 183. 
• 
Group 2 (N = approximately 20): bedside mix of rF1V 
vaccine + CpG 1018 (bedside mix is administered as 1 
injection) and placebo will be administered as 2 separate 
injections on Days 1 and 29; a 
f 
placebo will be administered on Day 183 
In addition, rFIV vaccine will be administered alone without CpG 
1018: 
• 
Group 3 (N = approximately 20): rF1V vaccine and placebo 
will be administered as 2 separate injections on Days 1 
, 
 
All Groups will receive 2 injections at each treatment visit to 
maintain the blind. 
A Data Monitoring Committee (DMC) will review safety for Part 
1 after the first dose: 
• 
72 hours after first dose in the first 6 subjects 
• 
14 days after first dose in the first 18 subjects 
In addition, the DMC may review safety data as needed at any 
time during the study (as defined in the DMC charter). 
The administration method of vaccine utilized in Part 2 of the 
study will be selected by Dynavax in consultation with the 
Department of Defense (DoD) after Day 57 immunogenicity data 
become available to determine whether the GMC 1 month after 2 
doses of rF1V vaccine with CpG 1018 using the selected 
administration method is at least 2 times higher than that 1 month 
after 2 doses of rF1V vaccine in Group 3. Prior to enrolling 
subjects in Part 2, the Pharmacy Manual will be updated to 
document the method of administration of rF1V vaccine and CpG 
1018 selected for Part 2. 
Part 2: 
Part 2 will begin after immunogenicity assessments from the Day 
57 visit in Part 1 are completed. The rF1V vaccine with CpG 
and 183. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 13 of 79 
 
 
 
1018 will be administered using the method selected from Part 1 
(Group 1 or Group 2). 
• 
Group 1 (if selected) (N=70): rF1V co-administered with 
CpG 1018 
• 
Group 3 (N=70): rF1V co-administered with placebo 
OR 
• 
Group 2 (if selected) (N = 70): bedside mix of rF1V and CpG 
1018 
• 
Group 3 (N=70): rF1V 
Subjects will be followed through Day 393 (Week 56) 
Study Duration 
• 
The total duration of individual subject participation in the 
Screening Treatment and Follow-up parts of this study is up 
to approximately 60 weeks. 
Study Population: 
Adults 18 to 55 years of age 
Planned Number of 
Participants: 
Part 1: N = approximately 60 
Part 2: N = approximately 140 
Eligibility Criteria: 
Inclusion Criteria 
A subject must meet the following criteria to be eligible for 
enrollment (defined as receiving study treatment) in the study: 
1) Adults aged 18 to 55 years 
2) Healthy participants or participants with pre-existing medical 
conditions who are in a stable medical condition. 
Pre-existing stable medical condition means a subject who: 
has full capacity of daily activity and no major medication 
modification within 3 months prior to Day 1; has not 
undergone surgical or minimally-invasive intervention or had 
any hospitalization/emergency room visit for the specific 
medical condition. 
3) Able to comply with the protocol schedule and procedures 
4) Able and willing to provide written informed consent 
5) If female of child-bearing potential and heterosexually active, 
has practiced adequate contraception for 28 days prior to 
vaccination and has negative pregnancy tests just prior to 
vaccination and has agreed to continue adequate 
contraception until 28 days after vaccination. Adequate 
contraception is defined as a contraceptive method with a 
failure rate of < 1% per year when used consistently and 
correctly and, when applicable, in accordance with the 
product label. Examples include the following: 
• 
Combined (estrogen and progestogen containing) 
hormonal contraception associated with inhibition of 
ovulation: oral, intravaginal, or transdermal 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 14 of 79 
 
 
 
• 
Progestin-only hormonal contraception associated with 
inhibition of ovulation: oral, injectable, or implantable 
• 
Intrauterine device (IUD) with or without hormonal 
release 
• 
Vasectomized partner, provided he is the subject’s sole 
partner and that he has received a medical assessment of 
the surgical success 
• 
Credible self-reported history of heterosexual abstinence 
for at least 28 days prior to vaccine administration 
• 
Female partner 
Female subjects of nonchildbearing potential may be enrolled 
in the study. Nonchildbearing potential is defined as 
surgically sterile (history of bilateral tubal ligation, bilateral 
oophorectomy, hysterectomy) or postmenopausal (defined as 
amenorrhea for 2' l2 consecutive months prior to Screening 
without an alternative medical cause). 
Exclusion Criteria 
A subject with any 1 of the following criteria is not eligible for 
enrollment (defined as receiving study injection) in the study: 
1) A history of plague disease or have previously received any 
plague vaccine. 
2) Active tuberculosis or other systemic infectious process. 
3) History of human immunodeficiency virus (HIV), hepatitis B 
(HBV) or hepatitis C (HCV) infection, or positive test for 
antibody to HIV, HBV, or HCV 
4) History of autoimmune disorder 
5) History of sensitivity to any component of study vaccines 
6) Body mass index 2' 30 kg/m2 
7) Has received the following prior to the injection: 
• 
:: 14 days: 
• 
Any licensed COVID-19 vaccine or any inactivated 
vaccines (including vaccines containing mRNA or 
CpG) 
• 
:: 28 days: 
• 
Any live vaccine 
• 
Systemic corticosteroids (more than 3 consecutive 
days) or other immunomodulators immune 
suppressive medication, with the exception of inhaled 
steroids 
• 
Any other investigational medicinal agent 
• 
:: 90 days: 
• 
Granulocyte or granulocyte-macrophage colony- 
stimulating factor 
• 
Immunoglobulins or any blood products 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 15 of 79 
 
 
and 2 , and 2 injections of 0.25 mL placebo will be 
administered on Day 183 
 
• 
Antisense oligonucleotides 
• 
Drugs/investigational agents with very long half-lives 
(defined as 2' 60 days) 
• 
At any time: DNA plasmids or other genetic therapy 
intended to integrate permanently into host cells 
8) If female is pregnant (known before or established at the time 
of screening), breastfeeding, or planning breastfeeding or a 
pregnancy 
9) Is undergoing chemotherapy or expected to receive 
chemotherapy during the study period; has a diagnosis of 
cancer within the last 5 years other than squamous cell or 
basal cell carcinoma of the skin 
10) History or current evidence of any condition, therapy, or 
laboratory abnormality that might confound the results of the 
study, interfere with the subject's participation for the full 
duration of the study, or is not in the best interest of the 
subject to participate, in the opinion of the treating 
investigator 
11) Oral temperature >100.0°F at the time of vaccine 
administration. 
12) History of acute myocardial infarction (AMI) or documented 
coronary artery disease (CAD) 
Study Treatments: 
Investigational Medicinal Product: 
• 
Recombinant F1V (rF1V) plague antigens with aluminum 
hydroxide 
• 
CpG 1018 
• 
Placebo (normal saline) 
Dose and Administration: 
When investigational product is co-administered as 2 separate 
injections, the injections should be administered in close physical 
proximity to each other (within approximately 1 inch). 
Part 1 
Group 1: 0.5 mL of rF1V vaccine (160 mcg rF1V + 750 mcg 
alum) and 0.25 mL of CpG 1018 (3000 mcg) will be administered 
intramuscularly in the deltoid muscle of the non-dominant arm on 
Days 1 and 29, 
administered on Day 183. 
Group 2: 0.75 mL of the bedside mix of rF1V vaccine and CpG 
1018 (0.5 mL and 0.25 mL respectively) and 0.25 mL of placebo 
will be administered intramuscularly in the deltoid muscle of the 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 16 of 79 
 
 
and 2 , and 2 injections of 0.25 mL 
placebo will be administered on Day 183 
, 2 , and 183 
and 2 , and 2 injections of 0.25 mL 
placebo will be administered on Day 183 
9
, 2
and 
183. 
and 29; and 0. 5 mL placebo
will be administered on Day 183
9
, 2
and 183 
and 
; and 0 25 
non-dominant arm on Days 1 and 29, 
. 
Group 3: 0.5 mL of rF1V vaccine and 0.25 mL of placebo will be 
administered intramuscularly in the deltoid muscle of the non- 
dominant arm on Days 1 29, and 183. 
Part 2 
Scenario 1: Group 1 is selected. 
Group 1: 0.5 mL of rF1V vaccine and 0.25 mL of CpG 1018 will 
be administered intramuscularly in the deltoid muscle of the non- 
dominant arm on Days 1 
 
Group 3: 0.5 mL of rF1V vaccine and 0.25 mL of placebo will be 
administered intramuscularly in the same or nearby location of 
the deltoid muscle of the non-dominant arm on Days 
183. 
Scenario 2: Group 2 is selected. 
Group 2: 0.75 mL of the bedside mix of rF1V vaccine and CpG 
1018 will be administered intramuscularly in the deltoid muscle 
of the non-dominant arm on Days 1 
 
Group 3: 0.5 mL of rF1V vaccine will be administered 
intramuscularly the deltoid muscle of the non-dominant arm on 
Days 1 29 and 183 
1 29 and 
will be administered on Day 183. 
and 29, 
placebo will be administered on Day 183 . 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 17 of 79 
 
 
Part 
Dose 1 (Day 
Dose 2 (Day 2 
Dose 3 (Day 183 
Group 1 rF1V vaccine an
CpG 1018 coadministration 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.25 mL placebo 
Injection 2 
0.25 mL CpG 1018 
0.25 mL CpG 1018 
0.25 mL placebo 
Total
0.75 mL 
0.75 mL 
0.5 mL
Group 2 rF1V vaccine + CpG 1018 bedside mix 
Injection 1 
0.75 mL rF1V+ 
0.75 mL rF1V+
0.25 mL placebo 
CpG 1018 
CpG 1018 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Total
1.0 mL 
1.0 mL
0.5 mL
Group 3 rF1V vaccine 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Total
0.75 mL 
0.75 mL 
0.75 mL 
0.5 mL of rF1V vaccine = 160 mcg rF1V + 750 mcg alum 
0.25 mL of CpG 1018 = 3000 mcg 
Part 
Scenario 
Dose 1 (Day 
Dose 2 (Day 2 
Dose 3 (Day 183 
Group 1 rF1V vaccine and CpG 1018 coadministration 
Scenario 1 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.25 mL placebo 
(Group 1 and 3) 
Injection 2 
0.25 mL CpG 1018 
0.25 mL CpG 1018 
0.25 mL placebo 
Total
0.75 mL
0.75 mL 
0.5 mL 
Group 3 rF1V vaccine 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Total
0.75 mL
0.75 mL 
0.75 mL 
O
Scenario 2 
Group 2 rF1V vaccine + CpG 1018 bedside mix 
(Group 2 and 3) 
Injection 
0.75 mL rF1V+ 
0.75 
rF1V+ 
0.25 mL placebo 
CpG 1018 
CpG 1018 
Group 3 rF1V vaccine 
Injection 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL of rF1V vaccine = 160 mcg rF1V + 750 mcg alum 
Part 2 
vaccine 
1018 bedside mix 
Group 3 rF1V vaccine 
Study Vaccine Administration 
Part 1 
 
 
 
Dose 3 (Day 183) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0.75 mL rF1V+ 
CpG 1018 
0.75 mL rF1V+ 
CpG 1018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0.75 mL 
 
0.25 mL of CpG 1018 = 3000 mcg 
 
Dose 3 (Day 183) 
 
 
 
 
 
 
 
 
 
 
OR 
 
0.75 mL rF1V+ 
0.75 mL rF1V+ 
CpG 1018 
CpG 1018 
 
 
 
 
 
 
 
0.25 mL of CpG 1018 = 3000 mcg 
Group 1 rF1V vaccine and CpG 1018 coadministration 
I 
0.5 mL rF1V 
0.5 mL rF1V 
Injection 2 
0.25 mL CpG 1018 
0.25 mL CpG 1018 
0.25 mL placebo 
Total 
0.75 mL 
0.75 mL 
0.5 mL 
Group 2 rF1V vaccine 
CpG 1018 bedside mix 
I 
Total 
1.0 mL 
1.0 mL 
0.5 mL 
Group 3 rF1V vaccine 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Injection 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL of rF1V vaccine = 160 mcg rF1V + 750 mcg alum 
(Group 2 and 3) 
Scenario 2 
0.75 mL 
0.75 mL 
0.75 mL 
Total 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
Injection 1 
e
0.5 mL 
0.75 mL 
0.75 mL 
Total 
0.25 mL placebo 
0.25 mL CpG 1018 
0.25 mL CpG 1018 
Injection 2 
0.5 mL rF1V 
0.5 mL rF1V 
Group 1 rF1V vaccine and CpG 1018 coadministration 
Scenario 1 
(Group 1 and 3) 
Dose 2 (Day 29) 
Dose 1 (Day 1) 
Scenario 
0.75 mL 
0.75 mL 
Total 
Dose 2 (Day 29) 
Dose 1 (Day 1) 
0.25 mL placebo 
Injection 
0.25 mL placebo 
Injection 1 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 18 of 79 
 
 
ridge ELIS
 
Safety Assessments 
All subjects will be monitored for safety through Day 393. 
Safety assessments include the following: 
• 
Assessment of post-injection local and systemic reaction (for 
7 days post each injection) 
• 
Adverse events assessments (AEs, SAEs, AESIs, deaths) 
• 
Vital signs measurements 
• 
Physical examinations 
Stopping Rules 
Dosing of all subjects will be temporarily stopped for any of the 
following: 
• 
Two or more subjects who experience Grade 3 (severe) or 
higher severity solicited adverse reactions (considered by the 
sponsor to be possibly or probably related to treatment) 
lasting more than 48 hours AND considered by the DMC to 
be clinically significant 
• 
Two or more subjects who experience the same or similar 
grade 3 or higher unsolicited adverse event that is assessed as 
at least possibly related to the treatment 
• 
Any Suspected Unexpected Serious Adverse Reaction 
(SUSAR) (considered by the Sponsor to be possibly or 
probably related to treatment) 
• 
Any death or life-threatening SAE regardless of relationship 
to vaccine 
• 
Any type 1 AMI 
Dosing may be resumed following review of available safety data 
by the DMC as specified in the DMC Charter. 
Immunogenicity Assessments: 
Immunogenicity assessments include Serum rF1V Bridge ELISA 
concentration as outlined in the summary of trial events 
Statistical Methods 
All analyses of demographics, medical history, and safety will be 
summarized in a descriptive manner. In general, continuous 
variables will be summarized by number of subjects, mean, 
standard deviation, median, quartiles, minimum and maximum, 
and categorical variables will be summarized by number and 
percentage of subjects in each study group as appropriate. 
The Safety Population will comprise all subjects who receive at 
least 1 dose of the study vaccine, excluding subjects who have no 
on-study data. 
The modified intent-to-treat (mITT) population for the 
immunogenicity analysis will comprise all eligible subjects who 
received at least 1 dose of study vaccine and have a post-injection 
immunogenicity evaluation. 
The Per-protocol (PP) population for the immunogenicity 
analyses will comprise Groups 1 and 2 subjects who receive 2 
doses of study vaccine and Group 3 subjects who received 3 
doses of study vaccine, have no major protocol deviations (to be 
specified in the statistical analysis plan), and have 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 19 of 79 
 
 
Bridge ELISA 
Bridge ELISA 
Bridge ELISA 
Bridge ELISA 
Bridge 
Bridge ELISA 
Bridge ELISA 
Bridge ELISA 
Bridge ELISA 
immunogenicity data obtained within the study visit windows at 
Day 211. 
The primary and other immunogenicity endpoints will be 
analyzed using the mITT population. Sensitivity analyses on 
immunogenicity data will also be presented using the PP 
population. 
Immunogenicity will be measured by serum rF1V 
concentration at each visit. 
The administration method of vaccine utilized in Part 2 of the 
study will be selected after Day 57 immunogenicity data become 
available to determine whether the GMC 1 month after 2 doses of 
rF1V vaccine with CpG 1018 using the selected administration 
method is at least 2 times higher than that 1 month after 2 doses 
of rF1V vaccine in Group 3. 
threshold that corresponds to 50% predicted 
vaccine efficacy after 2 doses of rF1V vaccine with CpG 1018 
will be obtained from a model using 
data after 3 
doses of rF1V vaccine (or after 2 doses of rF1V with CpG 1018 
TBD) in this study. The threshold and the model used will be 
described in a separate report. 
Predicted protection rate (percentage of subjects reaching the 
threshold) and associated 95% two-sided Clopper- 
Pearson confidence intervals will be computed. Fisher’s exact 
tests will be used to compare predicted protection rate between 
study groups. 
The criterion for evaluation of the primary endpoint 1 in Part 2 is: 
a similar percentage of subjects reaching the 
threshold that corresponds to 50% predicted vaccine efficacy after 
2 doses of rF1V vaccine with CpG 1018 as compared to that after 
3 doses of rF1V vaccine. 
The criterion for evaluation of the primary endpoint 2 in Part 2 is: 
2-times increase of 
GMC point estimate after the 
second dose of rF1V vaccine with CpG 1018 compared to that 
after rF1V vaccine. 
Criteria for secondary objectives are GMC and seroconversion 
rate point estimates from rF1V vaccine with CpG 1018 to meet or 
exceed results from rF1V vaccine at relevant visits 
Safety data will be analyzed descriptively and will be based on 
the Safety Population. Summary statistics will be used to describe 
the incidence of all post-injection reactions, AEs, AESIs, SAEs, 
and deaths. Tables of adverse events will include incidence, 
severity, seriousness, and relationship to the investigational 
vaccines. 
Data from Part 1 subjects and Part 2 subjects will be combined to 
evaluate the Part 2 objectives. 
Bridge ELISA 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 20 of 79 
 
