A Phase 1, Randomized, Parallel-Group, Double-Blind Trial of AV7909 (Liquid) and Thermostable AV7909 (Lyophilized) in Healthy Adult Volunteers
Phase: PHASE1
Conditions: Anthrax, Anthrax Immunisation
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase 1, Randomized, Parallel-Group, Double-Blind Trial of AV7909 (Liquid) 
and Thermostable AV7909 (Lyophilized) in Healthy Adult Volunteers 
 
DMID Protocol Number: 17-0093 
 
 
DMID Funding Mechanism: Vaccine and Treatment Evaluation Units 
 
 
Pharmaceutical Support: 
Emergent BioSolutions 
 
 
IND Sponsor: Division of Microbiology and Infectious Diseases, National 
Institute of Allergy and Infectious Diseases, National Institutes of Health 
 
Lead Principal Investigator: James D. Campbell, MD, MS 
DMID Clinical Project Manager: Onyinye Erondu, RN, MS 
DMID Medical Monitor: Jorge Mejia-Galvis, MD, MBA 
DMID Medical Officer: Maryam Keshtkar-Jahromi, MD, MPH 
DMID Scientific Lead: Colleen Sico, ChemE MBA 
 
Version: 4.0 
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STATEMENT OF COMPLIANCE 
 
This trial will be carried out in accordance with Good Clinical Practice (GCP) as required by the 
following: 
 
• 
United States (US) Code of Federal Regulations (CFR) 45 CFR Part 46: Protection of 
Human Subjects 
 
• 
Food and Drug Administration (FDA) Regulations, as applicable: 21 CFR Part 50 
(Protection of Human Subjects), 21 CFR Part 54 (Financial Disclosure by Clinical 
Investigators), 21 CFR Part 56 (Institutional Review Boards), 21 CFR Part 11, and 21 
CFR Part 312 (Investigational New Drug Application), 21 CFR 812 (Investigational 
Device Exemptions) 
 
• 
International Council for Harmonisation (ICH) E6(R2) Good Clinical Practice: 
Integrated Addendum to ICH E6(R1) Guidance for Industry, published in the Federal 
Register (83 Federal Register 8882 (2018)) and future revisions 
 
• 
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects 
of Research, Report of the National Commission for the Protection of Human Subjects of 
Biomedical and Behavioral Research 
 
• 
National Institutes of Health (NIH) Office of Extramural Research, Research Involving 
Human Subjects, as applicable 
 
• 
National Institute of Allergy and Infectious Diseases (NIAID) Clinical Terms of Award, 
as applicable 
 
• 
Applicable Federal, State and Local Regulations and Guidance 

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SIGNATURE PAGE 
The signature below provides the necessary assurance that this trial will be conducted according 
to all stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal regulations and 
current ICH E6 GCP guidelines. 
 
I agree to conduct the study in compliance with GCP and applicable regulatory requirements. 
 
I agree to conduct the study in accordance with the current protocol and will not make changes to 
the protocol without obtaining the sponsor’s approval and Institutional Review Board 
(IRB)/Institutional Ethics Committee (IEC) approval, except when necessary to protect the 
safety, rights, or welfare of subjects. 
 
Site Principal Investigator: 
Signed: 
Date: 
Name:  James D. Campbell, MD, MS 
Title: 
Principal Investigator 

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TABLE OF CONTENTS 
STATEMENT OF COMPLIANCE ................................................................................................. 1 
SIGNATURE PAGE ........................................................................................................................ 2 
TABLE OF CONTENTS ................................................................................................................. 3 
LIST OF TABLES ........................................................................................................................... 7 
LIST OF FIGURES .......................................................................................................................... 8 
LIST OF ABBREVIATIONS .......................................................................................................... 9 
PROTOCOL SUMMARY ............................................................................................................. 12 
1 
Key Roles .............................................................................................................................. 18 
2 
Background Information and Scientific Rationale ................................................................ 20 
Background Information ........................................................................................... 20 
Scientific Rationale ................................................................................................... 20 
Potential Risks and Benefits ...................................................................................... 21 
2.3.1 Potential Risks ............................................................................................... 21 
2.3.2 Known Potential Benefits .............................................................................. 25 
3 
Study Objectives and Outcome Measures ............................................................................. 27 
4 
Study Design ......................................................................................................................... 28 
5 
Study Enrollment and Withdrawal ........................................................................................ 30 
Eligibility Criteria ..................................................................................................... 30 
5.1.1 Participant Inclusion Criteria......................................................................... 30 
5.1.2 Participant Exclusion Criteria ....................................................................... 32 
5.1.3 Screen Failures .............................................................................................. 35 
Treatment Assignment Procedures ............................................................................ 36 
5.2.1 Enrollment and Randomization Procedures .................................................. 36 
5.2.2 Masking Procedures ...................................................................................... 36 
5.2.3 Reasons for Withdrawals and Discontinuation of Study Product 
Administration ............................................................................................... 37 
5.2.4 Handling of Withdrawals and Discontinuation of Study Product 
Administration ............................................................................................... 38 
5.2.5 Participant Replacement ................................................................................ 38 
5.2.6 Termination of Study .................................................................................... 38 
6 
Study Intervention/Investigational Product ........................................................................... 40 
Study Product Description......................................................................................... 40 
6.1.1 Formulation, Storage, Packaging, and Labeling ........................................... 41 
6.1.2 Study Product Storage and Stability Procedures ........................................... 42 
Dosage, Preparation and Administration of Study Intervention/Investigational 
Product ...................................................................................................................... 42 
Accountability Procedures for the Study Intervention/Investigational Product ........ 43 

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Assessment of Participant Compliance with Study Intervention/Investigational 
Product ...................................................................................................................... 44 
Concomitant Medications/Treatments ....................................................................... 44 
7 
Study Procedures/Evaluations ............................................................................................... 45 
Clinical Evaluations .................................................................................................. 45 
Laboratory Evaluations ............................................................................................. 46 
7.2.1 Clinical Laboratory Evaluations .................................................................... 46 
7.2.2 Special Assays or Procedures ........................................................................ 48 
7.2.3 Specimen Preparation, Handling, and Shipping ............................................ 49 
8 
Study Schedule ...................................................................................................................... 51 
Screening and Enrollment Visits ............................................................................... 51 
8.1.1 Visit 0, Screening (Day -28 to -2), Clinic Visit ............................................ 51 
8.1.2 Visit 1, Day 1, Enrollment (Vaccination), Clinic Visit ................................. 52 
Follow-up Visits ........................................................................................................ 54 
8.2.1 Visit 2, Day 8, Clinic Visit (End of Solicited Reactogenicity Period after 
First Vaccination) .......................................................................................... 54 
8.2.2 Visit 3, Day 15, Clinic Visit (Second Vaccination) ...................................... 55 
8.2.3 Visit 4, Day 22, Clinic Visit (End of Solicited Reactogenicity Period after 
Second Vaccination) ...................................................................................... 56 
8.2.4 Visit 5, Day 29, Clinic Visit .......................................................................... 57 
8.2.5 Visit 6, Day 64, Clinic Visit .......................................................................... 58 
(Window: Day 60-68, inclusive) ............................................................................... 58 
8.2.6 Visit 7, Day 195, Clinic Visit ........................................................................ 58 
(Window: Day 188 to 202, inclusive) ....................................................................... 58 
Final Visit .................................................................................................................. 59 
8.3.1 Visit 8, Day 380, Clinic Visit ........................................................................ 59 
(Window: Day 373 to 387, inclusive) ....................................................................... 59 
Early Termination Visit (if needed) .......................................................................... 59 
Unscheduled Visit (if needed) ................................................................................... 60 
9 
Assessment of Safety ............................................................................................................ 62 
Specification of Safety Parameters ............................................................................ 62 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 63 
9.2.1 Adverse Events .............................................................................................. 63 
9.2.2 Reactogenicity ............................................................................................... 65 
9.2.3 Additional Adverse Event Severity Grading ................................................. 67 
9.2.4 Serious Adverse Events ................................................................................. 69 
9.2.5 Procedures to be Followed in the Event of Abnormal Laboratory Test 
Values or Abnormal Clinical Findings .......................................................... 70 
Reporting Procedures ................................................................................................ 70 
9.3.1 Serious Adverse Events ................................................................................. 71 

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9.3.2 Regulatory Reporting for Studies Conducted Under DMID-Sponsored IND 
.......................................................................................................................71 
9.3.3 Reporting of Pregnancy ................................................................................. 72 
Type and Duration of Follow-up of Participants after Adverse Events .................... 72 
Halting Rules ............................................................................................................. 73 
9.5.1 Individual Halting Rules ............................................................................... 73 
9.5.2 Study Halting Rules ...................................................................................... 73 
Safety Oversight ........................................................................................................ 74 
9.6.1 Independent Safety Monitor (ISM) ............................................................... 74 
9.6.2 Safety Monitoring Committee ....................................................................... 75 
10 
Clinical Monitoring ............................................................................................................... 76 
Site Monitoring Plan ................................................................................................. 76 
11 
Statistical Considerations ...................................................................................................... 77 
Introduction ............................................................................................................... 77 
Study Hypotheses ...................................................................................................... 77 
Study Outcome Measures .......................................................................................... 77 
Sample Size Considerations ...................................................................................... 77 
11.4.1 Study Population ........................................................................................... 77 
11.4.2 Participant Enrollment and Follow-up .......................................................... 77 
11.4.3 Sample Size ................................................................................................... 78 
Planned Interim Analyses .......................................................................................... 80 
11.5.1 Interim Safety Review ................................................................................... 80 
Final Analysis Plan .................................................................................................... 80 
11.6.1 Analysis Populations ..................................................................................... 80 
12 
Data Collection Forms and Access to Source Data/Documents ............................................ 83 
13 
Quality Control and Quality Assurance ................................................................................ 85 
14 
Ethics/Protection of Human Participants .............................................................................. 86 
Ethical Standard ........................................................................................................ 86 
Institutional Review Board (IRB) .............................................................................. 86 
Informed Consent Process ......................................................................................... 87 
Exclusion of Women, Minorities and Children (Special Populations) ..................... 88 
Participant Confidentiality ......................................................................................... 89 
Study Discontinuation ............................................................................................... 90 
Costs, Participant Compensation and Research Related Injuries .............................. 90 
Secondary Use of Stored Specimens ......................................................................... 91 
15 
Data Handling and Record Keeping ...................................................................................... 93 
Data Management Responsibilities ........................................................................... 93 
Data Capture Methods ............................................................................................... 94 
Types of Data ............................................................................................................ 94 
Timing/Reports .......................................................................................................... 94 

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Study Records Retention ........................................................................................... 95 
Protocol Deviations .................................................................................................... 95 
16 
Publication Policy ................................................................................................................. 96 
17 
Literature References ............................................................................................................ 97 
18 
Appendices ............................................................................................................................ 99 
    SCHEDULE OF STUDY PROCEDURES AND EVALUATIONS ............. 100 
Adverse Events of special interest ............................................................... 103 

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LIST OF TABLES 
 
Table 1: Study Objectives and Outcome Measures ....................................................................... 13 
Table 2: Study Groups ................................................................................................................... 16 
Table 3: Venipuncture Volumes .................................................................................................... 48 
Table 4: Safety/Tolerability Assessment Timeline ........................................................................ 62 
Table 5: Injection Site Reactogenicity Grading ............................................................................ 62 
Table 6: Injection Site Reactogenicity Measurements .................................................................. 63 
Table 7: Subjective Systemic Reactogenicity Grading ................................................................. 63 
Table 8: Quantitative Systemic (Oral Temperature) Reactogenicity Grading .............................. 64 
Table 9: Pulse and BP Adverse Event Grading ............................................................................. 64 
Table 10: Clinical Safety Laboratory Adverse Event Grading… ................................................. 65 
Table 11: Probability (%) to Detect Safety Events Emmes .......................................................... 75 
Table 12: Precision of Binomial Confidence Intervals ................................................................. 75 
Table 13: Minimum Detectable Difference in the Probability of Response with 80% Power ...... 76 

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LIST OF FIGURES 
Figure 1: Schematic of Study Design ............................................................................................. 17 

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LIST OF ABBREVIATIONS 
 
 
AE 
Adverse Event/Adverse Experience 
AESIs 
Adverse Events of Special Interest 
ALT 
Alanine Aminotransferase 
AVA 
Anthrax Vaccine Adsorbed 
AV7909 
Anthrax Vaccine with CPG7909 Adjuvant 
β hCG 
Beta- human Chorionic Gonadotropin (Pregnancy Test) 
BMI 
Body Mass Index 
BP 
Blood Pressure 
BUN 
Blood Urea Nitrogen 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CMS 
Clinical Materials Services 
COI 
Conflict of Interest 
CPG 7909 
a CPG oligodeoxynucleotide adjuvant 
CpG55.2 
a CPG oligodeoxynucleotide adjuvant 
Cr 
Creatinine 
CRP 
C-Reactive Protein 
CROMS 
Clinical Research Operations and Management Support 
CSR 
Clinical Study Report 
D 
Day(s) 
DNA 
Deoxyribonucleic Acid 
DCF 
Data Collection Form 
DMID 
Division of Microbiology and Infectious Diseases, NIAID, NIH 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
eClinical 
Electronic Data Capture System 
eMemory Aid 
Electronic Memory Aid 
ELISA 
Enzyme Linked ImmunoSorbent Assay 
FDA 
Food and Drug Administration 
FWA 
Federal-Wide Assurance 
GCP 
Good Clinical Practice 
GMT 
Geometric Mean Titer 
HBsAg 
Hepatitis B surface Antigen 
HCV 
Hepatitis C Virus 
HEENT 
Physical Exam of the Head, Eyes, Ears, Nose, and Throat 
Hgb 
Hemoglobin 
HIPAA 
Health Insurance Portability and Accountability Act 

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HIV 
Human Immunodeficiency Virus 
HLGT 
High Level Group Term 
HRPO 
Human Research Protections Office 
IATA 
International Air Transport Association 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
IgG 
Immunoglobulin G 
IM 
Intramuscular(ly) 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
IU/L 
International Unit(s) per Liter 
LLOQ 
Lower Limit of Quantitation 
MAAE 
Medically-Attended Adverse Event 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg/dL 
Milligrams per Deciliter 
mITT 
Modified Intent-to-Treat 
mL 
Milliliter(s) 
mm³ 
Cubic Millimeter(s) 
MOP 
Manual of Procedures 
N 
Number of Subjects 
NIAID 
National Institute of Allergy and Infectious Diseases, NIH, DHHS 
NIH 
National Institutes of Health 
OAC 
Office of Accountability and Compliance 
ODNs 
Synthetic oligodeoxynucleotides 
OER 
Office of Extramural Research 
OHRP 
Office for Human Research Protections 
PHI 
Personal (Protected) Health Information 
PA 
Protective Antigen 
PI 
Principal Investigator 
PII 
Personally Identifiable Information 
PIMMCs 
Potentially Immune-Mediated Medical Conditions 
PP 
Per Protocol 
QA 
Quality Assurance 
QC 
Quality Control 
RF 
Rheumatoid Factor 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SAP 
Statistical Analysis Plan 
SDCC 
Statistical and Data Coordinating Center 

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SIRVA 
Shoulder Injury Related to Vaccine Administration 
SMC 
Safety Monitoring Committee 
SOP 
Standard Operating Procedure 
TNA 
Toxin Neutralization Assay 
ULN 
Upper Limit of Normal 
UMB 
University of Maryland, Baltimore 
US 
United States 
V 
Visit(s) 
VTEU 
Vaccine and Treatment Evaluation Unit 
WHO 
World Health Organization 

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PROTOCOL SUMMARY 
 
 
Title: 
A Phase 1, Randomized, Parallel-Group, Double-Blind Trial of AV7909 
(Liquid) and Thermostable AV7909 (Lyophilized) in Healthy Adult 
Volunteers 
Phase: 
I 
Population: 
40 males and non-pregnant females, 18 to 45 years of age, inclusive, 
who are in good health and meet all eligibility criteria 
Number of Sites: 
1 Vaccine and Treatment Evaluation Unit (VTEU) 
Study Duration: 
Approximately 16 months from first screening visit for first participant 
until last follow-up visit for last participant 
Subject Participation Duration: 
Approximately 13 months 
Estimated Time to Complete 
Enrollment: 
Approximately6 months 
Description of Agents: 
• 
AV7909 liquid formulation vaccine 
• 
AV7909 lyophilized formulation vaccine 

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Table 1: Study Objectives and Outcome Measures 
Primary Objective: Safety 
Primary Safety Outcome Measures 
• 
To assess the safety of lyophilized and 
liquid formulations of AV7909. 
• 
Occurrence of all SAEs through approximately 12 
months following receipt of the second study 
vaccination (approximately Day 380). 
• 
Occurrence of abnormal clinical safety laboratory 
AEs at approximately Day 29. 
• 
Occurrence of all protocol specified AESIs (i.e., 
PIMMCs) and MAAEs, from the time of the first 
study vaccination through approximately 12 
months following the second vaccination 
(approximately Day 380). 
• 
Occurrence of unsolicited non-serious adverse 
events from the time of the first study vaccination 
through approximately Day 64. 
Primary Objective: Tolerability 
Primary Tolerability Outcome Measures 
• 
To assess the tolerability of lyophilized and 
liquid formulations of AV7909. 
• 
Occurrence of solicited injection site and systemic 
reactogenicity events in the week after each study 
vaccination (Days 1 through 8 and Days 15 
through 22, inclusive). 
Secondary Objective: Immunogenicity 
Secondary Immunogenicity Outcome Measures 
• 
To obtain initial estimate of comparative 
immunogenicity of liquid and lyophilized 
formulations of AV7909. 
• 
Geometric mean titer and 95% confidence 
intervals of antibodies assayed by toxin 
neutralization assay (ED50 and NF50) and anti-PA 
IgG by ELISA in each study group before 
vaccination and on approximately Days 8, 15, 22, 
29, 64, 195, and 380. 
• 
Proportion and 95% confidence intervals of 
participants in each study group with 
seroconversion for antibodies detected by TNA 
and ELISA (defined as a ≥4-fold increase over 
baseline levels, or a ≥4-fold increase over the 
lower limit of quantification [LLOQ] if the 
baseline value is < LLOQ) on approximately Days 
8, 15, 22, 29, 64, 195, and 380. 
• 
Proportion and 95% confidence intervals of 
participants in each study group with putative 
seroprotection (defined as NF50 ≥ 0.56) before 
vaccination and on approximately Days 8, 15, 22, 
29, 64, 195, and 380. 
Exploratory Immunogenicity Objectives 
Exploratory Immunogenicity 
Study Outcomes 
• 
None 
• 
None 

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Description of Study 
Design: 
The study is a phase I randomized, parallel-group, double-blind controlled 
interventional trial in which the safety, tolerability, and immunogenicity of 2 
formulations of adjuvanted anthrax vaccine (AV7909), lyophilized and liquid, 
both manufactured by Emergent BioSolutions, will be assessed and compared. 
AV7909 is an investigational vaccine that combines the currently licensed 
Anthrax Vaccine Adsorbed (AVA, BioThrax) with the adjuvant CPG 7909, an 
oligonucleotide. Forty healthy young adults, 18 to 45 years old, inclusive, who 
meet all eligibility criteria, will be randomly allocated to one of two study groups 
in a 1:1 ratio: 20 will receive AV7909 as the thermostable lyophilized product 
and 20 will receive AV7909 as the liquid product. Stratification by age category 
and by gender will assure that near equal numbers of younger (18-30 years) and 
older (31-45 years) males and females are assigned to each vaccine. The 
vaccines will be given intramuscularly in a 2-dose schedule, 2 weeks apart. Data 
entry will be “direct”, that is, without the significant use of paper source 
documents or case report forms. Participants will be followed for safety and 
tolerability by in-person visits, electronic reactogenicity records (eMemory 
Aids), and safety laboratory values. A Safety Monitoring Committee will 
evaluate the safety data if halting rules are met or if deemed necessary by the 
sponsor or principal investigator. Immunogenicity will be evaluated by pre- 
vaccination and multiple post-vaccination assessments of toxin-neutralizing 
antibodies and IgG anti-PA antibodies assayed by Enzyme Linked 
ImmunoSorbent Assay (ELISA) over approximately one year. Participants will 
be followed for 1 year following the second dose of vaccine. 
Safety will be assessed by evaluation of laboratory values, non-serious 
unsolicited Adverse Events, Serious Adverse Events (SAEs), Medically 
Attended Adverse Events (MAAEs), and Adverse Events of Special Interest 
(AESIs), which, for this protocol, are defined as Potentially Immune-Mediated 
Medical Conditions (PIMMCs). Unsolicited non-serious adverse events (AEs) 
will be collected from Day 1 through approximately Day 64, inclusive. SAEs, 
MAAEs, and AESIs (PIMMCs) will be collected from the time of study 
vaccination through approximately Day 380. Clinical safety laboratory 
evaluations will be performed at screening and at approximately Day 29 
Reactogenicity will be measured by the occurrence of solicited injection site and 
systemic reactions in the week after each study vaccination (Days 1 through 8 
and target of Days 15 through 22, inclusive). Any reactogenicity events that 
persist on Day 8 or Day 22 will be followed until resolution. Only pharmacy 
personnel, the SDCC unblinded team, and an unblinded vaccinator and checker 
will have access to the study codes; all other study personnel and the participants 
will be blinded. 
Immunogenicity testing will include performing serological assays to assess 
toxin neutralizing antibodies (reported as ED50 and NF50) and IgG anti-PA 
antibodies assayed by Enzyme Linked ImmunoSorbent Assay (ELISA) prior to 

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vaccination (on Day 1) and on approximately Days 8, 15, 22, 29, 64, 195, and 
380. 

16 
 
 
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Table 2: Study Groups 
 
Day 1 
Day 15 
Study Group 
N 
Study Vaccine 
Study Vaccine 
1 
20 
AV7909 liquid 
AV7909 liquid 
2 
20 
AV7909 lyophilized 
AV7909 lyophilized 
Total 
40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1: Schematic of Study Design 
 
 
 
 
 
 
Immunogenicity evaluated by pre-vaccination and post-vaccination 
assessments. 
Participants followed for safety and tolerability by in-person visits. 
 
