First-in-Human Safety and Immunogenicity Evaluation of an Intramuscular Campylobacter Jejuni Conjugate Vaccine (CJCV2) With and Without Army Liposome Formulation Containing QS-21 (ALFQ)
Phase: PHASE1
Conditions: Campylobacter Infection
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

DMID Protocol 19-0003 
Version 6.0 
Campylobacter jejuni vaccine (CJCV2)  
8 May 2023 
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First-in-Human Safety and Immunogenicity Evaluation of an Intramuscular 
Campylobacter jejuni Conjugate Vaccine (CJCV2) with and without Army Liposome 
Formulation containing QS-21 (ALFQ) 
DMID Protocol Number: 19-0003 
DMID Funding Mechanism: HHSN27201300016I 
IND Sponsor: DMID 
Principal Investigator: Robert W. Frenck, Jr, M.D. 
DMID Clinical Project Manager: Peter Wolff, MHA 
Draft or Version Number:  6.0 
 8 May 2023 
 
 
 

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STATEMENT OF ASSURANCE 
Each Institution will hold a current Federal Wide Assurance (FWA) issued by the Office of 
Human Research Protections (OHRP) for federally funded human subjects’ research. Each FWA 
will designate at least one Institutional Review Board (IRB)/Independent Ethics Committee 
(IEC) registered with OHRP, for which the research will be reviewed and approved by the 
IRB/IEC and will be subject to continuing review [45 CFR 46.103(b)]. The IRB/IEC designated 
under an FWA may include an institution’s IRB/IEC, an independent IRB/IEC, or an IRB/IEC of 
another institution after establishing a written agreement with that other institution. 

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STATEMENT OF COMPLIANCE 
The study trial will be carried out in accordance with Good Clinical Practice (GCP) and as 
required by the following: 
• 
United States 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 (Electronic Records; Electronic 
Signatures), and 21 CFR Part 312 (Investigational New Drug Application) 
• 
International Council for Harmonisation: Good Clinical Practice (ICH E6); 62 Federal 
Register 25691 (1997); 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 United States (US) federal 
regulations and ICH E6 Good Clinical Practice (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 IRB/IEC approval, except when 
necessary to protect the safety, rights, or welfare of subjects. 
Site Investigator Signature: 
 
Signed: 
 
Date: 
 
 
Name: Robert W. Frenck, Jr, M.D. 
Title: Principal Investigator 
 
 
 
 

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TABLE OF CONTENTS 
STATEMENT OF ASSURANCE ...................................................................................................2 
STATEMENT OF COMPLIANCE .................................................................................................3 
SIGNATURE PAGE .......................................................................................................................4 
TABLE OF CONTENTS .................................................................................................................5 
LIST OF TABLES .........................................................................................................................11 
LIST OF FIGURES .......................................................................................................................12 
LIST OF ABBREVIATIONS ........................................................................................................13 
PROTOCOL SUMMARY .............................................................................................................18 
 
KEY ROLES.........................................................................................................................21 
 
Background .................................................................................................................21 
 
Scientific Rationale .....................................................................................................22 
1.2.1 Purpose of Study ............................................................................................22 
1.2.2 Study Population ............................................................................................22 
 
Potential Risks and Benefits .......................................................................................22 
1.3.1 Potential Risks ...............................................................................................22 
1.3.1.1 
ALFQ ................................................................................................23 
1.3.1.2 
IM Vaccination .................................................................................24 
1.3.1.3 
Blood Collection ...............................................................................24 
1.3.1.4 
Other Risks .......................................................................................24 
1.3.2 Known Potential Benefits ..............................................................................25 
 
STUDY DESIGN, OBJECTIVES AND ENDPOINTS OR OUTCOME MEASURES .....26 
 
Study Design Description ...........................................................................................26 
 
Study Objectives .........................................................................................................28 
 
Study Endpoints or Outcome Measures .....................................................................29 
 
STUDY INTERVENTION/INVESTIGATIONAL PRODUCT .........................................31 

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Study Product Description ..........................................................................................31 
3.1.1 CJCV2 ............................................................................................................31 
3.1.2 ALFQ .............................................................................................................33 
3.1.3 Packaging .......................................................................................................34 
3.1.4 Formulation ....................................................................................................34 
3.1.5 Labeling .........................................................................................................35 
3.1.6 Product Storage ..............................................................................................35 
3.1.7 Product Stability .............................................................................................35 
 
Acquisition/Distribution .............................................................................................36 
 
Dosage/Regimen, Preparation, Dispensing and Administration of Study 
Intervention/Investigational Product.........................................................................37 
 
Accountability Procedures for the Study Intervention/Investigational Product(s) .....37 
 
SELECTION OF SUBJECTS AND STUDY ENROLLMENT AND WITHDRAWAL ....39 
 
Eligibility Criteria .......................................................................................................39 
4.1.1 Subject Inclusion Criteria...............................................................................39 
4.1.2 Subject Exclusion Criteria .............................................................................40 
4.1.3 Subject Qualification Criteria for Vaccinations 2, 3 ......................................42 
 
Withdrawal from the Study, Discontinuation of Study Product, or Study Termination
 ..................................................................................................................................43 
4.2.1 Withdrawal from the Study or Discontinuation of the Study Product ...........43 
4.2.2 Handling of Withdrawals ...............................................................................44 
4.2.3 Study Termination .........................................................................................45 
 
STUDY PROCEDURES ......................................................................................................46 
 
Screening ....................................................................................................................46 
 
Enrollment/Baseline ...................................................................................................48 
 
Follow up Visits ..........................................................................................................50 
5.3.1 Follow up: 3 Days (±1) and 15 Days (±2) following each vaccine ...............50 

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5.3.2 Follow up: 7 Days (+1) after each vaccination ..............................................51 
5.3.3 Subsequent Vaccination Visits: Day 29 (+2) and Day 57 (+2) .....................51 
5.3.4 Follow-up: Day 85 (±2) and Day 113 (±4) ....................................................53 
5.3.5 Safety Communication Follow Up, Day 240, 420 (±7) .................................53 
 
Unscheduled Study Visits ...........................................................................................54 
5.4.1 Early Termination Visit .................................................................................54 
 
Protocol Deviations ....................................................................................................54 
 
DESCRIPTION OF CLINICAL AND LABORATORY EVALUATIONS .......................56 
 
Clinical Evaluations ....................................................................................................56 
6.1.1 Research Procedures ......................................................................................57 
6.1.2 Assessment of Concomitant Medications/Treatments other than Study 
Product ...........................................................................................................57 
6.1.3 Assessment of Subject Compliance with Study Intervention/Investigational 
Product/Investigational Device ......................................................................58 
 
Laboratory Evaluations ...............................................................................................58 
6.2.1 Clinical Laboratory Evaluations ....................................................................58 
6.2.2 Research Assays .............................................................................................58 
6.2.2.1 
Laboratory Specimen Preparation, Handling, and Storage ...............59 
6.2.2.2 
Laboratory Specimen Shipping ........................................................59 
 
ASSESSMENT OF SAFETY ...............................................................................................60 
 
Assessing and Recording Safety Parameters ..............................................................60 
7.1.1 Adverse Events (AEs) ....................................................................................60 
7.1.1.1 
Adverse Events Grading ...................................................................61 
7.1.2 Reactogenicity ................................................................................................62 
7.1.3 Serious Adverse Events (SAEs) .....................................................................64 
 
Specification of Safety Parameters .............................................................................65 
7.2.1 Solicited Events .............................................................................................65 

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7.2.2 Unsolicited Events .........................................................................................66 
7.2.3 New-Onset Chronic Medical Conditions (NOCMCs) ...................................66 
7.2.4 Medically Attended Adverse Events (MAAEs).............................................66 
7.2.5 Potentially Immune-Mediated Medical Conditions (PIMMCs) ....................66 
7.2.6 Suspected Unexpected Serious Adverse Reactions (SUSAR) .......................67 
7.2.7 Dose Escalation Criteria ................................................................................67 
7.2.7.1 
Cohort Studies...................................................................................67 
 
Reporting Procedures ..................................................................................................67 
7.3.1 Reporting Serious Adverse Events ................................................................67 
7.3.2 Regulatory Reporting for Studies Conducted Under DMID-Sponsored IND
 ........................................................................................................................68 
7.3.3 Reporting of Pregnancy .................................................................................69 
 
Type and Duration of Follow-up of Subjects after Adverse Events ...........................69 
 
Procedures to be followed in the Event of Abnormal Laboratory Test Values or 
Abnormal Clinical Findings......................................................................................69 
 
Halting Rules ..............................................................................................................70 
7.6.1 Sentinel Halting Criteria ................................................................................70 
7.6.2 Cohort Halting Rules .....................................................................................70 
7.6.3 Study Halting Criteria ....................................................................................71 
7.6.4 Individual Halting Criteria .............................................................................71 
 
Safety Oversight by SMC ...........................................................................................72 
 
HUMAN SUBJECTS PROTECTION .................................................................................73 
 
Institutional Review Board/Independent Ethics Committee ......................................73 
 
Consent for Secondary Research of Stored Specimens and Data ...............................75 
 
Exclusion of Women, Minorities, and Children (Special Populations) ......................77 
 
Subject Confidentiality ...............................................................................................77 
 
Certificate of Confidentiality ......................................................................................78 

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Costs, Subject Compensation, and Research Related Injuries ...................................79 
 
STATISTICAL CONSIDERATIONS .................................................................................80 
 
Study Hypotheses .......................................................................................................80 
 
Sample Size Considerations .......................................................................................80 
 
Treatment Assignment Procedures .............................................................................80 
9.3.1 Randomization Procedures ............................................................................80 
9.3.2 Masking Procedures .......................................................................................81 
9.3.3 Interim Safety Review ...................................................................................82 
9.3.4 Interim Immunogenicity Review ...................................................................82 
 
Final Analysis Plan .....................................................................................................82 
9.4.1 Analysis Populations ......................................................................................82 
9.4.2 Safety Data .....................................................................................................83 
9.4.3 Immunogenicity Data .....................................................................................83 
9.4.4 Missing Values and Outliers ..........................................................................84 
 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ..............85 
 
QUALITY CONTROL AND QUALITY ASSURANCE ...................................................87 
 
DATA HANDLING AND RECORD KEEPING ................................................................88 
 Data Management Responsibilities ............................................................................88 
 Data Coordinating Center/Biostatistician Responsibilities ........................................88 
 Data Capture Methods ................................................................................................88 
 Types of Data ..............................................................................................................89 
 Study Records Retention ............................................................................................89 
 
CLINICAL MONITORING .................................................................................................90 
 
PUBLICATION POLICY ....................................................................................................91 
 
LITERATURE REFERENCES ............................................................................................92 
 
Schedule of Events............................................................................95 
 
Toxicity Table ...................................................................................98 

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PIMMCs list ......................................................................................99 

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LIST OF TABLES 
Table 1: Table of Study Design .....................................................................................................27 
Table 2: CCV vaccine efficacy in the Aotus nancymaae model with adjuvant .............................32 
Table 3: Injection Site Reactogenicity Grading .............................................................................62 
Table 4: Injection Site Reactogenicity Measurements ...................................................................63 
Table 5: Subjective Systemic Reactogenicity Grading ..................................................................63 
Table 6: Quantitative Systemic (Oral Temperature) Reactogenicity Grading ...............................64 

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LIST OF FIGURES 
Figure 1. Description of the ALFQ adjuvant [31] .........................................................................33 
Figure 2. CJCV2 Lot 010I0319 Label ...........................................................................................35 
Figure 3. ALFQ Lot 2010 Label ....................................................................................................35 
 
 

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LIST OF ABBREVIATIONS 
3D-PHAD 
Monophosphoryl 3-deacyl lipid A (synthetic) 
AE 
Adverse Event/Adverse Experience 
AH 
Aluminum hydroxide 
ALF 
Army Liposome Formulation  
ALFQ 
Army Liposome Formulation containing QS-21 
ALS 
Antibodies in Lymphocyte Supernatant 
ALT 
Alanine Aminotransferase 
ANC 
Absolute Neutrophil Count 
BMI 
Body Mass Index 
BP 
Blood Pressure 
bpm 
Beats Per Minute 
CCHMC 
Cincinnati Children’s Hospital Medical Center 
CCV 
Capsule-Conjugate Vaccine 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
cGMP 
Current Good Manufacturing Practices 
CHIM 
Controlled Human Infection Model 
CI 
Confidence Interval 
CJCV2 
Campylobacter jejuni Conjugate Vaccine 2 
CMS 
Clinical Materials Services 
CPS 
Capsular Polysaccharide 

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CRF 
Case Report Form 
CRM197 
Cross-Reactive Material 197 
CROMS 
Clinical Research Operations and Management Support 
CSR  
Clinical Study Report 
DDE 
Direct Data Entry 
DHHS 
Department of Health and Human Services 
DMID 
Division of Microbiology and Infectious Diseases, NIAID, 
NIH, DHHS 
eCRF 
Electronic Case Report Form 
ELISA 
Enzyme-Linked Immunosorbent Assay 
FDA 
Food and Drug Administration 
FoodNet 
Foodborne Diseases Active Surveillance Network 
FWA 
Federal Wide Assurance 
GBS 
Guillain-Barré Syndrome 
GCP 
Good Clinical Practice 
HBsAg 
Hepatitis B Surface Antigen 
HCV 
Hepatitis C Antibody 
Hgb 
Hemoglobin 
HIV 
Human Immunodeficiency Virus 
HLA-B27 
Human Leukocyte Antigen B27 
HR 
Heart Rate 
IB 
Investigator’s Brochure 
IBD 
Inflammatory Bowel Disease 

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IBS 
Irritable Bowel Syndrome 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
IDES 
Internet Data Entry System 
IEC 
Independent or Institutional Ethics Committee 
IgA 
Immunoglobulin A 
IgG 
Immunoglobulin G                                         
IgM 
Immunoglobulin M 
IM 
Intramuscular 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
LOS 
Lipooligosaccharide  
MAAE 
Medically Attended Adverse Event 
MedDRA 
Medical Dictionary for Regulatory Activities 
MeOPN 
O-methyl phosphoramidate 
mITT 
Modified Intent-to-Treat 
MOP 
Manual of Procedures 
MPLA 
Monophosphoryl Lipid A 
N 
Number (typically refers to subjects) 
NIAID 
National Institute of Allergy and Infectious Diseases, NIH, 
DHHS 
NIH 
National Institutes of Health 
NMRC 
Naval Medical Research Center 

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NOCMC 
New-Onset Chronic Medical Condition 
OER 
Office of Extramural Research 
OHRP 
Office of Human Research Protections 
OTC 
Over the Counter 
PBF 
Pilot Bioproduction Facility 
PBMC 
Peripheral Blood Mononuclear Cell 
PI 
Principal Investigator 
PIMMC 
Potentially Immune-Mediated Medical Condition 
PLT 
Platelets 
PP 
Per protocol 
QA 
Quality Assurance 
QC 
Quality Control 
RCD 
Reverse Cumulative Distribution 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SAP 
Statistical Analysis Plan 
SDCC 
Statistical and Data Coordinating Center 
SMC 
Safety Monitoring Committee 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SRC 
Safety Review Committee 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
SWI 
Sterile Water for Injection 
T. bili 
Total Bilirubin 

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UIP 
University of Iowa Pharmaceuticals 
US 
United States 
USP 
United States Pharmacopeia 
VTEU 
Vaccine and Treatment Evaluation Unit 
WBC 
White Blood Cell Count 
WRAIR 
Walter Reed Army Institute for Research 

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PROTOCOL SUMMARY 
Title: 
First-in-Human Safety and Immunogenicity Evaluation of an 
Intramuscular Campylobacter jejuni Conjugate Vaccine 
(CJCV2) with and without Army Liposome Formulation 
containing QS-21 (ALFQ) 
Design of the Study: 
 
This is a randomized, double-blind, dose-escalating, outpatient 
trial in a total of approximately 60 subjects, assigned to 3 cohorts 
(20 subjects per cohort) (Table 1). Each subject will receive one 
of three intramuscular (IM) vaccinations with CJCV2 (1 µg, 3 µg 
or 10 µg of capsular polysaccharide (CPS) conjugated to cross-
reactive material 197 (CRM197)) spaced 28 days between 
injections, without or with a fixed dose of the adjuvant ALFQ 
(200 µg 3D-PHAD and 100 µg QS-21 in Sorensen’s Phosphate 
Buffered Saline). 
As this is a first-in human study, there will be six sentinel 
subjects in each of the 3 cohorts. No more than two sentinels will 
be dosed per day with a minimum of two hours between dosing. 
All sentinels will be observed for at least 7 days after which a 
safety review will be conducted. If no safety signal is detected, 
the remaining 14 participants in the cohort will be dosed.   
Study Phase: 
Phase 1 
Study Population: 
Healthy male and non-pregnant, non-lactating female subjects, 
18-50 years of age, inclusive. 
Number of Sites: 
1  

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Description of Study 
Product or Intervention: 
The investigational products are the vaccine CJCV2 and the 
adjuvant ALFQ. CJCV2 is a purified HS23/36 CPS of 
Campylobacter jejuni conjugated to CRM197. ALFQ consists of 
two active components, a synthetic monophosphoryl lipid A, 3D-
PHAD and QS-21, a purified saponin extracted from the bark 
of the Quillaja saponaria tree. 
Three doses (1 ug, 3 ug and 10 ug) of CJCV2 will be evaluated. 
The first six participants at each dose will be sentinels and 
randomized in a 1:1 blinded fashion to receive CJCV2 with or 
without ALFQ.  
Study Objectives: 
 
 
 
Primary 
• Evaluate the safety of three different doses of IM 
injection of CJCV2 with and without ALFQ 
 
Secondary 
• 
Evaluate C. jejuni capsule-specific serum 
Immunoglobulin G (IgG) responses following 
vaccination  
 
Exploratory 
• 
Evaluate CRM197-specific serum-IgG responses 
 
• Evaluate C. jejuni capsule-specific IgG in Antibody 
Lymphocyte Supernatant (ALS) 
 
• Evaluate C. jejuni capsule- and CRM197-specific serum 
Immunoglobulin M (IgM) responses 
 
Secondary Research  
• Peripheral blood mononuclear cells (PBMCs), serum, and 
stool samples will be collected and stored for future use 

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to further characterize immune responses following 
vaccination.  
 