 
1 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE 
adverse event 
AESI 
adverse event of special interest 
alum 
Aluminum hydroxide 
AMI 
acute myocardial infarction 
ANCA 
anti-neutrophil cytoplasmic antibodies 
AR 
adverse reaction 
BP 
blood pressure 
CAD 
coronary artery disease 
CBER 
Center for Biologics Evaluation and Research 
CD4+ 
T-helper cells 
CFR 
Code of Federal Regulations 
COR 
contracting officer 
CpG 
cytidine-phospho-guanosine 
CpG 1018 
a 22-base cytidine-phospho-guanosine phosphorothioate oligodeoxynucleotide 
CRF 
case report form 
CRO 
Contract Research Organization 
CSR 
clinical study report 
DMC 
data monitoring committee 
DNA 
deoxyribonucleic acid 
DoD 
Department of Defense 
eCRF 
electronic case report form 
ELISA 
enzyme-linked immunosorbent assay 
EOS 
End of Study (visit) 
EUA 
emergency use authorization 
FDA 
Food and Drug Administration 
GCP 
good clinical practice 
GMC 
geometric mean concentration 
GMR 
geometric mean ratio 
GMT 
geometric mean titer 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HPV 
human papilloma virus 
HR 
heart rate 
 
IB 
investigators brochure 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 21 of 79 
 
 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IM 
intramuscular 
IMAE 
immune-mediated adverse events 
IND 
investigational new drug 
IRB 
Institutional Review Board 
ITAR 
International Traffic in Arms Regulations 
IUD 
intrauterine device 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
modified intent-to-treat (population) 
mIU/mL 
milli-international units per liter 
NIH 
National Institutes of Health 
ODN 
oligodeoxynucleotides 
OVRR 
Office of Vaccines Research and Review 
PBMC 
peripheral blood mononuclear cell 
PIR 
post-injection reactions 
PP 
per protocol 
PS ODN 
phosphorothioate oligodeoxynucleotide 
rF1V 
recombinant F1 capsular protein fused to V antigen 
RR 
respiratory rate 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SAR 
suspected adverse reaction 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SPR 
seroprotection rate 
TC 
telephone call 
 
TEAE 
treatment-emergent adverse event 
Th 
T helper 1 cells 
TLR9 
Toll-like receptor 9 
UNS 
unscheduled 
USG 
United States Government 
VAERS 
Vaccine Adverse Event Reporting System 
Y. Pestis 
Yersinia pestis 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 22 of 79 
 
 
2 
INTRODUCTION AND RATIONALE 
2.1 
Plague (Yersinia pestis) 
Plague is a zoonotic infection with Yersinia pestis that is normally transmitted from rodents to 
humans when humans are bitten by infected fleas. There are 3 manifestations of the disease, with 
flea bites usually causing the bubonic form in which a painful swelling (bubo) of the draining 
lymph nodes occurs (Vadyvaloo, Jarrett et al. 2007, Hinnebusch and Erickson 2008). Left 
untreated, the infection will cause sepsis and death in approximately half of the cases. Bubo 
formation is not present in the second form of disease, which leads directly to sepsis, and occurs 
in about a third of the cases. Bubonic and septicemic infections occasionally progress to 
secondary pneumonic infections. Infection with Y. pestis also rarely occurs through inhalation of 
the organism, and, after 1 to 6 days, the disease manifests in its pneumonic form, which is nearly 
always fatal unless the patient is treated with antibiotics within 20 hours of symptom onset (Daya 
and Nakamura 2005). Clinical signs include fever with cough and dyspnea, and there may be 
production of bloody, watery sputum. Nausea, vomiting, abdominal pain, and diarrhea may also 
be present. The pneumonic form spreads from person to person by respiratory droplets formed 
during coughing (McGovern 1997, Perry and Fetherston 1997, Inglesby, Dennis et al. 2000, 
Koirala 2006, Prentice and Rahalison 2007). 
Historically, plague (Y. pestis) has resulted in three pandemics over the last 1,700 years. It is 
estimated to have caused 200 million deaths worldwide. Y. pestis is currently classified as 
a Category A priority pathogen by both the National Institute of Allergy and Infectious Diseases 
(NIAID) and the Centers for Disease Control and Prevention (CDC) (Hart, Saviolakis et al. 
2012). 
2.2 
rF1V Vaccine Background 
The proposed indication for Y. pestis Plague Recombinant Antigen (rF1V; F1 capsular protein 
fused to V antigen; Escherichia coli) (rF1V Plague Vaccine) is to provide pre-exposure 
prophylaxis to military personnel 18 to 55 years of age against pneumonic plague resulting from 
aerosol exposure to Y. pestis. 
The rF1V plague vaccine candidate was initially developed at the US Army Medical Research 
Institute for Infectious Diseases (USAMRIID) (Hart, Saviolakis et al. 2012). It was transferred to 
the Joint Vaccine Acquisition Program (JVAP) (subsequently to the DynPort Vaccine Company 
[DVC], and most recently to the Office of the Surgeon General) in an early stage of 
development. In 2016, the U.S. Food and Drug Administration (FDA) granted Orphan Drug 
Designation to recombinant rF1V plague vaccine as a biodefense countermeasure on behalf of 
the U.S. Department of Defense (DoD). The vaccine is intended to be administered to 
individuals considered to be at high risk for exposure to aerosolized Y. pestis. The target 
indication of this vaccine is protection of adults 18 to 55 years of age from disease caused by 
inhalational exposure to Y. pestis. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 23 of 79 
 
 
Bridge ELISA 
Bridge ELISA 
Bridge ELISA 
The rF1V vaccine candidate for plague comprises the F1 capsular protein and the V virulence 
protein of Y. pestis Colorado 92 (CO92) fused into a single protein, which is produced in E. coli 
and formulated with aluminum hydroxide, Alhydrogel® 2%, (alum). 
2.3 
Clinical Experience with rF1V Vaccine 
The rF1V vaccine was evaluated in one Phase 1 (rF1V-01), Phase 2a (rF1V-02a), and 1 phase 2b 
(rF1V-02b) clinical trial. In these clinical trials, assessments of vaccine safety and 
immunogenicity were the major objectives. The immune response to the vaccine was evaluated 
by measurement of the concentration of antibodies to rF1, rV, and rF1V by the 
 at 
predetermined intervals during the study and calculation of the seroconversion rate. Blood was 
also collected for passive transfer studies for evaluation of efficacy in animals. The safety 
population included all volunteers who received at least 1 dose of the rF1V vaccine and for 
whom any safety information was recorded. Reactogenicity, tolerability and safety were 
monitored in all vaccinated volunteers at multiple time points after vaccination using physical 
examination, clinical laboratory tests, and pre-specified or solicited adverse events (AEs) 
collected via volunteer diaries to enhance reporting of AEs by the Investigators. 
2.3.1 
Effectiveness Data with rF1V Vaccine – Bridge Strategy 
The efficacy of the rF1V vaccine as a prophylactic for pneumonic plague, resulting from 
inhalational exposure, cannot be determined directly in humans and, therefore, was evaluated by 
the Dynport Vaccine Company (DVC) for the DoD in accordance with the Animal Rule. Use of 
the Animal Rule requires that the pathophysiology of disease and the mechanism by which the 
vaccine ameliorates disease is well understood in animals. The animal models that DVC selected 
to evaluate vaccine efficacy were the Swiss Webster mouse and the cynomolgus macaque (CM). 
Aerosol model development studies have been performed in both animal species and have 
demonstrated sufficient similarity to the pathology of disease in humans to serve as useful animal 
models for pneumonic plague. DVC evaluated the rF1V vaccine in these animal models for the 
purpose of licensure using the Animal Rule. The agreed bridging strategy for rF1V vaccine was 
based on modeling the animal survival status (endpoint of interest) as a function of anti-rF1V 
antibody concentration measured by the rF1V 
(the correlate of protection). 
2.3.2 
rF1V Mechanism of Action 
Seeking licensure for a plague vaccine provides unique challenges in that the precise mechanism 
of protection against exposure to Y. pestis is unknown. Both cell-mediated immunity and 
humoral immunity are relevant in providing protection against plague. The agreed bridging 
strategy for rF1V vaccine is supported by data that demonstrate anti-rF1V antibody 
concentration correlate with rF1V vaccine efficacy in animal models (establishing the 
relationship between rF1V vaccine dose, anti-rF1V antibody concentration, and survival in the 
Swiss Webster mouse model and cynomolgus macaque following lethal aerosol challenge with 
Y. pestis CO92). 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 24 of 79 
 
 
The Phase 1, rF1V 01, clinical trial was a single center, open label trial designed to evaluate 
(a) the safety, tolerability and immunogenicity of four ascending doses (20 mcg , 
mcg , 
mcg
and 160 mcg) of rF1V Plague Vaccine with alum (Alhydrogel ® 2
given as an 0.5 mL IM 
-
injection at a 
dose vaccination regimen (Day 
and 2 ) and (b) the safety and tolerability of a 
third IM vaccination of 160 mcg rF1V Plague Vaccine given on Day 231 in volunteers 
previously vaccinated with 
doses of 160 mcg rF1V Plague Vaccine. The trial enrolled 44 
v lunteers in a 1:1:1:1 randomization. Eight volunteers from the 160 mcg group also received a 
third vaccination. All volunteers were followed for 180 days after the last vaccination. 
Results from the Phase 1 trial indicated that the rF1V Plague Vaccine for mulation and schedules 
were safe and that 
vaccinations elicited much higher antibody levels and higher seroconversion 
rates than 
vaccinations. Based on this trial, the 
highest doses (80 mcg and 160 mcg ) were 
e
selected for evaluation in the Phase 2a tr ial in a thre dose vaccination regimen 
V
2.3.3.2 Phase 2a Clinical Trial, rF1 
02(a) (NCT00332956) 
-
The Phase 2a, rF1V 02(a), clinical trial was a 
site, dose blinded, randomized trial designed 
to evaluate the safety, tolerability and immunogenicity of 
dose s (80 mcg and 160 mcg) 
-
rF1V Plague Vaccine with alum Alhydrogel 2%) given as an 0.5 mL IM injection at two 
dose
9
,
,
,
vaccination regimens (Day 
1
and Day 
1
The trial enrolled 400 volunteers in 
an approximate 1:1:1:1 randomization. A total of 352 volunteers reached Day 210 in the study, 
and 321 volunteers were followed for 540 days after the first vaccination. 
Results from the Phase 2a trial indicated that th e rF1V Plague Vaccine formulation and doses 
tested (80 mcg and 160 mcg) were safe and immunogenic. Overall, the most frequent treatment 
,
emergent adverse events ( TEAE
were local reactions and the majority of TEAEs were mild or 
.
moderate There were no sig nificant differences between dose and treatment schedules in the 
incidence of local and system reactions and other AEs during the study. There was no significant 
increase in the incidence of TEAEs upon re vaccination during the study. There were no delayed 
immunological reactions during the 12 month follow up. The immune response, assessed as 
,
anti rF1, anti r
and anti rF1V antibody GMCs and seroconversion rates, was maximal after 
administration of the third vaccination and it was similar among the selecte d dose and schedules 
following Vaccination 3. 
The Phase 1, rF1V-01, clinical trial was a single- 
-label trial designed to evaluate 
(a) the safety, tolerability and immunogenicity of four ascending doses (20 
, 40 
, 80 
and 160 
) of rF1V Plague Vaccine with alum (Alhydrogel® 2%) given as an 0.5 mL IM 
injection at a 2 dose vaccination regimen (Day 1 and 29) and 
the safety and tolerability of a 
third IM vaccination of 160 
rF1V Plague Vaccine given on Day 231 in volunteers 
previously vaccinated with 2 doses of 160 
r 1 
Plague Vaccine. he trial enrolled 44 
lunteers in a 1:1:1:1 randomization. Eight volunteers from the 160- 
group also received a 
third vaccination. All volunteers were followed for 180 days after the last vaccination. 
2.3.3.2 Phase 2a Clinical Trial, rF1V 02(a) (NCT00332956) 
- 
t 
rF1V 
, 
with alum ( 
1 29 183 
- 
2 dose 
and 160 
) 
3 dose 
1 57 183). The trial enrolled 400 volunteers in 
. 
and 321 volunteers 
Results from the Phase 2a trial indicated that th 
t 
and 160 
) 
(TEAEs) were local reactions 
treatment- 
moderate 
i 
i 
i 
anti r 
nificant differences between dose and treatment schedules in the 
e- 
2- 
i-rV and anti- 
administration of the third vaccination and it was similar 
d dose and schedules 
f 
. 
Additionally, DVC demonstrated the direct functional relationship between anti-rF1V antibody 
concentration and survival through the conduct of the Protective Capacity Assay (PCA). The 
PCA uses purified antibodies collected from rF1V immunized animals or humans to measure the 
functional capacity of anti-rF1V antibodies in a mouse model following aerosol challenge with 
Y. pestis. 
2.3.3 
Clinical Evaluation of rF1V Plague Vaccine 
2.3.3.1 Phase 1 Clinical Trial, Protocol rF1V-01 (NCT00097396) 
 
 
Results from the Phase 1 trial indicated that the rF1V Plague Vaccine formulation and schedules 
were safe and that 3 vaccinations elicited much higher antibody levels and higher seroconversion 
rates than 2 vaccinations. Based on this trial, the 2 highest doses (80 
and 160
) were 
selected for evaluation in the Phase 2a trial in a three dose vaccination regimen. 
 
 
 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
AND PROPRIETARY 
Page 25 of 79 
CONFI NTIALDE 
CONFIDENTIAL AND PROPRIETARY 
Page 25 of 79 
 
 
-
Figure 
Geometric Mean Concentrations o anti rF1V i Phase 2
2.3.3.2.1 Clinical Immunogenicity Data from Phase 2a Cohort 3 (IND #12031) 
Figur
-
2 1 shows the GMCs of anti rF1V from the Phase 2a clinical trial. The highest rates of 
seroconversion were observed after 3 doses of the vaccin (160 mcg) administered on Days , 
and 1
(Cohort 3 n 
9
Seroconversion was defined as the presence of detectable antibody 
-
(defined as 2' 1 U/mL) in subjects who had no detectable antibody levels at Day 0, or a 2' 2 fold 
increase in antibody level in subjects who had detectable antibody levels at Day 0. The 
seroconversion rate for anti rF1V was 100% at 7 and 14 days and 96.2% at 
months after the 
third vaccination. The seroconversion rate for anti rF1V at Day 270 (3 months following last 
vaccination) was 100.0%, and at Day 364 wa 98.7%. All 
antibodies 
rF1, anti rV, and 
anti rF1V) showed robust conversion rates after Vaccination 3, and the durability o this
respons through Day 540 wa not affected. Anti rF1V GM
a
days after Vaccination 
range
from 1558.61 U/mL t 2619.78 U/mL at 
days after Vaccination 
GM
ranged from 1166 U/mL to 1964 U/mL, and a Day 270 
range
from 530 U/mL t
910 U/mL. At Day 540, the GMCs ranged from 87 U/mL to 184 U/mL, and the great majority of 
volunteers had anti rF1V levels above the lower limit of quantification (LLOQ) of 10 U/mL. 
The seroconversion rates and anti rF1V antibody concentr tions withi the
week period after 
the third vaccination were statistically similar in all cohorts studied in the Phase 2a trial as well as 
in the Phase 2 trial. 
The Phase 2b, rF1V-02b, clinical trial was a multicenter, single-blinded, randomized comparison 
f 2 formulations of rF1V Plague Vaccine (80 mcg), with and without alum (Alhydrogel 2%) at 
wo 3-vaccination schedules (Day 1, 57, 122 and Day 1, 57, 183) in 400 healthy adult volunteers 
n 4 parallel cohorts: 2 rF1V Plague Vaccine cohorts (N=160 each) and 2 rF1V antigen-only 
ohorts (N=40 each). The adjuvanted cohorts had higher GMCs and seroconversion rates than 
seroconversion rate for anti-rF1V was 100% at 7 and 14 days and 96.2% at 12 months after the 
increase in antibody level in subjects who had detectable antibody levels at Day 0. The 
99). Seroconversion was defined as the presence of detectable antibody 
and 183 (Cohort 3
third vaccination. The seroconversion rate for anti-rF1V at Day 270 (3 monthsfollowing last 
anti-rF1V) showed robust conversion rates after Vaccination 3, and the durability of this 
vaccination) was 100.0%, and at Day 364 
a 98.7%. All 3 antibodies (anti-rF1, anti-rV, and 
(defined as 2' 10 U/mL) in subjects who had no detectable antibody levels at Day 0, or a 2' 2 fold 
seroconversion were observed after 3 doses of the vaccine (160 mcg) administered on Days 1, 29 
Figure 2 1 shows the GMCs of anti-rF1V from the Phase 2a clinical trial. The highest rates of 
; 
r 
through Day 540 
a not affected Anti-rF1V GMC at 7 days afterVaccination 3 ranged 
from 1558.61 U/mL to 2619.78 U/mL at 28 days after Vaccination 3. 
e 2 1: 
Geometric Mean Concentrations f anti-rF1V in Phase 2a 
 
 
 
 
GMC ranged from 1166 U/mL to 1964 U/mL, and at Day 270 it ranged from 530 U/mL to 
910 
volunteers had anti-rF1V levels above the lower limit of quantification (LLOQ) of 10 U/mL. 
Theseroconversion rates and anti-rF1V antibody concentrations within the 4-week period after 
the thirdvaccination were statistically similar in all cohorts studied in the Phase 2a trial as well as 
in the Phase 2b trial 
 
 
 
 
 
2.3.3.3 Phase 2b Clinical Trial, rF1V-02b (NCT01122784) 
 
 
o 
t 
i 
c 
2.3.3.2.1 Clinical Immunogenicity Data from Phase 2a Cohort 3 (IND #12031) 
Note: Group = Cohort 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 26 of 79 
 
 
 