 
 
 
 
 
 
 
 
 
Vaccination: 
1 of 2 formulations 
of adjuvanted 
anthrax vaccine 
(AV7909) 
Enrollment: 
Eligible participants randomly allocated 1:1 to one of two study groups 
Screen for eligibility 
N= 20 participants 
receive AV7909 as 
thermostable 
lyophilized product. 
N=20 participants 
receive AV7909 as 
liquid product. 

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1 
KEY ROLES 
 
 
Principal Investigator: 
James D. Campbell, MD, MS 
University of Maryland School of Medicine 
Center for Vaccine Development 
Baltimore, MD 21201 
DMID Clinical Project Manager: 
Onyinye Erondu, RN, MS 
Division of Microbiology and Infectious Diseases 
NIAID, NIH 
DMID Medical Monitor: 
Jorge Mejia-Galvis, MD, MBA 
Division of Microbiology and Infectious Diseases 
NIAID, NIH 
DMID Medical Officer: 
Maryam Keshtkar-Jahromi, MD, MPH 
Division of Microbiology and Infectious Diseases 
NIAID, NIH 
DMID Scientific Lead: 
Colleen Sico, ChemE MBA 
Division of Microbiology and Infectious Diseases 
NIAID, NIH 
Safety and Pharmacovigilance: 
DMID Pharmacovigilance Group 
Clinical Research Operations and Management Support 
(CROMS) 
Site Principal Investigators: 
Not applicable (This is a single site study.) 
Statistical and Data Coordinating 
Center: 
The Emmes Company, LLC 
Clinical Materials Services: 
Fisher BioServices 
Central (Clinical) Laboratory: 
Garcia Laboratory 

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Anthrax Toxin Neutralization and 
ELISA Serological Assays 
Laboratory: 
Battelle 

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2 
BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE 
 
Background Information 
 
Bacillus anthracis is an aerobic, spore‑forming, gram‑positive bacterium that causes the disease 
anthrax in animals and people. Zoonotic anthrax still occurs in many parts of the world but is 
completely controlled in the United States as a result of animal vaccination programs and other 
measures, although sporadic cases of anthrax are reported after exposure to imported animal 
hides.1 Unintentional human disease usually occurs after contact with infected animals or animal 
products. Routes of transmission and types of disease are cutaneous, injection drug use 
associated, gastrointestinal, and inhalational. Inhalational anthrax may occur when spores 
become airborne as a result of certain industrial processes, as a result of laboratory accidents, and 
due to intentional exposure related to biological terrorism or biological warfare.2 
Anthrax has previously been used as a biological agent of terror.3 In 2001, 22 people were 
exposed to anthrax spores distributed through the US Postal Service and 5 of the cases were 
fatal. This event caused widespread fear and panic. Even today, it remains one of the most likely 
agents to be used in an act of bioterror because it is easy to cultivate, easy to weaponize, easy to 
distribute, and has a high case fatality rate.2 
The anthrax vaccine that is currently licensed in the US, Anthrax Vaccine Adsorbed (AVA, 
BioThrax™) is produced from the culture filtrate of an attenuated, toxigenic strain of B. 
anthracis, and contains Protective Antigen (PA, the binding domain of the anthrax toxin), small 
amounts of other anthrax bacterial products, the adjuvant aluminum hydroxide (Alhydrogel), the 
stabilizer formaldehyde, and the preservative benzethonium chloride. This vaccine is highly 
protective against inhalational B. anthracis spore challenge in rabbits and monkeys 4. A similar 
vaccine had 92% efficacy against clinical anthrax among workers in New England wool mills in 
the middle of the last century,5 but no other human efficacy trials have ever been performed. The 
vaccine is recommended as pre‑exposure prophylaxis for members of the US Armed Forces, for 
some laboratory workers, some “first responders”, and for others who may be occupationally 
exposed.6 It has also been offered, and is recommended, for cases of post‑exposure in 
conjunction with antibiotics.6 It has not been studied in children. 
 
Scientific Rationale 
 
The anthrax vaccine that is currently licensed in the US, AVA, has been shown to be safe and 
immunogenic in people and has been shown to lead to antibody responses that, in non-human 
primate models of lethal anthrax spore challenge, are protective, even in the absence of 

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antibiotics4. However, the vaccine was first given subcutaneously, leading to significant local 
reactogenicity, and it requires 3 priming doses and an onerous schedule for recipients to remain 
immune. An improved vaccine that leads to faster immune responses and requires fewer doses, 
while remaining safe and well tolerated, would be welcomed. 
 
Due to the large number of doses required to generate a primary immune response in humans 
that leads to putative protective levels, as evidenced by animal challenge model protection, 
various approaches have been taken to improve anthrax vaccines. One approach that has proven 
successful to date is the addition of the TLR9 agonist adjuvant CPG 7909 to the currently 
licensed vaccine. This new vaccine, named AV7909, is being developed by Emergent 
BioSolutions as a vaccine with an indication for postexposure prophylaxis (PEP) that is intended 
to decrease the risk of anthrax disease after exposure. AV7909 has been shown to be safe and has 
improved immunogenicity when compared to AVA.7-9 Early studies have shown that the 
addition of CPG 7909 to AVA has allowed for intramuscular injection, a priming series of only 2 
doses, and resulted in more rapid induction of putatively protective antibody responses. AV7909 
has been studied in animals and humans with a safety record similar to AVA itself. This vaccine, 
once studied in increasing numbers of persons, may prove superior enough to AVA to allow it to 
replace AVA as the standard of care. However, the current formulation is liquid and therefore 
prone to a shorter shelf life and stricter temperature storage requirements. Since anthrax vaccine 
sufficient for a response to an intentional act of bioterror is stored in the National Strategic 
Stockpile, a thermostable (lyophilized) formulation of the AV7909 adjuvanted anthrax vaccine 
would offer many advantages to a liquid formulation. 
 
The proposed trial will assess, in healthy adults, the safety, reactogenicity, and immunogenicity 
of the thermostable lyophilized formulation of AV7909 compared to the liquid formation of 
AV7909. 
 
Potential Risks and Benefits 
 
2.3.1 Potential Risks 
 
The potential risks of participating in this trial are those that may occur due to blood drawing, the 
IM injection itself, reactions to the vaccines, and breach of confidentiality. 
 
Phlebotomy Risks. Drawing blood is typically well tolerated and uneventful. It often causes 
transient mild discomfort. Approximately 2% of persons who have blood drawn will experience 
“near syncope”, in which they feel lightheaded or have other symptoms, but do not lose 
consciousness. Syncope (fainting) is a transient autonomic (vasovagal) response to phlebotomy 
that occurs in approximately 1% of blood donors and fewer than 1% of those having diagnostic 
phlebotomy.10 It is managed by having the participant lie down, loosening his or her clothes, 

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monitoring vital signs, reassuring the participant, and giving fluids. Minor bruising at the blood 
draw site may occur in up to 12% and a hematoma in 2-3%. These events can be prevented or 
decreased in frequency by employing experienced phlebotomists and can be ameliorated, when 
they occur, by applying pressure to the draw site for several minutes. Rarely, following 
phlebotomy, persons may have nerve injury (typically lateral antebrachial nerve) causing pain, 
paresthesia, and motor or sensory loss. This phenomenon is uncommon and typically resolves 
quickly with watchful waiting only.11 Infection at the site of the blood draw is exceedingly rare 
and can be avoided by using antiseptics and other appropriate techniques. In a study of over 4000 
persons undergoing routine venipuncture for insurance applications, there were no serious local 
reactions such as cellulitis or phlebitis.10 
Intramuscular Injection Risks. The injection of a study product into the deltoid muscle, as will be 
done in this study, is typically well tolerated. However, it often causes transient discomfort. 
Intramuscular injections may cause near syncope or syncope, although less commonly than 
phlebotomy. It can also cause an abscess, a hematoma, injury to blood vessels and peripheral 
nerves, or tingling or numbness. Injection too proximally on the lateral aspect of the deltoid can 
lead to injury of the bursa, which can cause Shoulder Injury Related to Vaccine Administration, 
or SIRVA.12 Proper education and technique reduce the risk of adverse events after IM injection. 
Vaccine Administration Risks. The risk profile for AVA (BioThrax) is well known, given that 
millions of persons have been vaccinated. The risks of AV7909 are less well characterized, given 
that fewer persons have been vaccinated with this product. 
 
Risks of AVA (BioThrax). Since the licensure of BioThrax in 1970, more than 3.3 million 
individuals, primarily military personnel, have been vaccinated in the pre-exposure setting. The 
safety profile of BioThrax and its associated risks are summarized in the BioThrax prescribing 
information. The most common (≥ 10%) local (injection-site) adverse reactions observed in 
clinical studies are tenderness, pain, erythema, edema, and arm motion limitation. The most 
common (≥ 5%) systemic adverse reactions are muscle aches, headache, and fatigue. 
 
Risks of CPG 7909. CPG 7909 has been investigated clinically since the mid-1990s for 
indications that have included cancer monotherapy, combination use with anti-cancer therapies, 
and vaccine adjuvant against infectious diseases and cancers. Potential risks associated with 
AV7909 include hypersensitivity reactions, autoimmune reactions, and more minor local and 
systemic reactogenicity effects. Other oligonucleotides have been evaluated as vaccine adjuvants, 
including CPG1018, the adjuvant in Heplisav-B, a hepatitis B vaccine now licensed in the US for 
persons 18 years and older. 
 
Risks of AV7909. Emergent BioSolutions has sponsored three completed clinical studies in 
healthy participants 18 through 50 years of age as part of the AV7909 development program: a 
phase 1, a phase 1/2, and a phase 2 trial. 7,9,13 A total of 241 participants have been exposed to a 

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combination of AVA and CPG7909. In the initial trial, a formulation with AVA + 1.0 mg CPG 
7909 was tested and was well tolerated with a trend toward increased frequency and severity of 
local and systemic reactions in the AV7909 formulation compared to BioThrax.9 The second trial 
identified a formulation of AV7909 with a lower CPG7909 concentration (0.25 mg CPG 7909) for 
further clinical development that produced an enhanced immune response without increased 
reactogenicity. 7 This formulation was evaluated in the phase 2 trial described below and is the 
formulation to be tested in the current study. 
 
In 2014, a phase 2, randomized, double-blinded, BioThrax-controlled study was conducted to 
evaluate the safety and immunogenicity of 3 IM vaccination schedules and 2 dose levels of 
AV7909 in 168 healthy adults.13 The results of this study found that AV7909 was well tolerated: 
4.2% of subjects discontinued vaccination due to AEs; no serious adverse events (SAEs) were 
reported that were potentially vaccine related; no reported AEs of potential autoimmune etiology 
were reported. The vaccine produced a more rapid immune response compared to BioThrax as 
measured by TNA NF50 values≥0.56 (a putative correlate of protection) obtained through Day 63. 
 
Hypersensitivity and Anaphylactic/Anaphylactoid Reactions. Parenteral administration of any 
protein product may be associated with immediate-type hypersensitivity reactions that can manifest 
as urticaria, shortness of breath, wheezing, nausea and cramping, and in severe cases, hypotension. 
Acute allergic reactions, including anaphylaxis, have occurred with BioThrax. Reports of 
hypersensitivity, urticaria, and pruritus have rarely occurred following administration of AV7909. 
Appropriate medical treatment and supervision will be available to manage possible anaphylactic 
reactions following administration of the vaccine and the vaccine will not be administered to 
participants with known sensitivity to any of the vaccine components, e.g., synthetic 
oligodeoxynucleotides (ODNs), formaldehyde, benzethonium chloride (phemerol), or aluminum. 
The vaccine stoppers do not contain latex. 
 
Potentially Immune Mediated Medical Conditions (PIMMCs). There is a plausible potential for 
CPG ODN adjuvants to trigger autoimmune disease in susceptible individuals 14, possibly as a 
result of non-specific activation of T or B lymphocytes. No participants in completed AV7909 
clinical trials have reported AEs related to autoimmune disorders. Additionally, no AEs suggestive 
of autoimmune disease have been reported in the reviewed published data on the CPG 7909- 
adjuvanted infectious disease vaccine trials. A number of these trials reported participants with 
moderate, transient elevations above the normal range of anti-double stranded deoxyribonucleic 
acid (anti-dsDNA) antibody values or positive antinuclear antibody (ANA) or mild elevations in 
rheumatoid factor (RF) following vaccination, which typically returned to normal by the next dose 
or by the end of the study and were not associated with clinical symptoms.15-18 In a phase 3 trial of 
Heplisav-B, a recently FDA-licensed vaccine that contains a different CPG ODN, CPG 1018, in 
participants followed for 13 months after the first dose of vaccine, the incidences of new onset 
immune-mediated AEs (as reviewed by independent adjudicators) were not clinically different 

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between the Heplisav-B group (0.1%; 4/5587) and the non-adjuvanted Engerix-B group (0%; 
n=2781), nor were these AEs in the Heplisav-B group considered related to vaccination. 
 
In oncology trials of CPG 7909, which typically have used higher doses and treatment durations 
than expected with AV7909 vaccine exposure, autoimmune disease has been reported in multiple 
participants, although causal attribution to the study product has been complicated by 
comorbidities and concomitant products/therapies. The autoimmune conditions observed have 
included polyarthralgia, arthritis, Sjögren’s Syndrome, autoimmune thyroiditis, vitiligo, Guillain- 
Barré syndrome, and ulcerative colitis. 
 
Because of this potential risk, individuals with a history of autoimmune disorders or active 
autoimmune disease (PIMMCs) will be ineligible for this trial. Additionally, because of the 
possibility of a delay between the vaccination and onset of symptoms indicative of a disease 
process of this kind, all participants will be followed for PIMMCs throughout the trial (for 12 
months after the second vaccination, to approximately Day 380). PIMMCs will be captured as 
“Adverse Events of Special Interest” (AESI). Blood samples will be collected before vaccination 
from all participants for possible laboratory evaluation should suspicion of a PIMMC arise during 
study participation. Participants who discontinue study treatment will be encouraged to attend all 
subsequent clinic visits and safety follow-up contacts to facilitate this monitoring. 
 
Local Reactogenicity. During clinical testing in which 241 participants were exposed to the 
combination of BioThrax + CPG 7909, the most common local reactions were mild to moderate 
pain, tenderness, and arm motion limitation. These reactions often resolved within 48 hours after 
vaccination. The most common local AEs (reported in ≥ 5% of participants in at least one of the 
AV7909 arm(s) from the three completed clinical trials) included injection site pain, arm 
movement impairment, warmth, edema/induration, erythema, hemorrhage, and pruritus. 
 
Systemic Reactogenicity. During clinical testing to date, in completed trials in which participants 
were exposed to the combination of BioThrax + CPG 7909, systemic reactogenicity manifested 
primarily as mild to moderate fatigue, muscle ache, and headache. The most common systemic 
AEs (reported in ≥ 5% of participants in at least one of the AV7909 arm(s) from the three 
completed clinical trials) included fatigue, myalgia, headache, respiratory rate increased, pyrexia, 
pharyngolaryngeal pain, nausea, upper respiratory tract infection, and chills. 
 
Laboratory Findings. During clinical testing to date, in completed trials in which participants were 
exposed to the combination of BioThrax + CPG 7909, the most common reported laboratory 
findings after vaccination were hypokalemia, lymphocyte count decreased, leukopenia, 
hypoglycemia, blood creatine phosphokinase increased, and hemoglobin decreased. 
 
Pregnancy and Lactation. No reproductive toxicity studies have been performed with AV7909. 
BioThrax can cause fetal harm when administered to a pregnant woman. CPG 7909 has been 

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determined to be embryolethal in rabbits and teratogenic in developing rats and rabbits at doses far 
in excess of the individual vaccination dose for AV7909 (0.25 mg). In rats, fetal skeletal anomalies 
were noted when administered at a dose of > 3 mg/kg/day; in rabbits, slightly reduced numbers of 
viable fetuses were noted when administered at a dose of 3 mg/kg/day, and external, visceral, and 
skeletal malformations occurred when administered at >1 mg/kg/day. 
 
Given these findings, breastfeeding or a positive pregnancy test will preclude study enrollment. All 
women of childbearing potential will have a negative pregnancy test before each vaccine 
administration and will agree to use effective contraception from at least one month prior to Day 1 
and continued through Day 75 (60 days after second vaccination). Confirmed pregnancy will result 
in discontinuation of vaccinations. Participants who become inadvertently pregnant during the trial 
will be monitored for pregnancy outcomes, if the participant provides permission, according to 
protocol-specified procedures. 
 
Risk of loss of privacy or confidentiality. Participants will be asked to provide, in a private 
setting, Personally Identifying Information (PII) and Protected Health Information (PHI). All 
attempts will be made to keep PII and PHI confidential within the limits of the law. However, 
there is a chance that unauthorized persons will gain access to a participant’s PII or PHI. All 
hard copy research records will be kept in a locked file cabinet or maintained in a locked room at 
the participating VTEU site. Electronic files and access to the central clinical and laboratory 
websites at which study-related data are stored will be password protected. Only people who are 
involved in the conduct, oversight, monitoring, or auditing of this study will be allowed access to 
the confidential information that is collected. Any publications from this study will not use 
information that will identify participants by name. Organizations that may inspect and/or copy 
research records maintained at the participating VTEU site for quality assurance and data 
analysis include groups such as National Institute of Allergy and Infectious Diseases (NIAID) 
and the Food and Drug Administration (FDA) and their contractors. They also include the 
Human Research Protections Office (HRPO) at the University of Maryland, Baltimore (UMB) 
and its Institutional Review Board (IRB), and the Office of Accountability and Compliance 
(OAC) at UMB. 
 
Unknown risks. There may be unknown risks, discomforts, or side effects. 
 
2.3.2 Known Potential Benefits 
 
Participants in this study may have no personal, direct benefits from participation. Although they 
are not currently identified as a person at risk for contracting anthrax, participants may develop 
immune responses to the anthrax vaccines being studied in this protocol that are protective 
against anthrax or that may mitigate anthrax disease following exposure. Even without any 
personal direct benefits, participants may contribute to a societal benefit through the 

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improvement of our understanding of these vaccines and by contributing to the protection of 
persons at risk for or exposed to anthrax. 

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3 
STUDY OBJECTIVES AND OUTCOME MEASURES 
 
Refer to Table 1: Study Objectives and Outcome Measures 

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4 
STUDY DESIGN 
 
The study is a phase I randomized, parallel-group, double-blind controlled interventional trial in 
which the safety, tolerability, and immunogenicity of 2 formulations of adjuvanted anthrax 
vaccine (AV7909), lyophilized and liquid, both manufactured by Emergent BioSolutions, will be 
assessed and compared. AV7909 is an investigational vaccine that combines the currently 
licensed Anthrax Vaccine Adsorbed (AVA, BioThrax) with the adjuvant CPG 7909, an 
oligonucleotide. Forty healthy young adults, 18 to 45 years old, inclusive, who meet all 
eligibility criteria, will be randomly allocated to one of two study groups in a 1:1 ratio: 20 will 
receive AV7909 as the thermostable lyophilized product and 20 will receive AV7909 as the 
liquid product. Stratification by age category and by gender will assure that near equal numbers 
of younger (18-30 years) and older (31-45 years) males and females will be assigned to each 
vaccine. The vaccines will be given intramuscularly in a 2-dose schedule, 2 weeks apart. Data 
entry will be “direct”, that is, without the significant use of paper source documents. Participants 
will be followed for safety and tolerability by in-person visits, electronic reactogenicity records 
(eMemory Aids), and safety laboratory values. A Safety Monitoring Committee will evaluate the 
safety data whenever necessary (as determined by the sponsor or principal investigator) and in 
the event of a halting rule occurring. Immunogenicity will be evaluated by pre-vaccination and 
multiple post-vaccination assessments of toxin-neutralizing antibodies as determined by ED50 
and NF50 and by IgG antibodies against PA measured by ELISA. Participants will be followed 
for 1 year following the second dose (through approximately Day 380). 
 
Safety will be assessed by evaluation of non-serious unsolicited Adverse Events, Serious 
Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of 
Special Interest (AESIs) [the AESIs collected in this study are Potentially Immune-Mediated 
Medical Conditions (PIMMCs)], and by laboratory evaluations. SAEs, MAAEs, and AESIs will 
be collected from the time of study vaccination through approximately Day 380. Non-serious 
unsolicited AEs will be collected from Day 1 to Day 64, inclusive. Clinical laboratory 
evaluations for eligibility will be the following: specific hematology parameters, chemistry 
parameters, , specific urine tests for drugs of abuse, and hemoglobin A1C. Also, an 
electrocardiogram will be performed at screening and reviewed by an investigator and 
cardiologist. The cardiologist will determine if any findings on the electrocardiogram are 
significant and thereby exclusionary. At approximately Day 29, laboratory tests for hematology 
and chemistries will be repeated. 
 
Reactogenicity will be measured by the occurrence of solicited injection site and systemic 
reactions in the week after each study vaccination (Days 1 through 8 and target of Days 15 
through 22, inclusive). The window for dose 2 includes Days 15 to 18. For participants who are 
vaccinated beyond Day 15, the study schedule will adjust so that a full week of reactogenicity 
data are collected, regardless. Any of these events that persist on Day 8 or Day 22 (or the final 

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day of the second reactogenicity period) will be followed until resolution. Only pharmacy 
personnel, the Emmes unblinded team, and an unblinded vaccinator and checker will have access 
to the study codes; all other study personnel and all participants will be blinded. 
 
Immunogenicity testing will include performing serological assays to assess for toxin 
neutralizing antibodies (reported as ED50 and NF50), the gold standard assay for assessing 
response and protection following anthrax vaccines, prior to vaccination and on approximately 
Days 8, 15, 22, 29, 64, 195, and 380. Should the second dose of vaccine be given after Day 15 
(the acceptable window is Days 15 to 18, inclusive) the remainder of the study schedule days 
shift accordingly, to maintain the intervals in the schedule. In addition, anti-PA IgG antibodies 
will be measured by ELISA from the serum of participants, on those same days. 
 
For additional details on study procedures and evaluations and the study schedule by study 
visits/days, see Sections 7 and 8 as well as Appendix A: Schedule of Study Procedures and 
Evaluations and Appendix B: Adverse Events of Special Interest. 