Duration of Individual 
Subject Participation: 
Approximately 15 months  
Estimated Time to Last 
Subject/Last Study Day: 
Approximately 24 months  
 
 

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KEY ROLES 
This study is sponsored by DMID. Decisions related to this study will be made by the protocol 
team, which includes representatives from the participating clinical research site (Principal 
Investigator) and DMID (sponsor). Key Roles are noted in the protocol-specific manual of 
procedures (MOP).  
 
Background   
Campylobacter species are among the most common causes of diarrheal disease worldwide with 
C. jejuni being the primary species associated with human disease [1].  Campylobacteriosis 
ranges from hyperendemic levels (prevalence up to 84.9% in children <1 year of age) in 
developing regions [2], to sporadic disease in young adults and infants, in developed countries 
[3], or traveler's diarrhea in persons from industrialized countries, including deployed troops, 
visiting hyperendemic regions [4-7]. Campylobacter is one of the most severe forms of travelers’ 
diarrhea with a longer duration, increased numbers of unformed stools, and more frequent 
association with abdominal pain, nausea, vomiting and fever in comparison to the other common 
causes [3, 5, 7-9]. In addition to the acute effects, Campylobacter infection is associated with a 
number of important sequelae, including Guillain-Barré syndrome (GBS), reactive arthritis, 
irritable bowel syndrome and, to a lesser extent, inflammatory bowel disease [10-15].  
• Public health impact and current standard of care for treatment/prevention 
Campylobacter is the most common bacterial cause of foodborne illnesses in the US; in 2016 the 
Centers for Disease Control and Prevention (CDC) Foodborne Diseases Active Surveillance 
Network (FoodNet) reported 24,029 foodborne infections, 5,512 hospitalizations, and 98 deaths 
[3]. Globally, Campylobacter is 1 of the 4 key global causes of diarrheal diseases [9].  The high 
incidence of Campylobacter diarrhea, as well as its duration and possible complications, makes it 
highly important from a socio-economic perspective. In developing countries, Campylobacter 
infections in children under the age of 2 years are especially frequent, sometimes resulting in 
death. Until recently, campylobacteriosis has been viewed as a self-limited illness ameliorated by 
antibiotic treatment. However, the resistance of Campylobacter to many antibiotics, particularly 
fluoroquinolones, is rapidly rising as a single point mutation is sufficient for the development of 
resistance [16-18]. Thus, alternative measures to control the infection, including vaccination, are 
required. 

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Scientific Rationale 
1.2.1 
Purpose of Study 
This is a first-in-human study to test the safety and immunogenicity of a vaccine comprised of a 
CPS of C. jejuni conjugated to CRM197 and whether ALFQ will enhance the immune response 
without significantly altering safety of CJCV2. The study hypothesis is that the CJCV2 vaccine 
alone and CJCV2 + ALFQ adjuvant will be safe and that the CJCV2 alone will be immunogenic, 
with immunogenicity enhanced through the use of the adjuvant ALFQ.  
1.2.2 
Study Population 
As this is the first time the CJCV2 ± ALFQ will be tested in humans, the study population will 
be comprised of generally healthy males and non-pregnant, non-lactating females, aged 18-50 
years inclusive at the time of first vaccination, regardless of religion, sex, or ethnic background, 
who meet all the inclusion and none of the exclusion criteria. Subjects will be recruited from the 
general population of the participating Vaccine and Treatment Evaluation Unit (VTEU) site. As 
this is a Phase 1 study, minors and pregnant or breastfeeding women will be excluded from study 
participation. A successful outcome of the current trial may lead to future evaluation of the study 
product which then may incorporate a broader participant population including children.  
 
Potential Risks and Benefits 
1.3.1 
Potential Risks 
CJCV2 is a vaccine comprised of C. jejuni capsule conjugated to CRM197 that will be 
administered IM using standard techniques. The IM route of vaccination, in general, has been 
shown to be a safe and effective route of administration. Based on the safety results of the 
CJCV1 clinical trial as well as other studies evaluating IM administration of conjugated 
vaccines, it is anticipated that subjects may experience pain, redness, and/or swelling at the 
injection site. 
Additionally, general symptoms of fever, fatigue, headache, muscle aches, joint aches, malaise, 
and nausea/vomiting may also occur. Any vaccine may be associated with a wide range of 
systemic events, and the frequency and type of systemic reactions will be addressed and 
analyzed with respect to study products. 

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Theoretical Risks  
Post-infectious sequelae following Campylobacter enteritis must be considered as theoretical 
risks with a Campylobacter capsule-conjugate vaccine (CCV). Campylobacter infections have 
been associated with the development of reactive arthritis [19-24] and GBS [25-27]. Possibly as 
many as 1% of C. jejuni enteritis cases may be followed approximately 10 days post-infection 
with reactive arthritis characterized as an asymmetric oligoarticular arthritis commonly involving 
the knees, ankles, or wrists. A proportion of the patients reported to have Campylobacter-
associated post-infectious reactive arthritis are human leukocyte antigen B27 (HLA-B27) 
positive. Although the majority (approximately 80%) of patients with reactive arthritis associated 
with an enteric infection become asymptomatic within one year, as many as 20% may relapse. 
The pathogenesis for a post-infectious reactive arthritis is less understood. Although it is unlikely 
to be related to the purified Campylobacter capsule, there is enough uncertainty to include 
specific entry criteria related to this theoretical risk by excluding a volunteer if positive for HLA-
B27 or if the volunteer or a first-degree relative (parent or sibling) has a history of inflammatory 
arthritis.  
The pathogenesis of GBS is not fully understood; however, it is thought to be an autoimmune 
response against peripheral nerves due to a molecular mimicry between Campylobacter 
lipooligosaccharide (LOS) cores containing sialic acid structures that resemble human nerve 
tissue gangliosides [28-30]. Certain heat-stable serotypes (correlating with the Penner typing 
system but still with strain-to-strain variation) contain a carbohydrate portion of the LOS that 
mimics certain mammalian tissue gangliosides (particularly GM1, GD1a and GQ1b) that are 
components of nerve tissue (myelin sheath and/or axon). This mimicry may lead to the induction 
of anti-ganglioside antibodies that in some yet undetermined way led to immune-mediated 
damage to nerve fibers. To minimize risk of GBS, the polysaccharide used to synthesize the 
CJCV2 vaccine was extracted from a mutant of 81-176 (strain PG3208.1) that lacks ganglioside 
mimicry in its LOS core. Importantly, there has been no association between the Campylobacter 
capsule and GBS risk. Therefore, subjects receiving the CJCV2 vaccine are not considered to be 
at risk of developing GBS. 
1.3.1.1 
ALFQ  
This family of adjuvants formulation containing saturated phospholipids, cholesterol, and 
monophosphoryl lipid A (MPLA) is known as Army Liposome Formulation or ALF.  ALFQ is a 
phospholipid: cholesterol liposome containing a combination of synthetic monophosphoryl lipid 
A (MPLA; 3D-PHAD® (Avanti Polar Lipids, Alabaster, AL)) and QS-21 (Desert King, San 

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Diego, CA), a purified saponin extracted from the bark of the Quillaja saponaria tree. Forms of 
MPLA have been used in many previous clinical trials. MPLA is the active component of 
lipopolysaccharide (i.e., endotoxin). Encapsulation of MPLA in liposomes detoxifies MPLA, 
since the toxic fatty acids are buried in the lipid bilayer. Walter Reed Army Institute of Research 
(WRAIR) liposomes containing MPLA have been safely used in fourteen Phase 1 and two Phase 
2 clinical trials. QS-21 (Q component of ALFQ) as an adjuvant, has been studied in many 
clinical trials for human immunodeficiency virus (HIV), malaria, hepatitis B, and cancer. In the 
past, subjects immunized with QS-21-adjuvanted vaccines have reported mild to moderate local 
and systemic responses. In addition, QS-21 is a component of AS01B, which has been used 
safely as the adjuvant in the Shingrix®vaccine. Additionally, ALFQ has been administered to 
subjects participating in a trial to evaluate a vaccine against malaria (NCT04296279, 
NCT04268420), and preliminary safety data are summarized in section 3.1.2. The current trial 
will provide additional experience with ALFQ as a vaccine adjuvant.   
1.3.1.2 
IM Vaccination 
Expected local adverse events (AEs) of IM vaccine administration include pain/tenderness, 
redness, and induration/swelling/nodules at the site of vaccination. 
1.3.1.3 
Blood Collection 
Drawing blood may cause transient discomfort and may cause people to feel faint. Bruising at 
the blood draw site may occur but can be prevented or lessened by applying pressure for several 
minutes. Infection at the site of blood collection is a rare but possible event. Rarely, infection or 
a blood clot may develop. Risks of blood collection will be minimized by using sterile technique 
and having experienced personnel perform the blood collection. 
1.3.1.4 
Other Risks 
The inclusion and exclusion criteria have been constructed to selecta population of healthy adults 
which should minimize the risks to study participants. However, unrecognized risks may still be 
associated with administration of the vaccine.  
As with any Investigational New Drug (IND) product administration and no matter what 
precautions are taken, there is always the risk of a serious, or even life-threatening, allergic 
reaction. Although anaphylactic reactions are not anticipated, as with any vaccination, the rare 
possibility exists. For this reason, all subjects will be observed at the study site for a minimum of 
30 minutes following vaccine dosing. Appropriate emergency equipment (e.g., automated 
external defibrillator, air-shields manual breathing unit bag) and medication [e.g., antihistamines 

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and adrenaline (epinephrine)] for initial treatment of an allergic reaction will be available at the 
site whenever immunizations are given. This equipment is available to handle emergencies such 
as anaphylaxis, angioedema, bronchospasm, and laryngospasm. 
Because the risks of the vaccine to a pregnant or nursing woman or fetus are unknown, 
pregnancy is an exclusion and women of childbearing potential will be counseled against 
becoming pregnant during their participation in the study. 
1.3.2 
Known Potential Benefits 
There are no direct medical benefits to the subject because of study participation. However, 
participation could benefit society by developing data about the safety, tolerability, and 
immunogenicity of this candidate vaccine against C. jejuni infection. These data will be 
instrumental in further development of a Campylobacter vaccine for licensure. Development of 
an efficacious vaccine against C. jejuni would significantly improve the health of children living 
in Campylobacter-endemic areas, as well as adults traveling to such areas. 
 

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STUDY DESIGN, OBJECTIVES AND ENDPOINTS OR 
OUTCOME MEASURES 
 
Study Design Description 
This is a randomized, double-blind, dose-escalating, outpatient, first-in-human study to test the 
safety and immunogenicity of a vaccine comprised of a CPS of C. jejuni conjugated to CRM197 
and whether ALFQ will enhance the immune response without significantly altering safety.  
Sixty subjects, divided into 3 cohorts (20 subjects per cohort), will receive three IM vaccinations 
spaced 28 days apart. Each subject will be administered CJCV2 with or without a fixed dose of 
the adjuvant ALFQ (1:1 allocation, CJCV2:CJCV2+ALFQ). A range of vaccine doses (1 µg, 3 
µg and 10 µg) will be evaluated in the study. These doses were picked as 1 µg is thought to be 
the lowest dose that will stimulate an immune response, 3 µg is likely to stimulate an effective 
immune response, and 10 µg is the highest dose that would be practical to use in a multivalent 
vaccine (the long-term plan for a vaccine against Campylobacter). The three-dose regimen and 
use of ALFQ was based on previous evaluation of a 1st generation Campylobacter vaccine 
named CJCV1 which demonstrated that 2 doses of vaccine using aluminum hydroxide (AH) as 
an adjuvant was safe, but immunogenicity was poor. As this is the first time the CJCV2 vaccine 
will be tested in humans, the study population will be comprised of generally healthy young 
adults (male and non-pregnant or -lactating female) 18-50 years of age, inclusive (See Table 1 
below for dosing scheme).  

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Table 1: Table of Study Design 
Cohort a 
Group b 
N 
CJCV2 (µg) 
ALFQ 
1 
Sentinel 1-A c 
3 
1 
0 
Sentinel 1-B c 
3 
1 
200 µg 3D-PHAD®, 
100 µg QS-21 
1-A 
7 
1 
0 
1-B 
7 
1 
200 µg 3D-PHAD®, 
100 µg QS-21 
2 
Sentinel 2-A c 
3 
3 
0 
Sentinel 2-B c 
3 
3 
200 µg 3D-PHAD®, 
100 µg QS-21 
2-A 
7 
3 
0 
2-B 
7 
3 
200 µg 3D-PHAD®, 
100 µg QS-21 
3 
Sentinel 3-A c 
3 
10 
0 
Sentinel 3-B c 
3 
10 
200 µg 3D-PHAD®, 
100 µg QS-21 
3-A 
7 
10 
0 
3-B 
7 
10 
200 µg 3D-PHAD®, 
100 µg QS-21 
Note: Subjects will receive vaccinations on study days 1, 29, and 57. 
a. 
SRC Review (PI, Medical Officer, Medical Monitor) through the final vaccine reactogenicity period for 
each cohort prior to dose escalation. 
b. Sentinels in each cohort will be randomized 1:1 in a blinded fashion to receive CJCV2 with or without 
ALFQ. Sentinels will be dosed at least 2 hours apart with no more than 2 sentinels per day. 
c. 
SRC Review (PI, Medical Officer, Medical Monitor) 7-9 days after the first dose. SRC review after second 
and third doses in Sentinel groups will be completed only if a stopping rule is met. 
  
Vaccine safety will be assessed by evaluating post-vaccination local and systemic reactions 
through targeted physical exams, symptom surveys and other AE monitoring. All subjects will 
be observed in the clinic for at least 30 minutes after receipt of the investigational product. 
Subject e-memory aid data entered via web-based e-memory aid will be reviewed by the study 
team for AEs during the collection period. After review and reconciliation, data from the study e-
memory aid will be transferred by study staff into the electronic Case Report Form (eCRF). 
Virtual visits will be performed at 48 hours and outpatient clinic visits will be performed 7 days 

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after study vaccine administration for observation and reporting of any local and/or systemic 
AE’s. Additionally, if a subject were to experience an unanticipated AE, an unscheduled clinic 
visit may be conducted.  
Three doses (1 ug, 3 ug and 10 ug) of CJCV2 will be evaluated. The first six participants at each 
dose will be sentinels and randomized in a 1:1 blinded fashion to receive CJCV2 with or without 
ALFQ. Sentinels will be dosed at least two hours apart with no more than two sentinels per day 
vaccinated. Sentinels will be observed for at least 7 days after which a safety review will be 
conducted. If no safety signal is detected, the remaining 14 participants in the cohort will be 
dosed using the same randomization scheme for the sentinels. This sentinel design will be 
followed for Cohorts 2 and 3.  
Assuming no safety concerns arise after review of the first cohort, the dose of CJCV2 will be 
raised to 3 μg for the second cohort. Similar rationale and plan will be used to escalate to Cohort 
3. The investigational products will be co-formulated just prior to IM injection.  
Between the time of vaccination of the first six sentinels to 7 days after enrollment of the last 
sentinels, no new subjects will be vaccinated, but screening may continue. The Safety Review 
Committee (SRC) will review safety data following the first dose of the six sentinel subjects in 
each cohort, and again after each cohort has completed vaccination, to decide if the study may 
proceed to the next dosage level. SRC members include the Principal Investigator (PI), the 
DMID Medical Monitor, and the DMID Medical Officer, with input provided from Emmes.  
 
Study Objectives 
• Primary 
• Evaluate the safety of the three different doses of IM injection of CJCV2 with and 
without ALFQ 
 
• Secondary 
• Evaluate C. jejuni capsule-specific serum IgG responses following vaccination  
 
• Exploratory 
• Evaluate CRM197-specific serum IgG responses 
 
• Evaluate C. jejuni capsule-specific IgG in ALS 
 

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• Evaluate C. jejuni capsule-and CRM197-specific serum IgM responses 
 
• Secondary Research 
• PBMCs, serum, and stool samples will be collected and stored for secondary research 
to further characterize immune responses following vaccination. 
 