 
2.4 
CpG 1018 Background 
2.4.1 CpG 1018 Mechanism of Action 
CpG 1018 is a synthetic oligonucleotide containing immunostimulatory cytidine-phospho- 
guanosine (CpG) sequence motifs that mimic bacterial and viral DNA. CpG 1018 exerts its 
actions solely through a single, well-defined pattern recognition receptor in the innate immune 
system, Toll-like receptor 9 (TLR9), a mechanism that is distinct from other commercial 
adjuvants, including oil-in-water adjuvants. CpG 1018 efficiently induces dendritic cells to 
develop into highly effective antigen presenting cells. These activated dendritic cells drive the 
induction of helper T cells (Th) that are essential for the generation of antibodies and T and B 
cell memory to vaccine antigens. CpG-1018 is particularly effective in stimulating development 
of the Th1 subset of helper T cells, the Th subset that is essential for protection against most 
viruses and intracellular bacteria. Therefore, the mechanism of action of the CpG 1018 adjuvant 
is well understood and highly specific. CpG 1018 specifically activates a key innate receptor, 
TLR9, and does not have demonstrable off-target activities. 
2.4.2 Review of Available Clinical Data Supporting Rationale for CpG 1018 with rF1V 
Antigen 
There are no clinical data available adding CpG 1018 to rF1V antigen. There are substantial 
safety and immunogenicity data available where CpG 1018 has been added to hepatitis B surface 
antigen (HBsAg) in preventive vaccines and a growing database of CpG 1018 combined with 
SARS-CoV-2 spike protein with and without alum. 
2.4.2.1 Summary of Clinical Experience in CpG 1018 
2.4.2.1.1 HEPLISAV-B (CpG 1018 + HBsAg) 
CpG 1018 3000 mcg with HBsAg has been evaluated in the clinical development program for 
HEPLISAV-B®, approved by the US FDA on 9 November 2017 (Dynavax Technologies 
Corporation 2020) and by the European Medicines Agency (EMA) on 18 February 2021 
(Dynavax Technologies Corporation 2021). Data are available for 10,038 adult subjects between 
the ages of 18 and 70 years who received HEPLISAV-B in 3 phase 3 pivotal trials (HBV-10, 
HBV-16, and HBV-23) and 8 additional supportive trials HBV0001, HBV-02, HBV-03, 
HBV-04, HBV-05, HBV-08, HBV-14, and HBV-22. 
the antigen-only cohorts at either schedule. Moreover, the cohort that received the rF1V Plague 
Vaccine on the Day 1-, 57-, 183-schedule had statistically higher immune response after the third 
vaccination than the cohort that received vaccine on the Day 1, 57, 122 schedule. Vaccination 
with the rF1V Plague Vaccine was well-tolerated under both administration schedules. The 
majority of TEAEs were mild or moderate in severity, and the most frequently observed TEAEs 
were local reactions. The incidence of local and systemic reactions and other TEAEs did not 
increase with re-exposure to the vaccine during the study. No late-onset safety issues were 
apparent during 12 months of follow-up. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 27 of 79 
 
 
In the HEPLISAV-B clinical development program of over 14,000 subjects, comparative studies 
of 2 doses of HEPLISAV-B (20 mcg HBsAg + 3,000 mcg CpG 1018) over 1 month (Days 1 and 
29) with 3 doses of the alum adjuvanted Engerix-B® (20 mcg HBsAg + 500 mcg alum) over 6 
months (Days 1, 29, and 183) showed statistically significantly higher immunogenicity in 
HEPLISAV-B recipients than Engerix-B recipients with a similar safety and tolerability profile. 
Seroprotection rates (SPR; % with antibodies to hepatitis B surface antigen [anti-HBs] 2' l0 
mIU/mL) of more than 90% were produced in all populations studied and were statistically 
significantly higher than those induced by Engerix-B (Figure 2-2). 
Figure 2-2: 
Example of Typical Seroprotection Rates by Visit in the Pivotal Trials 
(Trial HBV-10 Per Protocol Population; 18 to 55 year old adults) 
 
(Halperin, Ward et al. 2012) 
PP = Per-protocol; SPR = seroprotection rate. 
Note: The median time to seroprotection of the 2-dose HEPLISAV-B schedule occurred 5 months earlier than the 
3-dose Engerix-B schedule, denoted by the red arrows. Similar time courses of seroprotection were observed in 
HBV-16 (Heyward, Kyle et al. 2013) and HBV-23 (Jackson, Lentino et al. 2018). 
 
In the Dynavax study HBV-10 of adults 18 to 55 years of age, the SPR at four weeks after the 
second dose of HEPLISAV-B, at week 8, was statistically significantly higher than the SPR in 
the Engerix-B group at week 8 (88.4% vs 26.7%, p < 0.0001). It was also significantly higher 
than the peak SPR following three doses of Engerix-B at week 28 (81.3%, p < 0.001). At week 8, 
the geometric mean concentration (GMC) of anti-HBs antibodies was 83.1 mIU/mL in the 
HEPLISAV-B group and 6.5 mIU/mL in the Engerix-B group (p < 0.0001). The peak GMC in 
the HEPLISAV-B group (341.6 mIU/mL) was similar to the peak GMC in the Engerix-B group 
(352.1 mIU/mL). 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 28 of 79 
 
 
In summary, the CpG 1018 adjuvanted HBV vaccine, HEPLISAV-B, with a 2-dose regimen 
administered within 1 month induced a peak SPR, GMC, as well as duration of response greater 
than or similar to what was seen after 3 doses of Engerix administered over 6 months. The 
improved dosing schedule achieved by adjuvating HBsAg with CpG 1018 is comparable to the 
goal identified by the Military in this prototype project, namely accelerating the onset of 
protection and a non-inferior or superior immunological response to rF1V antigen in a 
dramatically shortened vaccination schedule. 
Safety data are available for 9365 adult participants who received CpG 1018 in the three phase 3 
HEPLISAV-B pivotal trials (HBV-23, HBV-16, and HBV-10) and 31,000 HEPLISAV-B recipients 
in a post-marketing study. In addition, over 900,000 doses of HEPLISAV-B have been distributed in 
the US since 2017 with benign spontaneous safety reports both to the Vaccine Adverse Events 
Reporting System (VAERS) and Dynavax. 
HEPLISAV-B induces a similar frequency of local post-injection reactions (PIRs) and a lower 
frequency of systemic PIRs (including fever) compared to Engerix-B. Overall, 55.1% of subjects in 
the HEPLISAV-B arm experienced any PIR compared to 57.1% of subjects in the Engerix-B arm. 
Systemic PIRs occurred in 32.3% of the HEPLISAV-B group and 37.4% of the Engerix-B group, 
and local PIRs occurred in 42.8% of the HEPLISAV-B group and 41.1% of the Engerix-B group. 
Adverse events, serious adverse events, immune-mediated adverse events of special interest, and 
deaths were balanced between the HEPLISAV-B and Engerix-B groups. Changes in autoantibodies 
including ANA, anti-dsDNA, and ANCA were similar between vaccine groups (Hyer, McGuire et al. 
2018). 
2.4.2.1.2 CpG 1018 as a Biological Response Modifier in Ongoing Clinical and Preclinical 
Programs 
Dynavax is evaluating CpG 1018 in multiple clinical development programs. In all of these 
studies, CpG 1018 was combined with aluminum hydroxide (ie, alum, Alhydrogel® 2%) as the 
adjuvant. Preclinical studies in multiple animal models, and now humans, have shown 
substantially greater adjuvant activity of a combination of CpG 1018 and alum than with either 
of the individual adjuvants. Studies in non-human primates have demonstrated the 
immunogenicity of two different SARS-CoV-2 spike protein antigens adjuvanted with CpG 1018 
and alum (Arunachalam, Walls et al. 2021) (and unpublished data from NIH Vaccine Research 
Center). In the NIH study, monkeys were immunized twice with recombinant spike from the 
original Wuhan strain of SARS-CoV-2 and were fully protected when challenged 8 months later 
with the SARS-CoV-2 beta variant, demonstrating the durability and breadth of the protective 
antibody response. Importantly, results from human studies with multiple COVID-19 vaccine 
antigens utilizing CpG-1018 and alum confirm the ability of this adjuvant formulation to 
stimulate high levels of IgG, neutralizing antibodies, and T cell responses with a 2-dose regimen 
with no safety concerns (Hsieh, Liu et al. 2021, Richmond, Hatchuel et al. 2021) (Valneva and 
BiologicalE unpublished data). 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 29 of 79 
 
 
Importantly, in two of the above studies, same day mixing of CpG-1018 with antigen and alum 
(Alhydrogel 2%) was employed, and the resulting mixture given as a single injection (Richmond, 
Hatchuel et al. 2021) (Valneva unpublished data). 
The two most advanced subunit COVID-19 vaccines provide substantial evidence of the 
effectiveness, tolerability, and safety of the combined CpG 1018 + alum (Alhydrogel 2%) 
adjuvant. The immunogenicity of MCV-COV1901, a COVID-19 vaccine using the NIH SARS- 
CoV-2 spike protein with 750 mcg of CpG 1018 and alum was evaluated in a phase 1, open-label 
dose-finding study. After the second vaccination with MCV-COV1901, the spike specific IgG 
titers increased with peak geometric mean titers of 7178 (low antigen dose), 7746 (middle 
antigen dose), and 11220 (high antigen dose) (Hsieh, Liu et al. 2021). In addition, serum 
neutralizing activity geometric mean values were 1.8 to 3.9 times higher than those of a panel of 
control human convalescent sera. A phase 2 study of over 3800 participants > 19 years of age, 
randomized 6:1, has recently reported a geometric mean neutralization titer of 662, a GMT ratio 
of 163, and a seroconversion rate of 99.8% (Hsieh, Liu et al. 2021). These results meet the 
criteria established by the Taiwan FDA for Emergency Use Authorization. The vaccine was well 
tolerated with no severe adverse reactions. Injection site pain (71.2%), most of mild severity, was 
the most frequent post-injection reaction. The most frequent systemic post-injection reactions 
were fatigue (MCV-COV1901: 36%; placebo: 29.7%), myalgia (MCV-COV1901: 27.6%; 
placebo: 16.6%), and headache (MCV-COV1901: 22.2%; placebo: 20%). Fever was uncommon 
(MCV-COV1901: 0.7%; placebo: 0.4%) (Hsieh, Liu et al. 2021) 
The safety and immunogenicity of the second COVID-19 vaccine, SCB-2019, were evaluated in 
a phase 1, randomized, double-blind, placebo-controlled dose-finding study in healthy adults 
(Richmond, Hatchuel et al. 2021). SCB-2019 is a protein subunit vaccine candidate containing a 
stabilized trimeric form of the SARS-CoV-2 spike protein (S-Trimer) combined with 1500 mcg 
of CpG 1018 and 750 mcg of alum. SCB-2019 with no adjuvant elicited minimal immune 
responses, but adjuvanted SCB-2019 induced high titers and seroconversion rates of binding and 
neutralizing antibodies. IgG responses were observed at all dose levels after the first dose, but 
titers were greatly increased after the second dose, with GMTs of 478–2440 on Day 36. High 
GMTs were maintained to Day 50, when seroconversion rates were 87.5–93.8%. CpG 1018 + 
alum titers were 2.1-fold higher than those recorded in a panel of convalescent sera from patients 
with COVID-19. SCB-2019 elicited Th-1-biased CD4+ T-cell responses. 
In a follow up analysis (Richmond, Hatchuel et al. 2021), immunoglobulin G (IgG) antibodies 
were measured against SCB-2019, angiotensin-converting enzyme 2 (ACE2) competitive 
binding antibodies, and neutralizing antibodies against wild-type SARS-CoV-2 (Wuhan-Hu-1) at 
Days 101 and 184, and neutralizing antibodies against 3 VoCs, Alpha (B.1.1.7), Beta (B.1.351), 
and Gamma (P.1), in Day 36 sera. Titers waned from their peak at Days 36–50, but SCB-2019 
IgG antibodies, ACE2 competitive binding antibodies, and neutralizing antibodies against wild- 
type SARS-CoV-2 persisted at 25%–35% of their observed peak levels at Day 184. Day 36 sera 
also demonstrated dose-dependent increases in neutralizing titers against the 3 VoCs. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 30 of 79 
 
 
2
The vaccine was well tolerated with no severe adverse reactions. Injection site pain (62.5), most 
of mild severity, was the most frequent post-injection reaction. The only systemic post-injection 
reactions were headache (SCB-2019: 25.0%; placebo: 14.3) and fatigue (SCB-2019: 12.5%; 
placebo: 0). 
Based on a model by Khoury and colleagues (Khoury, Cromer et al. 2021), both vaccines, with a 
ratio of neutralizing antibodies to antibodies in human convalescent sera greater than 2, are likely 
to have an efficacy against COVID-19 greater than 85% to 90%. 
2.5 
Study Rationale and Doses to Be Evaluated 
Dynavax will conduct an adaptive clinical trial to determine if CpG 1018, the adjuvant used in 
HEPLISAV-B, can be utilized as a Biological Response Modifier (BRM) to improve the 
operational utility of the current investigational rF1V vaccine for the Military without re- 
formulation of the adjuvant. Dynavax will evaluate both coadministration (rF1V and CpG 1018 
administered in two concurrent injections in the same location), and a bedside mix (rF1V and 
CpG 1018 combined in a single syringe prior to vaccination) compared to rF1V alone to 
determine the method of administration that provides an acceptable immune response conducive 
to field deployment. A two-dose schedule at Day 1 and Day 29 will be tested which would 
enhance military rapid-response capabilities afforded by the investigational rF1V vaccine. 
Dynavax has designed the trial to be powered to support the current rF1V pre-Emergency Use 
Authorization. Completion of the proposed prototype project will support the development of 
next generation rF1V vaccine(s) with an enhanced operational utility for the military and for the 
prevention and/or curtailment of a pneumonic plague outbreak. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 31 of 79 
 
 
Bridge ELISA 
Bridg
ELIS
5
(Week 8)
211 (Week 30) 
3 
STUDY OBJECTIVES AND ENDPOINTS 
The study objectives and endpoints are: 
 
Objectives 
Endpoints 
PART 1 
Primary 
• To select one of the two methods of 
administration of rF1V vaccine with 
CpG 1018 for Part 2 by comparing 
humoral immunization response 28 days 
after the second dose of vaccine 
• Ratio of geometric mean ELISA 
concentration (GMC) between rF1V 
vaccine with CpG 1018 and rF1V vaccine 
Secondary 
• To assess the safety and tolerability of 
rF1V vaccine with CpG 1018 compared 
with rF1V vaccine 
• Rate of reactogenicity: solicited local and 
systemic post-injection reactions 
• Rate of adverse events (AEs), severe AEs, 
serious adverse events (SAEs), immune- 
mediated adverse events of special interest 
(AESI), and deaths 
PART 2 
Primary 
• To assess the utility of a 2-dose 
schedule of rF1V vaccine with CpG 
1018 as measured by reduction in time 
to onset of predicted rF1V protection 
• Predicted protection (percentage of 
subjects reaching the Bridge ELISA 
threshold that corresponds to 50% 
predicted vaccine efficacy) after 2 doses of 
rF1V vaccine with CpG 1018 compared to 
that of 3 doses of rF1V vaccine 
Criterion for evaluation: Similar 
percentage of subjects reaching the Bridge 
ELISA threshold that corresponds to 50% 
predicted vaccine efficacy after 2 doses of 
rF1V vaccine with CpG 1018 at Day 57 
(Week 8) compared to that after 3 doses of 
rF1V vaccine at Day 211 (Week 30) 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 32 of 79 
 
 
Bridge ELISA 
Bridge 
Bridge ELISA 
Bridge ELISA
57 (Week 8) 
Week 0/baseline: prior to the first 
injection 
Week 4: prior to the second injection: 1 
month after the first injection for each
vaccine group. 
Week 
4 weeks after the 
injection for each vaccine group 
Week 12: 8 weeks after the 
injection for each vaccine group 
Week 16: 12 weeks after the 
injection for each vaccine group 
Week 30: 28 days ( 4 weeks ) after ird 
injection for Group 3 / 26 weeks after 
second dose of CpG 1018 vaccine for 
Groups 1 or 2 
 
• To assess the serum Bridge ELISA 
antibody concentration to rF1V with 
CpG 1018 compared with rF1V vaccine 
28 days after the second dose of vaccine 
• Ratio of geometric mean ELISA 
concentration (GMC) between rF1V 
vaccine with CpG 1018 and rF1V vaccine 
28 days after the second dose 
Criterion for evaluation: 2-times increase 
in Bridge ELISA GMC point estimate after 
the second dose of rF1V vaccine with CpG 
1018 to that after the second dose of rF1V 
vaccine at Day 57 (Week 8) 
Secondary 
• To assess the safety and tolerability of 
rF1V vaccine with CpG 1018 compared 
with rF1V vaccine 
• Rate of reactogenicity: solicited local and 
systemic post-injection reactions 
• Rate of AEs, severe AEs, SAEs, AESIs, 
and deaths 
• To assess the serum Bridge ELISA 
concentration to rF1V with CpG 1018 at 
selected time points after each dose 
• GMC and seroconversion rate of serum 
rF1V 
titers at the following 
selected time points after each dose of 
vaccine: 
• Week 0/baseline: prior to the first 
injection 
• 
month after the first injection for each 
vaccine group. 
• Week 8: 4 weeks after the second 
injection for each vaccine group 
• Week 12: 8 weeks after the second 
injection for each vaccine group 
• Week 16: 12 weeks after the second 
injection for each vaccine group 
• Week 30: 28 days (4 weeks) after third 
second dose of CpG 1018 vaccine for 
Groups 1 or 2 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 33 of 79 
 
 
Exploratory 
• 
To assess long term clinical benefit from • 
Risk ratio of subjects with 2' 6 months 
rF1V vaccine with CpG 1018 compared 
 
clinical benefit between rF1V vaccine with 
with rF1V vaccine 
 
CpG 1018 and rF1V vaccine 
Criterion for evaluation: 2' 6 months 
clinical benefit is defined as retaining the 
predicted protection antibody level at 6 
months after the complete series. Previous 
rF1V vaccine data showed a small 
percentage of subjects who received 3 
doses of rF1V vaccine had 2' 6 months 
clinical benefit. Similar levels are expected 
for those who received rF1V vaccine with 
CpG 1018 at Day 197 (Week 30). 
• 
To assess the utility of a 2-dose 
• 
Predicted protection using peak serum 
schedule of rF1V vaccine with CpG 
 
rF1V Bridge ELISA concentration after 2 
1018 as measured by reduction in time 
 
doses of rF1V vaccine with CpG 1018 
to onset of predicted rF1V 
compared to that at 28 days after 3 doses of 
protection using peak serum Bridge 
rF1V vaccine 
ELISA concentration 
 Criterion for evaluation: Similar 
percentage of subjects reaching the Bridge 
Week 38: 84 days ( 12 weeks ) after the 
third injection for Group 3 / 34 weeks 
after the second injection for Groups 1 
or 
Week 50: 168 days ( 24 weeks ) after the 
third injection for Group 3 / 46 weeks 
after the second injection for Group 1 
or 
• Week 38: 84 days (12 weeks 
third injection for Group 3 / 34 weeks 
after the second injection for Groups 1 
or 2 
• 
 