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5 
STUDY ENROLLMENT AND WITHDRAWAL 
 
Forty (40) males and non-pregnant females, 18 to 45 years of age, inclusive, who are in good 
health and meet all eligibility criteria will be enrolled at one VTEU site. The target population 
will reflect the community at large at the participating VTEU site, but in order to assure 
enrollment of near equal numbers in each study group (AV7909 Liquid and AV7909 
Lyophilized) by sex and age category, a stratified enrollment procedure will be employed. The 
strata used will be males/females and age 18-30 years/age 31-45 years. 
 
The estimated time to complete enrollment in this trial, from first participant enrolled until last 
participant enrolled, is approximately 3 months. Information regarding this trial may be provided 
to potential participants who have previously participated in vaccine trials, other than anthrax 
vaccine trials, conducted at the VTEU site. Other forms and/or mechanisms of recruitment may 
also be used. The IRB will approve the recruitment process and all materials prior to use. 
 
Participant inclusion and exclusion criteria will be assessed by a study clinician licensed to make 
medical diagnoses and listed on the Form FDA 1572 as the site principal investigator (PI) or sub- 
investigator. 
 
No exemptions are granted on participant inclusion or exclusion criteria in DMID-sponsored 
studies. Questions about eligibility will be directed toward the DMID Medical Officer for this 
trial. 
 
Eligibility Criteria 
 
5.1.1 Participant Inclusion Criteria 
 
Participants eligible to participate in this trial must meet all the following inclusion criteria: 
 
1. Provide written informed consent prior to initiation of any study procedures. 
 
2. Understand and comply with planned study procedures, including completion of the 
electronic memory aid, and be available for all study visits. 
 
3. Agree to the collection of venous blood, per protocol. 
 
4. Have adequate venous access for phlebotomies. 
 
5. Be a male or non-pregnant female, 18 to 45 years of age, inclusive, at the time of 
enrollment. 

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6. Be in good health1. 
 
1As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical 
diagnoses or conditions, which would affect the assessment of the safety of participants or the immunogenicity of study 
vaccinations. Chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, 
should be stable (not worsening) for the last 60 days (no hospitalizations, emergency room or urgent care for 
condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication 
change indicative of worsening/supplemental oxygen). This includes no change in chronic prescription medication, 
dose or frequency, indicative of worsening disease, in the 60 days prior to enrollment. Any prescription change that is 
due to change of health care provider, insurance company, etc., or that is done for financial reasons, will not be 
considered a deviation of this inclusion criterion. Participants may be on chronic or as needed (prn) medications if, in 
the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to participant safety or 
assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms 
of medical diagnosis or condition. Herbals, vitamins, and supplements are permitted. 
 
7. Have an oral temperature less than 100.0°F. 
 
8. Have a pulse 51 to 100 beats per minute, inclusive. 
 
9. Have a systolic blood pressure 85 to 140 mmHg, inclusive. 
 
10. Have a diastolic blood pressure 55 to 90 mmHg, inclusive. 
 
11. Have a calculated body mass index (BMI) less than or equal to 35.0 kg/m2 at screening. 
 
12. Screening laboratories2 in table below are within acceptable parameters. 
 
2 
 
 
Test 
Eligibility Criterion 
BUN 
<23 mg/dL 
Serum creatinine (female) 
<1.3 mg/dL 
Serum creatinine (male) 
< 1.4 mg/dL 
Alkaline phosphatase (female) 
<147 U/L 
Alkaline phosphatase (male) 
<192 U/L 
ALT (aka SGPT) 
<68 U/L 
Total bilirubin 
< 1.3 mg/dL 
Hemoglobin (female) 
>10.9 g/dL 
Hemoglobin (male) 
> 12.4 g/dL 
White blood cell count 
3000-12,000 cells/mm3 
Absolute eosinophil count 
<1201 cells/mm3 
Absolute neutrophil count 
>1200 cells/mm3 
Platelets 
>126,000 cells/mm3 
Hemoglobin A1C 
<6.5% 

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Urine for Drugs of Abuse* 
All negative 
HBsAg 
Non-reactive 
HCV antibodies 
Negative 
HIV 4th generation test 
Negative 
 
*amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, oxycodone/oxymorphone, 
phencyclidine (PCP), and propoxyphene. Note that a prospective participant with a positive urine for drugs 
of abuse test for a medication reported by the participant and used to treat a condition that does not make 
them otherwise ineligible, may be permitted to enroll, at the discretion of the investigator or his designee. 
 
13. Have no clinically significant findings3 on 12-lead electrocardiogram. 
 
3Clinical significance will be determined by a cardiologist. Examples of findings that will lead to exclusion are significant 
left ventricular hypertrophy, right or left bundle branch block, advanced A-V heart block, non-sinus rhythm (excluding 
isolated premature atrial contractions), pathologic Q wave abnormalities, significant ST-T wave changes, prolonged 
QTc interval. 
 
14. Heterosexually active females of childbearing potential4 must use an acceptable 
contraception method5 from at least 30 days before the first until 60 days after the second 
study vaccination. 
 
4Not sterilized via bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, 
non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the 
procedure, and still menstruating or <1 year has passed since the last menses, if menopausal. 
 
5Includes full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized 
partner who has been vasectomized for 180 days or more or shown to be azoospermic prior to the participant receiving 
the study vaccination, barrier methods such as condoms or diaphragms/cervical cap, intrauterine devices, NuvaRing®, 
tubal ligation, and licensed hormonal methods such as implants, injectables or oral contraceptives (“the pill”). 
 
15. Females of childbearing potential must have a negative serum pregnancy test at screening 
and a negative urine pregnancy test within 24 hours prior to each study vaccination. 
 
16. For a female with potential to become pregnant, she understands that in the event of 
pregnancy during the study she will be asked to allow us to follow her during pregnancy 
through outcome. 
 
17. Must agree to have blood collected, stored, and potentially used for auto-antibody studies 
(if a suspected PIMMC occurs in this participant). 
 
5.1.2 Participant Exclusion Criteria 
 
Participants eligible to participate in this trial must not meet any of the following exclusion 
criteria: 

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1. Have an acute illness6, as determined by the site PI or appropriate sub-investigator, 
within 72 hours prior to study vaccination. 
6An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion 
of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety 
parameters and systemic reactogenicity events as required by the protocol. 
 
2. Have any medical disease or condition that, in the opinion of the site PI or appropriate 
sub-investigator, is a contraindication to study participation7 
7Including acute, subacute, intermittent, or chronic medical disease or condition that would place the participant at an 
unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere 
with the evaluation of responses or the participant’s successful completion of this trial. 
 
3. Have immunosuppression as a result of an underlying illness or treatment, a recent 
history or current use of immunosuppressive or immunomodulating disease therapy8. 
8These include oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study 
vaccination, or high-dose inhaled corticosteroids within 30 days prior to study vaccination, with high-dose defined as 
per age as using inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute Guidelines for 
the Diagnosis and Management of Asthma (EPR-3) or other lists published in UPTODATE. Intranasal corticosteroids 
are not exclusionary. Low and moderate potency topical corticosteroids are permitted. 
 
4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to 
study vaccination. 
 
5. Have known active or recently active (12 months) neoplastic disease or a history of any 
hematologic malignancy. Non-melanoma treated skin cancers are permitted. 
 
6. Have known human immunodeficiency virus (HIV), chronic hepatitis B, or hepatitis C 
infection. 
 
7. Have known hypersensitivity or allergy to any components of the study vaccines (AVA, 
CPG adjuvants, aluminum, benzethonium chloride [phemerol], formaldehyde). 
 
8. Have a history of receipt or plan to receive, while enrolled in this study, a licensed or 
unlicensed anthrax vaccine (except for the vaccines under study herein). 
 
9. Have a history of PIMMCs9. 
 
9Refer to Appendix B: Adverse Events of Special Interest 
 
10. Have a history of alcohol or drug abuse within 5 years prior to study enrollment or test 
positive on the screening urine test for drugs of abuse10. 

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10Note that a prospective participant with a positive urine for drugs of abuse test for a medication reported by the 
participant and used to treat a condition that does not make them otherwise ineligible, may be permitted to enroll, at 
the discretion of the investigator or his designee. 
 
11. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric 
diagnosis that may interfere10 with participant compliance or safety evaluations. 
11As determined by the site PI or appropriate sub-investigator. 
 
12. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement 
for danger to self or others within 5 years prior to study vaccination. 
 
13. Received or plan to receive a licensed, live vaccine within 30 days before or after each 
study vaccination. 
 
14. Received or plan to receive a licensed, inactivated vaccine within 14 days before or after 
each study vaccination. 
 
15. Have a known history of documented anthrax disease or suspected exposure to anthrax. 
 
16. Received immunoglobulin or other blood products, except Rho(D) immunoglobulin, 
within 90 days prior to study vaccination. 
 
17. Received an experimental agent12within 30 days prior to the study vaccination or expect 
to receive another experimental agent13 during the trial-reporting period14. 
12Including vaccine, drug, biologic, device, blood product, or medication. 
 
13Other than from participation in this trial. 
 
14Approximately 12 months after the second study vaccination. 
 
18. Are participating or plan to participate in another clinical trial with an interventional 
agent15 that will be received during the trial-reporting period16. 
15Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. 
 
16Approximately 12 months after the second study vaccination. 
 
19. Female participants who are breastfeeding or plan to breastfeed from the time of the first 
study vaccination through 30 days after the second study vaccination. 
 
20. Planning to donate blood within 4 months following second vaccination. 
 
21. Planned elective surgery during study participation. 

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22. Member or immediate family member of the site research staff found on the delegation 
log. 
 
23. Previously served in the military any time after 1990 and/or plan to enlist in the military 
at any time during the study. 
 
5.1.3 Screen Failures 
 
A screen failure is defined as a participant from whom informed consent is obtained and 
documented in writing, but who is not subsequently randomized to study treatment. 
Reasons for screen failure are to be recorded on the electronic case report forms (eCRFs). 
 
All screening procedures must occur 2 to 28 days before the Day 1 study visit. On Day 1, 
participants are allocated to a treatment group and receive their first vaccination. The 
results of clinical laboratory tests at screening must be within the acceptable ranges for 
this study. Each clinical laboratory test for screening will not be performed more than 
twice (one initial and one repeat test for a total of two times). If the laboratory results are 
abnormal due to a processing or handling error, the test may be repeated without counting 
towards the not-to-exceed total of twice performed. 
 
Participants who are screen failures are permitted to be rescreened one time (only) 
according to the PI’s discretion. Otherwise eligible prospective participants may undergo 
additional rescreening visits in the event that they originally failed screening due to an 
eligibility criterion, such as a laboratory test, that is subsequently amended and does, 
upon amendment, then allow for inclusion. Such rescreening must occur in the time 
period before vaccination as specified in the protocol, and a single repeat of any 
laboratory test, as allowable during the original screening, is again allowable in this 
situation. In the event that the participant is rescreened for trial participation, a new 
informed consent form (ICF) must be signed. (This does not apply to those who are 
simply having an abnormal laboratory test repeated to determine eligibility.) For 
example, if there are any delays between screening and enrollment that cause eligible 
participants to fall outside the screening window, these participants may be re-consented 
and rescreened. Participants who complete the rescreening and are randomized in the 
study will not be considered screen failures. 

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Treatment Assignment Procedures 
 
5.2.1 Enrollment and Randomization Procedures 
 
Per ICH E6 GCP, screening records will be kept at the participating VTEU site to document the 
reason why an individual was screened, but failed trial entry criteria. The reasons why 
individuals failed screening will be recorded in the Statistical and Data Coordinating Center’s 
(SDCC) Advantage eClinicalSM (Electronic Data Capture System). 
Once consented and upon entry of demographic data and confirmation of eligibility for this trial, 
the participant will be enrolled in the electronic data capture system. The participant will be 
enrolled and randomly assigned with equal allocation (1:1) to 1 of 2 treatment groups, stratified 
by age category (18-30 years old and 31-45 years old) and by gender. 
 
Enrollment of participants will be done online using the enrollment module of Advantage 
eClinicalSM. The randomization code will be prepared by statisticians at the SDCC and included 
in the enrollment module for this trial. Advantage eClinicalSM will assign each participant to a 
treatment arm after the demographic and eligibility data have been entered into the system. A 
designated individual at the VTEU site will be provided with a code list for emergency 
unblinding purposes, which will be kept in a secure place. 
 
Instructions for use of the enrollment module are included in the Advantage eClinicalSM User’s 
Guide. Manual back-up procedures and instructions are provided for use in the event that the 
participating VTEU site temporarily loses access to the internet or the online enrollment system 
is unavailable. 
 
5.2.2 Masking Procedures 
 
This is a double-blinded (masked) clinical trial. 
 
Participants, site investigators, and study personnel performing any study-related assessments 
following study vaccine administration are blinded to vaccine received. Laboratory personnel 
performing immunological assays will receive serum blinded to participant ID number, specimen 
visit number, and allocation group. 
 
The randomization scheme will be generated by the SDCC and provided to unblinded study 
personnel (i.e., research pharmacists performing study vaccination preparations and unblinded 
study vaccine administrators) at the participating VTEU site. 

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The unblinded study vaccine administrator is a study personnel member credentialed to 
administer vaccines and may also participate in dose preparation but will not be involved in 
study-related assessments or have participant contact for data collection following study vaccine 
administration. 
 
The Safety Monitoring Committee (SMC) may receive data in aggregate and presented by 
treatment group. The SMC may also be provided with expected and observed rates of the 
expected AEs in an unblinded fashion and may request the treatment assignment be unblinded 
for an individual participant if required for safety assessment. The SMC will review grouped and 
unblinded data in the closed session only. 
 
5.2.3 Reasons for Withdrawals and Discontinuation of Study Product Administration 
 
Participants may voluntarily withdraw their consent for trial participation at any time and for any 
reason, without penalty or loss of benefits to which they are otherwise entitled. 
 
The site PI or appropriate sub-investigator may also withdraw a participant from receiving the 
study vaccine for any reason. 
 
A participant may withdraw or be withdrawn from this trial for any of the following reasons: 
 
• Medical disease or condition, or any new clinical finding for which continued 
participation, in the opinion of the site PI or appropriate sub-investigator, would 
compromise the safety of the participant, or would interfere with the participant’s 
successful completion of this trial, or would interfere with the evaluation of responses. 
 
• Participant withdrawal of consent or refusal to be re-vaccinated. 
 
• Participant loss to follow-up. 
 
• Termination of this trial. 
 
• As deemed necessary by the site PI or appropriate sub-investigator for noncompliance or 
other reasons. 
 
• New information becomes available that makes further participation unsafe. 

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5.2.4 Handling of Withdrawals and Discontinuation of Study Product Administration 
 
The primary reason for withdrawal from this trial will be recorded on the Study Status electronic 
Case Report Form (eCRF). Participants will be encouraged to complete the Early Termination 
Visit. The Early Termination Visit procedures are listed in Section 8.4. 
 
Every attempt will be made to follow all AEs, including solicited injection site and systemic 
reactions, unsolicited non-serious AEs, SAEs, MAAEs, AESIs (PIMMCs) ongoing at the time of 
early withdrawal through resolution as per applicable collection times defined for the specific 
type of AE. 
 
In the case of participants who fail to appear for a follow-up safety assessment, extensive effort 
(i.e., three documented contact attempts via phone calls made on separate occasions and 
followed by a certified letter) will be made to locate or recall them, or at least to determine their 
health status. These efforts will be documented per site protocol. 
 
The site PI or appropriate sub-investigator will inform the participant that already collected data 
will be retained and analyzed even if the participant withdraws or is withdrawn from this study. 
 
5.2.5 Participant Replacement 
 
Participants who withdraw, or are withdrawn or terminated from this trial, or are lost to follow- 
up after signing the informed consent form (ICF), randomization, and receipt of study vaccine 
may be replaced. If a participant withdraws after signing the ICF, but before randomization 
and/or receipt of study vaccine, they may also be replaced. We do not believe that it is likely that 
there will be any such withdrawals, but, should replacement be required, the total number of 
persons enrolled may exceed 40 and approval for the overall number enrolled will be obtained 
from the IRB. 
 
5.2.6 Termination of Study 
 
Although the sponsor has every intention of completing this trial, it reserves the right to 
terminate this trial at any time for clinical or administrative reasons. Reasons for termination 
include, but are not limited to, study closure due to SMC review and recommendation, and at the 
discretion of DMID. 
 
If this trial is prematurely terminated by the sponsor, any regulatory authority, the site PI, or 
appropriate sub-investigator for any reason, the site PI or appropriate sub-investigator will 
promptly inform the participants and assure appropriate therapy or follow-up for them, as 

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necessary. The site PI or appropriate sub-investigator will provide a detailed written explanation 
of the termination to the IRB. 

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6 
STUDY  INTERVENTION/INVESTIGATIONAL  PRODUCT 
 
Study Product Description 
 
AV7909 Liquid Formulation 
 
AV7909 (Emergent BioSystems) is an investigational vaccine that is a preformulated, sterile, 
milky-white suspension (when mixed) for IM injection. It consists of the AVA bulk drug 
substance and CPG 7909 adjuvant. CPG 7909 is a white to off-white lyophilized powder 
manufactured by Avecia Nitto Denko (Avecia) in Milford, MA. CPG 7909’s natural 
deoxyribonucleic acid (DNA) phosphodiester backbone has been modified to a phosphorothioate 
backbone, providing the molecule with increased stability and resistance to degradation for 
improved in vivo activity. The final base sequence of the full-length CPG 7909 is 24 nucleotides 
in length. 
 
AV7909 Lyophilized Formulation 
 
Thermostable AV7909 is a lyophilized version of the liquid AV7909 formulation which, after 
reconstitution, is a sterile, milky-white suspension for intramuscular injection. The Thermostable 
AV7909 Bulk Intermediate Product is manufactured at Emergent’s Baltimore, MD facility by 
addition of Polysorbate 80 and CPG7909 adjuvant to AVA Bulk Drug Substance produced by 
Emergent’s Manufacturing facility at Lansing, MI. 
 
The Thermostable AV7909 Final Drug Product is manufactured by Integrity Bio Inc. The 
vaccine is supplied in a 10 mL Schott glass vial with a West 4432/50 Gray stopper treated with 
FluoroTec® fluorocarbon film and a 20 mm flip-top aluminum seal, stored at 2-8°C. After 
reconstitution with 4.0 mL Water For Injection, a single vial contains approximately 4.8 mL for a 
total of 8 doses per vial (0.5 mL each), with ~1.3 mg/mL aluminum, 0.45 mg/mL CPG7909, 
0.01% formaldehyde, 22.5 ppm benzethonium chloride (phemerol), 0.025% Polysorbate 80, 
0.9% NaCl and 25% trehalose dihydrate at a target pH of 8.0. 
 
Acquisition 
 
Both vaccine formulations will be provided by Emergent BioSolutions. 
 
Diluent for the lyophilized formulation will also be provided by Fisher BioServices. 
Upon request by DMID, both vaccines will be transferred to the following address: 
DMID Clinical Materials Services 
Fisher BioServices 

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20439 Seneca Meadows Parkway 
Germantown, MD 20876 
Phone: 240-477-1350 
Fax: 240-477-1360 
Email: DMID.CMS@thermofisher.com 
 
Study vaccine will be provided through the DMID CMS to the participating VTEU site prior to 
the start of this trial upon request and with prior approval from DMID. Should the site PI require 
additional vaccine or diluent, further instructions are provided in the protocol-specific MOP. 
 
6.1.1 Formulation, Storage, Packaging, and Labeling 
 
AV7909 Liquid Formulation 
 
The AV7909 liquid formulation vaccine will be supplied in 6 mL (nominal fill volume) clear 
borosilicate glass multi-dose vials with rubber stoppers and flip-top aluminum seals for storage. 
A single vial is filled with approximately 6.1 mL. For purposes of this trial, only a single dose 
(0.5 mL) will be used from each vial. 
 
AV7909 liquid formulation must be stored at 2-8 °C (36-46 °F). Do not freeze. Do not shake. 
Avoid foaming. 
 
AV7909 Lyophilized Formulation 
 
AV7909 lyophilized formulation must be stored between 2-8 °C (36-46 °F). Do not freeze. 
 
The AV7909 lyophilized product is mixed with the diluent. The diluent is USP grade sterile 
Water For Injection. After reconstitution with 4.0 mL Water For Injection, a single vial contains 
approximately 4.8 mL. This volume can allow for up to 8 doses per vial (0.5 mL for each dose). 
For purposes of this trial, only a single dose (0.5 mL) will be used from each vial. The 
reconstituted product must be used within 24 hours of the time of reconstitution. If not used 
immediately, the reconstituted vial can be stored at 2-8°C. 
 
Once the vaccine is pulled into a syringe, if not used immediately, the filled syringe must be 
stored at 2°C to 8°C (36°F to 46°F). Do not freeze. The storage time cannot exceed 24 hours. 
 
Each of the study products will be labeled according to manufacturer specifications and include 
the statement “Caution: New Drug Limited by Federal Law to Investigational Use.” 
 
Further details are included in the manufacturer’s Investigator Brochures for both vaccines. 
Diluent for the Lyophilized Formulation 

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AV7909 lyophilized product will be diluted with USP grade sterile Water For Injection as 
described above. This product will be provided via Fisher BioServices and stored at 2°C to 30°C 
(36°F to 86°F). 
 
6.1.2 Study Product Storage and Stability Procedures 
 
The temperature of the storage unit must be manually recorded daily (excluding non-business 
days and holidays, as applicable) and continuously monitored and recorded during the course of 
this trial per the participating VTEU site standard operating procedures (SOPs), and 
documentation will be maintained. If the temperature fluctuates outside of the required range, the 
affected study product(s) must be quarantined at the correct storage temperature and labeled as 
‘Do Not Use’ (until further notice). The participating VTEU site’s research pharmacist must alert 
the site PI and study coordinator if the temperature fluctuates outside of the required range. In 
the event the temperature fluctuates outside of the required range, including accidental deep- 
freezing or disruption of the cold chain, the affected study product(s) must not be administered. 
The site PI or responsible person should immediately contact the DMID Product Support Team 
at DMIDProductSupportTeam@niaid.nih.gov for further instructions before any additional study 
vaccinations are administered. Based on the information collected, DMID and/or the 
manufacturer will determine whether the affected study product(s) can be used. If it cannot be 
used, the site will receive specific instructions on how to return the affected study product(s) to 
the DMID CMS or destroy it on site. Additional instructions for quarantine and DMID contact 
information are provided in the protocol-specific MOP. 
 
