Clinical trial NCT05327816
Conditions: Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention
Sponsor: Janssen Vaccines & Prevention B.V.
Start date: 2022-04-13; Completion date: 2023-02-14
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (\>=) 60 years in stable health.

Detailed description:
RSV is an important cause of serious respiratory infections in adults aged 60 years and older. The current study is divided into four cohorts, evaluating various doses and combinations of RSV preF-based vaccines. Cohort 1 will assess the safety and reactogenicity of different RSV preF-based vaccines. Cohort 2 is an expansion of cohort 1 and will assess both safety and immunogenicity of these different RSV vaccines. based on C1 and 2 data the optimal vaccine composition will be selected and further evaluated in Cohort 3 and 4 including durability and revaccination. Cohort 3 will accumulate safety data on the selected vaccine and optimize its formulation. Cohort 4 is an expansion of several arms in cohort 3, aimed to understand the durability of the immune response induced by the selected vaccine, and to explore the possibility for revaccination.

Arms: arm 1: Participants will receive single dose of mixture of RSV preF-based vaccine in cohort (C) 1 (Group \[G\] 1) and C 2 through intramuscular injection on Day 1. arm 2: Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1. arm 3: Participants will receive single dose of placebo in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1. arm 4: Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. arm 5: Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. arm 6: Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. arm 7: Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. arm 8: Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1. arm 9: Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 3) and C 2 through intramuscular injection on Day 1. arm 10: Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 3) and C 2 through intramuscular injection on Day 1. arm 11: Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 4) and C 2 through intramuscular injection on Day 1. arm 12: Participants will receive a single dose of selected formulation (based on C 1 and 2 results) in C 3 through intramuscular injection on Day 1. arm 13: Participants in C 3 will receive a single dose of first vaccination with selected formulation (as per data C1 and 2) plus placebo on Day 1 and re-vaccination with selected formulation whenever revaccination would be needed through intramuscular injection. arm 14: Participants in C 3 will receive a single dose of first vaccination with selected formulation (as per data from C 1 and 2) plus placebo on Day 1 and re-vaccination with placebo whenever revaccination would be needed through intramuscular injection. arm 15: Participants in C 3 will receive first vaccination with placebo on Day 1 and re-vaccination with selected formulation (as per data from C 1 and 2) whenever revaccination would be needed through intramuscular injection. arm 16: Participants in C 3 will receive the mixture of RSV preF-based vaccine plus placebo on Day 1 through intramuscular injection. arm 17: Participants in C 4 will receive first vaccination with selected formulation (as per data from C 1 and 2) on Day 1 and re-vaccination with selected formulation whenever revaccination would be needed through intramuscular injection. arm 18: Participants in C 4 will receive first vaccination with selected formulation (as per data from C 1 and 2) on Day 1 and re-vaccination with placebo whenever revaccination would be needed through intramuscular injection. arm 19: Participants in C 4 will receive first vaccination with placebo on Day 1 and re-vaccination with selected formulation (as per data from C 1 and 2) whenever revaccination would be needed through intramuscular injection.
Interventions: intervention 1: RSV preF-based Vaccine intervention 2: Placebo
Intervention descriptions: intervention 1: RSV preF-based vaccine will be administered as intramuscular injection. intervention 2: Placebo will be administered as intramuscular injection.

Protocol documents:
Prot_000.pdf: 
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
1
Status: Approved,  Date: 22 December 2021
Janssen Vaccines & Prevention B.V.*
Clinical Protocol
A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and
Immunogenicity Evaluations of various RSV.preF-based Vaccine Formulations in Adults
Aged 60 Years and Older
Protocol VAC18195RSV1001; Phase 1/2a
Version: Original
VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
* Janssen Vaccines & Prevention B.V. is a Janssen pharmaceutical company of Johnson & Johnson and is
hereafter referred to as the sponsor of the study. The sponsor is identified on the Contact Information page
that accompanies the protocol.
Studies conducted at sites in the United States (US)will be conducted under US Food & Drug
Administration Investigational New Drug (IND) regulations (21 CFR Part 312).