Study Endpoints or Outcome Measures 
• Primary 
• Occurrence of solicited local and systemic AEs through 7 days after each study 
vaccination  
• Occurrence of vaccine-related unsolicited AEs through 28 days post last 
vaccination  
• Occurrence of serious adverse events (SAEs) through approximately 12 months 
post last vaccination  
• Occurrence of medically attended adverse events (MAAEs), new-onset chronic 
medical conditions (NOCMCs), and potentially immune-mediated medical 
conditions (PIMMCs) from the time of the first study vaccination through 
approximately 12 months (or throughout the period of their study participation) 
following the last vaccination 
• Secondary 
• Development of a ≥ 4-fold rise from baseline in C. jejuni capsule-specific IgG 
serum antibodies at Days 8, 29, 36, 57, 64, 85 and 113 
• Peak fold rise from baseline in C. jejuni capsule-specific IgG serum antibody titer 
across Days 8, 29, 36, 57, 64, 85 and 113 
• Maximum C. jejuni capsule-specific IgG serum antibody titer across Days 8, 29, 
36, 57, 64, 85 and 113 
• Exploratory  
 
CRM197 IgG 
• Development of a ≥ 4-fold rise from baseline in CRM197-specific IgG serum 
antibodies at Days 8, 29, 36, 57, 64, 85 and 113 
• Peak fold rise from baseline in CRM197-specific IgG serum antibody titer across 
Days 8, 29, 36, 57, 64, 85 and 113 

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• Maximum CRM197-specific IgG serum antibody titer across Days 8, 29, 36, 57, 
64, 85 and 113 
ALS CPS IgG 
• Development of a ≥ 4-fold rise from baseline in C. jejuni capsule-specific IgG 
antibodies in lymphocyte supernatant at Days 8, 36 and 64 
• Peak fold rise from baseline in C. jejuni capsule-specific IgG antibodies in 
lymphocyte supernatant across Days 8, 36 and 64 
• Maximum C. jejuni capsule-specific IgG antibodies in lymphocyte supernatant 
titer across Days 8, 36 and 64 
 
Serum IgM 
• Development of a ≥ 4-fold rise from baseline in C. jejuni capsule-specific serum 
IgM at Days 8, 29, 36, 57, 64, 85 and 113 
• Development of a ≥ 4-fold rise from baseline in CRM197-specific serum IgM at 
Days 8, 29, 36, 57, 64, 85 and113 
• Peak fold rise from baseline in C. jejuni capsule-specific serum IgM titer across 
Days 8, 29, 36, 57, 64, 85 and 113 
• Peak fold rise from baseline in CRM197-specific serum IgM titer across Days 8, 
29, 36, 57, 64, 85 and 113 
• Maximum C. jejuni capsule-specific serum IgM titer across Days 8, 29, 36, 57, 
64, 85 and 113 
• Maximum CRM197-specific serum IgM titer across Days 8, 29, 36, 57, 64, 85 and 
113 
 
• Secondary Research  
 
• Storage of  
• Serum 
• PBMC 
• Stool 

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STUDY INTERVENTION/INVESTIGATIONAL 
PRODUCT 
 
Study Product Description 
3.1.1 
CJCV2 
The vaccine to be evaluated in the current project is a C. jejuni CCV named CJCV2 produced 
from an engineered mutant of 81-176 that is lacking an enzyme responsible for the production of 
a LOS that could potentially trigger GBS. In contrast to the strain used for CJCV1 (which was 
made from strain 3208), a natural variant of 3208 (named 3208.1) was selected that presents the 
two O-methyl phosphoramidate (MeOPN) transferases in the "on" status to ensure that there is 
an optimum amount of MeOPN on the capsule.  The CPS is conjugated to CRM197, a non-toxic 
mutant protein of diphtheria toxin at a CPS: CRM197 ratio of 2:1. The CJCV2 vaccine product 
was manufactured at Inventprise LLC (Redmond, Washington) with final fill and finish 
completed by The University of Iowa Pharmaceuticals (Iowa City, Iowa), both performed under 
current Good Manufacturing Practices (cGMP) conditions. 
• Role of this study in clinical development  
This will be a Phase 1, first-in-human study of CJCV2 (1, 3, or 10 µg), with or without a fixed 
dose of ALFQ (200 µg 3D-PHADand 100 µg QS-21) to evaluate the safety and 
immunogenicity of the vaccine. A successful study will provide data for an increased number of 
subjects to receive an optimal CJCV2 dose (with or without adjuvant), and to potentially 
evaluate vaccine efficacy in a controlled human infection model (CHIM) with C. jejuni strain 
CG8421.  
• Prior studies of the study product 
Under US Army sponsorship, the Naval Medical Research Center (NMRC) recently completed a 
Phase 1, first-in-human trial with the prototype C. jejuni CPS vaccine conjugated to CRM197, 
called CJCV1 (ClinicalTrials.gov Identifier: NCT02067676). The vaccine was manufactured 
using NIAID funding (NIH U01 AI082105) and delivered intramuscularly with AH. Forty-eight 
subjects (eight per group) received two doses of 2, 5, or 10 µg of the CJCV1 intramuscularly 
with or without 125 µg of AH on Days 0 and 28. There were no vaccine-related SAEs or 
unanticipated events. The vaccine was well-tolerated, with all vaccine-related AEs being mild to 
moderate vaccine site pain or tenderness. Irrespective of the CJCV1 dose delivered, only 6 of 48 
subjects (12.5%) seroconverted against the CPS. 

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Several factors may have contributed to the sub-optimal immunogenicity, including: (1) 
insufficient dosing, (2) unconjugated CPS content, (3) low level MeOPN, (the apparent 
immunodominant epitope, on the capsule), and (4) AH being a suboptimal adjuvant. The 
possibility of insufficient dosing was addressed by adding a third dose on Day 57 (planned 
vaccination scheduled: Days 1, 29, 57). The levels of MeOPN have been addressed by 
manufacturing a new lot of the vaccine, yielding increased levels of MeOPN on the 
polysaccharide. Concerns with suboptimal adjuvant have resulted in additional preclinical testing 
of the vaccine combined with other adjuvant options, including ALF or ALFQ. Co-
administration of the CCV (CJCV1) with ALF or the combination adjuvant ALFQ to mice 
resulted in a significantly higher immune response when compared to animals receiving the 
vaccine with AH. In non-human primates, a research-grade formulation of the C. jejuni CCV 
delivered with ALFQ showed a superior immune response. Additionally, the highest vaccine 
efficacy occurred in the animals vaccinated with the CCV and ALFQ admixture (Table 2). 
Table 2: CCV vaccine efficacy in the Aotus nancymaae model with adjuvant 
Group 
No. of 
animals 
Diarrhea 
attack rate, n 
(%) 
Protective 
efficacy against 
diarrhea (%) 
p- value* 
CCV+AH 
10 
5 (50%) 
29% 
0.43 
CCV+ALF 
17* 
4 (24%) 
66% 
0.008 
CCV+ALFQ 
10 
1 (10%) 
86% 
0.005 
PBS 
20** 
14 (70%) 
- 
 
Three doses of 3.5 µg CCV given at 4-week intervals with the named adjuvants. Animals 
were orogastrically challenged 4 weeks following 3rd immunization with C. jejuni 
CG8421. *1 animal was excluded due to pregnancy **2 animals were excluded due to 
pre-existing health conditions 
 

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3.1.2 ALFQ 
 
Figure 1. Description of the ALFQ adjuvant [31]  
The vaccine will be co-administered with a combination adjuvant ALFQ. ALFQ is composed of 
ALF55, QS-21, and Sorensen’s Phosphate Buffer. ALF55 is a cGMP-manufactured Army 
Liposome Formulation containing the phospholipids dimyristoyl phosphatidyl choline and 
dimyristoyl phosphatidyl glycerol, 3D-PHAD and 55% cholesterol. Cholesterol serves as a 
structural lipid and binds to QS-21. QS-21 is a purified saponin extracted from the bark of the 
Quillaja saponaria tree. ALFQ was manufactured at the WRAIR Pilot Bioproduction Facility 
(Silver Spring, Maryland). A diagram of ALFQ is shown above in Figure 1. 
ALFQ has been used in numerous non-human primates, mouse, and rabbit studies and was well 
tolerated. A recent publication evaluated a malaria vaccine administered with ALFQ adjuvant 
[32]. Three groups of six Rhesus monkeys received half or a full human dose of the malaria 
vaccine + ALFQ on a 0-1-2-month schedule. Animals had mild local site reactions with no 
changes in red blood cell, liver, or kidney lab values. Immunization induced a transient systemic 
inﬂammatory response, including elevated white blood cell counts (WBCs) and mild fever 
receding to normal range by Day 7 post vaccination. A four-dose GLP toxicity study in rabbits 
conﬁrmed no local site reactions and transient systemic inﬂammation associated with ALFQ 
adjuvant administration. The good safety and immunogenicity profile of ALFQ in the animal 
studies resulted in the decision to move the product to a vaccination study/CHIM of malaria 

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which is active and ongoing (NCT04296279, NCT04268420). Volunteers in these studies received 
either low dose of one of two protein antigen vaccines with low dose of ALFQ adjuvant, or high 
dose of one of two protein antigen vaccines with high dose of ALFQ. ALFQ local reactogenicity 
in these studies appeared to be comprised primarily of local tenderness that is omnipresent, mild, 
and short-lived across both products and doses. Systemic reactogenicity primarily consisted of a 
flulike response that was also 24-36 hours in length that increased in intensity in the following 
order of dose and product: FMP013 low-dose (mostly absent or mild), FMP014 low-dose(mostly 
absent or mild), FMP013 high-dose (mild after first dose and mix of mild and moderate 
severities after 2nd and 3rd dose) , FMP014 high dose (mild to moderate severities after the first 
dose with mostly moderate severities after each dose with one subject having 24 hours of severe 
fever chills, myalgias, and moderate temperature of 101.5oF after the third dose). There were no 
SAEs associated with ALFQ reported in these studies. 
This proposed study will be the first time that the CJCV2 vaccine (either alone or in combination 
with ALFQ) will be administered to humans.  
3.1.3 
Packaging 
CJCV2 vaccine – CJCV2 is lyophilized in single 2 mL glass vials. Each CJCV2 vial contains 60 
µg of CPS and 40 µg CRM197 per vial of active components and excipients consisting of 8 mg 
Sodium Chloride; 0.7 mg Potassium Chloride; 0.8 mg Sodium Phosphate; 0.144 mg Potassium 
Phosphate, and 5.0 mg Sucrose. CPS is conjugated to CRM197 at a ratio of 2:1, CPS:CRM197. 
ALFQ adjuvant - Each single glass vial of ALFQ contains 0.6 mL and its active components are 
at a concentration of 400 µg/mL 3D-PHAD and 200 µg/mL QS-21 in Sorensen’s Phosphate 
Buffered Saline.  
3.1.4 
Formulation 
The sterile lyophilized CJCV2 product is to be reconstituted in 1 mL of sterile water for injection 
(SWI). The resuspended CJCV2 product will be diluted with sterile 0.9% Sodium Chloride for 
Injection, United States Pharmacopeia (USP) to a bulk 2x CJCV2 working solution (Cohort A: 2 
µg/mL, Cohort B: 6 µg/mL or Cohort C: 20 µg/mL). 
For subject-specific formulation, a total of 0.6 mL of the bulk 2x CJCV2 working solution will 
be transferred and mixed with a vial containing 0.6 mL of the adjuvant ALFQ or 0.6 mL of 
sterile 0.9% Sodium Chloride for Injection, USP to prepare 1.2 mL of a final 1x CJCV2 
formulation (Cohort 1: 1 µg/mL, Cohort 2: 3 µg/mL or Cohort 3: 10 µg/mL). One milliliter will 
be drawn into a syringe to be injected intramuscularly to achieve the final quantity of deliverable 

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active CJCV2 component as described above and the full dose of ALFQ (200 µg 3D-PHAD®, 
100 µg QS-21) in subjects receiving the adjuvant plus CJCV2.  Further details of formulation 
and administration are to be included in the MOP. 
3.1.5 
Labeling 
Renderings of the CJCV2 (Figure 2) and ALFQ (Figure 3) labels are included. 
  
Figure 2. CJCV2 Lot 010I0319 Label 
 
Figure 3. ALFQ Lot 2010 Label 
 
 
3.1.6 
Product Storage 
CJCV2 vials are stored at refrigerated conditions (2°C-8°C).  
ALFQ vials are stored at refrigerated conditions (2°C-8°C). 
3.1.7 
Product Stability 
Separate stability studies are being conducted to assess CJCV2 and ALFQ stored at various 
temperatures. 

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To date, CJCV2 has shown stability through the 24-month time point with a plan to continue 
testing at 36- and 48-month timepoints. Detailed descriptions of the CJCV2 stability program are 
included in the Investigator’s Brochure (IB). 
The stability of ALFQ will be tested throughout the course of this study. The complete stability 
information can be found in the Drug Master File 18760. 
Acquisition/Distribution 
The CJCV2 product is stored at the University of Iowa Pharmaceuticals (UIP), 
The ALFQ product is stored at the WRAIR Pilot Bioproduction Facility (PBF), 
SWI will be provided by DMID Clinical Materials Services (CMS) Contract. 
Sterile 0.9% Sodium Chloride for Injection, USP will be provided by DMID CMS Contract. 
Upon DMID authorization, the CJCV2 and ALFQ will be transferred to the following address: 
DMID Clinical Materials Services (CMS) 
c/o Fisher BioServices 
Germantown, MD 20876, U.S.A. 
Tel: 
Fax: 
Email: 
All study products will be shipped to the Cincinnati Children’s Hospital Medical Center 
(CCHMC) upon request and approval from DMID. 

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Dosage/Regimen, Preparation, Dispensing and Administration of 
Study Intervention/Investigational Product 
CJCV2 Bulk Preparation 
CJCV2 will be administered intramuscularly in 3 doses separated by 28 days (Day 1, 29 and 57). 
Each lyophilized CJCV2 vial will be rehydrated with 1 mL SWI. A bulk 2x CJCV2 working 
solution will be prepared by diluting CJCV2 in sterile 0.9% Sodium Chloride for Injection, USP 
to obtain 2, 6, or 20 µg/mL suspension. This suspension will be used to prepare subject specific 
formulation as follows; 
CJCV2 Alone; 
A subject-specific formulation will be prepared by adding 0.6 mL of the bulk 2x CJCV2 working 
solution to 0.6 mL sterile 0.9% Sodium Chloride for Injection, USP to achieve a final 1x CJCV2 
solution (1, 3 or 10 µg/mL) and 1 mL will be injected intramuscularly to deliver to respect 
cohorts. 
CJCV2 + ALFQ 
ALFQ is provided as suspension. A subject-specific formulation will be prepared by adding 0.6 
mL of the bulk 2x CJCV2 working solution to 0.6 mL 2x ALFQ (product as provided; 400 
µg/mL 3D-PHAD and 200 µg/mL QS-21) to achieve a final 1x CJCV2 solution (1, 3 or 10 
µg/mL) and 1x ALFQ solution (200 µg/mL 3D-PHADand 100 µg/mL QS-21 solution). Prior to 
administration, 1 mL of the CJCV2-ALFQ admixture will be drawn into a syringe for IM 
injection to respective cohorts.  
 
Accountability Procedures for the Study Intervention/Investigational 
Product(s) 
CJCV2 will be shipped from UIP and ALFQ will be shipped from the WRAIR PBF to the DMID 
contract CMS for storage until sent to CCHMC. Once received, CJCV2 and ALFQ will be stored 
in and dispensed by the Investigational Pharmacy.  
Used and unused study product vials will be retained until monitored and released for 
disposition, as applicable. This can occur on an ongoing basis for used study products.  

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Used study product vials may be destroyed in accordance with site-specific standard operating 
procedures (SOPs) following each monitoring visit where study product accountability is 
monitored, and resolution of any discrepancies. 
Unused study product that has not been reconstituted may be destroyed or transferred for use in 
nonclinical research only according to the MOP once determined by DMID and communicated 
to the participating sites by the DMID Clinical Project Manager. 
The FDA requires accounting for the disposition of all investigational products. The PI is 
responsible for ensuring that a current record of product disposition is maintained, and product is 
dispensed only at an official study site by authorized personnel as required by applicable 
regulations and guidelines. Records of product disposition, as required by federal law, consist of 
the date received, date administered, quantity administered, and the subject number to whom the 
drug was administered.  
The Investigational Pharmacist will be responsible for maintaining accurate records of the 
shipment and dispensing of the investigational product. The pharmacy records must be available 
for inspection by the DMID monitoring contractors and is subject to inspection by a regulatory 
agency (e.g., FDA) at any time. An assigned Study Monitor will review the pharmacy records.  
All used containers of study product may either; 1) be sequestered from the unused supplies and 
stored at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] in the 
Investigational Pharmacy until study completion or until study product accountability has 
occurred by the monitor and written notification stating retention is no longer required is 
received, or; 2) may be destroyed in accordance with site-specific SOPs with a second pharmacy 
staff member’s observation and verification as documented in the pharmacy log and/or 
preparation worksheets. 
 
 

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SELECTION OF SUBJECTS AND STUDY 
ENROLLMENT AND WITHDRAWAL 
Approximately 60 individuals, including males and non-pregnant females 18 to 50 years old, at 
the time of the first vaccination, who are in good health by history and screening values and meet 
the inclusion and exclusion criteria will be enrolled in the study. The eligibility criteria apply 
only to enrollment of subjects into the study. The target population should reflect the community 
at large at the site.  
Subject inclusion and exclusion criteria must be assessed by a study clinician licensed to make 
medical diagnoses and listed on the Form FDA 1572 as the site PI or sub-investigator. 
No exemptions are granted on subject inclusion or exclusion criteria in DMID-sponsored studies. 
Questions about eligibility should be directed toward the DMID Medical Officer. 
 