Dosage, Preparation and Administration of Study 
Intervention/Investigational Product 
 
See the protocol-specific MOP Appendices for detailed information on the preparation, labeling, 
storage, and administration of study vaccine for each treatment arm. Study vaccine preparation 
will be performed by the participating VTEU site research pharmacist on the same day of study 
vaccination. 
 
Visually inspect the study product upon receipt and prior to use. If the study product(s) appear(s) 
to have been damaged, contaminated or discolored, contain visible particulate matter or if there 
are any concerns regarding its integrity, do NOT use the affected study product(s). The affected 
study product(s) must be quarantined as per storage requirements and labeled as ‘Do Not Use’ 
(until further notice). The site principal investigator or responsible person should immediately 
contact the DMID Product Support Team at DMIDProductSupportTeam@niaid.nih.gov and 
DMID Clinical Project Manager for further instructions before any additional study vaccinations 
are administered. Based on the information collected, DMID and/or the manufacturer will 

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determine whether the affected study product(s) can be used. If it cannot be used, the site will 
receive specific instructions on how to return the affected study product(s) to the DMID CMS or 
destroy it on site. If the study product is unusable, study personnel will use another vial from the 
study supply. Replacement vials may be requested by contacting DMID. Additional instructions 
for quarantine and DMID contact information are provided in the protocol-specific MOP. 
 
Study vaccine administration to the participant will be performed by an unblinded study 
personnel member who is credentialed to administer vaccines and may also participate in dose 
preparation but will not be involved in study-related assessments or have participant contact for 
data collection following study vaccine administration. One dose of study vaccine will be 
administered to the participant via a single IM injection into the deltoid muscle of the 
participant’s preferred arm on the day of study vaccine administration. See the protocol-specific 
MOP for information on how to administer IM injections. The site of injection (right or left arm) 
and time of study vaccine administration will be recorded on the appropriate eCRF. The second 
study vaccination will be given in the opposite arm. 
 
Preparation of the product will be performed as specified in detail in the protocol-specific MOP. 
 
Accountability Procedures for the Study Intervention/Investigational 
Product 
 
After receipt of the study vaccine(s), the site PI is responsible for study product distribution and 
disposition and has ultimate responsibility for study product accountability. The site PI may 
delegate responsibility for study product accountability to the participating VTEU site research 
pharmacist who will be responsible for maintaining complete records and documentation of 
study product receipt, accountability, dispensation, storage conditions, and final disposition of 
the study product(s). Study product accountability records and dispensing logs will also capture 
the date of study vaccine preparation/administration, time of study vaccine preparation, 
expiration of study vaccine preparation, time study vaccine is drawn into the syringe, and amount 
of study vaccine withdrawn for administration. Time of study vaccine administration will be 
recorded on the appropriate eCRF. All study product(s), whether administered or not, must be 
documented on the appropriate study product accountability record or dispensing log. The 
sponsor’s monitoring staff will verify the participating VTEU site study product accountability 
records and dispensing logs per the site monitoring plan. After a single dose is withdrawn from 
an AV7909 formulation vial (liquid or reconstituted lyophilized) for administration to a 
participant, the vial and any unused contents will thereafter be maintained at room temperature 
pending final drug accountability procedures. 

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Assessment of Participant Compliance with Study 
Intervention/Investigational Product 
 
Study vaccine will be administered to the participant by an unblinded study vaccine 
administrator via IM injection at all dosing times per the participant’s randomized treatment 
assignment and as described in Section 6.2. Study vaccine administration and any 
noncompliance with the dose schedule will be recorded on the appropriate eCRF. 
 
Concomitant Medications/Treatments 
 
Administration of any medications, therapies, or vaccines will be recorded on the appropriate 
eCRF. Concomitant medications will include all current medications and medications taken in 
the 60 days prior to signing the ICF through approximately Day 64 or early termination, 
whichever occurs first. Concomitant medications (new medications or changes to previously 
reported medications) that are reported after Day 64 will only be recorded when they are taken in 
relation to an MAAE, AESI (PIMMC), or SAE. Prescription and over-the-counter drugs will be 
included as well as herbals, vitamins, and supplements. Use of a new medication should prompt 
evaluation for the occurrence of any AE, MAAE, AESI (PIMMC), or SAE. 
 
Medications that might interfere with the evaluation of the investigational product(s) should not 
be used during the trial-reporting period (approximately 12 months after the second study 
vaccination, approximately Day 380) unless clinically indicated as part of the participant’s health 
care. Medications in this category include the prohibited medications per the Participant 
Exclusion Criteria (see Section 5.1.2). In addition, the site PI or appropriate sub-investigator may 
identify other medications, herbals, vitamins, or supplements that should not be used due to a 
risk to participant safety or assessment of reactogenicity and immunogenicity. 

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7 
STUDY PROCEDURES/EVALUATIONS 
 
Clinical Evaluations 
 
A complete medical history will be obtained by interview of participants at the screening visit. 
Participants will be queried regarding a history of significant medical disorders of the head, eyes, 
ears, nose, throat, cardiovascular system, lungs, gastrointestinal tract, liver, pancreas, kidney, 
urologic system, nervous system, blood, lymph nodes, endocrine system, musculoskeletal 
system, skin, and genital/reproductive tract. A history of any allergies, cancer, immune 
deficiency, psychiatric illness, substance abuse, autoimmune disease, and any other significant 
medical history will be solicited. At all subsequent visits, an interim medical history will be 
obtained by interview of participants and any changes since the previous clinic visit or phone call 
will be noted, when within the respective reporting period. The interim medical history will 
include an assessment for new medical conditions, MAAEs, and symptoms suggestive of AESIs 
(PIMMCs). 
 
Concomitant medications will be collected as described in Section 6.5. 
 
At the screening visit, a physical examination will be performed on all participants, by a study 
clinician licensed to make medical diagnoses and listed on the Form FDA 1572 as the site PI or 
sub-investigator, to include the following organs and organ systems: abdomen, 
cardiovascular/heart, extremities, general appearance, HEENT, hepatobiliary/spleen, lymph 
nodes, musculoskeletal, neck, neurological, pulmonary/chest, and skin. Specific attention will be 
placed in assessing for physical signs of PIMMCs. At the vaccination visit and at follow-up visits 
after each study vaccination, a targeted physical examination may be performed by a study 
clinician licensed to make medical diagnoses and listed on the Form FDA 1572 as the site PI or 
sub-investigator, if indicated, based on the participant’s interim medical history. Targeted 
physical examinations should also include an assessment for signs suggestive of PIMMCs. 
 
Height and weight will be collected at the screening visit for calculation of the BMI. Vital signs 
(oral temperature, pulse, and blood pressure) will be collected at the screening visit and prior to 
each study vaccination. Vital signs assessed on Day 1 prior to the first study vaccination will be 
considered as baseline. Participants must not eat or drink anything hot or cold, or smoke within 
10 minutes prior to taking an oral temperature. A 12-lead electrocardiogram will be performed at 
screening and reviewed by an investigator and designated cardiologist. 
 
Reactogenicity assessments will include an assessment of solicited AEs occurring for the week 
after each study vaccination (Days 1 through 8 and target of Days 15 through 22, inclusive), 
which includes an assessment of injection site reactions including pruritus, ecchymosis, 

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erythema, edema/induration, pain, and tenderness as well as systemic reactions including fever, 
feverishness, fatigue, malaise, myalgia (exclusive of the injection site muscle pain), arthralgia, 
headache, and nausea. If a reactogenicity event persists on Day 8 or 22 (or the last day of the 
second reactogenicity period, should the second vaccination occur after Day 15), it will be 
followed until resolution. Pre-administration reactogenicity assessments will be performed 
immediately prior to each study vaccination to establish baseline. 
 
Participants will be observed in the clinic for at least 30 minutes after each study vaccination. 
The study vaccination site will be examined, post-administration reactogenicity assessments will 
be performed, and any AE/SAEs will be recorded on the appropriate eCRF prior to discharge 
from the clinic. The study vaccination site will also be examined on approximately Day 8 after 
the first vaccination and Day 22 after the second (or the last day of the second reactogenicity 
period, should the second vaccination occur after Day 15). 
 
All participants will complete a memory aid using an eMemory Aid from the time of first study 
vaccination through Day 8 and the second vaccination through Day 22 (or the last day of the 
second reactogenicity period, should the second vaccination occur after Day 15). Memory aids 
will be completed online and reviewed by the study staff. 
 
Laboratory Evaluations 
 
Clinical laboratory evaluations and special assays are described below. Refer also to Sections 4 
and 8 as well as Appendix A: Schedule of Study Procedures and Evaluations and Appendix B: 
Adverse Events of Special Interest. 
 
7.2.1 Clinical Laboratory Evaluations 
 
A serum pregnancy test (β hCG) will be sent with the screening laboratory specimens and a 
point-of-care urine pregnancy test will be performed on Days 1 and 15 (or the day of second 
vaccination should the second vaccination occur after Day 15), with results determined to be 
negative before randomization and vaccination for all females of childbearing potential. Results 
must be negative and known prior to randomization on Day 1 and administration of vaccine on 
Day 15 (or the day of second vaccination should the second vaccination occur after Day 15) to 
be eligible for participation in this trial and receipt of study vaccinations. 
 
Clinical safety laboratory parameters will be collected at the screening study visit. The results 
from the clinical safety laboratory parameters collected at the screening visit will be reviewed 
prior to the first study vaccination and will be within acceptable ranges to be eligible for receipt 
of the first study vaccination. The safety laboratories will be repeated on approximately Day 29. 

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At screening, tests for HIV infection (fourth generation antigen-antibody test), acute and chronic 
hepatitis B infection (HBsAg), and hepatitis C infection (antibody) will be collected and must be 
negative for a participant to be deemed eligible. In addition, HgbA1C will be performed at 
screening and the value must fall within the protocol-specified eligibility range in order for 
prospective participants to join the study. A urine study for drugs of abuse must also be negative 
for prospective participants to be deemed eligible. Participants will be encouraged to review 
results, when abnormal, with their primary care physicians. These tests will not be routinely 
retested during the trial. 
 
Test 
Eligibility Criterion 
BUN 
<23 mg/dL 
Serum creatinine (female) 
<1.3 mg/dL 
Serum creatinine (male) 
< 1.4 mg/dL 
Alkaline phosphatase (female) 
<147 U/L 
Alkaline phosphatase (male) 
<192 U/L 
ALT (aka SGPT) 
<68 U/L 
Total bilirubin 
< 1.3 mg/dL 
Hemoglobin (female) 
>10.9 g/dL 
Hemoglobin (male) 
> 12.4 g/dL 
White blood cell count 
3000-12,000 cells/mm3 
Absolute eosinophil count 
<1201 cells/mm3 
Absolute neutrophil count 
>1200 cells/mm3 
Platelets 
>126,000 cells/mm3 
Hemoglobin A1C 
<6.5% 
Urine for Drugs of Abuse* 
All negative 
HBsAg 
Non-reactive 
HCV antibodies 
Negative 
HIV 4th generation test 
Negative 
 
*amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, oxycodone/oxymorphone, 
phencyclidine (PCP), and propoxyphene. Note that a prospective participant with a positive urine for drugs of 
abuse test for a medication reported by the participant and used to treat a condition that does not make them 
otherwise ineligible, may be permitted to enroll, at the discretion of the investigator or his designee. 
 
 
 
The volume of venous blood to be collected for laboratory evaluations is presented in Table 3. 

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7.2.2 Special Assays or Procedures 
 
Serological/Immunogenicity Assays 
 
Serum will be collected for toxin neutralization assay (TNA) and reported as ED50 and NF50 and 
collected for anti-PA IgG concentration by ELISA and reported as µg/mL. Blood samples (sera) 
for determination of TNA titers and anti-PA IgG will be collected on the days outlined in the 
Schedule of Events in Appendix A. Specific procedures related to collection, processing, storage, 
and shipment of the samples are provided in the Manual of Procedures. 
 
The TNA assay being used in this trial has been validated by Battelle Memorial Institute 
(Columbus, Ohio) under National Institute of Allergy and Infectious Diseases sponsorship 
{Clement, 2008}. The assay measures the functional ability of antisera containing anti-PA 
antibodies to specifically protect cells against B. anthracis lethal toxin cytotoxicity {Stinson et 
al, 2005; Li et al., 2008}. The TNA assay results will be reported as the reciprocal of a serum 
sample dilution that results in 50% neutralization of lethal toxin cytotoxicity (50% effective 
dilution; ED50). To standardize assay results, the results are divided by the ED50 of a serum 
reference standard, and the resulting ratio is reported as a 50% neutralization factor, NF50. 
Reference standard AVR801 will be used. 
 
The method of quantitative anti-PA IgG ELISA has been described previously (Semenova VA, 
Schiffer J, Steward-Clark E, Soroka S, Schmidt DS, Brawner MM, Lyde F, Thompson R, Brown 
N, Foster L, Fox S, Patel N, Freeman AE, Quinn CP J Immunol Methods. 2012 Feb 28; 376(1- 
2):97-107). 
 
 
 
 
 
 
 
 
 
Table 3: Venipuncture Volumes 
 
Visit Number 
0 
1 
2 
3 
4 
5 
6 
7 
8 
Cumulative Blood 
Volume Total (mL) 

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Day# 
Screening 
D-28 to -2 
1 
8 
15 
22 
29 
64 
195 
380 
Vaccination 
X 
X 
Serum 
pregnancy for 
women 
6 
6 
Hematology 
6 
6 
12 
Chemistry 
6 
6 
12 
Hgb A1C 
6 
6 
HIV, hepatitis 
B, hepatitis C 
12 
12 
Stored Serum* 
10 
10 
Serological 
Assays (TNA 
and anti-PA 
IgG) 
20† 
20 
20† 
20 
20 
20 
20 
20 
160 
Per Visit 
Blood Volume 
Total (mL) 
46 
20 
20 
20 
20 
32 
20 
20 
20 
Running 
Blood Volume 
Total (mL) 
46 
72 
92 
112 
132 
164 
184 
204 
224 
218 
# Note that Day 15, the visit at which the participant receives the second vaccination, has an acceptable window of 
Days 15 through 18, inclusive. Should the targeted Day 15 visit occur after Day 15, the subsequent dates are 
adjusted to keep the same intervals as in the Table above. 
* This blood is drawn to store serum that could be used in the event of a post-vaccination PIMMC. For participants 
who agree to secondary use, the serum may be used for other secondary use purposes; for those who do not agree 
to secondary use, the serum will be discarded when required after study completion. 
† Blood must be drawn prior to each study vaccination. 
 
7.2.3 Specimen Preparation, Handling, and Shipping 
 
7.2.3.1 
Instructions for Specimen Preparation, Handling, and Storage 
 
Instructions for specimen preparation, handling, and storage are included in the Central Clinical 
Laboratory Manual and protocol-specific MOP as appropriate. 
 
7.2.3.2 
Specimen Shipment 
 
Specimen shipment will occur at intervals during the course of this trial following all applicable 
International Air Transport Association (IATA) requirements and according to the specifics for 
storage temperature and documentation as detailed in the Central Clinical Laboratory Manual 
and protocol-specific MOP, as appropriate. 

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Specimens for clinical safety laboratory evaluations will be shipped from the participating VTEU 
site to the commercial laboratory except those done locally. 
 
Specimens for TNA and ELISA will be shipped from the participating VTEU as outlined in the 
MOP. 
 
Further instructions for specimen shipment are included in the protocol-specific MOP, as 
appropriate. 

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8 
STUDY SCHEDULE 
 
Complete study schedule details listed by type of visit are described below. Refer also to 
Sections 4 and 7 as well as Appendix A: Schedule of Study Procedures and Evaluations and 
Appendix B: Adverse Events of Special Interest. 
 
Screening and Enrollment Visits 
 
During recruitment, the prospective participant may provide to research team members personal 
information by phone or other means. This information may be used for screening and 
determining eligibility. The IRB will approve all methods of screening and recruiting along with 
any required documents or scripts, if used. 
 
8.1.1 Visit 0, Screening (Day -28 to -2), Clinic Visit 
 
• Participants will be provided with a description of this trial (purpose and study 
procedures) and asked to read and sign the ICF. The ICF will be signed prior to 
performing any study procedures. 
 
• Demographic information will be obtained by interview of participants. 
 
• Eligibility criteria will be reviewed with participants to ensure eligibility. 
 
• Complete medical history will be obtained by interview of participants to ensure 
eligibility. 
 
• All concomitant medications taken within 60 days prior to signing the ICF will be 
reviewed with participants and recorded to determine stability of chronic diseases and 
eligibility. 
 
• Vital signs (oral temperature, pulse, and BP) will be obtained to ensure eligibility. 
Participants must not eat or drink anything hot or cold, or smoke within 10 minutes prior 
to taking oral temperature. 
 
• Height and weight will be measured and recorded for the calculation of BMI. 
 
• A physical examination will be performed on all participants to include the following 
organs and organ systems: abdomen, cardiovascular/heart, extremities, general 
appearance, HEENT, hepatobiliary/spleen, lymph nodes, musculoskeletal, neck, 
neurological, pulmonary/chest, and skin. Specific attention will be placed in assessing for 

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physical signs of PIMMCs. The examination will be performed by a study clinician 
licensed to make medical diagnoses and listed on the Form FDA 1572 as the site PI or 
sub-investigator. 
 
• A serum pregnancy test will be performed for all females of childbearing potential. 
Results must be negative to ensure eligibility. Women of childbearing potential will be 
counseled to avoid pregnancy until 60 days after the second (final) vaccination, i.e., Day 
75. 
 
• Venous blood and urine will be collected for the tests outlined in Sections 7.2.1 and 7.2.2. 
The results must be within the acceptable range as outlined in the eligibility criteria to be 
eligible for randomization and vaccination. 
 
• A 12-lead electrocardiogram will be performed and reviewed by the investigator and the 
designated cardiologist. 
 
8.1.2 Visit 1, Day 1, Enrollment (Vaccination), Clinic Visit 
 
• Participant’s willingness to participate will be reconfirmed and documented in the study 
records prior to performing any further study procedures, including administration of 
study vaccination. 
 
• Eligibility criteria, including results from screening lab tests, will be reviewed with 
participants prior to the first study vaccination to ensure continued eligibility. 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of PIMMCs, will be obtained by interview of 
participants prior to study vaccination. Any changes in medical history since the 
screening visit will be reviewed with participants prior to study vaccination to ensure 
continued eligibility. 
 
• All concomitant medications will be reviewed with participants prior to study vaccination 
for accuracy and completeness. Any new concomitant medications taken since the 
screening visit will be reviewed with participants prior to study vaccination to ensure 
continued eligibility. Medications reported in the eCRF are limited to those taken within 
60 days prior to the first study vaccination. 
 
• Vital signs (oral temperature, pulse, and BP) will be obtained prior to study vaccination 
to ensure continued eligibility. Vital signs assessed on Day 1 prior to study vaccination 
will be considered as baseline. Participants must not eat or drink anything hot or cold, or 
smoke within 10 minutes prior to taking oral temperature. 

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• A targeted physical examination, including an assessment for signs suggestive of 
PIMMCs, may be performed, by a study clinician licensed to make medical diagnoses 
and listed on the Form FDA 1572 as the site PI or sub-investigator, prior to study 
vaccination, if indicated based on review of complete medical history and any updates 
obtained by interview of participants since the screening visit. If not indicated, no 
physical examination is necessary. 
 
• A urine pregnancy test will be performed locally by the site within 24 hours prior to study 
vaccination for all females of childbearing potential. Results must be negative and known 
prior to randomization and study vaccination. Women of childbearing potential will be 
counseled to avoid pregnancy until 60 days after the second (final) vaccination, i.e., Day 
75. 
 
• Venous blood will be collected prior to study vaccination for baseline serological assays 
(TNA and anti-PA ELISA). 
 
• Participants will be randomized in Advantage eClinicalSM and randomly assigned to a 
treatment arm prior to study vaccination. 
 
• Pre-administration reactogenicity assessments will be performed immediately prior to 
study vaccination to establish baseline. 
 
• Participants will then receive one dose of study vaccine via a single IM injection into the 
deltoid muscle of the participant’s preferred arm. The site of injection (right or left arm) 
and time of study vaccine administration will be recorded on the appropriate eCRF. 
Participants will be observed in the clinic for at least 30 minutes after study vaccination. 
The study vaccination site will be examined, post-administration reactogenicity 
assessments will be performed, and any AE/SAEs will be recorded on the appropriate 
eCRF prior to discharge from the clinic. 
 
• Participants will be trained to complete a web based “eMemory Aid” and are expected to 
enter information in the eMemory Aid each day. Participants using the eMemory Aid will 
also be provided a paper memory aid for their use in the event they are unable to access 
the web-based system. The participants will be asked to enter the information from the 
paper memory aid into the eMemory Aid once they are able to access the web-based 
system. Participants will be provided with instructions on completion of the electronic 
memory aid and other study-related materials. They will learn to record daily oral 
temperature, solicited injection site and systemic reactions, unsolicited AEs, and 
concomitant medications. Participants will be encouraged to take their oral temperature 
around the same time each day. They must not eat or drink anything hot or cold, or 
smoke within 10 minutes prior to taking their oral temperature. Participants will be 

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instructed on how to use their memory aid and how to measure and record AEs prior to 
discharge from the clinic. They will be instructed to notify the study center if they 
develop any severe reactions after study vaccination. If the site PI or appropriate sub- 
investigator deems the reaction severe enough, further instructions will be given to the 
participant on the proper course of action, including a return to the clinic for immediate 
evaluation if appropriate. 
 
Follow-up Visits 
 
Follow-up visits are scheduled in reference to the study vaccination date as indicated for each 
visit window. 
 