Status: 
Approved
Date: 
22 December 2021
EDMS number: 
EDMS-RIM-543812, 1.0
GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory
requirements.
Confidentiality Statement
The information provided herein contains Company trade secrets, commercial or financial information that the Company
customarily holds close and treats as confidential.  The information is being provided under the assurance that the recipient
will maintain the confidentiality of the information under applicable statutes, regulations, rules, protective orders or
otherwise.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
2
Status: Approved,  Date: 22 December 2021
TABLE OF CONTENTS
TABLE OF CONTENTS............................................................................................................................... 2
LIST OF IN-TEXT TABLES AND FIGURES................................................................................................ 5
1. 
PROTOCOL SUMMARY..................................................................................................................... 6
1.1. 
Synopsis........................................................................................................................................... 6
1.2. 
Schema.......................................................................................................................................... 18
1.3. 
Schedule of Activities (SoA)........................................................................................................... 21
1.3.1. 
Schedule of Activities –Cohort 1 and 2...................................................................................... 21
1.3.2. 
Schedule of Activities –Cohort 3 (Arms 10 and 13)................................................................... 23
1.3.3. 
Schedule of Activities –Revaccination/Durability: Cohort 3 (Arms 11a, 11b and 12) and
Cohort 4...................................................................................................................................... 25
2. 
INTRODUCTION................................................................................................................................ 29
2.1. 
Study Rationale.............................................................................................................................. 30
2.2. 
Background .................................................................................................................................... 30
2.3. 
Benefit-Risk Assessment............................................................................................................... 33
2.3.1. 
Risks for Study Participation....................................................................................................... 33
2.3.2. 
Benefits for Study Participation .................................................................................................. 35
2.3.3. 
Benefit-Risk Assessment for Study Participation ....................................................................... 36
3. 
OBJECTIVES AND ENDPOINTS..................................................................................................... 37
4. 
STUDY DESIGN ................................................................................................................................ 41
4.1. 
Overall Design................................................................................................................................ 41
4.2. 
Scientific Rationale for Study Design............................................................................................. 46
4.2.1. 
Study-Specific Ethical Design Considerations ........................................................................... 47
4.3. 
Justification for Dose...................................................................................................................... 47
4.4. 
End of Study Definition................................................................................................................... 48
5. 
STUDY POPULATION ...................................................................................................................... 48
5.1. 
Inclusion Criteria............................................................................................................................ 49
5.2. 
Exclusion Criteria........................................................................................................................... 50
5.3. 
Lifestyle Considerations................................................................................................................. 53
5.4. 
Screen Failures.............................................................................................................................. 53
5.5. 
Criteria for Temporarily Delaying Administration of Study Vaccine ............................................... 53
6. 
STUDY VACCINE(S) AND CONCOMITANT THERAPY................................................................. 54
6.1. 
Study Vaccine(s) Administered...................................................................................................... 54
6.2. 
Preparation/Handling/Storage/Accountability ................................................................................ 55
6.3. 
Measures to Minimize Bias: Randomization and Blinding............................................................. 56
6.4. 
Study Vaccine Compliance ............................................................................................................ 58
6.5. 
Dose Modification........................................................................................................................... 58
6.6. 
Continued Access to Study Vaccine After the End of the Study ................................................... 58
6.7. 
Treatment of Overdose .................................................................................................................. 58
6.8. 
Concomitant Therapy..................................................................................................................... 58
6.9. 
Study Pausing Rules...................................................................................................................... 59
7. 
DISCONTINUATION OF STUDY VACCINATION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL............................................................................................... 61
7.1. 
Discontinuation of Study Vaccination............................................................................................. 61
7.2. 
Participant Discontinuation/Withdrawal From the Study................................................................ 62
7.2.1. 
Withdrawal From the Use of Research Samples ....................................................................... 63
7.3. 
Lost to Follow-up............................................................................................................................ 63
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
3
Status: Approved,  Date: 22 December 2021
8. 
STUDY ASSESSMENTS AND PROCEDURES............................................................................... 63
8.1. 