Eligibility Criteria 
4.1.1 
Subject Inclusion Criteria 
1. Provide informed consent prior to initiation of any study procedures. 
2. Able to understand and comply with planned study procedures and be available for all 
study visits/safety communications.  
3. Non-pregnant/non-lactating subjects 18-50 years of age inclusive upon enrollment. 
4. In general, good health* to be safely enrolled in this study as determined by medical 
history, medication use**, and physical exam. 
*Good health is defined by the absence of any exclusionary medical conditions. If the subject has 
another current, ongoing medical condition, the condition cannot meet any of the following 
criteria; 1) first diagnosed within 3 months of enrollment; 2) is worsening in terms of clinical 
outcome in last 6 months; or 3) involves need for medication that may pose a risk to subject’s 
safety or impede assessment of AEs or immunogenicity if they participate in the study.  
** Topical, nasal, and inhaled medications (except for inhaled corticosteroids as outlined in the 
Subject Exclusion #17).  Herbals, vitamins, and supplements are permitted. 
5. Oral temperature is less than 100.4°F. 
6. Pulse is 50 to 100 beats per minute (bpm), inclusive.   
7. Systolic blood pressure (BP) is 90 to 140 mmHg, inclusive.  
8. Diastolic BP is 55 to 90 mmHg, inclusive. 
9. Body Mass Index (BMI) less than 40. 

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10. Females of childbearing potential* may enroll if subject has practiced adequate 
contraception** > 30 days prior to enrollment and agrees to continue adequate 
contraception for the entire study. 
* Child-bearing potential is defined as not sterilized via tubal ligation, 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 of the last menses if menopausal. 
** Adequate contraception includes non-male sexual relationships, abstinence from sexual intercourse 
with a male partner, monogamous relationship with vasectomized partner who has been 
vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier 
methods such as condoms or diaphragms with spermicide, effective intrauterine devices, 
NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives 
(“the pill”). 
11. Females of childbearing potential must have a negative urine pregnancy test within 24 
hours prior to enrollment.  
12. Agree not to participate in another interventional clinical trial during the study period that 
may affect the analysis or endpoint assessment. 
13. Negative urine drug screen for opiates. 
4.1.2 
Subject Exclusion Criteria 
1. Have any disease or medical condition that, in the opinion of the site PI or appropriate 
sub-investigator, is a contraindication to study participation+. 
+Including acute or chronic disease or medical condition that would place the subject at an 
unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may 
interfere with the evaluation of responses or the subject’s successful completion of this trial.  
These include: 
History of inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn’s disease, 
indeterminate colitis, or celiac disease). Within the past 12 months, has any of the following: irritable 
bowel syndrome (IBS) or any active uncontrolled gastrointestinal disorders or diseases as assessed by 
the investigator, including symptoms or evidence of active gastritis or gastroesophageal reflux disease, 
gastric surgery or gastric acid hyper-secretory disorders (e.g., Zollinger-Ellison syndrome), 
gastrointestinal obstruction, ileus, gastric retention, bowel perforation, toxic colitis, persistent 
infectious gastroenteritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile 
infection. History of immunodeficiency due to congenital or hereditary causes, underlying illness or 
treatment, autoimmune disorders, or chronic inflammatory disorders, refer to Appendix C. History of 
an inflammatory arthritis such as reactive arthritis, Reiter's syndrome, ankylosing spondylitis, 
rheumatoid arthritis, or GBS. Known active neoplastic disease^, a history of any hematologic 
malignancy, or have used anticancer chemotherapy/radiation therapy (cytotoxic) within 5 years prior 
to study vaccination. Other condition requiring daily therapy that would place the volunteer at 

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increased risk or AEs. Other laboratory abnormalities which in the opinion of the investigator 
precludes participation in the study. Clinically significant abnormalities on physical exam.  
^non-melanoma, treated, skin cancers are permitted. 
2. Documented history of auto-immune conditions in a first-degree relative. Examples 
include reactive arthritis, Reiter's syndrome, ankylosing spondylitis, rheumatoid arthritis, 
or GBS. 
3. History of PIMMCs.  
4. Evidence of inflammatory arthritis on exam and/or positive serology results for HLA-
B27.  
5. Positive HIV, Hepatitis B surface antigen (HBsAg), or Hepatitis C antibodies (HCVs). 
6. Participation in a previous Campylobacter study or reports having received vaccination 
against Campylobacter within the last 3 years.  
7. History of microbiologically confirmed Campylobacter infection in the last 3 years. 
8. Occupation involving handling of Campylobacter bacteria or vaccine products currently 
or in the past 3 years. 
9. Use of immunosuppressive/immunomodulating disease therapy within 90 days 
10. Received Ig or other blood products (with exception of Rho D Ig) within 90 days prior to 
enrollment. 
11. Have a history of severe reactions following previous immunization with any licensed or 
unlicensed vaccine. 
12. Known hypersensitivity to any components of vaccine, adjuvant, or diluent. 
13. Received or plan to receive a licensed live vaccine within 30 days prior to 1st vaccination 
and to 30 days after the last vaccination.  
14. Received or plan to receive a licensed, inactivated, vaccine within 14 days prior to 1st 
vaccination to 14 days after the last vaccination, or a seasonal influenza and/or COVID-
19 vaccine ± 7 days from study product vaccination.   
15. Individuals in whom the ability to observe possible local reactions at the eligible injection 
sites (deltoid region) is unacceptably obscured due to a physical condition or permanent 
body art.  
16. Within 14 days prior to vaccination has received an oral or parenteral (including intra-
articular) corticosteroid of any dose for 5 or more days, or high-dose inhaled 
corticosteroids.  
a. High dose defined per age as using inhaled high dose per reference chart 
(https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf)  
17. Current or history of alcohol or drug abuse within one year prior to enrollment. 

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18. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric 
diagnosis that may interfere with subject compliance or safety evaluations. 
19. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement 
for danger to self or others within one year prior to enrollment. 
20. Are pregnant, breastfeeding, or plan to become pregnant or breastfeed at any given time 
during the study. 
21. Have an acute illness as determined by study clinician licensed to make medical 
diagnoses and listed on the Form FDA 1572 as the site PI or sub-investigator, within 72 
hours prior to enrollment. 
a. An acute illness which is nearly resolved with only minor residual symptoms remaining is 
allowable if, in the opinion of a study clinician licensed to make medical diagnoses and listed on 
the Form FDA 1572 as the site PI or sub-investigator, the residual symptoms will not interfere with 
the ability to assess safety parameters as required by the protocol. 
22. Received an investigational product within 30 days prior to the first study vaccination or 
expect to receive an investigational product during the study period.  
a.  Including vaccine, drug, biologic, device, blood product, or medication, other than from 
participation in this trial. 
23.  Have abnormal screening laboratory values within 30 days prior to enrollment. 
a. Refer to Appendix B for range of normal laboratory values. 
b. Screening laboratory values that are outside acceptable range but are thought to be due to an acute 
condition or due to laboratory error may be repeated once. [see MOP] 
4.1.3 
Subject Qualification Criteria for Vaccinations 2, 3 
If Halting Criteria in section 7.6 are met, further study vaccinations will be halted pending SRC 
and Safety Monitoring Committee (SMC) review.  
Any subject with 1) a SAE assessed as related to the vaccine, or 2) a PIMMC regardless of 
vaccine relatedness criterion excluding subjects with a history of PIMMC, will be discontinued 
from study vaccinations. 
Subsequent vaccinations may proceed if the following criteria are all answered yes: 
1. Oral temperature less than 100.4°F. 
2. Negative urine pregnancy test, as applicable.  
3. Females of childbearing potential continue to agree to use acceptable contraception for 
the duration of the trial (including the safety communication follow up period). 

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4. Has not received or plans to receive a licensed, inactivated, vaccine within 14 days prior 
to 1st vaccination to 14 days after the last vaccination or a seasonal influenza and/or 
COVID-19 vaccine ± 7 days from study product vaccination. 
5. Has not received or plans to receive a licensed live vaccine through 30 days after the last 
vaccination. 
6. Within 14 days prior to vaccination has not received an oral or parenteral (including 
intra-articular) corticosteroids of any dose for 5 or more days, or high-dose inhaled 
corticosteroids. 
a. 
High dose defined per age as using inhaled high dose per reference chart 
(https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf 
7. Has not had an acute illness as determined by study clinician licensed to make medical 
diagnoses and listed on the Form FDA 1572, within 72 hours prior to vaccination. 
a. 
An 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 as required by the protocol. 
8. Has not had a new or prior unsolicited AE, unrelated to study product, that is more than 
Grade 2 at the time of vaccination.   
9. Has not had a new unsolicited AE related to study product that is greater than Grade 1 at 
the time of vaccination. 
10. Has not had a prior unsolicited AE related to study product persisting at the time of 
vaccination and is greater than Grade 1.  
11. Has not had a new solicited AE related to study product that is greater than Grade 1 at the 
time of vaccination. 
12. Has not had a prior solicited AE related to study product persisting at the time of 
vaccination and is greater than Grade 1. 
13. In the judgement of the PI does not have any other contraindication to dosing.  
 
Withdrawal from the Study, Discontinuation of Study Product, or 
Study Termination  
4.2.1 
Withdrawal from the Study or Discontinuation of the Study Product  
Subjects may voluntarily withdraw their consent for study participation at any time without 
penalty or loss of benefits to which they are otherwise entitled.  
An investigator may also discontinue a subject from receiving study product for any reason. 
Follow-up safety evaluations will be conducted if the subject agrees. If a subject discontinues 

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study product or is withdrawn from the study prior to completion, the reason for this decision 
must be recorded in the eCRFs.  
The reasons for withdrawal or discontinuation of study product, might include, but are not 
limited to the following: 
• 
Subject meets halting criteria  
• 
Subject becomes noncompliant 
• 
Disease or medical condition, or new clinical finding(s) for which continued participation, in 
the opinion of the investigator might compromise the safety of the subject, interfere with the 
subject's successful completion of this study, or interfere with the evaluation of responses 
• 
Subject becomes lost to follow-up 
• 
Subject becomes pregnant 
The investigator should be explicit regarding study follow-up (e.g., safety follow-up) that might 
be carried out despite the fact the subject will not receive further study product. The alternate 
visit schedule and procedures pertaining to subjects withdrawn from study product will be 
further explained in the MOP. If the subject agrees, every attempt will be made to follow all AEs 
through resolution or stabilization.  
The procedures that collect safety data for the purposes of research must be inclusive in the 
original informed consent or the investigator may seek subsequent informed consent using an 
IRB/IEC approved consent form with the revised procedures. 
Investigator will inform the subject that already collected data will be retained and analyzed even 
if the subject withdraws or is discontinued from this study.  
4.2.2 
Handling of Withdrawals 
In the case of subjects who are lost to follow-up, extensive effort (i.e., three documented contact 
attempts via phone calls, emails, text messages, etc., 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 in the subject’s study records. Every attempt will be 
made to follow all AEs, including solicited local site and systemic AEs, unsolicited non-serious 
AEs, and SAEs, ongoing at the time of early withdrawal through resolution or stabilization as per 
applicable collection times defined for the specific type of AE. 

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Subjects who withdraw, or are withdrawn from this study, or are lost to follow-up after signing 
the informed consent form (ICF) and administration of the study product will not be replaced. 
Subjects who withdraw, or are withdrawn from this study, or are lost to follow-up after signing 
the ICF but before administration of the study product may be replaced.  
4.2.3 
Study Termination  
If the study is prematurely terminated by the sponsor, any regulatory authority, or the 
investigator for any reason, the investigator will promptly inform the study subjects and assure 
appropriate therapy or follow-up for the subjects, as necessary. The investigator will provide a 
detailed written explanation of the termination to the IRB/IEC. 

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STUDY PROCEDURES 
Study Duration  
It is projected that the length of the overall study, from initiating screening to the completion of 
the last safety communication follow up visit, will be approximately 24 months. This projection 
is based on the six sentinel subjects in each cohort and the assumption that vaccination of the 
next cohort will begin after the SRC has reviewed blinded safety data through the reactogenicity 
period post-3rd study vaccination in the previous cohort. Additionally, as the study is using a 
novel adjuvant, study participants will receive a final safety call approximately 1 year after 
receiving their final vaccination to assess for new onset AEs of special interest. 
Duration of Individual Subject Participation 
Participation for an individual subject will be approximately 15 months, which includes a 30-day 
screening period, vaccination at Day 1, 29, and 57, and active surveillance through 28 days after 
the 3rd dose of vaccine. Safety communication contacts will be made at 6 months and 1 year post 
final vaccination. 
Study Schedule 
Complete study schedule details listed by type of visit are described below. Refer also to 
Appendix A. Schedule of Events. 
 
Screening 
Day -30 to -2 
The following activities will be performed at screening and may be done all at one visit or split 
into separate visits. 
• 
Subjects 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, including any screening procedures. 
• 
Demographic information will be obtained by interview of subjects. 
• 
Eligibility criteria will be reviewed with subjects.  

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The following screening procedures will be completed to ensure that the potential subject is 
eligible for the study: 
• 
Complete medical history will be obtained by interview of subjects, including current 
contraceptive history with females of childbearing potential and receipt of seasonal influenza 
and COVID-19 vaccines for all participants.  
• 
History of all concomitant medications taken within 30 days prior to signing the ICF will be 
obtained by interview of subjects or abstraction from eCRF.  
• 
Vital signs, including oral temperature, pulse, and BP, will be obtained. Subjects must not eat 
or drink anything hot or cold, or smoke within 10 minutes prior to taking oral temperature. 
• 
Height and weight will be collected for BMI calculation. 
• 
An abbreviated physical examination will be performed to include the following organs and 
organ systems: general appearance, skin, head and neck, lungs, heart, liver, spleen, 
extremities, musculoskeletal and lymph nodes by a study clinician licensed to make medical 
diagnoses and listed on the Form FDA 1572 as the site PI or sub-investigator. Breast, genito-
urinary and rectal exams are not considered a routine part of the abbreviated physical exam. 
• 
A urine pregnancy test will be performed on all females of childbearing potential and must 
be negative. 
• 
Counsel on avoidance of pregnancy for females of childbearing potential. 
• 
A urine dipstick will be performed for urine protein. 
• 
A urine toxicology will be performed for opiates.  
• 
A stool kit and collection instructions will be provided in anticipating for the expected 
sample at enrollment.  
• 
Venous blood will be collected for screening laboratory tests. These include:  
• 
Hematology: WBC, absolute neutrophil count (ANC) hemoglobin (Hgb), and platelets 
(PLTs)   
• 
Chemistry: total bilirubin (T. bili), alanine aminotransferase (ALT), creatinine, sodium, 
potassium 
• 
Serology: HIV – 1/2 antibody, HCV, HBsAg, HLA-B27  

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Testing results must be confirmed to meet the eligibility criteria as outlined in the Inclusion / 
Exclusion Criteria prior to randomization. Acceptable screening laboratory values are those that 
fall within the normal ranges as listed in Appendix B.  
• A low creatinine value or a low ALT value, as well as trace amounts of urinary protein, 
are acceptable for study inclusion.  
• As they are not considered to be clinically significant, subjects with a Grade 1 
abnormality may be re-screened once if there is a suspected inter-current, short-term 
medical illness or a suspected laboratory error.  
If screening labs are collected more than 30 days before vaccination, the screening labs may be 
re-collected to determine if the subject remains eligible for study participation. No subject may 
be screened more than twice due to a screening failure result as defined above. The Study 
Sponsor and PI will be contacted for clarification or questions regarding screening failures. All 
eligibility criteria must be satisfied before a subject is enrolled.  
A subject may also be re-screened if the subject was screened eligible for a previous cohort but 
was not enrolled (e.g., scheduling conflict, vacation). 
Subjects will be informed of their screening test results by a member of the study team. Subjects 
will be encouraged to follow up with their primary care providers if results are of clinical 
significance or are sensitive in nature.  
 