8.2.1 Visit 2, Day 8, Clinic Visit (End of Solicited Reactogenicity Period after First 
Vaccination) 
(Window: Day 8 to Day 11, inclusive) 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of AESIs (PIMMCs), will be obtained by 
interview of participants and any changes since the previous clinic visit will be noted. 
 
• All changes to concomitant medications will be recorded on the appropriate eCRF. 
 
• All MAAEs and AE/SAEs will be recorded on the appropriate eCRF. 
 
• eMemory Aid information will be reviewed with participants. If any reactogenicity 
events are on-going, they will be recorded as AEs. 
 
• A targeted physical examination, including an assessment for signs suggestive of AESIs 
(PIMMCs), may be performed, if indicated based on review of interim medical history, 
by a study clinician licensed to make medical diagnoses and listed on the Form FDA 
1572 as the site PI or sub-investigator. 
 
• The study vaccination site will be examined. 
 
• Venous blood will be collected for serological assays (TNA and anti-PA ELISA). 
 
• Women of childbearing potential will be counseled to avoid pregnancy until 60 days after 
the second (final) vaccination, i.e., Day 75. 

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8.2.2 Visit 3, Day 15, Clinic Visit (Second Vaccination) 
(Window: Day 15 to 18, inclusive) 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of AESIs (PIMMCs), will be obtained by 
interview of participants and any changes since the previous clinic visit will be noted. 
 
• All changes to concomitant medications will be recorded on the appropriate eCRF. 
 
• All MAAEs and AE/SAEs will be recorded on the appropriate eCRF. 
 
• A targeted physical examination, including an assessment for signs suggestive of AESIs 
(PIMMCs), may be performed, if indicated based on review of interim medical history, 
by a study clinician licensed to make medical diagnoses and listed on the Form FDA 
1572 as the site PI or sub-investigator. 
 
• Venous blood will be collected for serological assays (TNA and anti-PA ELISA). 
 
• Criteria for receipt of the second vaccination will be reviewed with participants prior to 
the second study vaccination to ensure continued eligibility. These criteria are identical to 
the eligibility criteria, with the following exceptions: continued consent must be 
confirmed, age will not be re-confirmed, physical exam will not be required to determine 
good health, BMI will not be recalculated, screening labs will not be repeated, and 
screening electrocardiogram will not be repeated. 
 
• Vital signs (oral temperature, pulse, and BP) will be obtained prior to study vaccination 
to ensure continued eligibility. Vital signs assessed on Day 1 prior to study vaccination 
will be considered as baseline. Participants must not eat or drink anything hot or cold, or 
smoke within 10 minutes prior to taking oral temperature. 
 
• A urine pregnancy test will be performed locally by the site within 24 hours prior to study 
vaccination for all females of childbearing potential. Results must be negative and known 
prior to study vaccination. Women of childbearing potential will be counseled to avoid 
pregnancy until 60 days after the second (final) vaccination, i.e., Day 75. 
 
• Pre-administration reactogenicity assessments will be performed immediately prior to 
study vaccination to establish baseline. 
 
• Participants will then receive their second dose of study vaccine via a single IM injection 
into the deltoid muscle of the opposite arm of the first vaccination. The site of injection 
(right or left arm) and time of study vaccine administration will be recorded on the 

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appropriate eCRF. Participants will be observed in the clinic for at least 30 minutes after 
study vaccination. The study vaccination site will be examined, post-administration 
reactogenicity assessments will be performed, and any AE/SAEs will be recorded on the 
appropriate eCRF prior to discharge from the clinic. 
 
• Participants will be re-trained to complete a web based eMemory Aid and are expected to 
enter information in the eMemory Aid each day. Participants using the eMemory Aid will 
also be provided a paper memory aid for their use in the event they are unable to access 
the web-based system. The participants will be asked to enter the information from the 
paper memory aid into the eMemory Aid once they are able to access the web-based 
system. Participants will be reminded to record daily oral temperature, solicited injection 
site and systemic reactions, unsolicited AEs, and concomitant medications. Participants 
will be encouraged to take their oral temperature around the same time each day. They 
must not eat or drink anything hot or cold, or smoke within 10 minutes prior to taking 
their oral temperature. Participants will be instructed on how to measure and record AEs 
prior to discharge from the clinic. They will be instructed to notify the study center if 
they develop any severe reactions after study vaccination. If the site PI or appropriate 
sub-investigator deems the reaction severe enough, further instructions will be given to 
the participant on the proper course of action, including a return to the clinic for 
immediate evaluation if appropriate. 
 
• Note that all subsequent visits are based on the day that Visit 3 occurs. If it occurs on Day 
15, all subsequent visits and windows are as written below. If it occurs after Day 15, 
subsequent visit days will be adjusted to maintain the intervals. For example, if Visit 3 
occurs on Day 16, then the remaining target Days are 23, 30, 65, 196, and 381. The 
number of days in the accompanying acceptable windows for each visit will remain the 
same. The dates as written below reflect the schedule assuming that Visit 3 occurs on 
Day 15. 
 
8.2.3 Visit 4, Day 22, Clinic Visit (End of Solicited Reactogenicity Period after Second 
Vaccination) 
(Window: Day 22 to 25, inclusive) 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of AESIs (PIMMCs), will be obtained by 
interview of participants and any changes since the previous clinic visit will be noted. 
 
• All changes to concomitant medications will be recorded on the appropriate eCRF. 
 
• All MAAEs and AE/SAEs will be recorded on the appropriate eCRF. 

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• eMemory Aid information will be reviewed with participants. If any reactogenicity 
events are on-going, they will be recorded as AEs. 
 
• A targeted physical examination, including an assessment for signs suggestive of AESIs 
(PIMMCs), may be performed, if indicated based on review of interim medical history, 
by a study clinician licensed to make medical diagnoses and listed on the Form FDA 
1572 as the site PI or sub-investigator. 
 
• The study vaccination site will be examined. 
 
• Venous blood will be collected for serological assays (TNA and anti-PA ELISA). 
 
• Women of childbearing potential will be counseled to avoid pregnancy until 60 days after 
the second (final) vaccination – Day 75. 
 
8.2.4 Visit 5, Day 29, Clinic Visit 
(Window: Day 27 to 31, inclusive) 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of AESIs (PIMMCs), will be obtained by 
interview of participants and any changes since the previous clinic visit will be noted. 
 
• All changes to concomitant medications will be recorded on the appropriate eCRF. 
 
• All MAAEs and AE/SAEs will be recorded on the appropriate eCRF. 
 
• A targeted physical examination, including an assessment for signs suggestive of AESIs 
(PIMMCs), may be performed, if indicated based on review of interim medical history, 
by a study clinician licensed to make medical diagnoses and listed on the Form FDA 
1572 as the site PI or sub-investigator. 
 
• Venous blood will be collected for serological assays (TNA and anti-PA ELISA). 
 
• Venous bloodwill be collected for standard clinical safety evaluations (tests outlined in 
Table 10). 
 
• Women of childbearing potential will be counseled to avoid pregnancy until 60 days after 
the second (final) vaccination, i.e., Day 75. 

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8.2.5 Visit 6, Day 64, Clinic Visit 
(Window: Day 60-68, inclusive) 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of AESIs (PIMMCs), will be obtained by 
interview of participants and any changes since the previous clinic visit will be noted. 
 
• All changes to concomitant medications will be recorded on the appropriate eCRF. 
 
• All MAAEs and AE/SAEs will be recorded on the appropriate eCRF. 
 
• A targeted physical examination, including an assessment for signs suggestive of AESIs 
(PIMMCs), may be performed, if indicated based on review of interim medical history, 
by a study clinician licensed to make medical diagnoses and listed on the Form FDA 
1572 as the site PI or sub-investigator. 
 
• Venous blood will be collected for serological assays (TNA and anti-PA ELISA). 
 
• Women of childbearing potential will be counseled to avoid pregnancy until 60 days after 
the second (final) vaccination, i.e., Day 75. 
 
8.2.6 Visit 7, Day 195, Clinic Visit 
(Window: Day 188 to 202, inclusive) 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of AESIs (PIMMCs), will be obtained by 
interview of participants and any changes since the previous clinic visit will be noted 
 
• All changes to concomitant medications will be recorded on the appropriate eCRF only if 
they occurred after Day 64 and in relation to an MAAE, SAE, or AESI (PIMMC). 
 
• MAAEs, SAEs, and AESIs (PIMMCs) will be recorded on the appropriate eCRF. 
 
• A targeted physical examination, including an assessment for signs suggestive of AESIs 
(PIMMCs), may be performed, if indicated based on review of interim medical history, 
by a study clinician licensed to make medical diagnoses and listed on the Form FDA 
1572 as the site PI or sub-investigator. 
 
• Venous blood will be collected for serological assays (TNA and anti-PA ELISA). 

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Final Visit 
 
8.3.1 Visit 8, Day 380, Clinic Visit 
(Window: Day 373 to 387, inclusive) 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of AESIs (PIMMCs) will be obtained by 
interview of participants and any changes since the previous clinic visit will be noted. 
 
• All changes to concomitant medications will be recorded on the appropriate eCRF only if 
they occurred after Day 64 and in relation to an MAAE, SAE, or AESI (PIMMC). 
 
• MAAEs, SAEs, and AESIs (PIMMCs) will be recorded on the appropriate eCRF. 
 
• A targeted physical examination, including an assessment for signs suggestive of AESIs 
(PIMMCs) may be performed, if indicated based on review of interim medical history, by 
a study clinician licensed to make medical diagnoses and listed on the Form FDA 1572 as 
the site PI or sub-investigator. 
 
• Venous blood will be collected for serological assays (TNA and anti-PA ELISA). 
 
Early Termination Visit (if needed) 
 
The following activities will be performed at the Early Termination Visit on participants who 
withdraw, or are withdrawn or terminated from this trial: 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of AESIs (PIMMCs), will be obtained by 
interview of participants and any changes since the previous clinic visit will be noted. 
 
• All changes to concomitant medications will be recorded on the appropriate eCRF if 
within the window. 
 
• All MAAEs and AE/SAEs will be recorded on the appropriate eCRF, if within the 
windows. 
 
• eMemory Aid information will be reviewed with participants, if not previously completed 
and reviewed. 

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• Vital signs (oral temperature, pulse, and BP) may be obtained if indicated. Participants 
must not eat or drink anything hot or cold, or smoke within 10 minutes prior to taking 
oral temperature. 
 
• A targeted physical examination, including an assessment for signs suggestive of AESIs 
(PIMMCs) may be performed, if indicated based on review of interim medical history, by 
a study clinician licensed to make medical diagnoses and listed on the Form FDA 1572 as 
the site PI or sub-investigator. 
 
• The study vaccination site will be examined, if the early termination falls from Days 1 to 
8 after either study vaccination. 
 
• Post-administration reactogenicity assessment will be performed, if the early termination 
falls from Days 1 to 8 after either study vaccination. 
 
• Venous blood will be collected for clinical safety labs and auto-antibodies, if not 
previously drawn. 
 
• Venous blood will be collected for serological assay (TNA and anti-PA ELISA). 
 
Unscheduled Visit (if needed) 
 
An Unscheduled Visit may occur at any time during this trial. Any of the following activities 
may be performed: 
 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms suggestive of AESIs (PIMMCs) will be obtained by 
interview of participants and any changes since the previous clinic visit or phone call will 
be noted (if indicated). 
 
• All changes to concomitant medications will be recorded on the appropriate eCRF, if 
within the window. 
 
• All MAAEs and AE/SAEs will be recorded on the appropriate eCRF, if within the 
windows. 
 
• eMemory Aid information will be reviewed with participants, if applicable. 
 
• Vital signs (oral temperature, pulse, and BP) may be obtained if indicated. Participants 
must not eat or drink anything hot or cold, or smoke within 10 minutes prior to taking 
oral temperature. 

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• A targeted physical examination, including an assessment for signs suggestive of AESIs 
(PIMMCs), may be performed, if indicated based on review of interim medical history, 
by a study clinician licensed to make medical diagnoses and listed on the Form FDA 
1572 as the site PI or sub-investigator. 
 
• The study vaccination site will be examined, if the unscheduled visit falls from Days 1 to 
8 after either study vaccination. 
 
• Post-administration reactogenicity assessment will be performed, if the unscheduled visit 
falls from Days 1 to 8 after either study vaccination. 
 
• Venous blood will be collected for clinical safety labs and serological testing (TNA and 
anti-PA ELISA), if not already performed. 

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9 
ASSESSMENT OF SAFETY 
 
Specification of Safety Parameters 
 
Safety will be assessed by the frequency and severity of the following: 
 
1. SAEs occurring from the time of the first study vaccination through approximately 12 
months after the second study vaccination (approximately Day 380). 
 
2. Solicited AEs – reactogenicity events occurring from the time of each study vaccination 
(Day 1) through Day 8 after each study vaccination (or until resolved): 
 
a) Injection site reactions including pruritus, ecchymosis, erythema, edema/induration, 
pain, and tenderness. 
 
b) Systemic reactions including fever, feverishness, fatigue, malaise, myalgia, arthralgia, 
headache, and nausea. 
 
3. Clinical safety laboratory AEs occurring from the time of the first study vaccination 
through approximately Day 29. Parameters are found in Table 10. 
 
4. Unsolicited AEs –non-serious unsolicited AEs occurring from the time of the first study 
vaccination through approximately Day 64. 
 
5. AESIs (PIMMCs) and MAAEs occurring from the time of the first study vaccination 
through approximately Day 380. 
 
Table 4: Safety/Tolerability Assessment Timeline 
 
 
Safety/Tolerability 
Evaluation # 
Day 1 
Day 8 
Day 15 
Day 22 
Day 29 
Day 64 
Day 195 
Day 380 
SAEs 
Solicited AEs* 
Clinical Safety Lab AEs 
Unsolicited non-serious AEs 
AESIs (PIMMCs) 
MAAEs 

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#Note that all visits after Visit 3 are based on the day that Visit 3 occurs. If it occurs on Day 15, all subsequent visits 
and windows are as written in the Table. If it occurs after Day 15, subsequent visit days will be adjusted to maintain 
the intervals. For example, if Visit 3 occurs on Day 16, then the remaining target Days are 23, 30, 65, 196, and 381. 
The dates as written in the Table reflect the schedule assuming that Visit 3 occurs on Day 15. 
 
*Solicited AEs may require recording beyond Days 8 and 22, if they persist. 
 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
 
9.2.1 Adverse Events 
 
Adverse Event (AE): ICH E6 (R2) GCP defines an AE as any untoward medical occurrence in a 
patient or clinical investigation participant administered a pharmaceutical product and which 
does not necessarily have a causal relationship with this treatment. The FDA defines an AE as 
any untoward medical occurrence associated with the use of a drug in humans, whether or not 
considered drug related. 
 
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal (investigational) 
product. The occurrence of an AE may come to the attention of study personnel during study 
visits and interviews of a study recipient presenting for medical care, or upon review by a study 
monitor. 
 
AEs, including solicited injection site and systemic (subjective and quantitative) reactions, not 
meeting the protocol-defined criteria for SAEs, will be recorded on the appropriate eCRF. 
Information to be collected for unsolicited non-serious AEs includes event description, date of 
onset, licensed study physician’s assessment of severity and relationship to study product or 
alternate etiology (if not related to study product) (assessed only by those with the training and 
authority to make a diagnosis and listed on the Form FDA 1572 as the site PI or sub- 
investigator), date of resolution, seriousness, and outcome. AEs occurring during the trial- 
collection and reporting period will be documented appropriately regardless of relationship to 
study product. AEs will be followed through resolution. 
 
Any medical condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the severity of any pre-existing 
medical condition increases, it will be recorded as an AE. 

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AEs must be assessed for severity and relationship to study product (see definitions below). AEs 
characterized as intermittent require documentation of onset and duration of each episode. The 
start and stop date of each reported AE will be recorded on the appropriate eCRF. 
 
Medically-Attended Adverse Events (MAAEs): For each unsolicited AE experienced, 
the participant will be asked if he/she had received medical attention, defined as 
hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from 
medical personnel for any reason. AEs characterized by such unscheduled medical care 
will be designated as MAAEs. 
 
Adverse Events of Special Interest (AESI): An adverse event of special interest 
(serious or nonserious) is one of scientific and medical concern specific to the sponsor’s 
product or program, for which ongoing monitoring and rapid communication by the 
investigator to the sponsor can be appropriate. Such an event might warrant further 
investigation in order to characterize and understand it. Depending on the nature of the 
event, rapid communication by the trial sponsor to other parties (e.g., regulators) might 
also be warranted. 
 
Potentially Immune-Mediated Medical Conditions (PIMMCs): PIMMCs constitute a 
group of AEs that includes diseases which are clearly autoimmune in etiology and other 
inflammatory and/or neurologic disorders which may or may not have autoimmune 
etiologies. PIMMCs are presented in Appendix B: Adverse Events of Special Interest. 
This is the only category of AESIs that will be collected for this trial. 
 
Protocol Specified AESIs: The only protocol-specific AESIs are those PIMMCs listed 
in Appendix B. 
 
Severity of Event: AEs will be assessed by a licensed study physician listed on the Form FDA 
1572 as the site PI or sub-investigator using a protocol-defined grading system (see Sections 
9.2.2 and 9.2.3). For events not included in the protocol-defined grading system, the following 
guidelines will be used to quantify severity: 
 
• 
Mild (Grade 1): Events require minimal or no treatment and do not interfere with the 
participant’s daily activities. 
 
• 
Moderate (Grade 2): Events result in a low level of inconvenience or concern with 
therapeutic measures. Moderate events may cause some interference with functioning and 
daily activities. 

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• 
Severe (Grade 3): Events interrupt the participant’s daily activities and may require 
systemic drug therapy or other treatment. Severe events are usually incapacitating. 
 
Relationship to Study Product: The licensed study physician’s assessment of an AE’s 
relationship to study product is part of the documentation process, but it is not a factor in 
determining what is or is not reported in this trial. If there is any doubt as to whether a clinical 
observation is an AE, the event should be reported. The relationship to study product must be 
assessed for AEs using the terms: related or not related. In a clinical trial, the study product must 
always be suspect. To help assess, the following guidelines are used: 
 
• Related – There is a reasonable possibility that the study product caused the AE. 
Reasonable possibility means that there is evidence to suggest a causal relationship 
between the study product and the AE. 
 
• Not Related – There is not a reasonable possibility that the administration of the study 
product caused the event. 
 
9.2.2 Reactogenicity 
 
Reactogenicity events are solicited AEs that are common and known to occur following 
administration of this type of study vaccine. The following Toxicity Grading Scales will be used 
to grade solicited injection site and systemic (subjective and quantitative) reactions: 
 
Table 5: Injection Site Reactogenicity Grading 
 
Injection Site Reaction 
Mild (Grade 1) 
Moderate (Grade 2) 
Severe (Grade 3) 
Pain – experienced 
without touching the 
injection site 
(spontaneous 
discomfort) 
Subject is aware of pain, 
but it does not interfere 
with daily activity, and if 
pain medication is used, it 
is Over the Counter 
(OTC) and used for less 
than 24 hours 
Subject is aware of pain; 
there is interference with 
daily activity or OTC 
pain medication is used 
for more than 24 hours 
Subject is aware of pain, 
and it prevents daily 
activity or pain requires 
prescription medication 
Tenderness-experienced 
with touching the 
injection site 
Subject is aware of pain, 
but it does not interfere 
with daily activity, and if 
pain medication is used, it 
is Over the Counter 
(OTC) and used for less 
than 24 hours 
Subject is aware of pain; 
there is interference with 
daily activity or OTC 
pain medication is used 
for more than 24 hours 
Subject is aware of pain, 
and it prevents daily 
activity or pain requires 
prescription medication 

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Injection Site Reaction 
Mild (Grade 1) 
Moderate (Grade 2) 
Severe (Grade 3) 
Pruritus 
Does not interfere with 
daily activity 
Interferes with daily 
activity 
Prevents daily activity or 
requires prescription 
medication 
Ecchymosis (Bruising)* 
Does not interfere with 
daily activity 
Interferes with daily 
activity 
Prevents daily activity 
Erythema (Redness)* 
Does not interfere with 
daily activity 
Interferes with daily 
activity 
Prevents daily activity 
Edema 
(Swelling)/Induration 
(Hardness)* 
Does not interfere with 
daily activity 
Interferes with daily 
activity 
Prevents daily activity 
* Will also be measured in mm but size will not be used as halting criteria. 
 
Ecchymosis, erythema and edema/induration as analyzed by measurement will be graded as 
follows: 
 
Table 6: Injection Site Reactogenicity Measurements 
 
Injection Site Reaction 
Small 
Medium 
Large 
Ecchymosis (Bruising)* 
<20 mm 
20 mm – 50 mm 
>50 mm 
Erythema (Redness)* 
<20 mm 
20 mm – 50 mm 
>50 mm 
Edema (Swelling)/Induration 
(Hardness)* 
<20 mm 
20 mm – 50 mm 
>50 mm 
* Will not be used as halting criteria. 
 
Table 7: Subjective Systemic Reactogenicity Grading 
 
Systemic (Subjective) 
Mild (Grade 1) 
Moderate (Grade 2) 
Severe (Grade 3) 
Feverishness 
No interference with 
daily activity 
Some interference with 
daily activity 
Significant interference, 
prevents daily activity 
Fatigue 
No interference with 
daily activity 
Some interference with 
daily activity 
Significant interference, 
prevents daily activity 
Malaise 
No interference with 
daily activity 
Some interference with 
daily activity 
Significant interference, 
prevents daily activity 

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Systemic (Subjective) 
Mild (Grade 1) 
Moderate (Grade 2) 
Severe (Grade 3) 
Myalgia* 
No interference with 
daily activity 
Some interference with 
daily activity 
Significant interference, 
prevents daily activity 
Arthralgia* 
No interference with 
daily activity 
Some interference with 
daily activity 
Significant interference, 
prevents daily activity 
Headache 
No interference with 
daily activity 
Some interference with 
daily activity 
Significant interference, 
prevents daily activity or 
headache requires 
prescription medication 
Nausea 
No interference with 
daily activity 
Some interference with 
daily activity 
Significant interference, 
prevents daily activity or 
nausea requires prescription 
medication 
* Not at injection site. 
 