 
 
Seroconversion is defined as the presence 
of detectable antibody in subjects who had 
no detectable antibody levels at Day 1, or a 
2' 2-fold increase in antibody level in 
subjects who had detectable antibody 
levels at Day 1. 
Criterion for evaluation: GMC and 
seroconversion rate point estimates from 
rF1V vaccine with CpG 1018 to meet or 
exceed results from rF1V vaccine at 
relevant visits 
Week 50: 168 days (24 weeks 
third injection for Group 3 / 46 weeks 
after the second injection for Group 1 
or 2 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 34 of 79 
 
 
 
ELISA threshold that corresponds to 50% 
predicted vaccine efficacy after 2 doses of 
rF1V vaccine with CpG 1018 at peak 
(Days 57, 85, 113 / Weeks 8, 12, 16) as 
compared to that after 3 doses of rF1V 
vaccine at Day 211 (Week 30) 
• To assess the peak serum bridge 
• 
Ratio of GMCs and seroconversion rates 
ELISA concentration from rF1V with 
 
between rF1V Bridge ELISA serum 
CpG 1018 compared with rF1V 
concentration at peak in rF1V vaccine with 
vaccine 28 days after the complete 
CpG 1018 group and at 28 days in rF1V 
series 
vaccine group after the complete series 
Criterion for evaluation: Similar GMC 
and seroconversion rate after 2 doses of 
rF1V vaccine with CpG 1018 at peak 
(Days 57, 85, 113 / Weeks 8, 12, 16) as 
compared to that after 3 doses of rF1V 
vaccine at Day 211 (Week 30) 
• To assess the serum Bridge ELISA 
concentration to rF1, and rV with CpG 
1018 at selected time points after each 
dose 
• GMC and seroconversion rate of serum 
rF1, and rV Bridge ELISA titers at the 
following selected time points after each 
dose of vaccine: 
• Week 0/baseline: prior to the first 
injection 
• Week 4: prior to the second injection: 4 
weeks after the first injection for each 
vaccine group. 
• Week 8: 4 weeks after the second 
injection for each vaccine group 
• Week 12: 8 weeks after the second 
injection for each vaccine group 
• Week 16: 12 weeks after the second 
injection for each vaccine group 
• Week 30: 4 weeks after third injection 
for Group 3 / 26 weeks after second 
dose of CpG 1018 vaccine for Groups 
1 or 2 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 35 of 79 
 
 
 
• Week 38: 12 weeks after the third 
injection for Group 3 / 34 weeks after 
the second injection for Groups 1 or 2 
• Week 50: 24 weeks after the third 
injection for Group 3 / 46 weeks after 
the second injection for Group 1 or 2 
• Seroconversion is defined as the 
presence of detectable antibody in 
subjects who had no detectable 
antibody levels at Day l, or a 2' 2-fold 
increase in antibody level in subjects 
who had detectable antibody levels at 
Day 1 
• Criterion for evaluation: GMC and 
seroconversion rate point estimates 
from rF1V vaccine with CpG 1018 to 
meet or exceed results from rF1V 
vaccine at relevant visits 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 36 of 79 
 
 
1, 29, and 183 
and 29 (and placebo at Day 183 
1 and 
and 2 injections of placebo will be administered on 
Day 183 
1 and 
and 
2 separate injections of placebo will be administered on Day 183 
1
29, and 183 
1 and 
and 2 injections of placebo will be administered on 
and 
1, 29, and 183. 
and 
(and placebo at Day 183) 
4 
INVESTIGATIONAL PLAN 
4.1 
Study Design 
This is a phase 2, randomized, active-controlled, observer-blinded, multicenter trial of the 
immunogenicity, safety, and tolerability of rF1V vaccine with CpG 1018 compared with rF1V 
vaccine alone in adults. Approximately two hundred healthy adults 18 to 55 years of age will be 
enrolled to compare a two-dose regimen of rF1V with CpG 1018 administered on study Days 1 
with a three-dose regimen of rF1V vaccine alone administered 
on study Days 
The study will be conducted in 2 parts (Part 1 and Part 2). The table below outlines study drug 
administration in both parts. When investigational product is co-administered as 2 separate 
injections, the injections should be administered in close physical proximity to each other (within 
approximately 1 inch). 
Injections will be administered by study personnel not otherwise involved in the subjects’ safety 
evaluation. Recording and evaluation of safety information and laboratory data will be 
performed by observers blinded to the subjects’ treatment assignment. 
Part 1: 
There will be 2 methods of rF1V vaccine with CpG 1018 administration: 
• Group 1 (N = approximately 20): rF1V vaccine and CpG 1018 will be co-administered as 2 
separate injections on Days 
; 
 
• Group 2 (N = approximately 20): bedside mix of rF1V vaccine + CpG 1018 (administered as 
1 injection) and placebo will be administered as 2 separate injections on Days 1 and 29; 
 
In addition, rFIV vaccine will be administered alone without CpG 1018: 
• Group 3 (N=20): rF1V and placebo will be administered as 2 separate injections on Days 
 
All Groups will receive 2 injections at each treatment visit to maintain the blind. 
A Data Monitoring Committee (DMC) will review safety for Part 1 after the first dose: 
• 72 hours after first dose in the first 6 subjects 
• 14 days after first dose in the first 18 subjects 
Day 183. 
29, and 183. 
1, 
2 separate injections of placebo will be administered on Day 183 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 37 of 79 
 
 
5
In addition, the DMC may review safety data as needed at any time during the study (as defined 
in the DMC charter). 
The administration method of vaccine utilized in Part 2 of the study will be selected by Dynavax 
in consultation with the DoD after Day 57 immunogenicity data become available to determine 
whether the GMC 1 month after 2 doses of rF1V vaccine with CpG 1018 using the selected 
administration method is at least 2 times higher than the 4 weeks after 2 doses of rF1V vaccine in 
Group 3. Prior to enrolling subjects in Part 2, the Pharmacy Manual will be updated to document 
the method of administration of rF1V vaccine and CpG 1018 selected for Part 2. 
• Part 2: Part 2 will begin after immunogenicity assessments from the Day 57 visit in Part 1 
are completed. The method of vaccine administration method that is selected from Part 1 will 
be evaluated in Part 2. Group 1 (if selected) (N=70): rF1V vaccine co-administered with 
CpG 1018 
• Group 3 (N=70): rF1V vaccine co-administered with placebo 
OR 
• Group 2 (if selected) (N = 70): bedside mix of rF1V vaccine and CpG 1018 
• Group 3 (N=70): rF1V vaccine 
Subjects will be followed through Day 393 (Week 56) 
4.2 
Study Duration 
The total duration of participation in the Screening, Treatment, and Follow-up parts of this study 
is up to approximately 60 weeks. This includes a Screening period beginning up to 4 weeks prior 
to the first study injection and End of Study (EOS) visit 56 weeks after the first study injection. 
4.3 
Randomization and Blinding 
This is an observer-blinded clinical study. Both the study subjects and the study personnel 
involved in safety assessment (observers) will be blinded to treatment assignments. Designated 
unblinded study-site personnel will be responsible for preparing and administering the study 
injection. 
In Part 1, subjects will be randomized 1:1:1 to Group 1, 2, or 3. In Part 2, subjects will be 
randomized 1:1 to 1 of 2 groups (ie, either Group 1 and 3 or Group 2 and 3) as determined from 
Part 1. Randomization will be stratified by site. 
4.4 
Appropriateness of Measurements 
The measures of both immunogenicity and safety in the study are routine clinical and laboratory 
procedures. Antibody response to rF1V must be above the assay defined cut-offs to be 
considered seropositive. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 38 of 79 
 
 
The secondary and exploratory evaluation of immunologic responses is based on recently 
developed and validated assays appropriate for use on serum that will provide deeper 
understanding of the quality of the immune response induced by rF1V and CpG 1018. 
 
5 
SELECTION OF SUBJECTS 
5.1 
Inclusion Criteria 
A subject must meet all the following criteria to be eligible for enrollment (defined as receiving 
any study vaccine) in the study: 
1) Adults aged 18 to 55 years 
2) Healthy subjects or subjects with pre-existing medical conditions who are in a stable medical 
condition. 
Pre-existing stable medical condition means a subject who within 3 months prior to Day 1: 
has full capacity of daily activity and no major medication modification; has not undergone 
surgical or minimally-invasive intervention or had any hospitalization/emergency room visit 
for the specific medical condition. 
3) Able to comply with the protocol schedule and procedures. 
4) Able and willing to provide written informed consent 
5) If female of child-bearing potential and heterosexually active, has practiced adequate 
contraception for 28 days prior to vaccination and has negative pregnancy tests just prior to 
vaccination and has agreed to continue adequate contraception until 28 days after last study 
injection. Adequate contraception is defined as a contraceptive method with a failure rate of 
< 1% per year when used consistently and correctly and, when applicable, in accordance with 
the product label. Examples include the following: 
• Combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulation: oral, intravaginal, or transdermal 
• Progestin-only hormonal contraception associated with inhibition of ovulation: oral, 
injectable, or implantable 
• Intrauterine device (IUD) with or without hormonal release 
• Vasectomized partner, provided he is the subject’s sole partner and that he has received a 
medical assessment of the surgical success 
• Credible self-reported history of heterosexual abstinence for at least 28 days prior to 
vaccine administration 
• Female partner 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 39 of 79 
 
 
5.2 
Exclusion Criteria 
A subject with any 1 of the following criteria is not eligible for enrollment (defined as receiving 
any study vaccine) in the study: 
1) A history of plague disease or have previously received any plague vaccine. 
2) Active tuberculosis or other systemic infectious process. 
3) History of human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) 
infection, or positive test for antibody to HIV, HBV, or HCV 
4) History of autoimmune disorder (Appendix 3) 
5) History of sensitivity to any component of study vaccines 
6) Body mass index 2' 30 kg/m2 
7) Has received the following prior to the injection: 
• :: 14 days: 
• Any licensed COVID-19 vaccine or any inactivated vaccines (including vaccines 
containing mRNA or CpG) 
• :: 28 days: 
• Any live vaccine 
• Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators 
or immunomodulators immune suppressive medication, with the exception of inhaled 
steroids 
• Any other investigational medicinal agent 
• :: 90 days: 
• Antisense oligonucleotides 
• Granulocyte or granulocyte-macrophage colony-stimulating factor 
• Immunoglobulins or any blood products 
• Drugs/investigational agents with very long half-lives (defined as 2' 60 days) 
• At any time: DNA plasmids or other genetic therapy intended to integrate permanently 
into host cells 
8) If female is pregnant (known before or established at the time of screening), breastfeeding, or 
planning a pregnancy 
9) Is undergoing chemotherapy or expected to receive chemotherapy during the study period; 
has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell 
carcinoma of the skin 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 40 of 79 
 
 
10) History or current evidence of any condition, therapy, or laboratory abnormality that might 
confound the results of the study, interfere with the subject's participation for the full 
duration of the study, or is not in the best interest of the subject to participate, in the opinion 
of the treating investigator 
11) Oral temperature >100.0°F at the time of vaccine administration. 
12) History of acute myocardial infarction (AMI) or documented coronary artery disease (CAD) 
 
5.3 
Criteria for Discontinuation of Individual Subjects From Receiving 
Additional Study Injections 
The investigator will discontinue dosing of an individual subject and notify the sponsor within 
24 hours if the subject experiences an AE including any of the following: 
• Grade 4 post-injection reaction (PIR) within 7 days after any study injection 
• Clinically significant Grade 3 or higher systemic reaction (eg, angioedema, generalized 
urticaria) within 7 days after any study injection 
• Grade 3 or 4 hypotension within 24 hours of any study injection 
• Grade 3 or 4 respiratory reaction or symptoms occurring within 24 hours of any study 
injection 
• Any life-threatening AE, regardless of relationship to study drug 
• Any AMI 
• Any confirmed immune-mediated AE 
• Violation of protocol eligibility criteria 
• Subject received prohibited medications 
• SAE assessed as a suspected adverse reaction (SAR) or adverse reaction (AR) 
• Subject becomes pregnant or begins breastfeeding 
If the subject is not eligible for subsequent study injections, the subject will not be withdrawn 
from the study, but, if possible, will be followed for safety through End-of-Study (EOS) Visit. 
5.4 
Removal of Subjects From the Study 
Subjects may choose to withdraw from the study at any time. The reason for withdrawal will be 
recorded on the case report form (CRF). 
Subjects may also be discontinued from the study by the investigator for any of the following 
reasons: 
• Subject does not receive a dose of study vaccine 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 41 of 79 
 
 
• Noncompliance with study procedures as determined by the investigator or sponsor 
• At the discretion of the investigator if it is felt to no longer be in the best interest of the 
subject to remain in the study 
• The sponsor decides to terminate the study 
The investigator or designee should discuss with the medical monitor prior to withdrawing a 
subject from the study before study completion. 
• If a subject discontinues, the End of Study (EOS) assessments should be completed. 
Required procedures are listed in Section 9.7 and in the Schedule of Events (Appendix 1). 
• Additional information about terminating the study may be found in Section 6. 
 
5.5 
Replacement of Subjects 
Subjects randomized and not treated may be replaced at the discretion of the Dynavax medical 
monitor. 
5.6 
Study Termination 
The sponsor reserves the right to terminate the study at any time. Reasons for discontinuation of 
the study include but are not limited to: 
• Inability to enroll sufficient subjects into the study 
• Good clinical practice (GCP) compliance issues that compromise the validity of the study 
• Emerging safety or efficacy data that deem the study unethical or impractical for 
continuation 
Procedures for withdrawal of individual subjects can be found in Section 5.3. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 42 of 79 
 
 
6 
STUDY TREATMENT AND SUPPLIES 
6.1 
Study Treatments 
6.1.1 
rFIV Vaccine 
rFIV vaccine is comprised of Y. pestis plague recombinant antigen (F1 capsular protein and the 
V virulence protein of Y. pestis Colorado 92 [CO92] fused into a single protein) adsorbed to 
Alhydrogel® (aluminum hydroxide). 
The rF1V Plague Vaccine is a liquid formulation, containing no preservatives, in 3 mL, single 
dose USP Type 1 glass vials with a latex-free butyl stopper and aluminum flip-off seal 
containing 0.8 mL of the vaccine, and each dose of 0.5 mL contains 160 mcg rF1V, 750 mcg 
aluminum hydroxide (alum, Alhydrogel®) and phosphate buffer. 
Please refer to the Investigator’s Brochure and Pharmacy Manual for additional information. 
6.1.2 
CpG 1018 
CpG 1018 adjuvant solution (12 mg/mL) is a clear to slightly opalescent, colorless to pale yellow 
liquid dosage form. CpG 1018 is formulated in 20 mM Tris, 100 mM NaCl pH 7.5 buffer. Each 
vial contains 6 mg of CpG 1018 formulated in 0.5 mL at a concentration of 12 mg/mL in a 
single-use 2 mL, clear glass vial with rubber stopper and flip-off aluminum seal. 
Please refer to the rF1V Vaccine with CpG 1018 Investigator’s Brochure for additional 
information. 
6.1.3 
Placebo 
Placebo will be normal saline. 
6.2 
Instructions for Preparation and Administration 
6.2.1 
rFIV vaccine and CpG 1018 Preparation 
Please refer to the Pharmacy Manual for additional information. 
6.2.2 
Study Vaccine Administration 
Designated unblinded study-site personnel will be responsible for preparing and administering 
the study injection. These individuals will not be blinded to the treatment assignment in order to 
prepare and administer the study injections, which will be prepared at a location isolated from 
blinded personnel. These individuals will not be involved in assessing safety and laboratory data 
and will be instructed not to communicate treatment assignments to blinded study personnel. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 43 of 79 
 
 
and 
, and 2 injections of 0.25 mL placebo will be administered on Day 183 
and 
, and 2 injections of 0.25 mL placebo will be administered 
o Day 183 
9
, 
and
183
and 
and 2 injections of 0.25 mL placebo will be administered o n Day 183 
9
, 
and
183.
183 
9
, 2
and 183. 
and 2
1 
9, 
1 and 29, and 2 injections of 0.25 mL placebo will be administered 
1 and 29, and 2 injections of 0.25 mL placebo will be administered o  Day 183. 
1, 29 and 
183. 
1 and 29, 
The unblinded study personnel should ensure that a physical barrier is used to obstruct the view 
of the investigational product and that the subject turns their head away from the arm being 
injected to prevent the subject becoming aware of their treatment assignment. 
6.2.2.1 
Part 1 
Group 1: 0.5 mL of rF1V vaccine and 0.25 mL of CpG 1018 will be administered 
intramuscularly in the same or nearby location of the deltoid muscle of the non-dominant arm on 
Days 
. 
Group 2: 0.75 mL of the bedside mix of rF1V vaccine and CpG 1018 and 0.25 mL of placebo 
will be administered intramuscularly in the same or nearby location of the deltoid muscle of the 
non-dominant arm on Days 
 
Group 3: 0.5 mL of rF1V vaccine and 0.25 mL of placebo will be administered intramuscularly 
in the same or nearby location of the deltoid muscle of the non-dominant arm on Days 
 
6.2.2.2 
Part 2 
Scenario 1: Group 1 is selected. 
Group 1: 0.5 mL of rF1V vaccine and 0.25 mL of CpG 1018 will be administered 
intramuscularly in the same or nearby location of the deltoid muscle of the non-dominant arm on 
Days 
Group 3: 0.5 mL of rF1V vaccine and 0.25 mL of placebo will be administered intramuscularly 
in the same or nearby location of the deltoid muscle of the non-dominant arm on Days 
 