Immunogenicity Assessments ....................................................................................................... 67
8.2. 
Safety Assessments....................................................................................................................... 68
8.2.1. 
Physical Examinations................................................................................................................ 68
8.2.2. 
Vital Signs................................................................................................................................... 68
8.2.3. 
Clinical Safety Laboratory Assessments .................................................................................... 69
8.3. 
Adverse Events, Serious Adverse Events, Adverse Events of Special Interest and Other
Safety Reporting ............................................................................................................................ 69
8.3.1. 
Time Period and Frequency for Collecting Adverse Event, Serious Adverse Event and
Adverse Event of Special Interest Information ........................................................................... 69
8.3.2. 
Method of Detecting Adverse Events and Serious Adverse Events and Adverse Events
of Special Interest....................................................................................................................... 70
8.3.3. 
Follow-up of Adverse Events, Serious Adverse Events and Adverse Events of Special
Interest........................................................................................................................................ 72
8.3.4. 
Regulatory Reporting Requirements for Serious Adverse Events ............................................. 72
8.3.5. 
Pregnancy................................................................................................................................... 72
8.3.6. 
Adverse Events of Special Interest............................................................................................. 72
8.3.6.1. 
Thrombosis with Thrombocytopenia Syndrome...................................................................... 73
8.4. 
Pharmacokinetics........................................................................................................................... 74
8.5. 
Genetics and Pharmacogenomics................................................................................................. 74
8.6. 
Biomarkers..................................................................................................................................... 74
8.7. 
Medical Resource Utilization and Health Economics .................................................................... 74
9. 
STATISTICAL CONSIDERATIONS.................................................................................................. 74
9.1. 
Statistical Hypotheses.................................................................................................................... 75
9.2. 
Sample Size Determination ........................................................................................................... 75
9.2.1. 
Initial Safety Cohort (Cohort 1)................................................................................................... 75
9.2.2. 
Vaccine Components Selection Cohort (Cohorts 1 and 2)......................................................... 75
9.2.3. 
Expanded Safety Cohort (Cohort 3) ........................................................................................... 76
9.2.4. 
Revaccination and Durability Cohort (Cohort 4)......................................................................... 77
9.3. 
Populations for Analysis Sets ........................................................................................................ 77
9.4. 
Statistical Analyses ........................................................................................................................ 78
9.4.1. 
General Considerations.............................................................................................................. 78
9.4.2. 
Participant Information................................................................................................................ 78
9.4.3. 
Immunogenicity Analyses........................................................................................................... 78
9.4.4. 
Safety Analyses.......................................................................................................................... 79
9.4.5. 
Other Analyses ........................................................................................................................... 80
9.5. 
Planned Analyses .......................................................................................................................... 80
10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS............................ 82
10.1. 
Appendix 1: Abbreviations ............................................................................................................. 82
10.2. 
Appendix 2: Clinical Laboratory Tests ........................................................................................... 84
10.3. 
Appendix 3: Regulatory, Ethical, and Study Oversight Considerations......................................... 86
10.3.1. 
Regulatory and Ethical Considerations ...................................................................................... 86
10.3.2. 
Financial Disclosure.................................................................................................................... 89
10.3.3. 
Informed Consent Process ......................................................................................................... 89
10.3.4. 
Data Protection........................................................................................................................... 90
10.3.5. 
Long-Term Retention of Samples for Additional Future Research ............................................ 91
10.3.6. 
Committees Structure................................................................................................................. 91
10.3.7. 
Publication Policy/Dissemination of Clinical Study Data............................................................ 91
10.3.8. 
Data Quality Assurance.............................................................................................................. 93
10.3.9. 
Case Report Form Completion................................................................................................... 93
10.3.10. Source Documents ..................................................................................................................... 94
10.3.11. Monitoring ................................................................................................................................... 94
10.3.12. On-Site Audits............................................................................................................................. 95
10.3.13. Record Retention........................................................................................................................ 95
10.3.14. Study and Site Start and Closure ............................................................................................... 96
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
4
Status: Approved,  Date: 22 December 2021
10.4. 