Oral temperature# will be graded as follows: 
 
Table 8: Quantitative Systemic (Oral Temperature) Reactogenicity Grading 
 
Systemic (Quantitative) 
Mild (Grade 1) 
Moderate (Grade 2) 
Severe (Grade 3) 
Fever* – oral† 
38.0°C – 38.4°C 
100.4°F – 101.1°F 
38.5°C – 38.9°C 
101.2°F – 102.0°F 
>38.9°C 
>102.0°F 
# Oral temperature assessed on Day 1 prior to the first study vaccination will be considered as baseline. 
* A fever can be considered not related to the study product if an alternative etiology can be documented. 
† Participants must not eat or drink anything hot or cold, or smoke within 10 minutes prior to taking oral temperature. 
 
9.2.3 Additional Adverse Event Severity Grading 
 
Pulse and BP# will be graded as follows: 
 
Table 9: Pulse and BP Adverse Event Grading 
 
Physiologic Parameter 
Mild (Grade 1) 
Moderate (Grade 2) 
Severe (Grade 3) 
Bradycardia – beats per minute 
45 – 50 
40 – 44 
<40 

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Tachycardia – beats per minute 
101 – 130 
131 – 155 
>155 
Hypotension (systolic) mmHg 
80 – 84 
75 – 79 
<75 
Hypotension (diastolic) mmHg 
50 – 54 
45 – 49 
<45 
Hypertension (systolic) mmHg 
141 – 155 
156 – 160 
>160 
Hypertension (diastolic) mmHg 
91 – 100 
101 – 110 
>110 
# Pulse and BP assessed on Day 1 prior to the first study vaccination will be considered as baseline. 
 
Clinical safety laboratory values will be graded as follows: 
 
Table 10: Clinical Safety Laboratory Adverse Event Grading 
 
Panel and Analytea 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 
3) 
Serum Chemistry 
Blood Urea Nitrogen (mg/dL) 
23–26 
27–31 
>31 
Creatinine (mg/dL) female 
1.3–1.7 
1.8–2.0 
>2.0 
Creatinine (mg/dL) male 
1.4–1.7 
1.8–2.0 
>2.0 
Alkaline phosphatase (U/L) 
female 
147-196 
197-294 
>294 
Alkaline phosphatase (U/L) 
male 
192-256 
257-384 
>384 
ALT(U/L) 
68-113 
114-225 
>225 
Total Bilirubin when 
accompanied by any grade 
ALT (mg/dL) 
1.3-1.6 
1.7-2.0 
>2.0 
Total Bilirubin when not 
accompanied by any grade 
ALT (mg/dL) 
1.3-2.0 
2.1-2.6 
>2.6 
Hematology 
Hemoglobin, female (g/dL) 
10.0-10.9 
9.0-9.9 
<9.0 
Hemoglobin decrease from 
baseline value, female (g/dL) 
1.0–1.5 
1.6–2.0 
>2.0 
Hemoglobin, male (g/dL) 
11.5-12.4 
10.5-11.4 
<10.5 
Hemoglobin decrease from 
baseline value, male (g/dL) 
1.0–1.5 
1.6–2.0 
>2. 0 
WBC (leukocytosis) 
(cell/mm3) 
12,001–15,000 
15,001–20,000 
>20,000 
WBC (leukopenia) (cell/mm3) 
2,500–2999 
1,500–2,499 
<1,500 

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Panel and Analytea 
Mild (Grade 1) 
Moderate (Grade 
2) 
Severe (Grade 
3) 
Eosinophils (absolute 
eosinophilia) (cell/mm3) 
1201-1500 
1,501–5,000 
>5,000 
Neutrophil (neutropenia) 
(cell/mm3) 
1001-1200 
751-1,000 
<751 
Platelets 
(thrombocytopenia)(cell/mm3) 
100,000– 
126,000 
50,000-99,999 
<50,000 
ALT = alanine aminotransferase; WBC = white blood cell. 
a Laboratory normal reference ranges have been taken into consideration for the toxicity grading scale. If the laboratory provides 
a value that has additional significant digits beyond what is provided in the table, digits of 0-4 will be rounded down and digits of 
5-9 will be rounded up, for purposes of delineating a grade. 
 
9.2.4 Serious Adverse Events 
 
Serious Adverse Event (SAE): An AE or suspected adverse reaction is considered “serious” if, 
in the view of either the site PI (or appropriate sub-investigator) or sponsor, it results in any of 
the following outcomes: 
 
• Death, 
 
• A life-threatening AE*, 
 
• Inpatient hospitalization or prolongation of existing hospitalization, 
 
• A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, or 
 
• A congenital anomaly/birth defect. 
 
• Important medical events that may not result in death, be life-threatening, or require 
hospitalizations may be considered serious when, based upon appropriate medical 
judgment they may jeopardize the patient or participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. Examples of 
such medical events include allergic bronchospasm requiring intensive treatment in an 
emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse. 
 
* Life-threatening AE: An AE is considered “life-threatening” if, in the view of either the site PI 
(or appropriate sub-investigator) or sponsor, its occurrence places the patient or participant at 
immediate risk of death. It does not include an AE that, had it occurred in a more severe form, 
might have caused death. 

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SAEs will be: 
 
• 
Assessed for severity and relationship to study product or alternate etiology (if not related 
to study product) by a licensed study physician listed on the Form FDA 1572 as the site 
PI or sub-investigator. 
 
• 
Recorded on the appropriate SAE form and entered into the eCRF. 
 
• 
Followed through resolution by a licensed study physician listed on the Form FDA 1572 
as the site PI or sub-investigator. 
 
• 
Reviewed and evaluated by the SMC (periodic review unless related), DMID, and IRB, 
as required. 
 
9.2.5 Procedures to be Followed in the Event of Abnormal Laboratory Test Values or 
Abnormal Clinical Findings 
 
The site PI or appropriate sub-investigator is responsible for recording all AE/SAEs that are 
observed or reported during this trial, regardless of relationship to study product. AE/SAEs, 
abnormal laboratory test values, or abnormal clinical findings will be collected, assessed, 
documented, reported, and followed appropriately, using a local laboratory as necessary. In 
determining eligibility, refer to Section 5.1 and the protocol-specific MOP. 
 
Reporting Procedures 
 
Solicited injection site and systemic reactogenicity events will be documented and reported from 
the time of each study vaccination through 7 days after each study vaccination. These recording 
intervals are Days 1 through 8, inclusive, and Days 15 through 22, inclusive. If reactogenicity 
events are still present on Days 8 or 22, they will continue to be recorded until resolved. 
 
Clinical safety laboratory AEs will be documented and reported following the post-vaccination 
clinical safety laboratory studies collected on approximately Day 29. 
 
Unsolicited non-serious AEs will be documented and reported from the time of the first study 
vaccination through approximately Day 64. 
 
MAAEs, SAEs, and AESIs (PIMMCs) will be documented and reported from the time of the 
first study vaccination through approximately 12 months after the second study vaccination (the 
entire time the participant is followed from first vaccination until study completion), i.e., through 
approximately Day 380. 

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9.3.1 Serious Adverse Events 
 
Any AE that meets a protocol-defined serious criterion must be submitted immediately (within 
24 hours of site awareness) on an SAE form to the DMID Pharmacovigilance Group, at the 
following address: 
DMID Pharmacovigilance Group 
Clinical Research Operations and Management Support (CROMS) 
6500 Rock Spring Dr. Suite 650 
Bethesda, MD 20817, USA 
SAE Hot Line: 1-800-537-9979 (US) or 1-301-897-1709 (outside US) 
SAE FAX: 1-800-275-7619 (US) or 1-301-897-1710 (outside US) 
SAE Email Address: PVG@dmidcroms.com 
 
In addition to the SAE form, selected SAE data fields must also be entered into Advantage 
eClinicalSM. Please see the protocol-specific MOP for details regarding this procedure. 
 
Other supporting documentation of the event may be requested by the DMID Pharmacovigilance 
Group and should be provided as soon as possible. 
 
The DMID Medical Monitor and DMID Clinical Project Manager will be notified of the SAE by 
the DMID Pharmacovigilance Group. 
 
The DMID Medical Monitor will review and assess the SAE for regulatory reporting and 
potential impact on participant safety and protocol conduct. 
 
At any time after completion of this trial, if the site PI or appropriate sub-investigator becomes 
aware of an SAE that is suspected to be related to study product, the site PI or appropriate sub- 
investigator will report the event to the DMID Pharmacovigilance Group. 
 
9.3.2 Regulatory Reporting for Studies Conducted Under DMID-Sponsored IND 
 
Following notification from the site PI or appropriate sub-investigator, DMID, the 
Investigational New Drug (IND) sponsor, will report any suspected adverse reaction that is both 
serious and unexpected. DMID will report an AE as a suspected adverse reaction only if there is 
evidence to suggest a causal relationship between the drug and the AE. DMID will notify the 
FDA and all investigators (i.e., the participating VTEU site PI to whom the sponsor is providing 
drug under its IND(s) or under any PI’s IND(s)) in an IND safety report of potential serious risks 
from clinical trials or any other source, as soon as possible, but in no case later than 15 calendar 
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CFR Part 312.32. DMID will also notify the FDA of any unexpected fatal or life-threatening 
suspected adverse reaction as soon as possible, but in no case later than 7 calendar days after the 
sponsor’s initial receipt of the information. Relevant follow up information to an IND safety 
report will be submitted as soon as the information is available. Upon request from the FDA, 
DMID will submit to the FDA any additional data or information that the agency deems 
necessary, as soon as possible, but in no case later than 15 calendar days after receiving the 
request. 
 
All serious adverse events designated as “not related” to study product(s) will be reported to the 
FDA at least annually in a summary format. 
 
9.3.3 Reporting of Pregnancy 
 
Upon awareness, pregnancies occurring in participants will be recorded on the Pregnancy Report 
eCRF. All pregnancies reported during the course of this trial will be followed to pregnancy 
outcome, if allowable to the participant. With the participant’s permission, we will continue to 
follow the participant for safety and immune response. If the participant becomes pregnant after 
the first vaccination, the second vaccination will not be given. 
 
Type and Duration of Follow-up of Participants after Adverse Events 
 
Non-serious unsolicited AEs will be collected, assessed, and followed through resolution from 
the time of first study vaccination through approximately Day 64. 
 
MAAEs, SAEs, and AESIs (PIMMCs) will be collected, assessed and followed from the time of 
the first study vaccination through resolution even if this extends beyond the trial-reporting 
period (approximately 12 months after the second study vaccination, i.e., approximately Day 
380). 
 
Resolution of an AE/SAE is defined as the return to pretreatment status or stabilization of the 
condition with the expectation that it will remain chronic. 
 
Follow-up procedures, evaluations, and outcomes will be recorded on the appropriate eCRF. 

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Halting Rules 
 
9.5.1 Individual Halting Rules 
 
• Any participant experiences ulceration, abscess, or necrosis at the injection site from 
vaccination until 7 days later (Days 1 through 8, inclusively, for the first vaccination and 
Days 15 through 22, inclusively, for the second vaccination. Should the second 
vaccination occur after Day 15, the reactogenicity period will occur from the day of 
vaccination until 7 days later) 
 
• Any participant experiences laryngospasm, bronchospasm, or anaphylaxis within 24 
hours after administration of the study products 
 
• Any participant experiences generalized urticaria (defined as urticarial lesions occurring 
at more than two body parts) within 72 hours after administration of study product. 
 
• Any participant experiences an SAE (except for accident or trauma) after administration 
of the study product. 
 
• Any participant experiences a grade 3 AE including lab, local, or systemic solicited 
reactogenicity events (excluding measured grades of ecchymosis, erythema, and 
edema/induration alone) 
 
9.5.2 Study Halting Rules 
 
 
Additional enrollment and study interventions/administration of study products in this trial will 
be halted for SMC review/recommendation if any of the following are reported after the first 
study vaccination: 
 
• Any participant experiences ulceration, abscess or necrosis at the injection site in the 
week after vaccination (Days 1 through 8, inclusively, for the first vaccination and Days 
15 through 22, inclusively, for the second vaccination; should the second vaccination 
occur after Day 15, the reactogenicity period will occur from the day of vaccination until 
7 days later) that is considered related to study product administration. 
 
• Any participant experiences laryngospasm, bronchospasm or anaphylaxis within 24 hours 
after administration of study product that is considered related to study product. 

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• Two or more participants experience generalized urticaria (defined as urticarial lesions 
occurring at more than two body parts) within 72 hours after administration of study 
product that is considered related to study product. 
 
• Any participant experiences an SAE after administration of study product that is 
considered related to study product. 
 
• Any participant develops a PIMMC after administration of study product from receipt of 
study product until last study visit (approximately Day 380). 
 
• Three or more participants experience a grade 3 injection site or systemic solicited 
adverse event (excluding measured grades of ecchymosis, erythema, and 
edema/induration alone). 
 
• Three or more participants experience the same grade 3 AE (unsolicited and laboratory 
abnormality), in the same HLGT by MedDRA coding, considered related to study 
product. 
 
Grading scales for solicited injection site and systemic (subjective and quantitative) reactions are 
included in Section 9.2.2. Grading scales for clinical safety laboratory AEs are included in 
Section 9.2.3. 
 
If any of the halting rules are met following any participant receipt of study vaccination, then this 
trial will not continue with the remaining enrollments or study vaccinations without a review by 
and recommendation from the SMC to proceed. 
 
DMID retains the authority to suspend additional enrollment, study interventions, and 
administration of study products during this trial, as applicable. 
 
The DMID Medical Monitor is empowered to stop enrollment and study vaccinations if AEs that 
meet the halting criteria are reported. 
 
Safety Oversight 
 
9.6.1 Independent Safety Monitor (ISM) 
 
For this clinical trial, an ISM is not required. The site PI or appropriate sub-investigator will 
send to the DMID Medical Monitor a summary of the events and include the site PI assessments. 

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9.6.2 Safety Monitoring Committee 
Safety oversight will be conducted by an SMC that is an independent group of experts that 
monitors participant safety and advises DMID. The SMC members will be separate and 
independent of study personnel participating in this trial and will not have scientific, financial, or 
other COI related to this trial. The SMC will consist of members with appropriate expertise to 
contribute to the interpretation of the data from this trial. 
 
The SMC will operate under the rules of a DMID-approved charter that will be written at the 
organizational meeting of the SMC. At this time, each data element that the SMC needs to assess 
will be clearly defined. Procedures for SMC reviews/meetings will be defined in the charter. The 
SMC will review applicable data to include, but not limited to, study progress and clinical, 
safety, reactogenicity, and immunogenicity data. Reports may include enrollment and 
demographic information, medical history, concomitant medications, physical assessments, 
clinical laboratory values, dosing compliance, solicited and unsolicited AEs, MAAEs, SAEs, and 
AESIs (PIMMCs). The SMC will review SAEs on a regular basis and ad hoc during this trial. 
The DMID Medical Monitor will be responsible for reviewing SAEs in real time. 
 
The SMC will conduct the following reviews: 
 
• An Organizational Meeting that occurs prior to participant enrollment 
 
• Ad hoc when a halting rule is met, or DMID/SMC chair may convene an ad hoc meeting 
if there are immediate concerns regarding observations during the course of this trial. The 
DMID Medical Monitor is empowered to stop enrollment and study vaccinations if AEs 
that meet the halting criteria are reported. 
 
• Final review meeting: 6 to 8 months after database lock to review the cumulative 
unblinded safety and immunogenicity data for this trial. The data will be provided in a 
standard summary format. The SMC may be asked to provide recommendations in 
response to questions posed by DMID. 
 
Additional data may be requested by the SMC, and interim statistical reports may be generated 
as deemed necessary and appropriate by DMID. The SMC may receive data in aggregate and 
presented by treatment arm. The SMC may also be provided with expected and observed rates of 
the expected AEs in an unblinded fashion and may request the treatment assignment be 
unblinded for an individual participant if required for safety assessment. The SMC will review 
grouped and unblinded data in the closed session only. As an outcome of each review/meeting, 
the SMC will make a recommendation as to the advisability of proceeding with study 
vaccinations, as applicable, and to continue, modify or terminate this trial. 

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10 
CLINICAL MONITORING 
 
Site Monitoring Plan 
 
Site monitoring is conducted to ensure that the human participants’ protections, study and 
laboratory procedures, study interventions/administration of study products, and data collection 
processes are of high quality and meet sponsor and ICH E6 GCP guidelines and applicable 
federal regulations, and that this trial is conducted in accordance with the protocol, protocol- 
specific MOP and applicable sponsor SOPs. DMID, the sponsoring agency, or its designee will 
conduct site-monitoring visits as detailed in the clinical monitoring plan. DMID-designated 
clinical monitors will verify that this trial is conducted, and data are generated, documented 
(recorded), and reported in compliance with the protocol, ICH E6 GCP guidelines, and 
applicable regulatory requirements. Clinical monitoring reports will be submitted to DMID. 
 
Site visits will be made at standard intervals as defined by DMID and may be made more 
frequently as directed by DMID. Monitoring visits will include, but are not limited to, review of 
regulatory files, accountability records, eCRFs, ICFs, medical and laboratory reports, and 
protocol and GCP compliance. Site monitors will have access to each participating VTEU site, 
study personnel, and all study documentation according to the DMID-approved site monitoring 
plan. Study monitors will meet with site PIs to discuss any problems and actions to be taken and 
document visit findings and discussions. 

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11 
STATISTICAL CONSIDERATIONS 
 
Introduction 
 
The goal of this clinical study is to assess in healthy adults, 18-45 years of age, the safety, 
reactogenicity, and immunogenicity of two doses of AV7909 administered as either the 
thermostable lyophilized product or as the liquid product. 
 
Study Hypotheses 
 
This Phase I study is not designed to test a formal null hypothesis. Rather, it is intended to obtain 
sufficient data to obtain meaningful estimates of the immune response induced by either vaccine 
formulation, and to uncover any safety issues that occur at a sufficiently high rate that they might 
be observed in a study of this size. The sample size facilitates formal testing of selected 
hypotheses as discussed in Section 11.4.3, along with the probability of observing safety 
outcomes and the precision of immunogenicity outcomes. 
 
Study Outcome Measures 
 
Please refer to Study Outcome Measures outlined in Table 1. 
 
Sample Size Considerations 
 
Please refer to Study Design outlined in Section 4. 
 
11.4.1 Study Population 
 
The study population for this clinical trial includes males and non-pregnant females, 18-45 years 
of age, who are in good health and meet all eligibility criteria. The participants will be recruited 
from the general population at one participating VTEU site. 
 
11.4.2 Participant Enrollment and Follow-up 
 
Based on the accrual rates observed in similar studies, it seems reasonable to expect that the 
participating VTEU will be able to enroll this trial in a timely fashion, about 12 weeks from first 
participant vaccinated until the final participant receives his/her first vaccination. 

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A total of 40 participants will be enrolled. Assuming up to 10% drop out by Day 64, it is 
expected that at least 18 subjects per group will be available for the primary immunogenicity 
analysis. 
 
11.4.3 Sample Size 
While this study is not designed to test any specific null hypothesis, the following illustrates the 
precision and power that are available for select estimates and comparisons of interest, based on 
the planned sample size of N=20 participants per study arm. 
 
Table 11 indicates the probability of observing one or more safety events, such as solicited 
injection site or systemic reactogenicity events or an unsolicited AE of a particular type, for a 
single treatment arm (N=20), and for all enrolled subjects (N=40). 
 
Table 11: Probability (%) to Detect Safety Events Emmes 
 
 
Event 
Frequency 
N = 20 
N = 40 
≥10% 
Very Common 
87 
98 
≥1% 
Common 
18 
33 
≥0.1% 
Uncommon 
1 
3 
≥0.01% 
Rare 
<0.1 
<0.1 
 
 
Binomial confidence intervals (CI) are widest (have the least precision) when the response rate is 
50%. Table 12 is presented to indicate the worst-case scenario for precision of observed exact 
(Clopper-Pearson) binomial confidence intervals. 
 
 
Table 12: Precision of Binomial Confidence Intervals 
 
N 
95% CI 
20 
27-73 
40 
34-66 

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For each of the primary immunogenicity objectives, a power analysis is provided below for 
testing the following hypotheses with the planned sample size, where pc = probability of 
response in comparator arm; where pe = probability of response in experimental arm. 
 
Test for difference in proportion responders: 
H0: pc – pe = 0 – No difference in response probabilities 
H1: pc – pe ≠ 0 – difference in response probabilities 
 
Table 13 illustrates the minimum detectable differences in the probability of responding (e.g., 
attaining seroconversion or NF50 ≥0.56 [seroprotection]) between participants who receive 
AV7909 as the lyophilized formulation or liquid formulation using a two-sided likelihood ratio 
test with 80% power and alpha = 0.05. It is assumed that up to 10% of subjects (N=2) will be 
excluded from the per-protocol analysis in each group. Seroconversion rates of 10% to 60% are 
considered. 
 
Table 13: Minimum Detectable Difference in the Probability of Response with 80% Power 
 
N per Group 
Probability of 
Response in 
Comparator Group A 
80% Power 
Minimal 
Detectable 
Difference 
Probability of 
Response in 
Experimental 
Group B 
N = 18 
0.10 
0.39 
0.49 
0.20 
0.43 
0.63 
0.30 
0.43 
0.73 
0.40 
0.42 
0.82 
0.50 
0.39 
0.89 
0.60 
0.35 
0.95 

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Planned Interim Analyses 
No interim analyses are planned. 
 
11.5.1 Interim Safety Review 
An interim safety review may include enrollment and demographic information, medical history, 
concomitant medications, physical assessments, clinical laboratory values, dosing compliance, 
and solicited and unsolicited AE/SAEs. Additional data may be requested by the SMC, and 
interim statistical reports may be generated as deemed necessary and appropriate by DMID. The 
SMC may receive data in aggregate and presented by treatment arm, including expected and 
observed rates of the expected AEs. The SMC will review grouped data in the closed session 
only. The SMC will meet and review this data at scheduled time points or ad hoc as needed 
during this trial as defined in the SMC charter. As an outcome of each review/meeting, the 
SMC will make a recommendation as to the advisability of proceeding with study vaccinations 
(as applicable), and to continue, modify, or terminate this trial. 
 
Additionally, this trial will be monitored to determine if any of the halting rules described in 
Section 9.5 are met. 
 