Scenario 2: Group 2 is selected. 
Group 2: 0.75 mL of the bedside mix of rF1V vaccine and CpG 1018 will be administered 
intramuscularly in the deltoid muscle of the non-dominant arm on Days 
and 0.25 mL 
placebo will be administered on Day 
Group 3: 0.5 mL of rF1V vaccine will be administered intramuscularly in the same or nearby 
location of the deltoid muscle of the non-dominant arm on Days 
Study treatments are presented in Table 7-1. 
6.3 
Labeling 
rF1V vaccine and CpG 1018 adjuvant solution will be provided for the study and labeled for 
clinical study use. 
Day 183. 
1, 29 and 
183. 
183. 
1 29 and 183 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 44 of 79 
 
 
At a minimum, both rF1V vaccine and CpG 1018 adjuvant solution will be labeled with the 
following information: product name, product lot number, contents, volume, concentration, 
sponsor name, and a statement indicating that the drug is for investigational use only. 
6.4 
Storage and Handling Instructions 
The clinical supplies storage area at the site must be monitored closely by the designated site 
staff for temperature consistency and documentation of temperature monitoring must be 
maintained. Temperature excursions outside of the recommended storage range may impact 
product quality and must be reported to Dynavax or its designee per the detailed instructions in 
the Pharmacy Manual. 
6.4.1 rF1V and CpG 1018 
Both rF1V vaccine and CpG 1018 must be kept under refrigeration (2°C to 8°C). After 
preparation of drug product, it must be used within 6 hours. 
Do not freeze. If product is frozen, do not use. A Pharmacy Manual will be provided with 
specific instructions for management of temperature excursions. 
6.4.2 Bedside mix of rF1V vaccine and CpG 1018 
Please refer to the Pharmacy Manual for additional information. 
7 
TREATMENT OF SUBJECTS 
7.1 
Study Treatments 
Study treatments are presented in Table 7-1. For each dose, injections are to be administered in 
the order specified in the table. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
 
CONFIDENTIAL 
Part 1 
Dose 1 (Day 
Dose 2 (Day 2 
Dose 3 ( Day 183 
Group 1 rF1V vaccine and CpG 1018 coadministration 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.25 mL placebo 
Injection 2 
0.25 
CpG 1018
0.25 
CpG 1018 
0.25 mL placebo 
Tota
0.75 
0.75 
0.5 
Group 2 rF1V vaccin + CpG 1018 bedside mix 
Injection 1 
0.75 mL rF1V+1018 
0.75 mL rF1V+1018 
0.25 mL placebo 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Tota
1.0 
1.0 
0.5 
Group 3 rF1V vaccine 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Tota
0.75 
0.75 
0.75 
Part 2 
Dose 1 (Day 
Dose 2 (Day 2 
Dose 3 ( Day 183 
Group 1 rF1V vaccine and CpG 1018 coadministration 
Scenario 1 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.25 mL placebo 
(Group 1 and 3) 
Injection 2 
0.25 
CpG 1018 
0.25 
CpG 1018 
0.25 mL placebo 
Tota
0.75 
0.75 
0.5 
Group 3 rF1V vaccine 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Tota
0.75 
0.75 
0.75 
OR 
Scenario 2 
Group 2 rF1V vaccine + CpG 1018 bedside mix 
(Group 2 and 3) 
Injection 
0.75 mL rF1V+1018 
0.75 mL rF1V+1018 
0.25 mL placebo 
Group 3 rF1V vaccine 
Injection 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL of rF1V vaccine = 160 mcg rF1V + 750 mcg alum 
0.25 mL of CpG 1018 = 3000 mcg 
, Day 9, and Day 183
Table 7-1: 
Study Treatments 
 
Part 1 
y 1) 
9) 
3) 
Group 1 rF1V vaccine and CpG 1018 coadministration 
0.5 mL rF1V 
0.5 mL rF1V 
Injection 2 
Total 
0.25 mL CpG 1018 
0.25 mL CpG 1018 
0.25 mL placebo 
0.75 mL 
0.75 mL 
0.5 mL 
Group 2 rF1V vaccine 
CpG 1018 bedside mix 
0.75 mL rF1V+1018 
0.75 mL rF1V+1018 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Total 
1.0 mL 
1.0 mL 
0.5 mL 
Group 3 rF1V vaccine 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Total 
0.75 mL 
0.75 mL 
0.75 mL 
Part 2 
Dose 1 (Day 1) 
Dose 2 (Day 29) 
Dose 3 (Day 183) 
Group 1 rF1Vvaccine and CpG 1018 coadministration 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.25 mL placebo 
Injection 2 
0.25 mL CpG 1018 
0.25 mL CpG 1018 
0.25 mL placebo 
Total 
0.75 mL 
0.75 mL 
0.5 mL 
Group 3 rF1V vaccine 
Injection 1 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
 
 
 
 
Scenario 2 
(Group 2 and 3) 
Injection 2 
0.25 mL placebo 
0.25 mL placebo 
0.25 mL placebo 
Total 
0.75 mL 
0.75 mL 
0.75 mL 
OR 
Group 2 rF1Vvaccine + CpG 1018 bedside mix 
Injection 
0.75 mL rF1V+1018 
0.75 mL rF1V+1018 
0.25 mL placebo 
Group 3 rF1V vaccine 
Injection 
0.5 mL rF1V 
0.5 mL rF1V 
0.5 mL rF1V 
 
0.25 mL of CpG 1018 = 3000 mcg 
 
7.2 
Dosage and Dosage Regimen 
Subjects will receive their assigned vaccine on Day 
7.3 
Treatment Compliance 
All study injections will be administered by the designated unblinded study personnel only. 
 
 
 
 
 
AND PROPRIETARY 
Page 45 of 79 
1, Day 29, and Day 183. 
Scenario 1 
CONFIDENTIAL 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 46 of 79 
 
 
7.4 
Control and Accountability of Investigational Medicinal Product 
All investigational medicinal product (IMP) must be received by a trained designated person at 
the study site, handled and stored safely and properly, and kept in a secured location with limited 
access. 
The investigator (or responsible designee) must maintain current and accurate records of the 
receipt (documentation from shipments of study treatments received), administration (by subject 
and overall accounting) and return of study treatments to a Dynavax-specified facility for 
destruction (or destroyed by procedures approved by Dynavax). All study treatments must be 
stored in a location with access restricted to authorized personnel only. 
A study monitor will be responsible for monitoring the drug accountability at the site. The study 
monitor should be contacted with any questions concerning administration of study treatments. 
Records of study treatment accountability, storage, and handling must be made available to the 
study monitor for the purposes of study treatments accountability. Any discrepancy and/or 
deficiency must be recorded with an explanation. 
Unless superseded by Standard Operating Procedures (SOPs), the investigator must retain all 
used vials, expired vials, damaged vials, and unused vials of study vaccine until accountability 
has been confirmed by the study monitor. Any exceptions to this policy must be specifically 
granted by Dynavax or its designee. 
At the end of the study, or upon request by Dynavax, all used, partially used, and unused study 
treatments must be destroyed by procedures approved by Dynavax or returned to a Dynavax- 
specified facility for adequate disposition. 
Refer to the Pharmacy Manual for detailed instructions on handling, control, and accountability 
of study vaccine. 
Study vaccine may not be used for any purpose other than that described in this protocol. 
7.5 
Concomitant Medications 
7.5.1 
Prohibited Treatments or Therapies 
The following non-study medications are prohibited: 
• Any licensed COVID-19 vaccine or inactivated vaccine (including vaccines containing 
mRNA or CpG) 
• :S 14 days prior to each study injection through 14 days after each study injection 
• Any live vaccine 
• :S 28 days prior to each study injection through 28 days after each study injection 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 47 of 79 
 
 
• Other concomitant medications 
• :S 28 days prior to vaccine injection (Day 1) through 28 days after the third study vaccine 
injection Week 26 (Day 183): 
• Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators 
or immunomodulators immune suppressive medication, with the exception of inhaled 
steroids 
• Any other investigational medicinal agent 
• :S 90 days prior to vaccine injection (Day 1) and through 28 days after the third study 
vaccine injection Week 26 (Day 183): 
• Granulocyte or granulocyte-macrophage colony-stimulating factor 
• Immunoglobulins or any blood products 
• Antisense oligonucleotides 
• Drugs/investigational agents with very long half-lives (defined as 2' 60 days) 
• At any time prior to vaccine injection (Day 1) and through 28 days after the third study 
vaccine injection Week 26 (Day 183): 
• DNA plasmids or other genetic therapy intended to integrate permanently into host 
cells 
 
If a subject requires treatment that is prohibited, the subject will not be withdrawn from the 
study but will be followed for safety through Week 56. 
7.5.2 
Permitted Therapy 
Use of any permitted medications, including over-the-counter medications or vaccine(s) during 
the 28 days prior to the first study vaccine injection through Week 56 or Early 
Discontinuation/EOS Visit, should be solicited from each subject and recorded in source 
documents. Use of vitamins and dietary supplements will not be collected. Medications started 
prior to dosing, and any medication used within the 28 days prior to dosing will be recorded. 
All collected concomitant medications will be recorded in the CRF. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 48 of 79 
 
 
8 
MANAGEMENT OF SUBJECT SAFETY 
8.1 
Data Monitoring Committee 
The Sponsor will establish a DMC for this study. The DMC members and procedures will be 
described in the DMC charter. 
8.2 
Potential Reasons for Stopping the Study 
Dosing of all subjects will be temporarily stopped for any of the following: 
• Two or more subjects with Grade 3 (severe) or higher severity solicited adverse reactions 
(considered by the sponsor to be possibly or probably related to treatment) lasting more than 
48 hours AND considered by the DMC to be clinically significant 
• Two or more subjects who experience the same or similar grade 3 or higher unsolicited 
adverse event that is assessed as at least possibly related to the treatment 
• Any Suspected Unexpected Serious Adverse Reaction (SUSAR) (considered by the Sponsor 
to be possibly or probably related to treatment) 
• Any death or life-threatening SAE regardless of relationship to vaccine 
• Any type 1 acute myocardial infarction 
Dosing may be resumed following review of available safety data by the DMC, as specified in 
the DMC Charter. 
8.3 
Injection Site Reactions 
Injection-site reactions are expected to spontaneously subside. Local pruritus and pain can be 
treated with oral medications. If significant symptoms of pain and induration persist for more 
than 12 hours, an ice pack may be applied locally for 30 minutes every 2 hours, as needed. Use 
of an ice pack prior to 12 hours after the onset of symptoms is discouraged, as it may interfere 
with the action of the study vaccine. Do not inject into a site if local pain, tenderness, swelling, 
or pruritus persist from a previous injection or other cause. 
8.4 
Observation Period After Study Vaccine Injection 
Subjects will be observed for safety for a minimum of 30 minutes after each study vaccine 
injection. See Section 10.0 for reporting of adverse events. 
8.5 
Other Supportive Care 
Subjects should receive appropriate supportive care measures as deemed necessary by the 
investigator. The investigator should ensure that adequate medical care is provided to a subject 
for any adverse events (AEs) related to the study. For each disorder, attempts should be made to 
rule out other causes, which might require additional supportive care. The investigator should 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 49 of 79 
 
 
inform the study medical monitor when medical care is needed for intercurrent illness(es) of 
which the investigator becomes aware. 
 
An unscheduled visit (UNS) should be performed if there are suspected subject safety concerns. 
All supportive therapies will be recorded in the subject’s electronic case report form (eCRF). 
Subjects who are discontinued from the study will complete the Early Discontinuation/EOS 
Visit, if possible, not earlier than 28 days following their vaccine administration. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 50 of 79 
 
 
9 
STUDY PROCEDURES 
9.1 
Informed Consent, Screening, and Eligibility 
9.1.1 
Informed Consent 
The investigator or designee must review the informed consent form (ICF) with each prospective 
subject to be certain that the prospective subject understands the procedures and risks of the 
study. Prospective subjects who wish to participate in the study must provide written informed 
consent by signing the ICF before undergoing any screening procedures. 
The information from the consent form should be translated and communicated to the subject in 
language understandable to the subject and/or legal representative. 
A copy of the signed and dated consent form should be offered to the subject or subject’s legally 
acceptable representative before participation in the study. The subject or his/her legally 
acceptable representative should be informed in a timely manner if new information becomes 
available that may be relevant to the subject’s willingness to continue participation in the study. 
The communication of this information should be documented. 
The investigator or designee will maintain a log of all subjects who sign the ICF. At a minimum, 
the log will include a subject identifier, the dates of informed consent and screening procedures, 
the outcome of the screening, and, if a screen failure, the reason the subject did not enroll in the 
study. Other items that will be collected on consented participants are age, sex, ethnicity and 
race. These will be captured in the study database. 
Additional requirements for informed consent are presented in Section 13.2. 
9.1.2 
Screening and Eligibility 
After written consent is obtained, screening procedures must be carried out per the Schedule of 
Events (Appendix 1). Subjects who fail screening may not be rescreened. Subjects may have the 
screening window extended an additional 7-calendar days if they have equivocal laboratory 
results or if they cannot be enrolled during the screening window. The screening window may 
only be extended one time and must have prior approval by the sponsor’s medical monitor. A 
subject must meet all of the inclusion criteria and none of the exclusion criteria to be eligible to 
participate in the study (Section 5.0). Documentation to support a subject’s eligibility must be in 
the study records. 
9.1.3 
Demographics and Medical and Medication History 
Demographic and baseline characteristics of sex, race, ethnicity, age, weight, and height of the 
subject will be collected. 
Medical history includes clinically significant diseases and surgeries. Concomitant medications 
(Section 7.5) used by the subject within 28 days prior to Day 1 of the study will be recorded. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 51 of 79 
 
 
9.2 
Study Visits 
Procedures should be performed as close to the scheduled time as possible. A detailed outline of 
all scheduled study procedures is provided in the Schedule of Events (Appendix 1). 
The exact time at which a procedure is performed should be recorded in the subject’s study 
records or appropriate worksheet (if applicable). 
Blood collection must be performed prior to administration of the study vaccine on each vaccine 
administration day. 
An Unscheduled (UNS) Visit (Section 9.5) should be performed if there are suspected subject 
safety concerns. All supportive therapies will be recorded in the subject’s CRF. 
All subjects should be followed for at least 28 days after the last study vaccine injection 
(Section 9.6). 
9.3 
Immunogenicity Assessments 
All immunogenicity assessments will be performed in a blinded manner in participating 
laboratories. 
9.3.1 
Antibodies to rF1V 
Serum samples will be obtained to measure antibodies against rF1V. On vaccine days, samples 
will be collected prior to administration of study vaccine. Standardized 
used to determine serum concentrations of antibodies to rF1V. 
9.4 
Safety Assessments 
will be 
The measures of safety in the study are routine clinical and laboratory procedures. Safety will be 
assessed by the reporting and analysis of post-injection reactions (PIRs), AEs, SAEs, AESIs, and 
deaths (Section 10.0). The safety assessments are described below. The timing for Safety 
Assessments is provided in the Schedule of Events (Appendix 1). 
9.4.1 
Vital Signs 
Vital signs will include oral temperature and measurements of heart rate, respiratory rate, 
systolic and diastolic blood pressure. Vital signs taken at the Day 1, Day 29, and Day 183 visits 
will be measured prior to study vaccine administration. 
Vital signs will be recorded as indicated in the Schedule of Events (Appendix 1). 
Bridge ELISA 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 52 of 79 
 
 
, Day 9 and Day 183 
9.4.2 
Physical Examinations 
The investigator or qualified designee will conduct physical examinations. A complete physical 
examination is conducted at Screening. A symptom-directed physical exam at all other 
timepoints as outlined in Appendix 1. 
9.4.3 
Laboratory Assessments 
Laboratory assessments are listed below and will be performed according to the Schedule of 
Events (Appendix 1). Sample collections will be prior to administration of the study vaccine on 
injection days. 
• HIV, HBV, HCV testing at Screening Visit 
• Pregnancy testing: For female of childbearing potential (ie, onset of menarche), a serum 
pregnancy test will be performed at screening and must be negative for the subject to 
participate. Additionally, a urine pregnancy test will be performed within 24 hours prior to 
administration of each study vaccine and must be negative for the subject to receive study 
injection. 
• Chemistry Panel: sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), 
creatinine, glucose, calcium, aspartate transaminase (AST), alanine transaminase (ALT), 
lactate dehydrogenase (LDH), bilirubin, alkaline phosphatase 
• Hematology: red blood cell count, hemoglobin, hematocrit, white blood cell count with 
differential, and platelet count 
• Reserve serum aliquot specimens will be collected and stored frozen at a central location for 
possible future testing 
Additional details for collection and processing of laboratory samples are provided in the 
Laboratory Manual. 
9.4.4 
Post-Injection Reaction Assessments 
Assessments of PIRs (Section 10.2) will be collected for a minimum of 30 minutes following 
each study injection at the clinical site. 
On Day 1 Day 29, and Day 183, subjects will be asked to complete an e-diary (or equivalent) to 
record any solicited local (pain, redness, pruritus [itchiness], and swelling at the injection site) 
and solicited systemic signs and symptoms (fatigue, temperature, chills, malaise, myalgia, 
gastrointestinal symptoms, and headache) during the 7-day follow-up period after vaccination. 
The severity of the post-injection reactions will be graded using the Toxicity Grading Scale for 
Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 
(Appendix 2). 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 53 of 79 
 