Enrollment/Baseline 
Day 1, Visit 01 
Subjects who pass screening and meet all the inclusion criteria and none of the exclusion criteria 
may be considered for study enrollment. 
• Screening blood testing and study entry requirements will be reviewed with subjects prior 
to the first study vaccination to ensure subjects continue to qualify for vaccination. 
Laboratory results must be within acceptable parameters as outlined in the inclusion / 
exclusion criteria.  
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases, MAAEs, NOCMCs and symptoms suggestive of PIMMCs, will be 
obtained by interview of subjects prior to study vaccination. Any changes in medical 

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history since the screening visit will be reviewed to ensure subjects continue to qualify 
for vaccination. 
• All concomitant medications will be reviewed with subjects prior to study vaccination for 
accuracy and completeness. Any new concomitant medications will be reviewed to 
ensure subjects continue to qualify for vaccination.  
• Vital signs, including oral temperature, pulse, and BP, will be obtained prior to study 
vaccination to ensure subjects continue to qualify for vaccination. Vital signs assessed on 
Day 1 prior to study vaccination will be considered as baseline. Subjects must not eat or 
drink anything hot or cold, or smoke within 10 minutes prior to taking oral temperature. 
• If indicated, a targeted physical examination may be performed prior to study 
vaccination. 
• For all participants of childbearing potential, a urine pregnancy test will be performed 
within 24 hours of vaccination. Results must be negative and known prior to study 
vaccination.  
• Pre-vaccination Reactogenicity assessments will be completed. 
• Venous blood will be collected immediately prior to study vaccination for: 
• Serum for Serology 
• PBMC for ALS  
• PBMC for secondary research 
• Serum for secondary research   
• Attempt to collect stool sample for future use. Every attempt should be made to collect 
sample from participant. Enrollment can continue in the rare case the sample cannot be 
collected. 
• Subjects will be enrolled in Advantage eClinical® and randomly assigned to a treatment 
arm prior to study vaccination. 
• Subjects will receive one dose of study vaccine via a single IM injection into the deltoid 
muscle of the subject’s arm. It is strongly recommended the unblinded administrator 
administers the study product(s) into the subject’s left deltoid. The site of injection and 
time of study vaccine administration to the subject will be recorded on the appropriate 
eCRF  
• Subjects 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 

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will be performed, and any AE/SAEs will be recorded on the appropriate eCRF prior to 
discharge from the clinic. 
• Subjects will be instructed how to complete their e-memory aid. Subjects will be 
provided with study-related materials (including a digital thermometer and measuring 
ruler) to record daily oral temperature and potential solicited injection site reactions. 
Subjects will be encouraged to take their oral temperature around the same time each day. 
Subjects must not eat or drink anything hot or cold, or smoke within 10 minutes prior to 
taking oral temperature. Subjects 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 
subject on the proper course of action, including a return to the clinic for immediate 
evaluation if appropriate. 
• Counsel on avoidance of pregnancy for females of childbearing potential.  
 
Follow up Visits  
Follow-up visits are scheduled in reference to most recent study vaccination date. See Appendix 
A. Schedule of Events. 
5.3.1 
Follow up: 3 Days (±1) and 15 Days (±2) following each vaccine 
These visits may be performed in the clinic or virtually. 
The following procedures as applicable, will occur. 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases, MAAEs, NOCMCs, and PIMMCs, will be obtained by interview of 
subjects and any changes since the previous visit will be noted. 
• All concomitant medications will be reviewed with subjects and recorded on the 
appropriate eCRF.  
• Vital signs, including oral temperature, pulse, and BP, will be obtained. Subjects must not 
eat or drink anything hot or cold, or smoke within 10 minutes prior to taking oral 
temperature. 
• A targeted physical examination may be performed if indicated based on review of 
complete medical history and any updates obtained by interview of subjects since the 
previous visit, by a study clinician licensed to make medical diagnoses and listed on the 
Form FDA 1572 as the site PI or sub-investigator. 

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• All AE/SAEs will be recorded on the appropriate eCRF. 
• The study vaccination site will be examined, except for visits 04, 08, and 12. 
• E-Memory Aid information will be reviewed with subjects, except for visits 04, 08, and 
12.  
• Counsel on avoidance of pregnancy for females of childbearing potential.  
• A stool kit and collection instructions will be provided in anticipation for the expected 
sample at the next visit, except for visits 04, 08 and 12. 
 
5.3.2 
Follow up: 7 Days (+1) after each vaccination 
All procedures listed in section 5.3.1 as well as procedures listed below are to be performed 
unless exceptions are noted.  
• Venous blood will be collected for:   
• WBC, Hgb, PLT, ANC, ALT, T. bili, creatinine, sodium, and potassium.  
• Serum for Serology 
• PBMC for ALS  
• PBMC for secondary research 
• Serum for secondary research   
• E-Memory Aid information will be reviewed with subjects 
• Attempt to collect stool sample. 
5.3.3 
Subsequent Vaccination Visits: Day 29 (+2) and Day 57 (+2) 
All subjects in each cohort will return on Day 29 (Visit 05) and Day 57 (Visit 09) after 
vaccination 1 and undergo the following procedures: 
• Qualification criteria for subsequent vaccination visits, will be reviewed prior to 
vaccination. Section 4.1.3 
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases, MAAEs, NOCMCs and symptoms suggestive of PIMMCs, will be 
obtained by interview of subjects prior to study vaccination. Any changes in medical 
history since the screening visit will be reviewed to ensure subjects continue to qualify 
for vaccination. 

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• Concomitant medications will be reviewed with subjects prior to study vaccination for 
accuracy and completeness. Any new concomitant medications will be reviewed to 
ensure subjects continue to qualify for vaccination.  
• Vital signs, including oral temperature, pulse, and BP, will be obtained prior to study 
vaccination to ensure subjects continue to qualify for vaccination. Subjects must not eat 
or drink anything hot or cold, or smoke within 10 minutes prior to taking oral 
temperature. 
• If indicated after review of subject history, a targeted physical examination may be 
performed prior to study vaccination. 
• For all participants of childbearing potential, a urine pregnancy test will be performed 
within 24 hours of vaccination. Results must be negative and known prior to study 
vaccination.  
• Pre-vaccination reactogenicity assessments will be completed 
• Venous blood will be collected immediately prior to study vaccination for:   
• Serum for Serology 
• PBMC for secondary research 
• Serum for secondary research 
• Subjects will receive one dose of study vaccine via a single IM injection into the deltoid 
muscle of the subject’s arm.  It is strongly recommended the unblinded administrator 
alternate the subject’s arms for injections. The site of injection (right or left arm) and time 
of study vaccine administration to the subject will be recorded on the appropriate eCRF. 
• Subjects 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. 
• Subjects will be instructed how to complete their e-memory aid. Subjects will be 
provided with study-related materials to record daily oral temperature and potential 
solicited injection site reactions. Subjects will be encouraged to take their oral 
temperature around the same time each day. Subjects must not eat or drink anything hot 
or cold, or smoke within 10 minutes prior to taking oral temperature. Subjects 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 

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enough, further instructions will be given to the subject on the proper course of action, 
including a return to the clinic for immediate evaluation if appropriate. 
• Counsel on avoidance of pregnancy for females of childbearing potential. 
 
5.3.4 
Follow-up: Day 85 (±2) and Day 113 (±4) 
All cohorts will return on Day 85 (Visit 13) and 113 (visit 14). The following procedures will be 
performed.  
• Interim medical history, including an assessment for new medical conditions, stability of 
chronic diseases and symptoms, MAAEs, NOCMCs, and suggestive of PIMMCs, will be 
obtained by interview of subjects. Please note that AEs (new medical conditions) will be 
assessed for 28 days post last vaccination. SAEs will be followed throughout the study 
duration.  
• Concomitant medications will be reviewed with subjects for accuracy and completeness. 
Only concomitant medications taken within 30 days of enrollment through 28 days post 
last vaccination are collected in Advantage eClinical®.    
• Vital signs, including oral temperature, pulse, and BP, will be obtained. Subjects must not 
eat or drink anything hot or cold, or smoke within 10 minutes prior to taking oral 
temperature. 
• If indicated after review of subject history, a targeted physical examination may be 
performed.  
• For all participants of childbearing potential, a urine pregnancy test will be performed.  
• Counsel on avoidance of pregnancy for females of childbearing potential. 
• Venous blood will be collected for:  
• Serum for Serology 
• PBMC for secondary research 
• Serum for secondary research 
 
5.3.5 
Safety Communication Follow Up, Day 240, 420 (±7) 
Participants will be contacted to complete a safety assessment via phone or email communication 
6 months and 1 year following the 3rd or final study vaccination. The safety assessment will 

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consist of inquiring about SAEs. MAAEs, NOCMCs, and symptoms suggestive of PIMMCs will 
be collected to satisfy outcome measures.  
 
Unscheduled Study Visits  
Subjects will be asked to notify the study staff promptly if they develop any illness. If the study 
staff determines the symptoms are potentially significant, the subject will be asked to come to the 
clinic for an evaluation. Subjects will be asked to complete an unscheduled visit for any event 
that warrants follow-up. All events will be followed to resolution or until determined to be 
stable. 
5.4.1 
Early Termination Visit 
If the subject decides to withdraw consent after receiving investigational product and declines 
study duration follow up, it will be requested that the subject return for a final visit where follow-
up safety evaluations will be conducted. 
 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or protocol-
specific MOP requirements. The noncompliance may be either on the part of the subject, the site 
PI, or the site personnel. As a result of deviations, corrective actions are to be developed by the 
site and implemented promptly. 
These practices are consistent with ICH E6: 
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 personnel to use continuous vigilance to identify and 
report deviations within five working days of identification of the protocol deviation, or within 
five working days of the scheduled protocol-required activity. All deviations must be promptly 
reported to DMID per the Statistical and Data Coordinating Center (SDCC) protocol deviation 
reporting procedures. 

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All protocol deviations, as defined above, must be addressed in study subject eCRFs. A 
completed copy of the DMID Protocol Deviation Form must be maintained in the Regulatory 
File, as well as in the subject's chart. Protocol deviations must be sent to the local IRB/IEC per 
their guidelines. The site PI and personnel are responsible for knowing and adhering to their IRB 
requirements. 

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DESCRIPTION OF CLINICAL AND LABORATORY 
EVALUATIONS 
 
Clinical Evaluations 
Following consent, a screening evaluation will be performed. Refer to Appendix A: Schedule of 
Events, for clinical evaluation time point specifics. Refer to the MOP for clinical evaluation 
specifics.  
Screening for eligibility will occur from Days -30 to -2 to determine health status of potential 
subjects. This will include the following clinical evaluations: 
• A complete medical history 
• Review of concomitant medications 
• Height and weight will be collected 
• Vital signs (heart rate (HR), BP, oral temperature)  
• Abbreviated physical exam 
• Collection of blood for screening laboratory testing 
• Urine for toxicology 
• Urine pregnancy test will be performed locally on all female subjects of childbearing 
potential and a positive result will exclude the subject from receipt of study product 
• Urine dipstick for protein 
 
Once screening eligibility has been verified, Day 1 vaccination will occur, and the enrollment 
period will begin. After enrollment, the following clinical evaluations will be performed. 
• Vital signs (HR, BP, oral temperature)  
• If indicated, a targeted physical examination may be performed prior to study 
vaccination. 
• Interim medical history 
• MAAE, NOCMC and PIMMCs assessments  
• Review of concomitant medications 
• A urine pregnancy test will be performed locally on all female subjects of childbearing 
potential and a positive result will exclude the subject from receipt of study product.  
• Collection of blood for baseline and safety laboratory testing 
 

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• Local and systemic symptom assessment using e-memory aid. Subjects will be followed 
for 7 days post-vaccine (through Study Day 8) 
• Safety follow up visits via phone or email communication 
 
6.1.1 
Research Procedures  
Refer to Appendix A: Schedule of Events, for time point specifics. Refer to section 6.2.2 for 
testing specifics. 
• E-memory aid review to validate the reactogenicity severity scores 
• Collection of blood  
• Collection of stools  
 
6.1.2 
Assessment of Concomitant Medications/Treatments other than Study Product 
• Administration of any medications or non-study vaccines will be documented in the 
appropriate eCRF. All concomitant medications, taken in the 30 days prior to study 
enrollment through 28 days following last vaccination or early termination, whichever 
occurs first, will be recorded. All concomitant medications associated with SAEs, 
MAAEs, NOCMCs, and PIMMCs through the assessment period for these events will be 
recorded.  
• All prescription and over-the-counter medications as well as vitamins and supplements 
will be recorded.  
Assessment of eligibility also will include a review of permitted and prohibited medications (per 
the exclusion criteria). 
Use of new medications should prompt evaluation for the presence of an AE or new chronic 
medical condition. 
Medications which may interfere with the evaluation of the investigational product should not be 
used unless absolutely necessary. Medications or treatments which are prohibited are listed in the 
exclusion criteria.  

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6.1.3 
Assessment of Subject Compliance with Study Intervention/Investigational 
Product/Investigational Device  
Subjects will be directly observed at the time of dosing by a member of the clinical research 
team who is delegated to administer the study product. Administration will be documented in the 
appropriate eCRF. 
 
Laboratory Evaluations 
6.2.1 
Clinical Laboratory Evaluations 
Safety laboratory evaluations will be performed by the local lab of the performance site.  
Clinical safety lab testing will include hematology and chemistry.  
Hematology: WBC, ANC, Hgb, and platelet count 
Chemistry: sodium, potassium, creatinine, ALT, and T. bili  
For females of childbearing potential, urine pregnancy testing will be performed in the clinic by 
a qualified study team member using a commercially available test at screening, Days 85 and 
113, and within 24 hours before each vaccination. Pregnancy test results must be negative for 
subjects to be eligible for enrollment and to be qualified to receive vaccination.  
Subjects will be tested for HLA-B27, HIV, HBsAg, and antibody to Hepatitis C at screening 
only.  
Urinalysis will be done to test for urine protein via dipstick in the clinic at screening only. A 
clean-catch, mid-stream urine specimen will be collected in a sterile urine cup. 
Urine test for opiates: A clean-catch, mid-stream urine specimen will be collected in a sterile 
urine cup and transported to the clinical laboratory for processing and examination at screening 
only. 
6.2.2 
Research Assays  
Serology: 
At times specified in the protocol and the MOP, blood will be collected for IgG and IgM assay 
by enzyme-linked immunosorbent assay (ELISA). The serum will be separated and stored frozen 
for determination of specific antibody responses against C. jejuni capsule and CRM197 antigens. 
 

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Antibody in Lymphocyte Supernatant (ALS): 
At times specified in the protocol and the MOP, the PBMCs will be isolated from whole blood 
and cryopreserved to be used in ALS assays. The ALS assay will measure by ELISA the 
secretion of C. jejuni capsule specific antibodies in cultures of PBMCs.  
Secondary Research: 
In addition to Research Assays listed above, serum, stool and PBMCs will be preserved for 
secondary research. Details of assays, methodology and location of testing will be determined 
under a separate research protocol yet to be determined. 
• Serum  
Blood for serum samples at days specified in the protocol will be collected, processed, 
and stored at -70°C until used for secondary research.  
 
• Stool  
A stool sample (4-5gm) will be placed in a 30 mL Oakridge tube and frozen at -70ºC or 
colder until used for secondary research. 
 
• PBMCs 
The PBMCs will be isolated from whole blood and cryopreserved until used for 
secondary research.  
 
6.2.2.1 
Laboratory Specimen Preparation, Handling, and Storage 
Biosamples (serum, stools, and PBMCs) for immunological assays will be collected, processed, 
cryopreserved, and stored as detailed in the protocol MOP. All immunological assays will be 
performed in batches after all samples have been collected for a given assay within a cohort.  
 
6.2.2.2 
Laboratory Specimen Shipping 
Instructions for specimen preparation, handling, storage, and shipment as applicable are included 
in the protocol-specific MOP.  

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ASSESSMENT OF SAFETY 
 
Assessing and Recording Safety Parameters 
This will be the first time that the CJCV2 vaccine (either alone or in combination with ALFQ) 
has been administered to humans. However, in a phase 1 clinical trial, CJCV1, the initial 
Campylobacter-CCV (co-administered with and without AH) was administered safely to 48 
human subjects in a 2-dose series (days 1 and 29). Across all cohorts of the study, the vaccine 
was well-tolerated with self-limited, post-vaccination AEs limited to mild severity without a 
clear increase in frequency upon dose escalation. Vaccine site reactions were most common 
when the AH adjuvant was co-administered. There were no AEs that met study stopping criteria. 
Both MPLA and QS-21 have been safely given to human subjects in multiple clinical trials in 
combination with multiple candidate vaccines against diverse diseases, including hepatitis B, 
malaria, varicella-zoster virus, and tuberculosis. Though significant safety events are not 
anticipated, they will be closely monitored as data are limited using 3D-PHAD® and QS-21 
together. 
Safety will be assessed by the frequency and severity of solicited and unsolicited AEs. 
7.1.1 
Adverse Events (AEs) 
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation 
subject administered a pharmaceutical product, regardless of its causal relationship to the study 
treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a 
drug in humans, whether 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 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.  
All AEs, including solicited local (injection site) and systemic (subjective and quantitative) 
reactions, will be captured on the appropriate eCRF. Information to be collected for AEs includes 
event description, date of onset, and assessment of severity, relationship to study product and 
alternate etiology (assessed only by those with the training and authority to make a diagnosis and 
listed on the Form FDA 1572 as an investigator/sub-investigator), date of resolution, seriousness, 

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and outcome. AEs occurring during the trial collection and reporting period will be documented 
appropriately regardless of relationship. AEs will be followed through resolution. 
Any medical condition that is present at the time that the subject 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 should be recorded as an AE. 
7.1.1.1 
Adverse Events Grading 
All AEs (laboratory and clinical symptoms) will be graded for severity and assessed for 
relationship to study product (see definitions). 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. Changes in the severity of an AE will be 
documented to allow an assessment of the duration of the event at each level of intensity. 
Severity of Event:  
AEs will be assessed by the investigator using a protocol-defined grading system (toxicity table 
included as Appendix B). For events not included in the protocol-defined grading system, the 
following guidelines will be used to quantify severity: 
• 
Mild (Grade 1): Events that are usually transient and may require only minimal or no 
treatment or therapeutic intervention and generally do not interfere with the subject’s usual 
activities of daily living. 
• 
Moderate (Grade 2): Events that are usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, causing discomfort but 
poses no significant or permanent risk of harm to the research participant. 
• 
Severe (Grade 3): Events interrupt usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention. Severe events are usually 
incapacitating. 
Relationship to Study Product: The assessment of the AE’s relationship to study product will 
be done by the study clinician licensed to make medical diagnoses and listed on the Form FDA 
1572 as the site PI or sub-investigator. Whether the AE is related or not, 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.  
In a clinical trial, the study product must always be suspect. The relationship to study product 
will be assessed for AEs using the terms related or not related: 

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• 
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. 
 