 
Final Analysis Plan 
Participant unblinding will occur and the final CSR will be completed after the last participant’s 
last visit is completed, the final clinical database including all long-term safety follow-up data is 
cleaned, monitored and locked, and all primary and secondary immunogenicity data are 
available. There are no planned exploratory immunogenicity endpoints. If any are added via 
protocol amendment, then the additional exploratory immunogenicity endpoint data not available 
at the time of CSR preparation may be included in an addendum to the CSR. 
 
A formal statistical analysis plan which defines the analyses to be included in the expedited 
report and the final CSR will be developed, finalized, and submitted to the FDA, prior to 
unblinding for any analysis. 
 
11.6.1 Analysis Populations 
 
The Safety Analysis population includes all participants who received the first dose of study 
vaccine. 
 
The modified intent-to-treat (mITT) population includes all randomized participants who 
received the first dose of study vaccine and contributed at least one post-first study vaccination 
venous blood sample for immunogenicity testing for which valid results were reported. For 

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analyses using the mITT population, participants will be grouped based on randomized treatment 
arm. 
 
The per protocol (PP) population includes all participants in the mITT with the following 
exclusions: 
• 
Data from all available visits for participants found to be ineligible at baseline. 
• 
Data from all visits for participants that did not contribute venous blood samples for 
immunogenicity testing. 
• 
Data from all visits subsequent to major protocol deviations, such as: 
o Second vaccination not received 
o Second vaccination received out of window 
o Receipt of immunosuppressive therapy (e.g., corticosteroids) within 30 days 
before or after the first study vaccination. 
o Receipt of non-study licensed live vaccine within 30 days before or after each 
study vaccination. 
o Receipt of non-study licensed, inactivated vaccine within 14 days before or 
after each study vaccination. 
• Data from any visit that occurs substantially out of window. 
 
For analyses using the PP population, participants will be grouped based on study vaccinations 
received. 
 
11.6.2 
Safety Data 
 
Summaries and analysis of safety data will be presented for the Safety Analysis Population. All 
summaries and analyses will be presented for all participants. 
 
Solicited AEs will be summarized by severity after each study vaccination (through 7 days post 
study vaccination, Days 1 through 8 and Days 15 through 22) and as the maximum severity over 
all days. Additionally, solicited AEs will be analyzed by taking the most severe response over 
the follow-up period, dichotomizing into a binary variable (none versus mild, moderate, or 
severe) and using standard techniques, such as exact confidence intervals, to summarize the 
proportion of subjects reporting each symptom, any injection site symptom, and any systemic 
symptom. Summaries of solicited AEs will be presented for each study vaccination by treatment 
arm. The proportion of participants reporting symptoms may be compared between treatment 
arms using Chi-square or Fisher’s exact test. 
 
Unsolicited AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) for 
preferred term and system organ class (SOC). The numbers of SAEs, MAAEs, and AESIs 

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(PIMMCs) are likely to be small in this trial and will be reported by detailed listings showing the 
event description, MedDRA preferred term and SOC, relevant dates (study vaccinations and 
AEs), severity, relatedness, and outcome for each event. Non-serious unsolicited AEs will be 
summarized as number and percentage of participants reporting at least one event in each 
MedDRA preferred term and SOC, cross tabulated by severity and relationship to study 
product. Additionally, the proportion of participants and exact 95% confidence intervals of AEs 
in aggregate and by MedDRA categories will be computed. 
 
Clinical laboratory data will be summarized by severity for each visit and as the maximum over 
all post-study vaccination visits. Graphical presentations may include box plots. 
 
11.6.3 
Humoral Immunogenicity Data 
 
Summaries and analysis of immunogenicity data will be presented for the mITT and PP 
populations; the PP population will be considered the primary analysis. Immune responses in 
terms of TNA ED50 and NF50, and anti-PA IgG by ELISA will be summarized by treatment arm 
at each time point. Analysis at all time points will include geometric mean titers (GMTs) and 
proportion of participants with seroconversion (defined as ≥4-fold increase over baseline levels, 
or a ≥4-fold increase over the LLOQ if the baseline value is <LLOQ). Additionally, the 
proportion of subjects in each study group with putative seroprotection (defined as NF50≥0.56) 
will be assessed at each time point. All summaries will include the corresponding 95% 
confidence interval. No exploratory immunologic outcomes are anticipated. 
 
11.6.4 
Exploratory Immunogenicity Data 
 
None. 
 
11.6.5 
Missing Values and Outliers 
 
All attempts will be made to collect all data per protocol. As missing data are expected to be 
minimal, no imputation will be performed for missing values. Any data point that appears to be 
erroneous or inexplicable based on clinical judgment will be investigated as a possible outlier. If 
data points are identified as outliers, sensitivity analyses will be performed to examine the 
impact of including or excluding the outliers. Any substantive differences in these analyses will 
be reported. 

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12 
DATA COLLECTION FORMS AND ACCESS TO SOURCE 
DATA/DOCUMENTS 
 
The participating VTEU site will maintain appropriate medical and research records for this 
clinical trial, in compliance with ICH E6 GCP Section 4.9 and regulatory and institutional 
requirements for the protection of confidentiality of participants. The participating VTEU site 
will permit the study monitor or other authorized representatives of DMID as well as 
governmental regulatory agencies, such as the FDA, to examine (and when required by 
applicable law, to copy) clinical trial records for the purposes of quality assurance reviews, 
audits, monitoring and evaluation of the study safety and progress. These representatives will be 
permitted access to all source data, which include, but are not limited to, hospital records, 
clinical and office charts, laboratory notes, memoranda, evaluation checklists, pharmacy 
dispensing records, recorded data from automated instruments, copies or transcriptions certified 
after verification as being accurate and complete, microfiches, photographic negatives, microfilm 
or magnetic media, x-rays, and participant files, and records kept at the pharmacy, at the 
laboratories and medico-technical departments involved in this clinical trial. Source data are all 
information, original records of clinical findings, observations, or other activities in a clinical 
trial necessary for the reconstruction and evaluation of the clinical trial. 
 
Interview of participants is sufficient for obtaining medical history. Solicitation of medical 
records from the participant’s primary care provider is not required. 
 
The study uses direct data entry for the participating clinic site and a web-based electronic 
Memory Aid (eMemory Aid) for participants. All eCRFs serve as the source documents. 
Participants will be trained to use a database to complete a web based “eMemory Aid” and are 
expected to enter information in the eMemory Aid each day. Participants using the eMemory 
Aid will also be provided a paper memory aid for their use in the event they are unable to access 
the web-based system. The participants will be asked to enter the information from the paper 
memory aid into the eMemory Aid once they are able to access the web-based system. 
 
Participants will record temperature, local and systemic symptoms, and if any new medications 
were used following vaccination or changes to previously reported medications daily for 8 days 
after any vaccination (Days 1 through 8 and Days 15 through 22). 
 
Participants will be instructed to contact the clinic staff immediately if they experience 
significant symptoms at any time during the study, for prompt follow-up in real time. The study 
clinic will be alerted in real time of any potential solicited events of Grade 3 severity entered in 
the eMemory Aid. An email alert will be sent to the clinic site and the Emmes study team. 
Within one business day of site awareness, the site must attempt to follow up with the participant 

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on the severe solicited event and send an email to Emmes confirming attempted follow up with 
the participant. Instructions for completing the eMemory Aid are provided in the MOP and in a 
separate eMemory Aid instructions document that will be provided to the participants at each 
vaccination. The site staff must review the eMemory Aid information and interview the 
participant at the next scheduled visit. The participant-entered data will be included in the 
clinical database on the Solicited Events eCRF and will be available for review by the clinician 
during the clinical interview. All participant-entered data are to undergo clinical review. 
 
Site staff who are delegated the responsibility by the study PI will be the data originators for 
clinical data entered directly into the eCRF in Advantage eClinical that will be used for the study 
endpoints. The central laboratory will be the data originator for laboratory data reported by an 
automated reporting system. A list of all authorized data originators, including site staff, will be 
included on the Study Personnel/Signature Responsibility List. 

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13 
QUALITY CONTROL AND QUALITY ASSURANCE 
 
Following a written DMID-accepted site quality management plan, each participating VTEU site 
(and its subcontractors) is responsible for conducting routine quality assurance (QA) and quality 
control (QC) activities to internally monitor study progress and protocol compliance. Each site PI 
will provide direct access to all study-related sites, source data/eCRFs and reports for the 
purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory 
authorities. Each site PI will ensure all study personnel are appropriately trained and applicable 
documentation is current and maintained on site. 
 
The SDCC will implement QC procedures beginning with the data entry system and generate 
data QC checks that will be run on the database. Any missing data or data anomalies will be 
communicated to the participating VTEU site(s) for clarification and resolution. 

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14 
ETHICS/PROTECTION OF HUMAN PARTICIPANTS 
 
Ethical Standard 
 
The site PI will ensure that this trial is conducted in full conformity with principles of the 
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of 
Research (National Commission for the Protection of Human Subjects of Biomedical and 
Behavioral Research [April 18, 1979]) and codified in 45 CFR 46, 21 CFR 50 and 21 CFR 56, as 
applicable. The site PI will also ensure conformity with ICH E6 GCP and applicable federal 
regulations, guidance and guidelines for GCP and Clinical Trials with humans. 
 
Institutional Review Board (IRB) 
 
The institution engaged in this research will hold a current Federal Wide Assurance (FWA) 
issued by the Office for Human Research Protections (OHRP) for federally funded research. The 
IRB must be registered with OHRP [OHRP-only or OHRP/FDA] as applicable to the research. 
The IRB FWA number will be provided to DMID. 
 
The site PI will obtain IRB approval for this protocol to be conducted at his/her research site(s) 
and send supporting documentation to DMID before initiating recruitment of participants. The 
site PI will submit applicable information to the IRB on which it relies for the review, to conduct 
the review in accordance with 45 CFR 46, ICH E6 GCP guidelines, and as applicable, 21 CFR 
56 (Institutional Review Boards), 21 CFR 50 (Protection of Human Subjects), and other federal, 
state, and local regulations and guidance. IRB approved recruitment process, screening script, 
and materials for participants may be utilized. DMID must receive the documentation that 
verifies IRB approval for this protocol, associated informed consent documents, and upon 
request, any recruitment material and handouts or surveys intended for the participants, prior to 
the recruitment and enrollment of participants. 
 
Any amendments to the protocol or consent materials will be approved by the IRB before they 
are implemented. IRB review and approval will occur at least annually throughout the enrollment 
and follow-up of participants and may cease if annual review is no longer required by applicable 
regulations. The site PI will notify the IRB of protocol deviations and reportable SAEs in 
accordance with IRB requirements. 

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Informed Consent Process 
 
Informed consent is a process that is initiated prior to an individual agreeing to participate in a 
trial and continuing throughout the individual’s trial participation. During recruitment, potential 
participants may be screened for eligibility by phone or email before obtaining written consent, 
per an IRB-approved process that ensures confidentiality. At the first clinic visit, before any 
study procedures are performed, informed consent will be obtained and documented. Participants 
will receive a concise and focused presentation of key information about the trial, verbally and 
with a written ICF. The explanation will be organized and presented in lay terminology and 
language that facilitates understanding why one might or might not want to participate. The ICF 
must not include any exculpatory statements. 
 
The site PI or his designees will describe the protocol to potential participants face-to-face. The 
key information about the purpose of the trial, the procedures and experimental aspects of the 
trial, risks and discomforts, any expected benefits to the participants, and alternative treatment 
will be presented first to the participant. 
 
Participants will also receive an explanation that the trial involves research and a detailed 
summary of the proposed study procedures and study interventions/study products. This 
discussion will include aspects of the trial that are experimental, the probability for random 
assignment to treatment arms, any expected benefits, all possible risks (including a statement that 
the particular treatment or procedure may involve risks to the participant or to the embryo or 
fetus, if the participant is or may become pregnant, that are currently unforeseeable), the 
expected duration of the participant’s participation in the trial, alternative treatment/procedures 
that may be available, and the important potential benefits and risks of these available alternative 
treatment/procedures. 
 
Participants will be informed that they will be notified in a timely manner if information 
becomes available that may be relevant to their willingness to continue participation in the trial. 
Participants will receive an explanation as to whether any compensation and any medical 
treatments are available if injury occurs, and, if so, what they consist of or where further 
information may be obtained. Participants will be informed of the anticipated financial expenses, 
if any, for participating in the trial, as well as any anticipated prorated payments, if any, to the 
participant for participating in the trial. They will be informed of whom to contact (e.g., the site 
PI) for answers to any questions relating to the research project. 
 
Information will also include the foreseeable circumstances and/or reasons under which the 
participant’s participation in the trial may be terminated. The participants will be informed that 

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participation is voluntary and that they are free to withdraw from the study for any reason at any 
time without penalty or loss of benefits to which he or she is otherwise entitled. 
 
The extent of the confidentiality of the participant’s records will be defined, and participants will 
be informed that applicable data protection legislation will be followed. They will be informed 
that the monitors, auditors, IRB, NIAID, and regulatory authorities will be granted direct access 
to their original medical records for verification of trial procedures and/or data without violating 
the confidentiality of the participant, to the extent permitted by the applicable laws and 
regulations, and that, by signing a written ICF, the participant is authorizing such access. 
Participants will be informed that records identifying them will be kept confidential and, to the 
extent permitted by the applicable laws and/or regulations, will not be made publicly available 
and, if the results of the trial are published, the participant’s identity will remain confidential. 
Participants will be informed whether private information collected from this research and/or 
samples/specimens will be used for additional research, even if identifiers are removed. 
Participants will be allowed sufficient time to consider participation in the trial and have the 
opportunity to discuss the trial with their family, friends, or legally authorized representative, or 
think about it prior to agreeing to participate. 
 
ICFs will be IRB-approved and participants will be asked to read and review the ICF. 
Participants must sign the ICF prior to starting any study procedures being done specifically for 
the trial. Once signed, a copy of the ICF will be given to the participants for their records. The 
participant(s) may withdraw consent at any time throughout the course of the trial. Their rights 
and welfare will be protected by emphasizing to them that the quality of their medical care will 
not be adversely affected if they decline to participate in or withdraw from the trial. 
 
New information that significantly impacts the participant’s risk of receiving the study 
interventions/study products will be communicated by the site PI or his/her designees to the 
participants who consent to participate in the trial in accordance with IRB requirements. The ICF 
will be updated and participants will be re-consented in accordance with IRB requirements, if 
necessary. Participants will be given a copy of all ICFs that they sign. 
 
 
Exclusion of Women, Minorities and Children (Special Populations) 
 
This trial will be inclusive of all interested persons, 18 to 45 years of age, who meet the 
Participant Inclusion Criteria (see Section 5.1.1) and do not meet the Participant Exclusion 
Criteria (see Section 5.1.2), regardless of religion, sex or ethnic background. Should the outcome 
of this trial be deemed acceptable, additional trials may be initiated including those in other 
populations. 

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It is unknown if AV7909 poses any risks to an unborn child. Females of childbearing potential 
must utilize a highly effective method of contraception that is defined as one that results in a low 
failure rate (i.e., less than 1% per year) when used consistently and correctly (effective methods 
of birth control are outlined in the inclusion criteria, section 5.1.1). In addition to contraceptive 
use, all females of childbearing potential will be required to have a negative pregnancy test 
within 24 hours prior to each study vaccination. Female participants who become pregnant while 
participating in this trial will be asked to consider allowing the study team to follow them during 
pregnancy and record the outcome. 
 
Children will not be included in this trial. 
 
Participant Confidentiality 
 
Participant confidentiality is strictly held in trust by the site PI, other study personnel, the 
sponsor, and their agents. This confidentiality includes documentation, investigation data, 
participant’s clinical information, and all other information generated during participation in this 
trial. No information concerning this trial, or the data generated from this trial will be released to 
any unauthorized third party without written consent of the participant and approval by DMID. 
 
Participant confidentiality will be maintained when trial results are published or discussed in 
conferences and is extended to cover testing of samples/specimens. The study monitor or other 
authorized representatives of DMID as well as governmental regulatory agencies, such as the 
FDA, may inspect all documents and records required to be maintained by the site PIs. This 
includes, but is not limited to, medical records (office, clinic or hospital) and pharmacy records 
for the participants in this trial. The participating VTEU site will permit access to such records. 
All records will be kept locked and all computer entry and networking programs will be carried 
out with coded numbers only and with password-protected systems. All non-clinical 
samples/specimens, evaluation forms, reports, and other records that leave the site will be 
identified only by a coded number and will not be identified by the participant’s name. 
 
To protect privacy, we have received a Certificate of Confidentiality. With this Certificate, the 
researchers cannot be forced to release information that may identify the participant, even by a 
court subpoena, in any federal, state or local civil, criminal, administrative, legislative, or other 
proceedings. The researchers will use the Certificate to resist any demands for information that 
would identify the participant, except as explained below. 

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The Certificate cannot be used to resist a demand for information from personnel of the US 
Government that is used for auditing or evaluation of federally funded projects, like this trial, or 
for information that must be released in order to meet the requirements of the FDA. 
 
A Certificate of Confidentiality does not prevent the participant from voluntarily releasing 
information about themselves or their involvement in this research. If any person or agency 
obtains a written consent to receive research information, then the researchers may not use the 
Certificate to withhold that information. 
 
The Certificate of Confidentiality does not prevent the researchers from reporting without the 
participant’s consent, information that would identify the participant as a participant in the 
research project regarding matters that must be legally reported including: child and elder abuse, 
sexual abuse or wanting to harm themselves or others. 
 
Study Discontinuation 
 
If this trial is prematurely terminated by the sponsor, any regulatory authority, the site PI, or 
appropriate sub-investigator for any reason, the site PI or appropriate sub-investigator will 
promptly inform the participants and assure appropriate therapy or follow-up for them, as 
necessary. The site PI or appropriate sub-investigator will provide a detailed written explanation 
of the termination to the IRB. If any participant’s private information will continue to be 
collected for this trial, the IRB must approve an ICF with the study procedures, any risks and 
discomforts as well as applicable elements, and the site PI or designee will re-consent the 
participants as approved by the IRB. 
 
If this trial is discontinued, participants who have signed the ICF and are randomized and 
vaccinated will continue to be followed for safety for the duration of the prescribed safety 
follow-up period. No further study vaccinations will be administered. 
 
Costs, Participant Compensation and Research Related Injuries 
 
There is no cost to participants for the research tests, study procedures/evaluations or study 
vaccines while taking part in this trial. 
 
Participants may be compensated for their participation in this trial. Compensation will be in 
accordance with local IRB requirements, and subject to local IRB approval. 
 
If it is determined by the participating VTEU site and the site PI that an injury occurred to a 
participant as a direct result of the tests or treatments that are done for this trial, then referrals to 

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appropriate health care facilities will be provided to the participant. Study personnel will try to 
reduce, control, and treat any complications from this trial. Immediate medical treatment may be 
provided by the participating VTEU site, such as giving emergency medications to stop 
immediate allergic reactions to the study vaccine. No financial compensation will be provided to 
the participant by NIAID, NIH or the participating VTEU site for any injury suffered due to 
participation in this trial. 
 
Public Readiness and Emergency Preparedness Act 
This protocol and the vaccine tested are covered under the Public Readiness and Emergency 
Preparedness (PREP) Act. The PREP Act provides compensation to participants in the event of 
serious physical injury or death caused by covered drugs and vaccines, and liability protection 
for persons conducting the clinical study and the manufacturer of the drug or vaccine. 
The vaccine used in this clinical study is covered as a countermeasure under the PREP Act. This 
provides immunity for covered persons (including manufacturers, distributers, program planners, 
and other qualified persons who prescribe, administer, or dispense the vaccine) from tort 
liability, unless the injury was caused by willful misconduct. 
 
The Act authorizes an emergency fund administered by the Health Resources and Services 
Administration via the Countermeasures Injury Compensation Program (CICP). The CICP 
provides compensation to eligible individuals who suffer specified injuries from administration 
or use of a countermeasure pursuant to the declaration. Any requests for compensation must be 
filed with the CICP within 1 year of administration or use of the countermeasure. For more 
information please visit the CICP website at http://www.hrsa.gov/cicp/. It is also advised 
participants consult an attorney in the event they suffer a serious injury and wish to file a claim 
for compensation with the CICP. 
 
 
Secondary Use of Stored Specimens 
 
Participants who agree to participate in this trial will have venous blood collected for clinical 
safety laboratory evaluations, stored samples for use in the evaluation of suspected or confirmed 
PIMMCs, and serological immunology assays. Any excess aliquots of serum available from 
blood samples, once protocol-defined assays are completed, will be stored for use in new or 
different immunological laboratory tests, to provide information for the development of new 
vaccines, or for the studies of anthrax or other infections. These aliquots, other than the blood 
drawn specifically for evaluation of PIMMCs, are derived from blood already collected as part of 
the study, not from additional blood volumes collected solely for the purpose of secondary use. 

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Secondary research use specimens, upon written request and approval from DMID, may be 
shared with investigators at the participating VTEU site, with other investigators or designated 
research laboratories for purposes of conducting additional immunological assessments other 
than PP analysis. The IRB will approve the use and breadth of secondary use specimens. DMID 
would authorize shipment from the DMID CMS. There are no benefits to participants in the 
collection, storage, and secondary research use of their samples/specimens. Secondary research 
use samples/specimens will not be sold or used directly for production of any commercial 
product. No genetic tests will be performed on stored/secondary use specimens. Samples will be 
stored indefinitely at an NIH-designated research storage facility. 
 
Each sample/specimen will be encoded (labeled) only with a barcode and a unique tracking 
number to protect participant confidentiality. Reports from secondary research studies performed 
using participants’ samples/specimens will NOT be kept in their health records and will not be 
reported to the participant. Assaying of secondary use specimens and providing reports of 
secondary use results will not be done during this protocol. 
 
Participants will be asked to consent to the secondary research use of excess/residual specimens 
as an option, when they first consent to study participation. If they choose not to provide 
permission for excess blood and secondary use, they will still remain eligible for randomization 
and enrollment into the study. 
 