 
PIRs persisting beyond 7 days after each study injection are considered AEs and should be 
recorded and reported as AEs. These will be included in the electronic data capture (EDC) AE 
dataset. 
PIRs inadequately recorded by the subject in the e-diary and occurring during the diary period 
from Day 1 through Day 7 following each study injection can be reconstructed by the investigator 
in the AE CRF page. These will be included in the EDC AE dataset. 
Refer to the eCRF completion guidelines for additional details. 
9.4.5 
Adverse Events 
All AEs, as defined in Section 10.0, will be evaluated and reported from immediately after the 
study vaccine injection on Day 1 through EOS (Week 56 or Early Discontinuation) Visit. See the 
Schedule of Events (Appendix 1) for the AEs collection schedule. 
9.4.5.1 Serious Adverse Events 
All SAEs, as defined in Section 10.7.1, whether assessed as related or not related to study 
vaccine injection, will be evaluated from the time the consent is signed through completion of 
the subject’s participation in the study (EOS Visit). Any SAE must be reported to Dynavax or its 
designee within 24 hours of knowledge of the event. 
If the SAE is assessed as possibly or probably related to study treatment, it must be followed 
until it is considered stable or resolved, including beyond the EOS Visit. 
Any SAE assessed as not related to study treatment will be followed as clinically indicated until 
its resolution or, if non-resolving, until it is considered chronic or stable, or until study 
completion (EOS Visit). 
9.4.5.1.1 Type 1 Acute Myocardial Infarction (AMI) 
SAEs of myocardial infarction will be further classified as Type 1 AMI if they meet the 
following criteria (Thygesen, Alpert et al. 2018): 
• Detection of a rise and/or fall of cardiac troponin (cTn) values with at least 1 value above the 
99th percentile upper reference limit and at least 1 of the following: 
• Symptoms of acute myocardial ischemia 
• New ischemic ECG changes 
• Development of pathological Q waves 
• Imaging evidence of new loss of viable myocardium or new regional wall motion 
abnormality in a pattern consistent with an ischemic etiology 
• Identification of a coronary thrombus by angiography including intracoronary imaging or 
by autopsy 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 54 of 79 
 
 
 
9.4.6 
Concomitant Medications 
All concomitant medications must be recorded in the subject’s CRF according to Section 7.5 and 
per the Schedule of Events (Appendix 1). 
9.5 
Unscheduled Visit for Safety 
An UNS Visit should be performed if there are suspected subject safety concerns. Procedures for 
the visit will depend on the reason for visit as determined by the treating principal investigator or 
sub-investigator. If an UNS Visit is performed because of a safety concern related to study 
treatments, at a minimum, the following should be performed: 
• A targeted physical examination based on subject-reported symptoms including measurement 
of vital signs (heart rate, blood pressure, respiratory rate, and temperature). For additional 
details, see Section 9.4.1 and Section 9.4.2. 
9.6 
Duration of Follow-up 
All subjects should be followed for at least 28 days after administration of the study vaccine. If a 
subject is discontinued early from the study, an Early Discontinuation/EOS assessment should be 
conducted not earlier than 28 days after the last administration of study vaccine (Section 9.7). 
9.7 
Early Discontinuation/End of Study 
An EOS Assessment is required at Week 56 (Day 393) in alignment with the protocol, GCP as 
defined in International Council for Harmonisation (ICH) guidelines and US Code of Federal 
Regulations (CFR), and applicable local regulatory requirements. The EOS procedures will be 
performed as an Early Discontinuation assessment at least 28 days after the last study injection if 
the subject is permanently discontinued early from the trial. Investigators are responsible for 
monitoring the safety of subjects throughout the course of the study and for providing 
appropriate medical care. The investigator will perform all tasks directly or is responsible for 
overseeing and training qualified site personnel as delegated to perform study tasks. In addition, 
investigators are responsible for alerting Dynavax to any event that seems unusual and for 
reporting all AEs, SAEs, pregnancies, and deaths in the appropriate CRFs. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 55 of 79 
 
 
10 ADVERSE EVENTS 
10.1 Definition of Adverse Events 
An AE is any untoward medical occurrence associated with the use of a drug, whether or not 
considered drug related. An AE can therefore be any unfavorable and unintended sign (including 
a clinically significant abnormal laboratory finding), symptom, or disease temporally associated 
with the use of a medicinal (investigational) product, whether or not related to the study 
treatment. 
Medical conditions present at Screening (ie, before informed consent is obtained) or present 
before the study vaccine injection (Day 1) are not AEs and are not recorded on the AE CRF. 
These medical conditions should be adequately documented on the Medical History CRFs. Any 
increase in severity or frequency of a medical condition documented as medical history after the 
study vaccine injection will be recorded as an AE and will be captured on the AE CRF. 
Post-injection reactions (Section 10.2) persisting beyond 7 days after each study injection are 
considered to be AEs and need to be recorded and reported as AEs. These will be included in the 
electronic data capture (EDC) AE dataset. 
If a PIR is inadequately recorded by the subject in the e-diary and occurred during the diary 
period from Day 1 through Day 7 following each study injection, the investigator can 
retrospectively evaluate and report at their discretion (as a health care provider), as necessary, 
through the date of onset on the AE CRF page. These data will be included in the EDC AE 
dataset. 
An uncomplicated pregnancy is not an AE or SAE and should not be reported as an AE/SAE. 
Subjects should be followed as described in Section 10.9. 
The reporting period for all non-serious AEs begins at the time of the first study vaccine 
injection (Day 1) through EOS. All AEs will be captured on the AE CRF. 
The investigator will follow all related non-serious AEs observed during the study until the AEs 
are considered resolved or until EOS. Dynavax or the Dynavax designee may request additional 
follow-up on specific unresolved events. 
AEs should be documented in terms of a single medical diagnosis. When this is not possible, the 
AE should be documented in terms of signs and/or symptoms observed by the investigator or 
reported by the subject. 
Any Grade 3 (severe) solicited or unsolicited AE that is considered possibly or probably related 
to treatment must be reported to Dynavax or its designee within 24 hours of investigator 
awareness of the event. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 56 of 79 
 
 
10.2 Definition of Post-Injection Reactions 
Post-injection reactions persisting beyond 7 days after injection are considered to be AEs and 
need to be recorded and reported as AEs. The severity of the post-injection reactions will be 
graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled 
in Preventive Vaccine Clinical Trials (Appendix 2). 
Certain local and systemic events are routinely monitored in vaccine clinical trials as indicators 
of vaccine reactogenicity. It is recognized that each of these events, and particularly those of 
systemic nature, may under certain circumstances, in an individual subject, have a cause that is 
unrelated to study vaccine. However, as a matter of convenience and in accordance with 
common clinical practice, such events occurring within a specified period of time after 
immunization are herein termed ‘post-injection reactions’ and will be considered as related to 
treatment. 
Post-injection reactions documented by the subject will be collected via a diary, reviewed by the 
study nurse/coordinator with the subject and recorded appropriately. 
10.3 Overdoses 
If an AE is associated with or resulted from an overdose of study vaccine (for the purpose of this 
study defined as more than twice the protocol-specified dose), it will be documented on the AE 
CRF. If it is an SAE, it will also be reported to Dynavax or the Dynavax designee following the 
SAE reporting process (see Section 10.9.2). 
10.4 Adverse Events Associated With Cancer 
If an AE is associated with or resulted from cancer, it will be documented on the AE CRF. If it is 
an SAE, it will also be reported to Dynavax or the Dynavax designee following the SAE 
reporting process (see Section 10.9.2). 
 
 
10.5 Definition of Adverse Reaction 
An adverse reaction (AR) is defined as any AE caused by the use of a pharmaceutical product. 
ARs are a subset of all suspected AEs for which there is reason to conclude that the 
pharmaceutical product caused the event. 
10.6 Definition of Suspected Adverse Reaction 
Suspected adverse reaction (SAR) means any AE for which there is a reasonable possibility that 
the study treatment caused the AE. Reasonable possibility means there is evidence to suggest a 
causal relationship between the study treatment and AE. An SAR implies a lesser degree of 
certainty about causality than AR, which means an AE caused by a study treatment. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 57 of 79 
 
 
10.7 Definition of Unexpected Adverse Event or Unexpected Suspected Adverse 
Reactions 
An AE or SAR is considered unexpected if it is not listed in the Investigator’s Brochure or the 
approved product label or is not listed at the specificity or severity that has been previously 
observed. 
10.8 Definition of Immune-mediated Adverse Event of Special Interest 
Immune-mediated adverse events of special interest (imAESI) are defined according to a pre- 
specified list of event terms including autoimmune, autoinflammatory, and hypersensitivity 
disorders (Appendix 3). Each subject will be assessed for AESIs during the entire trial. 
10.9 Serious Adverse Events 
10.9.1 Definition of Serious Adverse Events 
An AE is considered an SAE if it meets any of the following criteria: 
• Results in death 
• Is life-threatening 
Note: An AE or SAR is considered life-threatening if, in the view of either the investigator or 
sponsor, its occurrence places the subject at immediate risk of death. It does not include an 
AE or SAR that, had it occurred in a more severe form, might have caused death. 
• Requires in-patient hospitalization or prolongs existing hospitalization 
• Results in persistent or significant disability or incapacity 
That is, the event severely or permanently disrupts the subject's ability to perform normal life 
functions or daily activities. 
• Results in a congenital anomaly or birth defect 
• Is medically significant (Important Medical Event) 
Medical and scientific judgment should be exercised in deciding whether SAE reporting is 
appropriate in other situations, such as important medical events that may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject. Examples 
of such events are allergic bronchospasm requiring treatment in an emergency room, serious 
blood dyscrasias, or seizures/convulsions that do not result in hospitalization. The 
development of drug dependence or drug abuse would also be examples of important medical 
events. 
Note: Elective surgery is not an SAE. Additionally, an Emergency Room visit does not fulfill the 
criteria of hospitalization by definition of an SAE. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 58 of 79 
 
 
10.9.2 Serious Adverse Event Reporting Requirements 
Any SAEs, including serious imAESIs, that occur from the time of signed consent through the 
EOS Visit, whether or not the SAE is related to the study vaccine must be reported to Dynavax 
or its designee within 24 hours of investigator awareness of the event. The contact 
information for reporting SAEs will be provided to each site. General SAE reporting instructions 
are as follows: 
• Submit SAE documents according to instructions provided. 
• Record all SAEs on the AE CRF. 
• For SAEs, record the primary event on the AE CRF; describe events occurring secondary to 
that primary event on the SAE form in the narrative description of the case. 
• Death is an outcome, not an event. Record the event that resulted in the death as the fatal 
event on the AE CRF. 
• For hospitalizations for surgical or diagnostic procedures, record the illness leading to the 
surgical or diagnostic procedure as the SAE, not the procedure itself. Capture the procedure 
in the narrative as part of the action taken in response to the illness. 
• Elective hospitalizations will not be considered SAEs and do not need to be reported. 
Complications that prolong elective hospitalizations should be recorded as SAEs. Emergency 
room visits of less than 24 hours do not meet the criterion of hospitalization for SAE 
reporting purposes. 
 
The SAE report should contain, at a minimum, the following information: 
• Subject identifiers (ie, subject number) 
• Suspected medicinal product 
• AE term (must be listed as serious) 
• Contact information for person reporting event 
The relationship of the SAE to study vaccine will be assessed by the investigator (Section 10.2). 
Follow-up information should be actively sought and submitted as it becomes available. 
The investigator will assess relationship to study treatment. In addition, the sponsor will assess 
relationship to study treatment and determine expectedness to study vaccine based on the current 
study vaccine Investigator's Brochure and USPI. The sponsor will report all study vaccine 
suspected unexpected serious adverse reactions (SUSARs) to regulatory authorities as expedited 
reports in accordance with applicable regulatory requirements (eg, 21 CFR 312.32[c] and 
314.80[e] in the US). All other SAEs will be reported as part of regulatory safety updates, as 
required, such as in annual reports. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 59 of 79 
 
 
10.10 Adverse Event Severity and Relationship to Study Treatment 
10.10.1 Severity Grading of Adverse Events and Abnormal Laboratory Test Results 
The severity of AEs and laboratory abnormalities will be graded based on the United States Food 
and Drug Administration’s (FDA) Guidance for Industry: Center for Biologics Evaluation and 
Research (CBER) Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled 
in Preventive Vaccine Clinical Trials in Appendix 2, with the modification that, by convention, 
all fatal AEs will be graded as Grade 5 (Fatal). 
All AEs not listed in the CBER toxicity grading scale will be graded as shown in Table 10-1. 
Table 10-1: 
Grading Scale for Adverse Events Not Included in the CBER 
Guidance on Toxicity Grading for Healthy Volunteers in Vaccine 
Clinical Trials 
 
AE Severity 
Definition 
Grade 1 – Mild 
No interference with activity 
Grade 2 – Moderate 
Some interference with activity, not requiring medical intervention 
Grade 3 – Severe 
Prevents daily activity and requires medical intervention 
Grade 4 – Potentially life-threatening 
Emergency room visit or hospitalization 
Grade 5 
Death 
CBER = Center for Biologics Evaluation and Research. 
 
For all AEs and SAEs, if there is a change in the severity after the event onset, the event should 
be reported as a single entry with the maximum severity grading captured. 
10.10.2 Relationship of Adverse Events to Study Treatment 
The investigator will determine the relationship of the AE to study vaccine using the definitions 
provided in Table 10-2. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 60 of 79 
 
 
Table 10-2: 
Definitions for Relationship of Adverse Events to Study Treatment 
 
Relationship to 
Study Vaccine 
Definition 
Not Related 
Another cause of the event is most plausible; or clinically plausible temporal sequence 
is inconsistent with the onset of the event and the study treatment administration; or a 
causal relationship is considered biologically implausible. 
Possibly Related 
An event that follows a reasonable temporal sequence from administration of the study 
treatment or a known or expected response pattern to the suspected drug, but that could 
readily have been produced by a number of other factors. 
Probably Related 
An event that follows a reasonable temporal sequence from administration of the study 
treatment, and there is a biologically plausible mechanism for study treatment causing 
or contributing to the AE, and the event could not be reasonably explained by the 
known characteristics of the subject’s clinical state. In addition, the relationship may be 
confirmed by improvement on stopping the study treatment and reappearance of the 
event on repeated exposure. 
AE = adverse event. 
 
If the SAE is assessed as possibly or probably related to study vaccine, the SAE must be 
followed until it is considered resolved, chronic or stable, including beyond EOS. 
Any SAE assessed as not related to study vaccine will be followed as clinically indicated until its 
resolution or, if non-resolving, until it is considered chronic or stable, or until 28 days after the 
last study vaccine injection or until EOS. 
The sponsor may request additional follow-up on specific unresolved AEs. 
10.11  Reporting and Documentation of Pregnancy and Exposure during 
Breastfeeding 
Any subject who becomes pregnant will be followed to pregnancy outcome even until after study 
conclusion. Subjects who begin breastfeeding during the study will be followed to EOS or 28 
days after last study injection. Follow-up information should be actively sought by the 
investigator and submitted to Dynavax or designee as soon as it becomes available. The 
investigator will complete the pregnancy reporting form and all other relevant eCRFs. 
Uncomplicated pregnancies are not considered an AE/SAE. A complicated pregnancy or a 
pregnancy with an adverse outcome may meet criteria for an AE or SAE and would then also be 
reported according to the appropriate requirements. 
A subject who becomes pregnant will be instructed to report the pregnancy to the study site as 
soon as possible. The subject should be followed by the investigator through the pregnancy for 
safety assessments and pregnancy outcome (including beyond EOS). A report of the pregnancy 
will be completed by the investigator or designee and will document details of the pregnancy, 
outcome of pregnancy, and details of delivery. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 61 of 79 
 
 
Pregnancies and breastfeeding that occur from Day 1 through EOS or 28 days after the last 
administration of the study vaccine must be reported by the investigator. The sponsor or designee 
must be notified as soon as possible once the study site learns of a pregnancy or breastfeeding. 
Pregnancy report forms provided by the sponsor or designee must be completed and reported to 
Dynavax or its designee within 24 hours of investigator awareness of the event. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 62 of 79 
 
 
Bridge ELISA 
11 STATISTICAL METHODS 
Part 1 objectives will be evaluated descriptively. The administration method of vaccine utilized 
in Part 2 of the study will be selected by Dynavax in consultation with the DoD after Day 57 
immunogenicity data become available to determine whether the GMC 1 month after 2 doses of 
rF1V vaccine with CpG 1018 using the selected administration method is at least 2 times higher 
than that 4 weeks after 2 doses of rF1V vaccine in Group 3. 
The proposed statistical planning for Part 2 is presented according to the objectives. No 
multiplicity adjustments are made, and all statistical tests will be conducted at 5% two-sided 
Type I level unless otherwise specified. 
All analyses of demographics, medical history, and safety will be summarized in a descriptive 
manner. In general, continuous variables will be summarized by number of subjects, mean, 
standard deviation, median, quartiles, minimum and maximum, and categorical variables will be 
summarized by number and percentage of subjects in each study group as appropriate. No 
specific safety hypotheses will be tested. 
11.1 Sample Size Considerations 
Part 2 primary objective 1 is to assess the utility of a 2-dose schedule of rF1V vaccine with CpG 
1018 as measured by reduction in time to onset of predicted rF1V protection. The predicted 
protection will be based on a Bridge ELISA titer threshold. Previous animal studies have 
established protective efficacy in animals. Since a human efficacy study is not feasible, an 
immunobridge from animal data to human data via the 
test will be used to predict 
the protective efficacy in humans using a regression model. An initial predicted protection 
threshold will be calculated based on the data generated in this study in Group 3 after 3 doses of 
rF1V vaccine. Once the threshold is identified, it will be applied to the study groups in Part 2 of 
the study to evaluate the objectives. In addition to the previous animal studies conducted to 
establish protective efficacy, a new animal model utilizing rF1V vaccine with CpG 1018 will be 
developed to establish the protective level of antibody for CpG 1018 containing vaccines. 
Additional analyses will include a predicted protection threshold that will be calculated based on 
the data generated under the new animal model after 2 doses of rF1V vaccine with CpG 1018. In 
both instances, the animal-to-human immunobridge and the identification of the predicted 
protection thresholds will be documented in a separate report. 
A similar approach was used to analyze the previous Phase 2a and Phase 2b study data using the 
animal model from the previous animal studies. Thresholds that corresponded to 50% predicted 
protective efficacy in humans were established for those trials. In a pooled analysis of these 
previous immunobridge studies, 93% (95% Clopper Pearson confidence interval [CI] = 85%, 
98%) of subjects reached the predicted protection threshold. 
It is assumed that a similar percentage of the subjects in Group 3 will reach the threshold 
identified in this study. When this threshold is applied to both Part 2 study groups, a similar 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 63 of 79 
 
 
Bridge ELISA 
211
lower bound of the 95% CI is desired across the groups. Table 11-1 shows the lower bound of 
95% Clopper Pearson CI for different observed levels of predicted protection assuming 85 of the 
90 planned subjects (Part 1 N = 20 and Part 2 N =70) will have data available for the evaluation. 
Thus, with a predicted protection level of 93%, the lower bound of the 95% CI would be 85%. 
Table 11-1: 
Precision Estimate at Various Level of Predicted Protection Using 
Clopper Pearson CI (N=85) 
 