7.1.2 
Reactogenicity  
Reactogenicity events are 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 
local (injection site) and systemic (subjective and quantitative) reactions: 
Table 3: 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 
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 

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Injection Site Reaction 
Mild (Grade 1) 
Moderate (Grade 2) 
Severe (Grade 3) 
Induration 
(Hardness)/Edema 
(Swelling)* 
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 induration/edema as analyzed by measurement will be graded as 
follows: 
 
Table 4: 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 
Induration (Hardness)/Edema 
(Swelling)* 
<20 mm 
20 mm – 50 mm 
>50 mm 
* Will not be used as halting criteria. 
 
Table 5: 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 
Myalgia* 
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) 
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 
Vomiting 
No interference with daily 
activity 
Some interference with 
daily activity 
Significant interference, prevents 
daily activity or vomiting requires 
prescription medication 
* Not at injection site. 
 
Table 6: 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. 
† Subjects must not eat or drink anything hot or cold, or smoke within 10 minutes prior to taking oral temperature. 
 
 
7.1.3 
Serious Adverse Events (SAEs) 
An AE or suspected adverse reaction is considered a SAE if, in the view of either the site PI or 
sponsor, it results in any of the following outcomes:  
• 
death, 

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• 
a life-threatening adverse event1,  
• 
inpatient hospitalization or prolongation of existing hospitalization,  
• 
a persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions,  
• 
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 subject 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. 
1 Life-threatening adverse event. An AE is considered “life-threatening” if, in the view of either 
the site PI or sponsor, its occurrence places the patient or subject at immediate risk of death. It 
does not include an AE that, had it occurred in a more severe form, might have caused death. 
SAEs will be: 
• 
Assessed for severity and relationship to study product and alternate etiology (if not related 
to study product) by a licensed study physician listed on the Form FDA 1572 or by the 
Institution as the site PI or Sub-Investigator. 
• 
Recorded on the appropriate SAE eCRF. 
• 
Followed through resolution by a licensed study physician (for IND studies, a physician 
listed on the Form FDA 1572 as the site PI or Sub-Investigator). 
• 
Reviewed and evaluated by DMID, SMC (periodic review unless related), and the IRB/IEC. 
 
Specification of Safety Parameters 
Safety will be assessed by the frequency and severity of the solicited and unsolicited AEs. 
7.2.1 
Solicited Events 
Solicited Events are AEs that are common and known to or expected to occur following the 
administration of the study product. Subjects will be assessed for AEs following vaccination 

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administration and will complete an e-memory aid to record symptoms for 7 days following each 
vaccination. The subjects will be provided with a thermometer. The subject e-memory aid will be 
reviewed with the subject at subsequent visits. Any symptoms still present after the solicited 
event collection period (Day 8 post vaccination doses) will continue to be followed until 
resolution or determined to be stable per investigator.  
• Solicited (local injection site) events listed for this protocol include pain, tenderness, 
ecchymosis, erythema, and induration/edema.  
• Solicited (systemic) events listed in this protocol include fever (elevated temperature), 
feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.  
7.2.2 
Unsolicited Events 
Unsolicited event(s), including MAAEs, NOCMCs, PIMMCs, and SAEs, that occur following 
administration of vaccination doses will be collected from subjects throughout their period of 
participation in the study. Unsolicited AEs will be followed until resolution or determined to be 
stable per investigator discretion. A summary of unsolicited AEs will be included as part of the 
clinical study report (CSR). 
7.2.3 
New-Onset Chronic Medical Conditions (NOCMCs) 
NOCMCs are defined as any new ICD-10 diagnosis that is applied to the subject during the 
duration of the study, after receipt of the study agent, that is expected to continue for at least 3 
months and requires continued health care intervention.  
7.2.4 
Medically Attended Adverse Events (MAAEs)  
For each unsolicited AE experienced, the subject will be asked if he/she had received medical 
attention, defined as hospitalization, an ER 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. 
7.2.5 
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 currently in effect are presented in Appendix C: List of 
PIMMCs.  

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7.2.6 
Suspected Unexpected Serious Adverse Reactions (SUSAR) 
A SUSAR is an adverse event reaction that meets all three of the following criteria: 
- 
Serious and  
- 
Unexpected and 
- 
At least possibly related to the study product. 
Unexpected event means an event unforeseen by the researcher or the participant, in terms of 
nature, severity, or frequency, and is not listed in the IB, package insert, and/or summary of 
product characteristics.  
7.2.7 
Dose Escalation Criteria 
7.2.7.1 
Cohort Studies 
The period from when the first sentinel subjects are vaccinated through seven days after the last 
sentinel subject was vaccinated will be reviewed. If no safety issues are noted, the remaining 
subjects in the cohort will be vaccinated. If issues are noted, an ad hoc SMC meeting may occur 
to potentially review unblinded data to decide if the remaining subjects in the cohort will be 
vaccinated.  
Prior to dose escalation, the SRC will review the study data and provide guidance on proceeding 
to the next dose level. The dose escalation data reviews will include blinded data, but if 
necessary for safety considerations, the SMC will have access to unblinded data.  
 
Reporting Procedures 
7.3.1 
Reporting Serious Adverse Events 
SAEs will be followed until resolution even if this extends beyond the study-reporting period. 
Resolution of an AE is defined as the return to pretreatment status or stabilization of the 
condition with the expectation that it will remain chronic.  
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) 

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Bethesda, MD 20817, USA 
SAE Hot Line: 
 
SAE FAX Number: 
 
SAE Email Address: 
 
In addition to the SAE form, select SAE data fields must also be entered into the SDCC system. 
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 site will send a copy of the SAE report. 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 study subject safety and protocol conduct. 
At any time after completion of the study, 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. 
 
7.3.2 
Regulatory Reporting for Studies Conducted Under DMID-Sponsored IND 
Following notification from the site PI or appropriate sub-investigator, DMID, as the IND 
sponsor, will report any suspected unexpected serious adverse reaction (SUSAR) and any SAEs 
related to study products to the FDA and will notify all site PI’s (i.e., all PI’s to whom the 
sponsor is providing drug) under its IND(s) or under any PI’s IND(s) of potential serious risks 
from clinical studies or any other source, as soon as possible. DMID will report to the FDA any 
SUSAR and related SAEs that are fatal or life-threatening as soon as possible, but in no case 
later than 7 calendar days after the sponsor’s initial receipt of the information. If the related SAE 
is not fatal or life-threatening the IND safety report will be submitted within 15 calendar days 
after the sponsor determines that the information qualifies for reporting as specified in 21 CFR 
Part 312.32. Relevant follow up information to an IND safety report will be submitted as soon as 
the information is available. Upon request from 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.  

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All SAEs designated as “not related” to study product(s), will be reported to the FDA at least 
annually in a summary format. 
7.3.3 
Reporting of Pregnancy 
Pregnancy is not an AE but is a collectible event. Pregnancies occurring in study subjects will be 
reported in IDES (internet data entry system). With the subject’s permission, all study mandated 
samples will be collected, and the subject will continue in follow-up for safety events. Efforts 
will be made to follow all pregnancies reported during the study to pregnancy outcome with the 
subject’s permission. 
 
Type and Duration of Follow-up of Subjects after Adverse Events 
All adverse and serious adverse events will be followed to resolution or until determined to be 
stable. 
AEs will be assessed and followed from initial recognition of the AE through end of the protocol 
defined follow-up period.  
SAEs will be followed up through resolution even if duration of follow-up goes beyond the 
protocol-defined the follow-up period. 
Resolution of an AE is defined as the return to pre-treatment status or stabilization of the 
condition with the expectation that it will remain chronic. 
 
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 the relationship to study product. AE/SAEs, 
abnormal laboratory test values, or abnormal clinical findings will be collected, assessed, 
documented, reported, and followed appropriately. Grading of the laboratory AEs will be based 
on the toxicity table. 

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Halting Rules 
7.6.1 
Sentinel Halting Criteria 
Sentinel subject safety data (from day 1 of the dosing of the first Sentinel through day 7 post-
dosing of the last Sentinel, for every dose) will be reviewed. Further study enrollment and dosing 
will be halted for SMC review/recommendation if any Halting Rules (listed below) are met from 
the time of the first study vaccination through the end of the first reactogenicity period (Day 8) at 
any dose for any sentinel participant.  
• Death of an enrolled subject or any SAE if the SAE is considered related to the 
investigational products.  
 
• Any Grade 3 unsolicited AE related to the investigational products.  
 
• Any Grade 3 solicited AE. The size (as measured in mm) of erythema, ecchymosis, and 
induration/swelling will not be used as a halting criterion. 
7.6.2 
Cohort Halting Rules 
Further study enrollment and dosing will be halted for SMC review/recommendation if any of 
the following Halting Rules are met after administration of any dose of study product within a 
cohort. 
• Death of an enrolled subject or any SAE that is considered by the Medical Monitor to be 
related to the investigational products. 
 
• Two (2) or more subjects in the same cohort experience the same or similar Grade 3 
unsolicited AE (including but not limited to the same parameter or next level of coding in 
the Medical Dictionary for Regulatory Activities (MedDRA) hierarchy, High Level Term 
per the MedDRA current version) related to the investigational products. 
• Two (2) or more subjects in the same cohort experience the same Grade 3 solicited AE. 
The size (as measured in mm) of erythema, ecchymosis, and induration/swelling will not 
be used as a halting criterion. 
 

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In the case of a halting rule being met due to Grade 3 solicited AEs in the CJCV2+adjuvant 
group, the cohort could proceed with CJCV2 alone for the following or remaining of the Cohorts 
(Cohorts 2 and/or 3) after review of the SMC. 
7.6.3 
Study Halting Criteria 
Further study enrollment and dosing will be halted for SMC review/recommendation if any of 
the following Halting Rules are met after administration of any dose of study product.  
• Death of an enrolled subject or any SAE if the SAE is considered by the Medical Monitor 
to be related to the investigational products.  
 
• Three (3) or more subjects experience the same or similar Grade 3 unsolicited AE 
(including but not limited to the same parameter or next level of coding in the MedDRA 
hierarchy, High Level Term per the MedDRA current version) related to the 
investigational products. 
 
Three (3) or more subjects experience the same Grade 3 solicited AE. The size (as 
measured in mm) of erythema, ecchymosis, and induration/swelling will not be used as a 
halting criterion 
If a halting rule is met, a thorough review of the event will be undertaken by the investigators 
and the SMC. Vaccination may be resumed with the concurrence of the SMC, sponsor’s 
representative, and the PI. 
The study may also be suspended because of safety findings such as an overall pattern of 
symptomatic, clinical, or laboratory events that the Medical Monitor considers related to the 
study products and that may appear minor in terms of individual events, but that may collectively 
represent a serious potential concern for safety 
 
7.6.4 
Individual Halting Criteria 
A subject may be removed from the study if an investigator or medical monitor deems it in the 
best interest of the subject. A subject also may halt (discontinue participation) at any time. If a 
subject meets an individual halting criterion, it will not halt the study but halt the subject’s 
involvement. 

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Safety Oversight by SMC 
Safety oversight will be conducted by a Safety Monitoring Committee (SMC) which is an 
independent group of experts that advises the DMID. The primary responsibility of the SMC is 
to monitor subject safety. The SMC is external to the DMID and comprises at least 3 voting 
members. The SMC will consist of members with appropriate phase 1 study expertise to 
contribute to the interpretation of the data from this trial. Its activities will be delineated in a 
SMC charter that will describe the membership, responsibilities, and the scope and frequency of 
data reviews. The SMC will operate on a conflict-free basis independently of the study team. The 
DMID or the SMC may convene ad hoc meetings of the SMC according to protocol criteria or if 
there are concerns that arise during the study. 
As defined in the charter, the SMC will meet before the initiation for the study and ad hoc as 
required due to occurrence of a safety event when a halting rule is met or for immediate concerns 
regarding observations during this study.  

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HUMAN SUBJECTS PROTECTION 
 
Institutional Review Board/Independent Ethics Committee 
The site PI will obtain IRB approval for this protocol to be conducted at his/her research site(s) 
and send supporting documentation to the DMID before initiating recruitment of subjects. The 
investigator will submit applicable information to the IRB/IEC on which it relies for the review, 
to conduct the review in accordance with 45 CFR 46, ICH E6 GCP, and as applicable, 21 CFR 
56 (Institutional Review Boards) and 21 CFR 50 (Protection of Human Subjects), other federal, 
state, and local regulations. The IRB/IEC must be registered with OHRP as applicable to the 
research. DMID must receive the documentation that verifies IRB/IEC-approval for this 
protocol, associated informed consent documents, and upon request any recruitment material and 
handouts or surveys intended for the subjects, prior to the recruitment and enrollment of subjects. 
Any amendments to the protocol or consent materials will be approved by the IRB/IEC before 
they are implemented. IRB/IEC review and approval will occur at least annually throughout the 
enrollment and follow-up of subjects and may cease if annual review is no longer required by 
applicable regulations and the IRB/IEC. The investigator will notify the IRB/IEC of deviations 
from the protocol and reportable SAEs, as applicable to the IRB/IEC policy. 
Each institution engaged in this research will hold a current FWA issued by the OHRP for 
federally funded research. 
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. Before any study procedures 
are performed, informed consent will be obtained and documented. Subjects will receive a 
concise and focused presentation of key information about the clinical trial, verbally and with a 
written consent form. The explanation will be organized and presented in lay terminology and 
language that facilitates understanding why one might or might not want to participate. 
An investigator or designee will describe the protocol to potential subjects face-to-face. The key 
information about the purpose of the study, the procedures and experimental aspects of the study, 
risks and discomforts, any expected benefits to the subject, and alternative treatment will be 
presented first to the subject.  

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Subjects will also receive an explanation that the trial involves research, and a detailed summary 
of the proposed study procedures and study interventions/products. This will include aspects of 
the trial that are experimental, the probability for random assignment to treatment groups, any 
expected benefits, all possible risks (including a statement that the particular treatment or 
procedure may involve risks to the subject or to the embryo or fetus, if the subject is or may 
become pregnant, that are currently unforeseeable), the expected duration of the subject’s 
participation in the trial, alternative procedures that may be available and the important potential 
benefits and risks of these available alternative procedures.  
Subjects 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. Subjects 
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. Subjects will be informed of the anticipated financial expenses, if any, to the subject 
for participating in the trial, as well as any anticipated prorated payments, if any, to the subject 
for participating in the trial. They will be informed of whom to contact (e.g., the investigator) for 
answers to any questions relating to the research project.  
Information will also include the foreseeable circumstances and/or reasons under which the 
subject’s participation in the trial may be terminated. The subjects will be informed that 
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 the subject is otherwise entitled.  
The extent of the confidentiality of the subjects’ records will be defined, and subjects will be 
informed that applicable data protection legislation will be followed. Subjects will be informed 
that the monitor(s), auditors(s), IRB, NIAID, and regulatory authority(ies) will be granted direct 
access to the subject’s original medical records for verification of clinical trial procedures and/or 
data without violating the confidentiality of the subject, to the extent permitted by the applicable 
laws and regulations, and that, by signing a written ICF, the subject is authorizing such access.  
Subjects will be informed that records identifying the subject 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 subject’s identity will remain 
confidential. Subjects will be informed whether private information collected from this research 
and/or specimens will be used for additional research, even if identifiers are removed.  

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Subjects will be allowed sufficient time to consider participation in this research trial and can 
discuss this trial with their family, friends, or legally authorized representative, or think about it 
prior to agreeing to participate. 
ICFs will be IRB-approved, and subjects will be asked to read and review the consent form. 
Subjects must sign the ICF prior to starting any study procedures being done specifically for this 
trial. 
Once signed, a copy of the ICF will be given to the subject(s) for their records. The subject(s) 
may withdraw consent at any time throughout the course of the trial. The rights and welfare of 
the subject(s) 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 this study. 
Study personnel may employ recruitment efforts prior to obtaining study consent if a patient-
specific screening consent is on record or if the IRB has agreed that chart review is allowed 
without a fully executed screening consent. In cases where there is not a patient-specific 
screening consent on record, site clinical staff may pre-screen via chart review and refer potential 
subjects to the Research staff. Research staff would obtain written consent per the standard 
informed consent process before conducting protocol-specific screening activities. 
New information will be communicated by the site PI to subjects who consent to participate in 
this trial in accordance with IRB requirements. The informed consent document will be updated, 
and subjects will be re-consented per IRB requirements, if necessary. Subjects will be offered a 
copy of all ICFs that they sign. 
 
Consent for Secondary Research of Stored Specimens and Data 
Subjects who consent to the study will have additional blood and stool collected for future use of 
remaining specimens. Collection of future use samples during the course of the study will help 
facilitate follow-on analyses, if warranted, to provide more comprehensive scientific insights into 
the impact (safety and immunological) of the vaccine on the host response to vaccination. It is 
important that extra blood and stool collection for future use be included in as many subjects as 
possible, due to the limited sample size.  
 