Participants who at first choose to allow for secondary use of excess/residual aliquots may 
withdraw permission to use samples for secondary use at any time, even if they do not withdraw 
consent for participation. Samples stored for secondary use will not be assayed for secondary 
use tests during this study. Participants who choose to withdraw permission for secondary use 
will need to contact the study site and the samples will be removed from the study repository 
after this study is completed. Documentation will be completed that outlines the reason for 
withdrawal of permission for secondary use of samples. 
 
There are no additional risks accrued by permitting secondary use of aliquots for the testing 
herein described. The scope of tests to be performed is similar in nature and detail to the 
immunologic tests already proposed in this protocol. The alternative is for participants to choose 
not to allow for secondary use of their stored specimens. 

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DATA HANDLING AND RECORD KEEPING 
 
The site PI is responsible to ensure the accuracy, completeness, legibility, and timeliness of the 
data reported. 
 
Data will be directly entered into the case report forms by study personnel or received by direct 
data transfer. Data will be entered into an eCRF via a 21 CFR 11-compliant Internet Data Entry 
System provided and maintained by the Study Data Coordinating Center (SDCC). The data 
system includes password protection and internal quality checks, such as automatic range checks, 
to identify data that appear inconsistent, incomplete, or inaccurate. 
 
For any forms requiring paper, data collection forms (DCFs) will be derived from the eCRF and 
provided by the SDCC to record and maintain data for each participant enrolled in this trial. All 
DCFs will be completed in a neat, legible manner to ensure accurate interpretation of data. Black 
or blue ink is required to ensure clarity of reproduced copies. When making a change or 
correction, research staff members will cross out the original entry with a single line and initial 
and date the change. They will not erase, overwrite, or use correction fluid or tape on the 
original. 
 
Electronic case report forms will serve as the source documents for data collected and will be 
created by the SDCC to record and maintain data for each participant enrolled in this study. 
 
The sponsor and/or its designee will provide guidance to the site PIs and other study personnel 
on making corrections to the DCFs and eCRF. Details on data handling procedures, procedures 
for data monitoring, and instructions for use of the system and completion of the eCRFs are 
provided in the study MOP, eCRF Instructions, and Advantage eClinical User’s Guide. 
 
Data Management Responsibilities 
 
All eCRFs and laboratory reports will be reviewed by the clinical team and data entry personnel, 
who will ensure that they are accurate and complete. AEs will be recorded on the appropriate 
eCRF, assessed for severity and relationship, and reviewed by the site PI or appropriate sub- 
investigator. 
 
Data collection is the responsibility of the study personnel at the participating VTEU site under 
the supervision of the site PI. During this trial, the site PI will maintain complete and accurate 
documentation for this trial. 

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The SDCC for this trial will be responsible for data management, quality review, analysis, and 
reporting of the study data. 
 
Data Capture Methods 
 
Clinical (including, but not limited to, AE/SAEs, MAAEs, AESIs [PIMMCs], concomitant 
medications, medical history, physical assessments, and clinical laboratory values), 
reactogenicity, and immunogenicity data will be entered into a 21 CFR 11-compliant Internet 
Data Entry System provided and maintained by the SDCC. The data system includes password 
protection and internal quality checks, such as automatic range checks, to identify data that 
appear inconsistent, incomplete or inaccurate. Clinical and reactogenicity data will be entered 
directly onto eCRFs by the study personnel. 
 
Types of Data 
 
Data for this trial will include clinical, safety, and outcome measures (e.g., clinical laboratory 
values, and reactogenicity and immunogenicity data). 
 
Timing/Reports 
 
The final CSR will be completed after the last participant's last visit is completed, the final 
clinical database including all long-term safety follow-up data is cleaned, monitored and locked, 
and all primary and secondary immunogenicity data are available. There are no planned 
exploratory immunogenicity endpoints. If any are added via protocol amendment, then the 
additional exploratory immunogenicity endpoint data not available at the time of CSR 
preparation may be included in an addendum to the CSR. 
 
A formal statistical analysis plan will be developed, finalized, and submitted to the FDA, prior to 
unblinding for any analysis, which defines the analyses to be included in the expedited report and 
the final CSR. 
 
Additional statistical reports may be generated as deemed necessary and appropriate by DMID. 
Safety and immunogenicity summary reports may be generated for the SMC. 
 
After the final CSR is complete, and upon request and DMID approval, the SDCC will provide 
the participating VTEU site with a summary of results by treatment arm and/or participant 
treatment assignment. In this regard, the participating VTEU site requesting such information to 
share with participants must do so in accordance with IRB requirements. 

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Study Records Retention 
 
Study records and reports, including, but not limited to, eCRFs, source documents, ICFs, and 
study drug disposition records shall be maintained for 2 years after a marketing application is 
approved for the drug for the indication for which it is being investigated; or, if no application is 
to be filed or if the application is not approved for the drug, until 2 years after the investigation is 
discontinued and the FDA has been notified. These documents will be retained for a longer 
period, however, if required by local regulations. ICFs for secondary research use will be 
maintained as long as the sample/specimen exists. 
 
No records will be destroyed without the written consent of the sponsor. It is the responsibility of 
the sponsor to inform the site PI when these documents no longer need to be retained. The 
participating VTEU sites must contact DMID for authorization prior to the destruction of any 
study records. 
 
Protocol Deviations 
 
A protocol deviation is any noncompliance with the study protocol, GCP, or protocol-specific 
MOP requirements. The noncompliance may be either on the part of the participant, the site PI, 
or other study personnel. As a result of protocol deviations, corrective actions are to be 
developed by the site and implemented promptly. 
 
These practices are consistent with ICH E6 GCP guidelines: 
 
4.5 
Compliance with Protocol, Sections 4.5.1, 4.5.2 and 4.5.3 
 
5.1 
Quality Assurance and Quality Control, Section 5.1.1 
 
5.20 
Noncompliance, Sections 5.20.1 and 5.20.2 
 
It is the responsibility of the site PI and other study personnel to use continuous vigilance to 
identify and report protocol deviations within five working days of identification of the protocol 
deviation, or within five working days of the scheduled protocol-required activity. All protocol 
deviations must be promptly reported to DMID, via the SDCC’s Advantage eClinicalSM. 
 
All protocol deviations, as defined above, must be addressed on the appropriate eCRF. A 
completed copy of the Protocol Deviation eCRF must be maintained in the regulatory file as well 
as in the participants’ chart. Protocol deviations must be sent to the IRB in accordance with IRB 
requirements. The site PI and other study personnel are responsible for knowing and adhering to 
IRB requirements. 

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16 
PUBLICATION POLICY 
 
All investigators funded by the NIH must submit or have submitted for them to the National 
Library of Medicine’s PubMed Central (http://www.ncbi.nlm.nih.gov/pmc/) an electronic 
version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made 
publicly available no later than 12 months after the official date of publication. The NIH Public 
Access Policy ensures the public has access to the published results of NIH funded research. It 
requires all investigators to submit final peer-reviewed journal manuscripts that arise from NIH 
funds to the digital archive PubMed Central upon acceptance for publication. Further, the policy 
stipulates that these papers must be accessible to the public on PubMed Central no later than 12 
months after publication. 
 
Refer to: 
 
• 
NIH Public Access Policy, http://publicaccess.nih.gov/ 
 
• 
NIH Office of Extramural Research (OER) Grants and Funding, 
http://grants.nih.gov/grants/oer.htm 
 
As of January 2018, all clinical trials supported by the NIH must be registered on 
ClinicalTrials.gov, no later than 21 days after the enrollment of the first participant. Results of all 
clinical trials supported by the NIH, generally, need to be submitted no later than 12 months 
following the primary completion date. A delay of up to 2 years is available for trials that meet 
certain criteria and have applied for certification of delayed posting. 
 
As part of the result posting a copy of this protocol (and its amendments) and a copy of the 
Statistical Analysis Plan will be posted on ClincialTrials.gov. 
 
For this clinical trial, the responsible party is DMID which will register this trial and post results. 
The responsible party does not plan to request certification of delayed posting. 
 
 
Refer to: 
 
• 
Public Law 110-85, Section 801, Clinical Trial Databases 
 
• 
42CFR11 
 
• 
NIH NOT-OD-16-149 

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17 
LITERATURE REFERENCES 
 
1. 
Centers for Disease C, Prevention. Cutaneous anthrax associated with drum making using 
goat hides from West Africa--Connecticut, 2007. MMWR Morb Mortal Wkly Rep 2008;57:628- 
31. 
2. 
Inglesby TV, Henderson DA, Bartlett JG, et al. Anthrax as a biological weapon: medical 
and public health management. Working Group on Civilian Biodefense. JAMA 1999;281:1735- 
45. 
3. 
Jernigan DB, Raghunathan PL, Bell BP, et al. Investigation of bioterrorism-related 
anthrax, United States, 2001: epidemiologic findings. Emerg Infect Dis 2002;8:1019-28. 
4. 
Fellows PF, Linscott MK, Ivins BE, et al. Efficacy of a human anthrax vaccine in guinea 
pigs, rabbits, and rhesus macaques against challenge by Bacillus anthracis isolates of diverse 
geographical origin. Vaccine 2001;19:3241-7. 
5. 
Brachman PS, Gold H, Plotkin SA, Fekety FR, Werrin M, Ingraham NR. Field 
Evaluation of a Human Anthrax Vaccine. Am J Public Health Nations Health 1962;52:632-45. 
6. 
Wright JG, Quinn CP, Shadomy S, Messonnier N, Centers for Disease C, Prevention. 
Use of anthrax vaccine in the United States: recommendations of the Advisory Committee on 
Immunization Practices (ACIP), 2009. MMWR Recomm Rep 2010;59:1-30. 
7. 
Hopkins RJ, Daczkowski NF, Kaptur PE, et al. Randomized, double-blind, placebo- 
controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed 
plus CPG 7909 (AV7909) in healthy adult volunteers. Vaccine 2013;31:3051-8. 
8. 
Minang JT, Inglefield JR, Harris AM, et al. Enhanced early innate and T cell-mediated 
responses in subjects immunized with Anthrax Vaccine Adsorbed Plus CPG 7909 (AV7909). 
Vaccine 2014;32:6847-54. 
9. 
Rynkiewicz D, Rathkopf M, Sim I, et al. Marked enhancement of the immune response to 
BioThrax(R) (Anthrax Vaccine Adsorbed) by the TLR9 agonist CPG 7909 in healthy volunteers. 
Vaccine 2011;29:6313-20. 
10. 
Galena HJ. Complications occurring from diagnostic venipuncture. J Fam Pract 
1992;34:582-4. 
11. 
Ramos JA. Venipuncture-related lateral antebrachial cutaneous nerve injury: what to 
know? Braz J Anesthesiol 2014;64:131-3. 
12. 
Atanasoff S, Ryan T, Lightfoot R, Johann-Liang R. Shoulder injury related to vaccine 
administration (SIRVA). Vaccine 2010;28:8049-52. 
13. 
Hopkins RJ, Kalsi G, Montalvo-Lugo VM, et al. Randomized, double-blind, active- 
controlled study evaluating the safety and immunogenicity of three vaccination schedules and 
two dose levels of AV7909 vaccine for anthrax post-exposure prophylaxis in healthy adults. 
Vaccine 2016;34:2096-105. 
14. 
Segal BM, Chang JT, Shevach EM. CpG oligonucleotides are potent adjuvants for the 
activation of autoreactive encephalitogenic T cells in vivo. J Immunol 2000;164:5683-8. 
15. 
Cooper CL, Angel JB, Seguin I, Davis HL, Cameron DW. CPG 7909 adjuvant plus 
hepatitis B virus vaccination in HIV-infected adults achieves long-term seroprotection for up to 5 
years. Clin Infect Dis 2008;46:1310-4. 

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16. 
Cooper CL, Davis HL, Angel JB, et al. CPG 7909 adjuvant improves hepatitis B virus 
vaccine seroprotection in antiretroviral-treated HIV-infected adults. AIDS 2005;19:1473-9. 
17. 
Ellis RD, Martin LB, Shaffer D, et al. Phase 1 trial of the Plasmodium falciparum blood 
stage vaccine MSP1(42)-C1/Alhydrogel with and without CPG 7909 in malaria naive adults. 
PLoS One 2010;5:e8787. 
18. 
Mullen GE, Ellis RD, Miura K, et al. Phase 1 trial of AMA1-C1/Alhydrogel plus CPG 
7909: an asexual blood-stage vaccine for Plasmodium falciparum malaria. PLoS One 
2008;3:e2940. 

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18 
APPENDICES 
 
Appendix A: Schedule of Study Procedures and Evaluations 
 
Appendix B: Adverse Events of Special Interest 

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SCHEDULE OF STUDY PROCEDURES AND 
EVALUATIONS 
 
Study Visit (V) 
0 
1 
2 
3 
4 
5 
6 
7 
8 
Early 
Termination 
Study Day# 
pre 
1 
8 
15# 
22# 
29# 
64# 
195# 
380# 
Window Open 
-28 
1 
8 
15 
22 
27 
60 
188 
373 
Window Close 
-2 
1 
11 
18 
25 
31 
68 
202 
387 
Study Week 
pre 
1 
1 
2 
3 
4 
9 
28 
54 
Activity/Procedure 
Inform prospective participant about study details1 
X 
Obtain informed consent, HIPAA authorization, 
enroll2 
X 
Obtain, record, update demographics, medical 
history, concomitant medications3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Perform physical examination4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Collect blood/urine for eligibility or post- 
vaccination safety5 
X 
X 
X 
Perform pregnancy test6 
X 
X 
X 
Perform 12-lead electrocardiogram7 
X 
Review eligibility criteria or criteria for 
subsequent vacination8 
X 
X 
X 
Perform randomization9 
X 
Vaccinate10 
X 
X 
Perform post-vaccination reactogenicity 
assessment, instruct on eMemory Aid, & provide 
study related materials11 
X 
X 
Counsel on avoidance of pregnancy12 
X 
X 
X 
X 
X 
X 
X 
Review memory aid (solicited AEs/reactogenicity) 
& confirm data13 
X 
X 
Examine study vaccination site14 
X 
X 
X 
Collect blood – Toxin Neutralization Assay 
(TNA) and anti-PA IgG by ELISA15 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Collect blood – to be stored for use if PIMMC 
occurs16 
X 
Perform assessment17 of non-serious unsolicited 
AEs 
X 
X 
X 
X 
X 
X 
X 
Perform SAE, MAAE, and AESI assessment18 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
# Note that all visits after Visit 3 (target Day 15, second vaccination) are based on the day that Visit 3 occurs. If 
it occurs on Day 15, all subsequent visits and windows are as written in Appendix A. If it occurs after Day 15, 
subsequent visit days will be adjusted to maintain the intervals. For example, if Visit 3 occurs on Day 16, then 
the remaining target Days are 23, 30, 65, 196, and 381. The number of days in the accompanying acceptable 
windows for each visit will remain the same. The Days for each visit, as written in the Table above and 
described throughout the protocol and elsewhere, reflect the schedule assuming that Visit 3 occurs on Day 15. 
 
1. Prior to screening, participants may be given information about the study design and purpose, eligibility 
criteria, procedures, and other approved details by telephone or otherwise. At the screening visit, 
prospective participants will be provided detailed information about the trial, will be asked to review the 
informed consent document, will have all their questions answered, and will be evaluated for their ability to 
provide informed consent. 

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2. Participants will provide written informed consent, including optional secondary use provisions, HIPAA 
authorization, acknowledgment of the Notice of Privacy Practices, and other study research related 
documents. Upon completion of the initial informed consent process, they will be enrolled and will begin 
screening. 
3. In a private space, trained study team members will collect demographics, medical history, and 
concomitant medications. At screening and the Day 1 visit, these activities will be performed for the 
purposes of determining eligibility and baseline health status. On subsequent visits, updates to the medical 
history and medications will be collected and recorded to evaluate for AEs. Concomitant medications will 
be recorded routinely through Day 64. After Day 64, only concomitant medications (new and updates to 
previously reported ones) that are taken in relation to MAAEs, SAEs, and AESIs (PIMMCs) will be 
recorded. 
4. At screening, a more detailed physical examination will be performed to determine eligibility and any 
baseline findings. This exam includes a height and weight for the determination of Body Mass Index 
(BMI). At Day 1 and at subsequent visits, a physical examination will only be performed if the participant 
reports a symptom warranting an exam. The screening exam will be “detailed”; the subsequent exams, 
when needed, will be “targeted”. The screening exam, Day 1, Day 15, and ET visits will also include vital 
signs (blood pressure, heart rate, oral temperature). Vital signs may be repeated at the discretion of the 
clinician, up to 3 times. 
5. Blood and urine will be collected at screening to determine eligibility. Blood will be collected at Day 29 to 
determine laboratory safety. Tests performed are found in the protocol. 
6. A serum pregnancy test (β hCG) will be sent with the screening laboratory specimens and a point-of-care 
urine pregnancy test will be performed on Days 1 and 15, with results determined to be negative before 
randomization and vaccination. Should Visit 3 (second vaccination) occur after Day 15, the pregnancy test 
will be performed on the day of the visit, with results determined to be negative before vaccination. 
7. A routine 12-lead electrocardiogram will be performed at screening. It will be read by the automated ECG 
machine, reviewed by the investigator, and officially read by a cardiologist. Participants with clinically 
significant abnormalities will be excluded. Adjustments may be made while the ECG is being performed, 
but once it is complete, no repeat ECGs will be performed unless the reviewing cardiologist requires a 
repeat study for clarification. No repeat ECGs will be performed after vaccination. 
8. Prior to randomization and enrollment, the PI or his/her delegate will review all eligibility criteria and 
record his/her determination. Prior to the second dose on Day 15 (or as late as Day 18), the PI or his/her 
delegate will review all criteria for subsequent dosing and record his/her determination. 
9. Upon determination of eligibility, the pharmacy will be notified to proceed with randomization and 
preparation of the vaccine either as the liquid formulation or lyophilized formulation. 
10. A pre-administration reactogenicity assessments will be performed immediately prior to study vaccination 
to establish baseline. The participant will be vaccinated intramuscularly, in the deltoid of the arm chosen by 
the participant, by an unblinded study team member. 
11. In the 30 minutes after vaccination, the participant will be evaluated for immediate reactogenicity and will 
be instructed on the use of the electronic memory aid to record solicited adverse events (reactogenicity) on 
Days 1 through 8 and Days 15 through 22, inclusive. Should Visit 3 (second vaccination) occur after Day 
15, the reactogenicity period will be adjusted to collect a full 7 days of data. Any other study-related 
materials available for the participant, such as study contact information, ruler, and thermometer, will be 
provided. 
12. Women of childbearing potential will be counseled to avoid pregnancy until 60 days after the second (final) 
vaccination, i.e., Day 75 if Visit 3 occurs on Day 15. 
13. In the 7 days following vaccination (Days 1 through 8, inclusively and Days 15 through 22, inclusively; or 
adjusted, as described above, should second vaccination occur after Day 15), during which the participants 
will be directly entering their reactogenicity profiles through a secure web portal, the study team will be 
reviewing the entries, answering questions, and contacting the participant if they have failed to enter data. 
On Days 8 and 22 (or 7 days after the second vaccination, if the second vaccination occurs after Day 15), 
when the post-vaccination diaries will have been completed, the study team will confirm all entries. At 
these visits, the participant will also be asked about unsolicited AEs. If solicited AEs persist in Day 8 or 
Day 22 (beyond the seventh day after second vaccination), they will be followed to resolution. 
14. The site of the vaccination will be examined and findings recorded on the appropriate CRF. 

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15. The toxin neutralization assay is the gold standard immunologic assay for protection against anthrax. It is 
performed on serum. ELISA will also be performed, to measure the concentration of anti-PA IgG. On 
vaccination days (Visits 1 and 3), these will be collected prior to vaccination. 
16. Blood will be collected for storage in case the participant develops signs and/or symptoms of a PIMMC. 
17. Information on unsolicited AEs that are not serious will be collected from the time of the first study 
vaccination to the Day 64 visit (or the Day as determined in an adjusted schedule, should the second 
vaccination, Visit 3, occur after Day 15). 
18. Information on SAEs, MAAEs, and AESIs will be collected from the time of the first study vaccination to 
the Day 380 visit (which may be adjusted, should the second vaccination, Visit 3, occur after Day 15). The 
only AESIs for this study are potentially immune mediated diseases (PIMMCs). If an AESI is reported, the 
participant will be asked to have an evaluation performed. 

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PIMMCs: 
ADVERSE EVENTS OF SPECIAL INTEREST 
 
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 I 
• 
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 
 
Neuroinflammatory disorders 

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• 
Acute disseminated encephalomyelitis, including site-specific variants (e.g., non- 
infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis) 
• 
Cranial nerve disorders, including paralyses/paresis (e.g., Bell’s palsy) 
• 
Guillain-Barré syndrome, including Miller Fisher syndrome and other variants 
• 
Immune-mediated peripheral neuropathies and plexopathies, including chronic 
inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and 
polyneuropathies associated with monoclonal gammopathy 
• 
Multiple sclerosis 
• 
Narcolepsy 
• 
Optic neuritis 
• 
Transverse myelitis 
• 
Myasthenia gravis, including Eaton-Lambert syndrome 
 
Skin disorders 
 
• 
Alopecia areata 
• 
Autoimmune bullous skin diseases, including pemphigus, pemphigoid and dermatitis 
herpetiformis 
• 
Cutaneous lupus erythematosus 
• 
Erythema nodosum 
• 
Morphoea 
• 
Lichen planus 
• 
Psoriasis 
• 
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 
 
Others 
• 
Antiphospholipid syndrome 
• 
Autoimmune hemolytic anemia 

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• 
Autoimmune glomerulonephritis (including IgA nephropathy, glomerulonephritis 
rapidly progressive, membranous glomerulonephritis, membranoproliferative 
glomerulonephritis, and mesangioproliferative glomerulonephritis) 
• 
Autoimmune myocarditis/cardiomyopathy 
• 
Autoimmune parotitis 
• 
Autoimmune thrombocytopenia 
• 
Good pasture syndrome 
• 
Idiopathic pulmonary fibrosis 
• 
Pernicious anemia 
• 
Raynaud’s phenomenon 
• 
Sarcoidosis 
• 
Sjögren’s syndrome 
• 
Stevens-Johnson syndrome 
• 
Uveitis