Predicted Protection Level 
Lower Bound of 95% CI 
Upper Bound of 95% CI 
95% 
88% 
99% 
93% 
85% 
97% 
91% 
82% 
96% 
When the lower bound of 95% CI for the predicted protection after 2 doses of rF1V vaccine 
with CpG 1018 (ie, at Week 8) is similar to that (after 3 doses of rF1V vaccine (ie, at Week 30), 
the reduction of onset time to predicted rF1V protection is demonstrated. 
11.2 Study Analysis Populations 
The Safety Population will comprise all subjects who receive at least 1 dose of the study 
vaccine, excluding subjects who have no on-study data. 
The Modified intent-to-treat (mITT) population will comprise all eligible subjects who 
received at least 1 dose of study vaccine and have a post-injection immunogenicity evaluation. 
The Per-protocol (PP) Population for the immunogenicity analyses will comprise Groups 1 and 
2 subjects who received 2 doses of study vaccine and Group 3 subjects who received 3 doses of 
study vaccine, have no major protocol deviations (to be specified in the statistical analysis plan), 
and have immunogenicity data obtained within the study visit window at Day 211. 
Further details of statistical considerations are provided in a separate Statistical Analysis Plan. 
11.3 Demographics and Baseline Characteristics 
Demographic and baseline characteristics will be listed by subject and summarized using the 
Safety Population. Descriptive summary statistics (sample size, mean, median, SD, and range, 
when appropriate) will be provided for the continuous variables such as age, weight, and height. 
Count and percentage will be reported for categorical variables such as sex, race, and ethnicity. 
11.4 Immunogenicity Endpoints 
The primary and other immunogenicity endpoints will be analyzed using the mITT population. 
Sensitivity analyses on immunogenicity data will also be presented using the PP population. 
Immunogenicity will be measured by serum rF1V 
concentration at each visit. 
Part 2 Primary Objective 1: To assess the utility of a 2-dose schedule of rF1V vaccine with CpG 
1018 as measured by reduction in time to onset of predicted rF1V protection 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 64 of 79 
 
 
Bridge ELISA 
Bridge ELISA 
Bridge ELISA 
Bridge ELISA 
Bridge 
Part 2 Exploratory Objective 1: To assess long term clinical benefit from rF1V vaccine with CpG 
1018 compared with rF1V vaccine 
Endpoint: Risk ratio of subjects with 2' 6 months clinical benefit between rFlV vaccine with 
CpG 1018 and rF1V vaccine 
Criterion for evaluation: 2' 6 months clinical benefit is defined as retaining the predicted 
protection antibody level for 2' 6 months. Previous rF1V vaccine data showed a small percentage 
of subjects who received 3 doses of rF1V vaccine had 2' 6 months clinical benefit. Similar levels 
are expected for those who received 2 doses of rF1V vaccine with CpG 1018. 
Endpoint: predicted protection (percentage of subjects reaching the 
threshold that 
corresponds to 50% predicted vaccine efficacy) at Week 8 after 2 doses of rF1V vaccine with 
CpG 1018 as that at Week 30 after 3 doses of rF1V vaccine without CpG 1018 
Percentage of subjects reaching the 
threshold and associated 95% two-sided 
Clopper-Pearson confidence intervals will be computed. Fisher’s exact tests will be used to 
compare predicted protection rate between study groups. 
Criterion for evaluation: similar percentage of subjects reaching the 
threshold that 
corresponds to 50% predicted vaccine efficacy after 2 doses of rF1V vaccine with CpG 1018 as 
compared to that after 3 doses of rF1V vaccine. 
Part 2 Primary Objective 2: To assess the serum 
concentration to rF1V vaccine 
with CpG 1018 compared with rF1V vaccine 28 days after the second dose of vaccine 
Endpoint: Ratio of geometric mean ELISA concentration (GMC) between rF1V vaccine with 
CpG 1018 and rF1V vaccine at Week 8 
Criterion for evaluation: 2-times increase in 
GMC point estimate after the second 
dose of rF1V vaccine with CpG 1018 to that after the second dose of rF1V vaccine. 
 
Criteria for secondary objectives are GMC and seroconversion rate point estimates from rF1V 
vaccine with CpG 1018 to meet or exceed results from rF1V vaccine at relevant visits. 
Data from Part 1 subjects and Part 2 subjects will be combined to evaluate the Part 2 objectives. 
No multiplicity adjustment is proposed as the Part 1 objectives are not evaluated against the 3- 
dose regime control group. 
11.5 Safety Analyses 
Safety data will be analyzed descriptively and will be based on the Safety Population. Summary 
statistics will be used to describe the incidence of all post-injection reactions, AEs, AESIs, SAEs, 
and deaths. Tables of adverse events will include incidence, severity, seriousness, and 
relationship to the investigational vaccines. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 65 of 79 
 
 
11.6 Interim Analysis 
This study has no planned interim analysis. 
12 DATA QUALITY ASSURANCE 
The study sites will be monitored by Dynavax or its designee according to GCP and standard 
operating procedures. Prior to initiation of the study, representatives from Dynavax or its 
designee will review with the site personnel information about the investigational product, 
proper storage of study treatments, protocol requirements, and monitoring requirements. During 
and after the study, periodic on-site and remote visits will be conducted to monitor for 
compliance, including verification of the accuracy and completeness of data recorded on the 
CRFs, source documents, and study treatments accountability records. 
13 ETHICS 
The protocol and informed consent documents must be reviewed and approved by an 
appropriately composed Institutional Review Board (IRB). The study will not be initiated at a 
site until appropriate written IRB approval of the protocol, ICF, and all recruiting materials (if 
applicable) is obtained by the investigator. Copies should be reviewed and approved by Dynavax 
prior to submission to the IRB. The investigator will submit periodic reports on the progress of 
the study as required by the IRB, in accordance with applicable governmental regulations, and in 
agreement with the policy established by Dynavax. In addition, the investigator will inform the 
IRB of any protocol amendments and administrative changes and will obtain appropriate written 
IRB approval of all protocol amendments. 
13.1 Ethical Conduct of the Study 
This study will be conducted in accordance with the protocol; GCP as defined in International 
Council for Harmonisation (ICH) guidelines and US CFR Title 21, Parts 11, 50, 54, 56, 312, and 
Title 45 Parts 46, 160 and 164; the EU Directives 2001/20/EC and 2005/28/EC; the Declaration 
of Helsinki (1989); IRB Guidelines; and applicable local legal and regulatory requirements. 
13.2 Informed Consent 
The investigator is responsible for maintaining the privacy and confidentiality of the subject’s 
medical or health information collected during the in compliance with US CFR Title 21 Part 50, 
Title 45 Part 46 and ICH and IRB guidelines. Prior to initiation of the study at the site, the ICF 
form must be reviewed and accepted by Dynavax and approved by the governing IRB. The 
investigator or authorized designee will discuss the purpose and pertinent details of the study 
with each subject, and the subject must understand, sign, and date the appropriate IRB-approved 
ICF before undergoing any study-specific procedures. The ICF must be personally signed and 
dated by the subject and by the person who conducted the informed consent discussion. 
Additional signature requirements may exist. The original signed and dated ICF will be retained 
with the subject’s study records, and a copy of the signed ICF will be made available to the 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 66 of 79 
 
 
subject. The investigator or designee will maintain a log of all subjects who sign the ICF. 
Screening log content is described in Section 9.1.1. 
13.3 Subject Confidentiality 
The investigator is responsible for maintaining the privacy and confidentiality of the subject’s 
medical or health information collected during the study. The investigator is also responsible for 
ensuring that all use, review, and disclosure of subject’s medical or health information is in 
accordance with the Health Insurance Portability and Accountability Act (HIPAA) regulations 
and with local/regional requirements and that the ICF is approved by the IRB and signed by the 
subject. 
13.4 Data Handling and Record Keeping 
13.4.1 Source Documents 
The investigator must maintain detailed records of all study subjects who are enrolled in the 
study or who undergo screening. Source documents include, but are not limited to, subject 
medical records and investigator’s subject study files, as well as all test results. 
The following minimum information should be entered into the enrolled subject’s source 
documents: 
• The date the subject entered the study (received study injection) and the subject number 
• The study protocol number and the name Dynavax Technologies or Dynavax 
• The date that informed consent/assent was signed/obtained 
• Evidence that informed consent/assent was obtained before the subject underwent any study- 
specific procedures 
• Evidence that the subject meets study eligibility requirements (e.g., medical history, study 
procedures, evaluations) 
• The dates of all study-related subject visits 
• Evidence that study-required procedures and/or evaluations were completed 
• Use of any concurrent medications 
• Documentation of study drug accountability 
• Subject e-diary (or equivalent) entries 
• Occurrence and status of any AEs 
• The date the subject exited the study, and a notation as to whether the subject completed the 
study or was discontinued early, including the reason for discontinuation 
• Any deviations from the protocol 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 67 of 79 
 
 
13.4.2 Direct Access to Source Data/Documents 
Qualified individuals designated by Dynavax or its representative will monitor all aspects of the 
study at regular intervals throughout the study and following study completion. This monitoring 
is for the purpose of verifying adherence to the protocol including appropriate storage of study 
treatment, completeness and exactness of the data being entered onto the CRFs, and compliance 
with FDA or other regulatory agency regulations. The investigator and investigator’s institution 
agree to allow these monitors access to all study records, CRFs, and corresponding portions of 
the subject’s clinical study files; to allow access to the clinical supplies, dispensing, and storage 
areas; and if requested, to assist the monitors. The investigator further agrees to permit direct 
access to source data/documents for study-related monitoring, audits, IRB review, and regulatory 
inspection(s). 
In certain circumstances, a secondary audit may be conducted by members of Dynavax’s Clinical 
Quality Assurance group or by Dynavax’s designated representative. The investigator will be 
notified if this is to take place and advised as to the nature of the audit. 
13.5 Case Report Forms 
Case report forms (CRFs) will be used at the clinical study site to collect study data for enrolled 
subjects. For screen failures, the sponsor will collect, at a minimum, age, sex, ethnicity, race, the 
reason for screen failure and any SAEs that occur during the screening period. 
When data are available, authorized clinical study site personnel will carefully and accurately 
record the data on the CRFs. Sites must ensure that all source documents are maintained 
according to ICH/GCP guidance and support the data that are entered onto the CRFs. 
Case report forms will be in electronic form (eCRFs) for this study. The eCRF data will be 
captured in a system validated according to procedures that comply with 21 CFR Part 11, and 
ICH Guidelines for GCP E6 (R2), November 2016, Section 5.5. The eCRFs will be reviewed and 
signed by the principal investigator or someone clinically qualified and identified on the 
delegation log as someone that can sign-off on the eCRF. 
13.6 Data Handling 
The sponsor may designate a Contract Research Organization (CRO) to perform data 
management. The CRO will write a data management plan outlining the data management 
systems, procedures, and agreements between the CRO and sponsor. The plan will be reviewed 
and signed by a representative of the sponsor’s data management department. 
Outside the electronic data capture (EDC) system, when appropriate, the sponsor or designee 
(CRO) will receive FDA 21 CFR Part 11 (or locally required equivalent) compliant external lab 
data transfers from a validated laboratory information management system and subject reported 
safety information from a validated electronic patient report outcome (ePRO) system. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 68 of 79 
 
 
After database lock, the investigator will receive a copy of the subject data for archiving at the 
study site. 
Validation checks will be conducted to capture data errors, and data clarification queries will be 
generated at the time of data monitoring. Validation checks and queries will be issued to the 
investigational site for resolution, and the database will be updated to reflect query resolutions as 
appropriate. 
Data verification against the source documents will be performed by the sponsor or its designee 
prior to locking of the study database. Following the completion of source data verification, a 
thorough review of data will be completed manually by the clinical data managers to ensure data 
consistency and to identify and request correction of any remaining data errors. All queries will 
be resolved or closed with written documentation providing reasons for irresolvable queries. 
Additional manual validation checks will be performed as needed. 
13.7 Coding of Adverse Events, Drugs, and Diseases 
AEs and medical histories will be coded using a current version of the MedDRA. Prior and 
concomitant medications will be coded according to the World Health Organization Drug 
Dictionary. 
13.8 Record Retention 
The investigator must retain all records relating to the conduct of this study (including subject’s 
study records, receipt and disposition of all investigational materials, subject exclusion logs, 
signed consent forms, eCRFs, all correspondence, and other supporting documentation) for at 
least 2 years after a marketing application for this indication is approved; or if an application is 
not filed or not approved for the drug for this indication, for at least 2 years after clinical 
development for the drug has been formally discontinued and the appropriate regulatory or 
health authorities have been notified. However, in certain instances, documents may need to be 
retained for a longer period if required by regulatory requirements or by an agreement with 
Dynavax. 
The investigator may withdraw from the responsibility of retaining records only after transferring 
custody of the records to another individual who will accept responsibility for them. A written 
notice of transfer must be provided to Dynavax prior to or no later than 10 days after transfer. 
The investigator must allow representatives of the FDA, the governing IRB, or other regulatory 
agencies to inspect all study records. If informed of such an inspection, the investigator will 
notify Dynavax within 24 hours of being informed. 
The investigator must obtain written approval from Dynavax prior to the destruction of any 
records relating to the conduct of this study. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 69 of 79 
 
 
14 USE OF INFORMATION AND PUBLICATION 
No information related to data obtained and generated in this study shall be released or 
publicized without the prior written consent of an Agreements Officer Representative of the U.S. 
Government. 
Any publication will have the following statement to acknowledge the support of the 
Government whenever publicizing the study in any media: 
This project has been funded in part by the U.S. Government under Agreement W911QY-21-9- 
0018. The US Government is authorized to reproduce and distribute reprints for Governmental 
purposes notwithstanding any copyright notation thereon. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 70 of 79 
 
 
15 REFERENCES 
Arunachalam, P. S., A. C. Walls, N. Golden, C. Atyeo, S. Fischinger, C. Li, P. Aye, M. J. 
Navarro, L. Lai, V. V. Edara, K. Röltgen, K. Rogers, L. Shirreff, D. E. Ferrell, S. Wrenn, D. 
Pettie, J. C. Kraft, M. C. Miranda, E. Kepl, C. Sydeman, N. Brunette, M. Murphy, B. Fiala, L. 
Carter, A. G. White, M. Trisal, C.-L. Hsieh, K. Russell-Lodrigue, C. Monjure, J. Dufour, S. 
Spencer, L. Doyle-Meyer, R. P. Bohm, N. J. Maness, C. Roy, J. A. Plante, K. S. Plante, A. Zhu, 
M. J. Gorman, S. Shin, X. Shen, J. Fontenot, S. Gupta, D. T. O’Hagan, R. Van Der Most, R. 
Rappuoli, R. L. Coffman, D. Novack, J. S. McLellan, S. Subramaniam, D. Montefiori, S. D. 
Boyd, J. L. Flynn, G. Alter, F. Villinger, H. Kleanthous, J. Rappaport, M. S. Suthar, N. P. King, 
D. Veesler and B. Pulendran (2021). "Adjuvanting a subunit COVID-19 vaccine to induce 
protective immunity." Nature. 
Center for Biologics Evaluation and Research (2007). Guidance for Industry: Toxicity Grading 
Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials, U.S. Department of Health and Human Services, Food and Drug Administration. 
Daya, M. and Y. Nakamura (2005). "Pulmonary disease from biological agents: anthrax, plague, 
Q fever, and tularemia." Crit Care Clin 21(4): 747-763, vii. 
Dynavax Technologies Corporation (2021). HEPLISAV-B SmPC. 
Dynavax Technologies Corporation, P. I. (2020). "HEPLISAV-B® Package Insert." 
Halperin, S. A., B. Ward, C. Cooper, G. Predy, F. Diaz-Mitoma, M. Dionne, J. Embree, A. 
McGeer, P. Zickler, K. H. Moltz, R. Martz, I. Meyer, S. McNeil, J. M. Langley, E. Martins, W. 
L. Heyward and J. T. Martin (2012). "Comparison of safety and immunogenicity of two doses of 
investigational hepatitis B virus surface antigen co-administered with an immunostimulatory 
phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in 
healthy adults 18-55 years of age." Vaccine 30(15): 2556-2563. 
Hart, M. K., G. A. Saviolakis, S. L. Welkos and R. V. House (2012). "Advanced Development of 
the rF1V and rBV A/B Vaccines: Progress and Challenges." Advances in preventive medicine 
2012: 731604-731604. 
Heyward, W. L., M. Kyle, J. Blumenau, M. Davis, K. Reisinger, M. L. Kabongo, S. Bennett, R. 
S. Janssen, H. Namini and J. T. Martin (2013). "Immunogenicity and safety of an investigational 
hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a 
licensed hepatitis B vaccine in healthy adults 40-70 years of age." Vaccine 31(46): 5300-5305. 
Hinnebusch, B. J. and D. L. Erickson (2008). "Yersinia pestis biofilm in the flea vector and its 
role in the transmission of plague." Curr Top Microbiol Immunol 322: 229-248. 
Hsieh, S.-M., M.-C. Liu, Y.-H. Chen, W.-S. Lee, S.-J. Hwang, S.-H. Cheng, W.-C. Ko, K.-P. 
Hwang, N.-C. Wang, Y.-L. Lee, Y.-L. Lin, S.-R. Shih, C.-G. Huang, C.-C. Liao, J.-J. Liang, C.- 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 71 of 79 
 