 

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Any remaining samples will be maintained for possible use in future research studies, such as 
examining additional immunological assessments or testing for antibodies against 
Campylobacter or other enteric vaccine development. These samples may be shared for purposes 
other than per protocol analysis with investigators at the participating VTEU site and with other 
investigators at other institutions once the CSR has been finalized.  
Exact studies for which the stored specimens will be used have not been determined, but may 
include immune assay development, assessing innate immune factors, cytokines, and other 
evaluations. 
The stored samples will be labeled with barcodes to maintain confidentiality. Research with 
identifiable samples and data may occur as needed, however, subject confidentiality will be 
maintained as described for this protocol and with IRB approval. 
Samples will not be sold for commercial profit. Although the results of any future research may 
be patentable or have commercial profit, subjects will have no legal or financial interest in any 
commercial development resulting from any future research. 
There are no direct benefits to the subject for extra specimens collected or from the secondary 
research. No results from secondary research will be entered into the subject’s medical record.  
Incidental findings will not be shared with the subject, including medically actionable incidental 
findings, unless required by law. 
Risks for loss of privacy and confidentiality are described below. 
Remaining and future use research samples will be stored indefinitely at a NIH-designated 
research storage facility. These samples will not be sold or used directly for production of any 
commercial product. Each sample will be encoded (labeled) only with a barcode and a unique 
tracking number to protect subject confidentiality. There are no benefits to subjects in the 
collection, storage, and subsequent use of their specimens for future research. Reports about 
future research done with subjects’ samples will NOT be kept in their health records.  
Subjects may withdraw consent to future use samples at any time. They will need to contact the 
study site and the samples will be removed from the study repository after this study is 
completed and documentation will be completed. However, any data from a previously collected 
sample prior to the withdrawn consent will not be removed. Subjects who withdraw consent 
before the last visit will not have the extra blood drawn for future use. 
 

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Human Genetic Testing 
Though there are no current plans for genetic testing, the research staff will seek the subjects’ 
consent for genetic research in this study. The rights and privacy of human subjects who 
participate in genomic or phenotypic research studies will be protected at all times. 
The consent process will include an explanation of the potential risks to the individual subjects 
and their families associated with data submitted to a NIH data repository and subsequent 
sharing. Data that may potentially identify human subjects will not be released in unrestricted 
databases. Subjects will be informed that the evolution of genomic technology and analytical 
methods raises the risk of re-identification, even when specimens are de-identified. The consent 
will include whether individual subject data will be shared through a NIH controlled access data 
repository. Data for genomic or phenotypic research will be submitted to a controlled access data 
repository, therefore, informed consent permitting the data sharing must be documented, even if 
the specimens are de-identified. 
 
 
Exclusion of Women, Minorities, and Children (Special Populations) 
As this is a Phase 1, first-in-human study, enrollment will be limited to males and non-
pregnant/non-lactating females between 18 and 50 years of age, inclusive, at the time of 
enrollment. Special populations, e.g., non-English speakers, children, illiterate or non-writing 
individuals and vulnerable populations will not be enrolled in this study.  
 
Subject Confidentiality 
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and 
the sponsor(s) and their agents. This confidentiality includes documentation, investigation data, 
subject’s clinical information, and all other information generated during participation in the 
study. No information concerning the study, or the data generated from the study will be released 
to any unauthorized third party without prior written approval of the DMID and the subject. 
Subject confidentiality will be maintained when study results are published or discussed in 
conferences. The study monitors or other authorized representatives of the sponsor or 
governmental regulatory agencies may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, medical records (office, clinic, or 
hospital) and pharmacy records for the subjects in this study. The clinical study site will permit 
access to such records. 

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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 specimens, 
evaluation forms, reports, and other records that leave the site will be identified only by a coded 
number. 
Each subject will be assigned a unique study identifier. All eCRFs will identify the subject by a 
unique identifier, and the date. Names will not be used on any samples or in any publication of 
this study.  
All efforts will be made by staff to protect the privacy of subjects, in accordance with the laws. 
These restrictions do not apply to: (1) information which becomes publicly available through no 
fault of the site PI or other study personnel; (2) information which is necessary to disclose in 
confidence to an IRB solely for the evaluation of the study; (3) information which it is necessary 
to disclose in order to provide appropriate medical care to a study subject; or (4) study results 
which may be published. 
 
Certificate of Confidentiality 
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 research subject, 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 subject, except as explained below. 
The Certificate cannot be used to resist a demand for information from personnel of the United 
States Government that is used for auditing or evaluation of federally funded projects, like this 
study, or for information that must be released in order to meet the requirements of the Federal 
FDA. 
A Certificate of Confidentiality does not prevent the subject 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 
subject’s consent, information that would identify the subject 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.  

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The release of individual private information or specimens for other research will only occur if 
consent was obtained from the individual to whom the information, document, or biospecimen 
pertains, or for the purposes of other research that is in compliance with applicable Federal 
regulations governing the protection of human subjects in research.  
 
Costs, Subject Compensation, and Research Related Injuries 
There is no cost to subjects for the research tests, procedures, and study product while taking part 
in this trial. Procedures and treatment for clinical care may be billed to the subject, subject’s 
insurance or third party. Subjects may be compensated for their participation in this trial. 
Compensation will be in accordance with the local IRB’s policies and procedures, and subject to 
IRB approval.  
If it is determined by the site PI that an injury occurred to a subject as a direct result of the tests 
or treatments that are done for this trial, then referrals to appropriate health care facilities will be 
provided to the subject. Study personnel will try to reduce, control, and treat any complications 
from this trial. Immediate medical treatment may be provided by the participating site. No 
financial compensation will be provided to the subject by the NIAID, NIH to the subject, or by 
the participating site for any injury suffered due to participation in this trial. 
 

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STATISTICAL CONSIDERATIONS 
 
Study Hypotheses 
This study, like other Phase 1 studies, is exploratory rather than confirmatory, and thus is not 
designed to formally test any hypotheses. Rather the study is designed to assess the safety and 
immune responses of a range of doses of the CJCV2 vaccine administered with and without the 
adjuvant ALFQ.  
 
Sample Size Considerations 
We plan to enroll 60 subjects (20 per group). The sample size for each cohort was chosen based 
on the number of participants deemed appropriate for a first-in-human Phase 1 study. Given the 
small number of subjects per group, the precision of our estimate for AEs is limited. For 
example, using an exact binomial interval for no observed AEs within the 10 subjects per group 
yields a 95% confidence interval (CI) of 0-31% (Clopper-Pearson). Follow-on studies evaluating 
seemingly safe and immunogenic doses will be required with larger numbers of volunteers in 
order to better define the safety profile.  
 
Treatment Assignment Procedures 
9.3.1 
Randomization Procedures 
Per International Council for Harmonisation (ICH) guideline E6: GCP, screening records will be 
kept at the 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 SDCC 
Advantage eClinical® (Electronic Data Capture System). Once consented and upon entry of 
demographic data and confirmation of eligibility for this trial, the subject will be enrolled. 
Subjects will be assigned randomly using permuted blocks to receive three IM doses of either 
CJCV2 (1 µg in Cohort 1, 3 µg in Cohort 2, or 10 µg in Cohort 3) vaccine alone or CJCV2 
vaccine + ALFQ (200 µg 3D-PHAD and 100 µg QS-21 in all Cohorts) adjuvant. The 
randomization scheme for this study is listed below and presented in Table 1. Subjects will be 
randomized such that the first six subjects of each cohort will be allocated to each of the two 
treatment arms as the sentinel group.  

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• CJCV2 alone group (N=30, 10 per cohort) will receive three-doses of CJCV2 
vaccine + diluent administered by IM on Days 1, 29, and 57. 
• CJCV2 + ALFQ group (N=30, 10 per cohort) will receive three-doses of CJCV2 
vaccine + ALFQ adjuvant administered by IM on Days 1, 29, and 57. 
Enrollment of subjects will be done online using the enrollment module of Advantage 
eClinical®. 
 
The randomization code will be prepared by statisticians at the SDCC and included in the 
enrollment module for this trial. Advantage eClinical® will assign each subject to a group after 
the demographic and eligibility data have been entered into the system. A designated individual 
at the 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 eClinical® User’s Guide. Manual back-up procedures and instructions are provided 
for use if the site temporarily loses access to the Internet, or the online enrollment system is 
unavailable. 
9.3.2 
Masking Procedures 
This is a double-blind study. The CJCV2 vaccine with or without ALFQ will be prepared by the 
unblinded site pharmacist and will be administered by an unblinded vaccinator. Vaccination will 
be the only activity performed by the unblinded vaccinator. The unblinded vaccinator will 
transport the prepared vaccination in a dark colored UV split top bag to maintain the blind. 
Subjects, investigators, study personnel performing any study-related assessments following 
study vaccine administration, and laboratory personnel performing antibody assays will be 
blinded to whether the subject received CJCV2 alone or CJCV2+ALFQ.  
The randomization scheme will be generated by the SDCC and provided to unblinded study 
personnel performing study vaccination preparations. 
The SMC may receive data in aggregate and presented by treatment group, but without the 
treatment group identified. The SMC may be unblinded to individual study treatment 
assignments of subjects, as needed to adequately assess safety issues. The SRC may be 
unblinded to individual study treatment assignments of sentinel subjects only, as needed to 
adequately assess safety before proceeding to enroll non-sentinel subjects. Refer to the MOP for 
unblinding procedures. 

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9.3.3 
Interim Safety Review  
No formal statistical interim analysis based on the safety data is planned. The SRC will review 
safety data through seven days after the last sentinel subject is vaccinated before proceeding to 
vaccinate additional subjects in each cohort. The SRC will review safety data, which may 
include solicited and unsolicited AE/SAEs, concomitant medications, clinical laboratory values, 
vital signs, and any physical examinations, through Day 64 for each cohort prior to dose 
escalation. 
9.3.4 
Interim Immunogenicity Review 
No interim immunogenicity review is planned.  
 
Final Analysis Plan 
A formal Statistical Analysis Plan (SAP) will be developed and finalized prior to unblinding for 
the final analysis, or database lock.  
The final analysis will be performed, and CSR completed and distributed when all primary, 
secondary, and exploratory endpoint data are available 
9.4.1 
Analysis Populations 
The Safety Population includes all subjects who received at least one dose of study vaccination.  
The Modified Intent-to-Treat (mITT) Population consists of all subjects who received any study 
product and contributed both pre- and at least one post-study vaccination blood sample for 
immunogenicity testing for which valid results were reported.  
The Per Protocol (PP) Population includes all subjects in the mITT Population with the following 
exclusions: 
• Data from all available visits for subjects found to be ineligible at baseline. 
• Data from all visits after major protocol deviations, such as: 
o Receipt of an incorrect study vaccination  
o Second or third vaccination not received 
o Second or third vaccination received out of window 
• Receipt of any of the following: 
o Licensed, live vaccine within 30 days of any vaccination 
o Licensed, inactivated vaccine within 14 days of any vaccination 
o Investigational products at any time during study period 

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• Data from any visit that occurs substantially out of window 
In the case of mis-randomization, subjects will be analyzed according to the study product 
actually received for all analysis populations. 
9.4.2 
Safety Data 
Safety data will be summarized for the Safety Analysis Population. Subjects receiving a 
vaccination according to a study arm other than the study arm to which they were randomized, 
will be analyzed according to the vaccination(s) they actually received. Safety summaries will be 
presented for each dose group by presence or absence of ALFQ.  
The proportion of subjects reporting at least one solicited AE will be summarized for each 
solicited AE, any systemic symptom, any local symptom, and any symptom. The 95% CI will be 
presented, and a Fisher’s exact test will be performed to test for differences in the proportion of 
subjects reporting a solicited AE within dose groups between those with and without adjuvant. 
Solicited AEs will be summarized by maximum severity for each day after each study 
vaccination for Days 1-8. The number, percentage (observed rate), and exact two-sided 95% CI 
for subjects reporting each solicited AE within 8 days following vaccination will be summarized. 
In addition, maximum severity for each solicited AE will be determined for each subject and 
reported by study arm and the resulting number and percentage of subjects will be summarized 
by severity grade (none, mild, moderate, severe). Summaries of solicited AEs will be presented 
separately by study arm for each study vaccination as well as overall study vaccinations. 
Vaccine-related unsolicited AEs will be coded by MedDRA® for preferred term and system 
organ class (SOC). The number of SAEs, MAAEs, NOCMCs, and 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 AE duration), 
severity, relatedness, and outcome. If the number of events permits, a Fisher’s exact test may be 
used to test for differences in unsolicited AE rates between adjuvant and non-adjuvant groups 
within dose levels, in a similar manner as for solicited AEs.  
9.4.3 
Immunogenicity Data 
Immunogenicity data summaries and analysis will be presented for the mITT and PP 
populations. Descriptive statistics will be presented for each assay summarizing the geometric 
mean titer and its corresponding 95% CI, as well as the minimum and maximum at each time 
point. 

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The proportion of subjects within each dose level (with and without adjuvant) who develop at 
least a 4-fold rise from baseline in C. jejuni capsule-specific serum IgG antibodies will be 
summarized along with 95% CIs at Days 8, 29, 36, 57, 64, 85 and 113. The peak fold rise from 
baseline in C. jejuni capsule-specific serum IgG antibody titer across Days 8, 29, 36, 57, 64, 85 
and 113 will be determined for each subject and summarized within each dose level (with and 
without adjuvant). Similarly, the maximum C. jejuni capsule-specific serum IgG antibody titer 
across all post-vaccination time points will be determined for each subject and summarized 
within each dose level (with and without adjuvant). Graphical presentations of immune 
responses may include reverse cumulative distribution (RCD) curves and longitudinal 
presentations of titers.  
Exploratory immunogenicity endpoints will be summarized similarly.  
9.4.4 
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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SOURCE DOCUMENTS AND ACCESS TO SOURCE 
DATA/DOCUMENTS 
The participating site will maintain appropriate medical and research records in compliance with 
ICH E6, Section 4.9 and regulatory and institutional requirements for the protection of 
confidentiality of subjects. The site will permit authorized representatives of the DMID, its 
designees, and appropriate regulatory agencies to examine (and when required by applicable law, 
to copy) clinical records for the purposes of quality assurance (QA) reviews, audits, and 
evaluation of the study safety and progress. These representatives will be permitted access to all 
source data and source documents, which include, but are not limited to, hospital records, clinical 
and office charts, laboratory notes, memoranda, 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 
subject files and records kept at the pharmacy, at the laboratories, and medico-technical 
departments involved in the clinical trial.  
The study uses direct data entry (DDE) for the participating clinic site and the eCRFs serve as 
the source documents for data collected. Subjects will be trained to use a database to complete a 
web-based electronic memory Aid (e-Memory aid) and are expected to enter information in the 
e-memory aid each day of the solicited event collection period. Subjects using the e-memory aid 
will also be provided a paper memory aid for their use in the event they are unable to access the 
web-based system. If subjects need to use a paper memory aid, they will be asked to enter the 
information from the paper memory aid into the e-memory aid once they are able to access the 
web-based system. The e-Memory Aid is not considered source data. After clinic staff review 
and save the data, the data will be entered into Advantage eClinical as a source. 
Subjects will record temperature, local and systemic symptoms and any new medications used 
following vaccination or changes to previously reported medications daily for 7 days after any 
vaccination.  
Subjects will be instructed to contact the clinic staff immediately if they experience severe 
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 e-
memory 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 subject on the severe 
solicited event and send an email to Emmes confirming attempted follow up with the subject. 

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Instructions for completing the e-memory aid are provided in the MOP and in a separate e-
memory aid instructions document that will be provided to the subjects at each vaccination. The 
site staff must review the e-memory aid information and interview the subject at the next 
scheduled visit. The subject-entered data will be available for review by the clinician during the 
clinical interview. 
The site staff will be the data originators for the clinically reviewed data in Advantage eClinical® 
that will be used for the study endpoints. A list of all authorized site staff data originators will be 
included on the Study Personnel/Signature Responsibility List. 
 

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QUALITY CONTROL AND QUALITY ASSURANCE 
Following a written DMID-accepted site quality management plan, the participating site and its 
subcontractors are responsible for conducting routine QA and quality control (QC) activities to 
internally monitor study progress and protocol compliance. The site PI will provide direct access 
to source data/eCRFs, and reports for the purpose of monitoring and auditing by the sponsor, and 
inspection by local and regulatory authorities. The site PI will ensure all study personnel are 
appropriately trained and applicable documentations are 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 site for clarification and resolution. 
DMID-designated clinical monitors will verify that the clinical trial is conducted, and data are 
generated, documented (recorded), and reported in compliance with the protocol, ICH/GCP 
guidelines, and the applicable regulatory requirements. Clinical monitoring reports will be 
submitted to DMID. 

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DATA HANDLING AND RECORD KEEPING 
 
Data Management Responsibilities 
The site PI is responsible to ensure the accuracy, completeness, and timeliness of the data 
reported. 
Data will be entered electronically over the Internet by site study staff into Advantage eClinical, 
developed and maintained by the SDCC. The eCRFs serve as the source documents for data 
collected. Paper CRFs derived from the eCRF are provided by the SDCC and are to be used only 
when Advantage eClinical is unavailable. 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. The 
sponsor and/or its designee will provide guidance to the site PI and other study personnel on 
making corrections to the eCRF. 
 
Data Coordinating Center/Biostatistician Responsibilities 
All eCRFs and laboratory reports must be reviewed by the clinical team and data entry 
personnel, who will ensure that they are accurate and complete. AEs must 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 clinical study site 
under the supervision of the site PI. During the study, the site PI must maintain complete and 
accurate documentation for the study. 
The SDCC for this study 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, concomitant medications, medical history, 
physical assessments, and clinical laboratory values) and reactogenicity will be entered into 
eCRFs via a 21 CFR Part 11-compliant IDES provided by the study SDCC. The data system 

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includes password protection and internal quality checks, such as automatic range checks, to 
identify data that appear inconsistent, incomplete, or inaccurate.  
Site staff who are delegated the responsibility by the study PI will be the data originators for the 
clinical data entered directly into the eCRF. The central laboratory will be the data originator for 
the laboratory data reported by an automated reporting system. A list if all authorized data 
originators, including site staff, will be included on the Study Personnel/Signature Responsibility 
List.   
 
Types of Data 
Data for this trial will include clinical, safety, and outcome measures (e.g., clinical laboratory 
values, reactogenicity, and immunogenicity data). 
 
Study Records Retention 
Study records and reports including, but not limited to, eCRFs, source documents, ICFs, 
laboratory test results, and study drug disposition records will be retained for 2 years after a 
marketing application is approved for the study product 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 study 
product, 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 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 site must contact DMID for authorization prior to the destruction of any 
study records. 
 

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CLINICAL MONITORING 
Site monitoring is conducted to ensure that the human subjects’ protections, study and laboratory 
procedures, study intervention administration, and data collection processes are of high quality 
and meet sponsor, ICH/GCP guidelines and applicable 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. 
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 the participating site, study 
personnel, and all study documentation according to the DMID-approved site monitoring plan. 
Study monitors will meet with the site PI to discuss any problems and actions to be taken and 
will document site visit findings and discussions. 
 

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PUBLICATION POLICY 
Following completion of the study, the PI is expected to publish the results of this research in a 
scientific journal. 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 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 subject. 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 SAP 
will be posted on ClincialTrials.gov. 
For this trial the responsible party is the NIH which will register the 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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LITERATURE REFERENCES 
1. 
Fitzgerald, C., Campylobacter. Clin Lab Med, 2015. 35(2): p. 289-98. 
2. 
Same, R.G. and P.D. Tamma, Campylobacter Infections in Children. Pediatr Rev, 2018. 
39(11): p. 533-541. 
3. 
Patrick, M.E., et al., Features of illnesses caused by five species of Campylobacter, 
Foodborne Diseases Active Surveillance Network (FoodNet) - 2010-2015. Epidemiol 
Infect, 2018. 146(1): p. 1-10. 
4. 
Jiang, Z.D. and H.L. DuPont, Etiology of travellers' diarrhea. J Travel Med, 2017. 
24(suppl_1): p. S13-s16. 
5. 
Amour, C., et al., Epidemiology and Impact of Campylobacter Infection in Children in 8 
Low-Resource Settings: Results From the MAL-ED Study. Clin Infect Dis, 2016. 63(9): p. 
1171-1179. 
6. 
Kaakoush, N.O., et al., Global Epidemiology of Campylobacter Infection. Clin Microbiol 
Rev, 2015. 28(3): p. 687-720. 
7. 
Shakoor, S., A.K. Zaidi, and R. Hasan, Tropical bacterial gastrointestinal infections. 
Infect Dis Clin North Am, 2012. 26(2): p. 437-53. 
8. 
White, A.E., et al., Characteristics of Campylobacter and Salmonella Infections and 
Acute Gastroenteritis in Older Adults in Australia, Canada, and the United States. Clin 
Infect Dis, 2019. 69(9): p. 1545-1552. 
9. 
Kotloff, K.L., et al., Burden and aetiology of diarrhoeal disease in infants and young 
children in developing countries (the Global Enteric Multicenter Study, GEMS): a 
prospective, case-control study. Lancet, 2013. 382(9888): p. 209-22. 
10. 
Mullaney, S.B., et al., Estimate of the annual burden of foodborne illness in nondeployed 
active duty US Army Service Members: five major pathogens, 2010-2015. Epidemiol 
Infect, 2019. 147: p. e161. 
11. 
O'Brien, S.J., The consequences of Campylobacter infection. Curr Opin Gastroenterol, 
2017. 33(1): p. 14-20. 
12. 
Jackson, B.R., et al., Binational outbreak of Guillain-Barre syndrome associated with 
Campylobacter jejuni infection, Mexico and USA, 2011. Epidemiol Infect, 2014. 142(5): 
p. 1089-99. 
13. 
Ajene, A.N., C.L. Fischer Walker, and R.E. Black, Enteric pathogens and reactive 
arthritis: a systematic review of Campylobacter, salmonella and Shigella-associated 
reactive arthritis. J Health Popul Nutr, 2013. 31(3): p. 299-307. 
14. 
Zhang, M., et al., Association study between an outbreak of Guillain-Barre syndrome in 
Jilin, China, and preceding Campylobacter jejuni infection. Foodborne Pathog Dis, 2010. 
7(8): p. 913-9. 

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15. 
Wierzba, T.F., et al., Campylobacter infection as a trigger for Guillain-Barre syndrome 
in Egypt. PLoS One, 2008. 3(11): p. e3674. 
16. 
Schiaffino, F., et al., Antibiotic Resistance of Campylobacter Species in a Pediatric 
Cohort Study. Antimicrob Agents Chemother, 2019. 63(2). 
17. 
Geissler, A.L., et al., Increasing Campylobacter Infections, Outbreaks, and Antimicrobial 
Resistance in the United States, 2004-2012. Clin Infect Dis, 2017. 65(10): p. 1624-1631. 
18. 
Ge, B., et al., Antimicrobial resistance in campylobacter: susceptibility testing methods 
and resistance trends. J Microbiol Methods, 2013. 95(1): p. 57-67. 
19. 
Peterson, M.C., Rheumatic manifestations of Campylobacter jejuni and C. fetus 
infections in adults. Scand.J Rheumatol., 1994. 23: p. 167-170. 
20. 
Bremell, T., A. Bjelle, and A. Svedhem, Rheumatic symptoms following an outbreak of 
campylobacter enteritis: a five year follow up. Ann Rheum.Dis, 1991. 50: p. 934-938. 
21. 
Gumpel, J.M., C. Martin, and P. Sanderson, J., Reactive arthritis associated with 
campylobacter enteritis. Ann Rheum Dis, 1981. 40: p. 64-65. 
22. 
Leung, F.Y., G.O. Littlejohn, and C. Bombardier, Reiter's syndrome after Campylobacter 
jejuni enteritis. Arthritis Rheum., 1980. 23: p. 948-950. 
23. 
van de Putte, L.B., et al., Reactive arthritis after Campylobacter jejuni enteritis. J 
Rheumatol., 1980. 7: p. 531-535. 
24. 
Berden, J.H., H.L. Muytjens, and L.B. van de Putte, Reactive arthritis associated with 
Campylobacter jejuni enteritis. Br.Med J, 1979. 1: p. 380-381. 
25. 
Nachamkin, I., Campylobacter Enteritis and the Guillain-Barre Syndrome. Curr Infect 
Dis Rep, 2001. 3(2): p. 116-122. 
26. 
Rees, J.H., et al., Epidemiological study of Guillain-Barre syndrome in south east 
England [see comments]. J.Neurol.Neurosurg.Psychiatry, 1998. 64: p. 74-77. 
27. 
Mishu, B. and M.J. Blaser, Role of infection due to Campylobacter jejuni in the initiation 
of Guillain-Barr:e syndrome. Clin Infect.Dis, 1993. 17: p. 104-108. 
28. 
Prendergast, M.M. and A.P. Moran, Lipopolysaccharides in the development of the 
Guillain-Barre syndrome and Miller Fisher syndrome forms of acute inflammatory 
peripheral neuropathies. J Endotoxin Res, 2000. 6(5): p. 341-59. 
29. 
Moran, A.P. and M.M. Prendergast, Molecular mimicry in Campylobacter jejuni 
lipopolysaccharides and the development of Guillain-Barre syndrome. J Infect Dis, 1998. 
178(5): p. 1549-51. 
30. 
Aspinall, G.O., A.G. McDonald, and H. Pang, Lipopolysaccharides of Campylobacter 
jejuni serotype O:19: structures of O antigen chains from the serostrain and two 
bacterial isolates from patients with the Guillain-Barre syndrome. Biochemistry, 1994. 
33(1): p. 250-5. 
31. 
Alving, C.R., et al., Adjuvants for human vaccines. Curr Opin Immunol, 2012. 24(3): p. 
310-5. 

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32. 
Cawlfield, A., et al., Safety, toxicity and immunogenicity of a malaria vaccine based on 
the circumsporozoite protein (FMP013) with the adjuvant army liposome formulation 
containing QS21 (ALFQ). Vaccine, 2019. 37(29): p. 3793-3803. 
 
 

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  Schedule of Events  
Study Visit o 
00 
01 
02 
03 
04 
05 
06 
07 
08 
09 
10 
11 
12 
13 
14 
15 
16 
U/Sn 
E/T 
  
Visit Type- Clinic 
x 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
x 
 
 
x 
x 
Visit Type, Clinic or Virtual 
 
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
 
 
 
 
 
 
Visit Type- Safety Communication q 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
x 
 
 
Study Day 
-30 to 
-2 
1 
3 
8 
15 
29 
31 
36 
43 
57 
59 
64 
71 
85 
113 
240 
420 
 
 
Visit Window n 
 
 
±1 
+1 
±2 
+2 
±1 
+1 
±2 
+2 
±1 
+1 
±2 
±2 
±4 
±7 
±7 
 
 
Informed Consent a 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vaccination 
 
x 
 
 
 
x 
 
 
 
x 
 
 
 
 
 
 
 
 
 
Demographics 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History b 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
x 
x 
Concomitant Medication Review c 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
 
x 
x 
Adverse Event Assessment d, e 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Counsel on avoidance of pregnancy p 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
 
 
Physical Exam f 
x 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
x 
 
 
x 
x 
Vital signs (BP, HR, Temp) g 
x 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
x 
 
 
x 
x 
Height & Weight  
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
 
Review Eligibility 
x 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy Test h, i 
x 
x 
 
 
 
x 
 
 
 
x 
 
 
 
x 
x 
 
 
x 
x 
Urine Dipstick for protein 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
 
Urine Opiate Test 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
 
Anti-HIV-1/2, HBsAg, Anti-HCV 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
 
HLA-B27 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematology & Chemistry j  
x 
 
 
x 
 
 
 
x 
 
 
 
x 
 
 
 
 
 
x 
x 

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8 May 2023 
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a) Prior to study procedures.  
b) Complete medical history will be obtained by interview of subjects at the screening visit and will be updated on Day 1 prior to the first study 
vaccination. Interim medical history will be obtained by interview of subjects at follow-up visits after the first study vaccination. Contraception history 
will be collected for females of childbearing potential. 
c) All current medications and medications taken within 30 days prior to signing the ICF. Concomitant medications taken within 30 days of enrollment 
through 28 days post last vaccination are collected in Advantage eClinical®. 
d) AEs will be assessed through 28 days post last vaccination. SAEs will be followed throughout the study duration  
e) Unsolicited AEs including MAAEs, NOCMCs, PIMMCs, and SAEs will be collected from subjects throughout their period of study participation and 
SAE to include concomitant medication(s) taken for these events.  
f) 
An abbreviated physical examination will be performed at screening. A targeted physical examination may be performed at subsequent visits, if 
indicated based on review of medical history and any updates obtained by interview of subjects.  
g) Subjects must not eat or drink anything hot or cold, or smoke within 10 minutes prior to taking oral temperature. 
h) Prior to vaccination. 
Study Visit o 
00 
01 
02 
03 
04 
05 
06 
07 
08 
09 
10 
11 
12 
13 
14 
15 
16 
U/Sn 
E/T 
  
Continued on the next page 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reactogenicity Assessment k 
 
x 
 
 
 
x 
 
 
 
x 
 
 
 
 
 
 
 
x 
 
E-Memory Aid l 
 
x 
x 
x 
 
x 
x 
x 
 
x 
x 
x 
 
 
 
 
 
x 
 
Study Vaccination Site Examination 
 
x 
x 
x 
 
x 
x 
x 
 
x 
x 
x 
 
 
 
 
 
x 
 
Serum (Serology)  
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
x 
 
 
x 
x 
Blood (PBMCs) for ALS  
 
x 
 
x 
 
 
 
x 
 
 
 
x 
 
 
 
 
 
x 
 
Blood (PBMCs) for Secondary 
Research  
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
x 
 
 
x 
x 
Serum for Secondary Research  
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
 
x 
x 
 
 
x 
x 
Stool for Secondary Research m 
 
x 
 
x 
 
 
 
x 
 
 
 
x 
 
 
 
 
 
x 
x 
Approx. blood mL by day 
37 
100 
 
70 
 
 
 
40 
 
 
70 
 
 
 
40 
 
 
70 
 
 
 
40 
 
40 
 
 
 
40 
40 

DMID Protocol 19-0003 
Version 6.0 
Campylobacter jejuni vaccine (CJCV2)  
8 May 2023 
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DMID eCTD Compliant Interventional Protocol Template and Instructions, Version 4.0, Dated May 15, 2018 
 
i) 
A urine pregnancy test will be performed within 24 hours prior to study vaccinations and results must be negative and known prior to each study 
vaccination. 
j) 
Hematology and Chemistry tests include WBC, Hgb, platelet count, ANC, sodium, potassium, creatinine, T. bili, ALT.  
k) Reactogenicity assessments will occur prior to and ≥ 30 minutes post vaccination.  
l) 
E-memory aid tools and education will be provided on the days of vaccination. E-memory aid review will occur 48 hours and 7 days post vaccination.  
m) Stool kits will be provided during the visits preceding expected stool collection days. 
n) Unscheduled study (U/S) events and Early Termination (E/T) events to occur as indicated. 
o) Visit Window to be initiated at Day 1 of each vaccination day. 
p) Counseling on avoidance of pregnancy will be performed on females of childbearing potential. 
q) Safety Communication follow up visits may occur via phone or email communication.  
 

DMID Protocol 19-0003 
Version 6.0 
Campylobacter jejuni vaccine (CJCV2)  
8 May 2023 
 ______________________________________________________________________________________________________  
 
DMID/NIAID/NIH 
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DMID eCTD Compliant Interventional Protocol Template and Instructions, Version 4.0, Dated May 15, 2018 
 
 
Toxicity Table 
Adverse Grading Event Grading Scale 
This protocol is CDISC compliant. The modified Toxicity Grading Scale for Laboratory 
Abnormalities below serves as a guideline and are dependent upon institutional normal 
parameters.  
Laboratory 
Mild  
(Grade 1) 
Moderate (Grade 2) 
Severe  
(Grade 3) 
Sodium, low, mEq/L 
132 – 135 
130 – 131 
<130 
Sodium, high, mEq/L 
146 – 147 
148 – 149 
150 or greater 
Potassium, high, mEq/L 
5.2 – 5.3 
5.4 – 5.5 
>5.5 
Potassium, low, mEq/L 
3.3 – 3.4 
3.1 – 3.2 
<3.1 
Creatinine, high mg/dL (female) 
1.0 - 1.1 
1.2 - 2.0 
>2 
Creatinine, high mg/dL (male) 
1.2 – 1.3 
1.4 – 2.0 
>2 
Liver Function Tests (ALT) increase 
by factor 
>1.0-2.5 x ULN 
>2.5-5.0 x ULN 
>5.0x ULN 
Total bilirubin  
>1.0-1.5 x ULN 
>1.5-2.0 x ULN 
>2.0 x ULN 
Hgb (female), low g/dL 
10.9-11.6 
9.4 – 10.8 
<9.3 
Hgb (male), low g/dL 
13.1-13.2 
12.5-13.0 
<12.4 
WBC, increase, cells,  
x 103u/L 
>11.1 –≤15.0  
>15 - ≤ 20 
>20.0  
WBC, decrease, cells, x 103u/L 
2.5-<4.4 
1.5-<2.5 
<1.5 
ANC, x 103u/L 
1.2-<1.7 
0.9-<1.2 
<0.9 
Platelets, decrease, cells/mm3 
124,000-<134,000 
100,000<124,000  
<100,000  
Urine protein 
Trace 
1+ 
2+ 
*** “ULN” is the upper limit of the normal range 

DMID Protocol 19-0003 
Version 6.0 
Campylobacter jejuni vaccine (CJCV2)  
8 May 2023 
 ______________________________________________________________________________________________________  
 
DMID/NIAID/NIH 
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DMID eCTD Compliant Interventional Protocol Template and Instructions, Version 4.0, Dated May 15, 2018 
 
 PIMMCs list 
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 
 
 

DMID Protocol 19-0003 
Version 6.0 
Campylobacter jejuni vaccine (CJCV2)  
8 May 2023 
 ______________________________________________________________________________________________________  
 
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DMID eCTD Compliant Interventional Protocol Template and Instructions, Version 4.0, Dated May 15, 2018 
 
Neuroinflammatory disorders 
• 
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 

DMID Protocol 19-0003 
Version 6.0 
Campylobacter jejuni vaccine (CJCV2)  
8 May 2023 
 ______________________________________________________________________________________________________  
 
DMID/NIAID/NIH 
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DMID eCTD Compliant Interventional Protocol Template and Instructions, Version 4.0, Dated May 15, 2018 
 
• 
Autoimmune hemolytic anemia 
• 
Autoimmune glomerulonephritis (including Immunoglobulin A (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