 
S. Chang, C. Chen, C. E. Lien, I.-C. Tai and T.-Y. Lin (2021). "Safety and Immunogenicity of 
CpG 1018 and Aluminium Hydroxide-Adjuvanted SARS-CoV-2 S-2P Protein Vaccine MVC- 
COV1901: A Large-Scale Double-Blinded, Randomised, Placebo-Controlled Phase 2 Trial." 
medRxiv: 2021.2008.2005.21261532. 
Hsieh, S.-M., M.-C. Liu, Y.-H. Chen, W.-S. Lee, S.-J. Hwang, S.-H. Cheng, W.-C. Ko, K.-P. 
Hwang, N.-C. Wang, Y.-L. Lee, Y.-L. Lin, S.-R. Shih, C.-G. Huang, C.-C. Liao, J.-J. Liang, C.- 
S. Chang, C. Chen, C. E. Lien, I. C. Tai and T.-Y. Lin (2021). "Safety and immunogenicity of 
CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC- 
COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 
trial in Taiwan." The Lancet Respiratory Medicine 9(12): 1396-1406. 
Hsieh, S.-M., W.-D. Liu, Y.-S. Huang, Y.-J. Lin, E.-F. Hsieh, W.-C. Lian, C. Chen, R. Janssen, 
S.-R. Shih, C.-G. Huang, I. C. Tai and S.-C. Chang (2021). "Safety and immunogenicity of a 
Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC COV1901) 
Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose- 
escalation study." EClinicalMedicine 38: 100989. 
Hyer, R., D. K. McGuire, B. Xing, S. Jackson and R. Janssen (2018). "Safety of a two-dose 
investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant in 
adults." Vaccine 36(19): 2604-2611. 
Inglesby, T. V., D. T. Dennis, D. A. Henderson, J. G. Bartlett, M. S. Ascher, E. Eitzen, A. D. 
Fine, A. M. Friedlander, J. Hauer, J. F. Koerner, M. Layton, J. McDade, M. T. Osterholm, T. 
O'Toole, G. Parker, T. M. Perl, P. K. Russell, M. Schoch-Spana and K. Tonat (2000). "Plague as 
a biological weapon: medical and public health management. Working Group on Civilian 
Biodefense." Jama 283(17): 2281-2290. 
Jackson, S., J. Lentino, J. Kopp, L. Murray, W. Ellison, M. Rhee, G. Shockey, L. Akella, K. 
Erby, W. L. Heyward and R. S. Janssen (2018). "Immunogenicity of a two-dose investigational 
hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a 
licensed hepatitis B vaccine in adults." Vaccine 36(5): 668-674. 
Khoury, D. S., D. Cromer, A. Reynaldi, T. E. Schlub, A. K. Wheatley, J. A. Juno, K. Subbarao, 
S. J. Kent, J. A. Triccas and M. P. Davenport (2021). "Neutralizing antibody levels are highly 
predictive of immune protection from symptomatic SARS-CoV-2 infection." Nature Medicine 
27(7): 1205-1211. 
Koirala, J. (2006). "Plague: disease, management, and recognition of act of terrorism." Infect Dis 
Clin North Am 20(2): 273-287, viii. 
McGovern, T. F., A.M. (1997). Plague. Medical Aspects of Chemical and Biological Warfare. 
Washington, DC, USA, US Department of the Army, Office of the Surgeon General, and Borden 
Institute: 479–502. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 5 
CONFIDENTIAL AND PROPRIETARY 
Page 72 of 79 
 
 
Perry, R. D. and J. D. Fetherston (1997). "Yersinia pestis--etiologic agent of plague." Clin 
Microbiol Rev 10(1): 35-66. 
Prentice, M. B. and L. Rahalison (2007). "Plague." Lancet 369(9568): 1196-1207. 
Richmond, P., L. Hatchuel, M. Dong, B. Ma, B. Hu, I. Smolenov, P. Li, P. Liang, H. H. Han, J. 
Liang and R. Clemens (2021). "Safety and immunogenicity of S-Trimer (SCB-2019), a protein 
subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, 
placebo-controlled trial." The Lancet 397: 682-694. 
Richmond, P. C., L. Hatchuel, F. Pacciarini, B. Hu, I. Smolenov, P. Li, P. Liang, H. H. Han, J. 
Liang and R. Clemens (2021). "Persistence of the Immune Responses and Cross-Neutralizing 
Activity With Variants of Concern Following 2 Doses of Adjuvanted SCB-2019 Coronavirus 
Disease 2019 Vaccine." The Journal of Infectious Diseases. 
Vadyvaloo, V., C. Jarrett, D. Sturdevant, F. Sebbane and B. J. Hinnebusch (2007). "Analysis of 
Yersinia pestis gene expression in the flea vector." Adv Exp Med Biol 603: 192-200. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 4 
APPENDIX 1: 
SCHEDULE OF TRIAL EVENTS 
CONFIDENTIAL AND PROPRIETARY 
Page 73 of 79 
 
 
BRIDGE ELISA 
2
T
2
5
8
113 
183 
211 
267 
351 
±3) 
±3) 
±3) 
±
±7) 
±7) 
±7) 
±7) 
1
1
2
3
3
5
5
Month 
1
 
 
Screen- 
inga 
 
Treat- 
ment 
 
Follow 
up 
 
Treat- 
ment 
 
 
Follow up 
 
Treat- 
ment 
 
 
Follow up 
EOS/ 
Early Discontinuationb 
(TC) 
393 (±14) 
(Early discontinuation: 
-28 
TC 
29 
57 
85 
113 
183 
211 
267 
351 
28 days after 
 
 
 
Informed Consent 
Inclusion/Exclusion Criteria 
Demographicse 
Medical and Medication Historye 
Vital Signs f 
Physical Examg 
HIV, HBV, HCV Testingh 
Pregnancy test i 
Serum chemistryk 
Hematologyl 
Days 
Weeks 
Months 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
1 
4c 
0 
0 
0 
 
 
 
X 
X 
( 
( 
( 
( 
) 
( 
4 
8 
12 
16 
26 
1 
2 
3 
4 
6 
 
 
 
 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
( 
( 
( 
30 
38 
50 
7 
9 
12 
last study vaccine) 
56 
13 
Blood sample for rF1V 
concentrationm 
Blood samples for reserve/exploratory objectivesn 
X 
Study injections for rF1V vaccine and CpG 1018o 
Study injections for rF1V vaccine and placeboo 
30-minute post-injection observationp 
Distribute and/or Review Subject e-Diary or equivalent) 
Instructions 
Review Subject e-Diary (or equivalent) with Daily 
Temperature and Local/Systemic Reactions j 
Assessment of AEs, SAEs, immune-mediated AESIs q,r 
Xr 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Xd 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
AE = adverse event; BP = blood pressure; CBC = complete blood count; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; HR = 
heart rate; RR = respiratory rate; SAE = serious adverse event; TC= telephone call. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 4 
CONFIDENTIAL AND PROPRIETARY 
Page 74 of 79 
 
 
(Bridge ELISA) 
232 days 3 weeks
1, Day 29, and 183 
APPENDIX 1: 
SCHEDULE OF TRIAL EVENTS (CONT’D) FOOTNOTES 
Screeninga 
Routine laboratory tests (serum chemistry, hematology) for screening should be performed within 28 days prior to enrollment. Subjects may 
have the screening window extended an additional 7-calendar days if they have equivocal laboratory results or if they cannot be enrolled during 
the screening window. The screening window may only be extended one time and must have prior approval by the sponsor’s medical monitor. 
EOS/Safety F/Ub 
A mandatory EOS/Safety Follow-up telephone call will be performed 232 days (30 weeks) after the administration of the last study vaccine. If 
a subject receives received less than 3 doses of vaccine, their EOS visit will be 28 days after their last dose. The EOS visit procedures will be 
performed as an Early Discontinuation visit if the subject is permanently discontinued early from the trial. 
Telephone Callc 
Telephone call Day 4 (Part 1 only) and EOS 
Part 1 Final immunogenicity 
Assessmentd 
Part 1 final immunogenicity assessment will be conducted based on Day 57. 
Demographics/Medical 
History/Prior Medicationse 
Demographic and baseline characteristics of sex, race, ethnicity, age, weight, and height, and medical history will be collected. Report 
complete medication history for 28 days prior to Baseline (Day 1). 
Vital Signsf 
Includes oral temperature (only at trial injection visits), heart rate, respiratory rate, systolic and diastolic blood pressure. 
Physical Examinationg 
The investigator or qualified designee will conduct physical examinations. A complete physical examination is conducted at Screening. A 
symptom-directed physical exam is conducted at all other designated time points. 
HIV, HBV, HCV Testingh 
HIV, HBV, HCV testing. 
Pregnancy Testi 
For females of childbearing potential, a serum pregnancy test will be collected at screening and must be negative for the subject to participate. 
A urine pregnancy test must be negative within 24 hours prior to administration of each study vaccine. The test must be negative for the subject 
to receive study injection. 
Subject Diaryj 
At the Day 1 visit, subjects are provided with a ruler, thermometer and instructions for completing the study diary. At Day 
and 183, 
subjects are instructed to complete the e-diary (or equivalent) to record any solicited local (pain, pruritus, redness, and swelling at the injection 
site) and solicited systemic signs and symptoms (fatigue, chills, myalgia, malaise, fever, gastrointestinal symptoms, and headache) during the 
7-day follow-up period after administration of each study vaccine. 
Serum Chemistryk 
Chemistry (includes sodium, potassium, chloride, bicarbonate, BUN, Cr, glucose, calcium, AST, ALT, LDH, bilirubin, alkaline phosphatase). 
Hematologyl 
Hematology includes red blood cell count, Hgb, hematocrit, WBC count with differential, and platelet count. 
Serologym 
Standardized enzyme-linked immunosorbent assays 
to determine serum concentrations of antibodies to rF1V. Samples will be 
drawn prior to study vaccine injection on vaccination days. The same sample will be used for the exploratory analysis to determine serum 
concentrations of antibodies to rF1 and rV. 
Reserve Serum Aliquotn 
An extra aliquot of serum collected and stored frozen for possible future testing (drawn prior to study injection on vaccine days) 
Study Vaccine Administrationo 
Subjects will be randomly assigned and receive an injection of study vaccine on vaccination days. 
If Group 2 is selected from the Part 1, then in Part 2, placebo will not be co-administered with rF1V. 
Post-Injection Observationp 
Subjects will remain in the clinic for 30 minutes after administration of study vaccine for observation of post-injection local and systemic 
reactions and AEs. 
Review AEsq 
All AEs will be graded per CBER Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine 
Clinical Trials and evaluated for seriousness. AEs will be collected Day 1 through Week 56 or Early Discontinuation Visit. 
Review SAEsr 
All SAEs will be evaluated from the time the consent is signed through the EOS Visit. SAEs must be reported to Dynavax or its designee 
within 24 hours of the knowledge of the event. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 4 
CONFIDENTIAL AND PROPRIETARY 
Page 75 of 79 
 
 
APPENDIX 2: 
TOXICITY GRADING SCALE FOR HEALTHY ADULT AND ADOLESCENT VOLUNTEERS ENROLLED 
IN PREVENTIVE VACCINE CLINICAL TRIALS 
Mild (Grade 1) 
Moderate (Grade 2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Local Injection Site) Reactions 
Pain 
Does not interfere with 
activity 
Repeated use of non-narcotic pain 
reliever > 24 hours or interferes with 
activity 
Any use of narcotic pain reliever or 
prevents daily activity 
Emergency room (ER) 
visit or hospitalization 
Tenderness 
Mild discomfort to touch Discomfort with movement 
Significant discomfort at rest 
ER visit or 
hospitalization 
Erythema/Rednessa 
2.5 – 5 cm 
5.1 – 10 cm 
> 10 cm 
Necrosis or exfoliative 
dermatitis 
Induration/Swellingb 
2.5 – 5 cm and does not 
interfere with activity 
5.1 – 10 cm or interferes with activity 
> 10 cm or prevents daily activity 
Necrosis 
Pruritusc 
No interference with 
activity 
Some interference with activity, not 
requiring medical intervention 
Prevents daily activity and requires 
medical intervention 
ER visit or 
hospitalization 
Systemic Reactions 
Fever (°C) 
38.0 – 38.4 
38.5-38.9 
39.0-40 
>40 
Myalgia 
No interference with 
activity 
Some interference with activity 
Significant: prevents daily activity 
ER visit or 
hospitalization 
Fatigue 
No interference with 
activity 
Some interference with activity 
Significant: prevents daily activity 
ER visit or 
hospitalization 
Malaise 
Uneasiness or lack of well 
being 
Uneasiness or lack of well being; limiting 
instrumental ADL 
A grade is not available 
A grade is not 
available 
Chillsc 
No interference with 
activity 
Some interference with activity, not 
requiring medical intervention 
Prevents daily activity and requires 
medical intervention 
ER visit or 
hospitalization 
Nausea/ 
vomiting 
No interference with 
activity or 1 – 2 
episodes/24 hours 
Some interference with activity or > 2 
episodes/24 hours 
Prevents daily activity, requires 
outpatient IV hydration 
ER visit or 
hospitalization for 
hypotensive shock 
Diarrhea 
2 – 3 loose stools or < 400 
gms 
/24 hours 
4 – 5 stools or 400 – 800 gms/24 hours 
6 or more watery stools or > 
800gms/24 hours or requires outpatient 
IV hydration 
ER visit or 
hospitalization 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 4 
CONFIDENTIAL AND PROPRIETARY 
Page 76 of 79 
 
 
 
Mild (Grade 1) 
Moderate (Grade 2) 
Severe (Grade 3) 
Potentially Life 
Threatening 
(Grade 4) 
Headache 
No interference with 
activity 
Repeated use of nonnarcotic pain reliever 
> 24 hours or some interference with 
activity 
Significant; any use of narcotic pain 
reliever or prevents daily activity 
ER visit or 
hospitalization 
Systemic Illness 
Illness or clinical adverse event (as 
defined according to applicable 
regulations) 
No interference with 
activity 
Some interference with activity not 
requiring medical intervention 
Prevents daily activity and requires 
medical intervention 
ER visit or 
hospitalization 
Source: (Center for Biologics Evaluation and Research 2007). 
ER = emergency room; IV = intravenous. 
a 
In addition to grading the measured local reaction at the greatest single diameter, the measurement should be recorded as a continuous variable. 
b 
Induration/swelling should be evaluated and graded using the functional scale as well as the actual measurement 
c 
Not part of CBER grading scale. 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 3 
CONFIDENTIAL AND PROPRIETARY 
Page 77 of 79 
 
 
APPENDIX 3: 
LIST OF AUTOIMMUNE CONDITIONS AND TERMS OF 
SPECIAL INTEREST 
Any of the conditions listed below that are newly occurring after vaccination are to be 
categorized as an AESI. In addition, subjects with any of the conditions listed below are 
excluded from the studya. 
Gastrointestinal disorders 
• Celiac disease 
• Crohn’s disease 
• Ulcerative colitis 
• Ulcerative proctitis 
 
Liver disorders 
• Autoimmune cholangitis 
• Autoimmune hepatitis 
• Primary biliary cirrhosis 
• Primary sclerosing cholangitis 
 
Metabolic diseases 
• Addison’s disease 
• Autoimmune thyroiditis (including Hashimoto thyroiditis) 
• Diabetes mellitus type 1 
• Grave’s or Basedow’s disease 
 
Musculoskeletal disorders 
• Antisynthetase syndrome 
• Dermatomyositis 
• Juvenile chronic arthritis (including Still’s disease) 
• Mixed connective tissue disorder 
• Polymyalgia rheumatic 
• Polymyositis 
• Psoriatic arthropathy 
• Relapsing polychondritis 
• Rheumatoid arthritis 
• Scleroderma, including diffuse systemic form and CREST syndrome 
• Spondyloarthritis, including ankylosing spondylitis, reactive arthritis (Reiter’s Syndrome) 
and undifferentiated spondyloarthritis 
• Systemic lupus erythematosus 
• Systemic sclerosis 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 3 
CONFIDENTIAL AND PROPRIETARY 
Page 78 of 79 
 
 
Neuroinflammatory disorders 
• Acute disseminated encephalomyelitis, including site specific variants: eg, non-infectious 
encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis 
• Cranial nerve disorders, including paralyses/paresis (eg, Bell’s palsy) 
• Guillain-Barré syndrome, including Miller Fisher syndrome and other variants 
• Tolosa Hunt syndromeb 
• Immune-mediated peripheral neuropathies and plexopathies (including chronic 
inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and 
polyneuropathies associated with monoclonal gammopathy) 
• Multiple sclerosis 
• Myasthenia gravis, including Eaton-Lambert syndrome 
• Narcolepsy 
• Optic neuritis 
• Transverse Myelitis 
 
Skin disorders 
• Alopecia areata 
• Autoimmune bullous skin diseases (including pemphigus, pemphigoid and dermatitis 
herpetiformis) 
• Cutaneous lupus erythematosus 
• Erythema nodosum 
• Morphoea 
• Lichen planus 
• Psoriasis 
• Rosacea 
• Sweet’s syndrome 
• Vitiligo 
 
Vasculitides 
• Large vessels vasculitis including: giant cell arteritis such as Takayasu’s arteritis and 
temporal arteritis 
• Medium sized and/or small vessels vasculitis including: polyarteritis nodosa, Kawasaki’s 
disease, microscopic polyangiitis, Wegener’s granulomatosis, Churg-Strauss syndrome 
(allergic granulomatous angiitis), Buerger’s disease (thromboangiitis obliterans), necrotizing 
vasculitis and anti-neutrophil cytoplasmic antibody (ANCA) positive vasculitis (type 
unspecified), Henoch-Schonlein purpura, Behcet’s syndrome, leukocytoclastic vasculitis 

Dynavax Technologies Corporation 
rF1V Vaccine with CpG 1018 
Protocol DV2-PLG-01 
Amendment 3 
CONFIDENTIAL AND PROPRIETARY 
Page 79 of 79 
 
 
Others 
• Antiphospholipid syndrome 
• Autoimmune hemolytic anemia 
• Autoimmune glomerulonephritis (including IgA nephropathy, glomerulonephritis rapidly 
progressive, membranous glomerulonephritis, membranoprofilerative glomerulonephritis, 
and masangioproliferative glomerulonephritis 
• Autoimmune myocarditis/cardiomyopathy 
• Autoimmune thrombocytopenia 
• Goodpasture syndrome 
• Idiopathic pulmonary fibrosis 
• Pernicious anemia 
• Raynaud’s phenomenon 
• Sarcoidosis 
• Sjögren’s syndrome 
• Stevens-johnson syndrome 
• Uveitis 
 
 
a 
List provided to Dynavax Technologies by FDA on 30 January 2019 
b 
Added by Dynavax