Appendix 4: Adverse Events, Serious Adverse Events, Product Quality Complaints, and
Other Safety Reporting: Definitions and Procedures for Recording, Evaluating, Follow-up,
and Reporting................................................................................................................................. 97
10.4.1. 
Adverse Event Definitions and Classifications ........................................................................... 97
10.4.2. 
Attribution Definitions.................................................................................................................. 98
10.4.3. 
Severity Criteria.......................................................................................................................... 98
10.4.4. 
Special Reporting Situations ...................................................................................................... 99
10.4.5. 
Procedures ................................................................................................................................. 99
10.4.6. 
Product Quality Complaint Handling......................................................................................... 101
10.4.7. 
Contacting Sponsor Regarding Safety, Including Product Quality........................................... 101
10.5. 
Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information......................... 102
10.6. 
Appendix 6: Toxicity Grading Scale............................................................................................. 103
10.7. 
Appendix 7: Thrombotic Events to be Reported as Potential AESIs ........................................... 108
10.8. 
Appendix 8: Study Conduct During a Natural Disaster................................................................ 109
10.9. 
Appendix 9: Protocol Amendment History................................................................................... 111
11. REFERENCES................................................................................................................................. 112
INVESTIGATOR AGREEMENT............................................................................................................... 114
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
5
Status: Approved,  Date: 22 December 2021
LIST OF IN-TEXT TABLES AND FIGURES
TABLES
Table 1: 
Study Design: Initial Safety Cohort (Cohort 1).......................................................................... 11
Table 2: 
Study Design: Supporting Vaccine Components Selection Cohort (Cohort 2)......................... 12
Table 3: 
Study Design: Expanded Safety Cohort (Cohort 3).................................................................. 13
Table 4: 
Study Design: Revaccination and Durability Cohort (Cohort 4) ............................................... 13
Table 5: 
Study Design: Initial Safety Cohort (Cohort 1).......................................................................... 44
Table 6: 
Study Design: Supporting Vaccine Components Selection Cohort (Cohort 2)......................... 45
Table 7: 
Study Design: Expanded Safety Cohort (Cohort 3).................................................................. 46
Table 8: 
Study Design: Revaccination and Durability Cohort (Cohort 4) ............................................... 46
Table 9: 
Visit Windows: Cohort 1 and 2.................................................................................................. 64
Table 10: Visit Windows: Cohort 3 (Arms 10 and 13).............................................................................. 65
Table 11: Visit Windows: Cohort 3 (Arms 11a, 11b and 12) and Cohort 4.............................................. 65
Table 12: Summary of Immunogenicity Assays........................................................................................ 67
Table 13: Probability of Observing at Least One AE in a Group of the Considered Sample Size
Given Several True AE Rates................................................................................................... 75
Table 14: Estimated 95% CIs, by Observed GMT Ratio of VNA Levels. ................................................. 76
Table 15: Probability of Observing at Least One Adverse Event in the Expanded Safety Cohort
(Cohort 3) at a Given True Adverse Event Rate....................................................................... 76
Table 16: Upper Limit of the 1-sided 95% CI if no Cases are Observed for Different Sample
Sizes ......................................................................................................................................... 76
Table 17: Probability of Observing at Least One Adverse Event for the Selected Formulation for
Future Clinical Development, at a Given True Adverse Event Rate ........................................ 77
Table 18: Upper Limit of the 1-sided 95% CI if no Cases are Observed for Different Sample
Sizes ......................................................................................................................................... 77
Table 19: Protocol-Required Safety Laboratory Assessments................................................................. 84
Table 20: Protocol-Required Laboratory Tests After Potential AESI Reporting ....................................... 84
Table 21: Laboratory Tests That May Be Requested by the Sponsor After Potential AESI
Reporting .................................................................................................................................. 85
FIGURES
Figure 1: Schematic Overview of the Study for Cohorts 1 and 2............................................................. 18
Figure 2: Schematic Overview of the Study for Cohort 3, Arms 10 and 13 ............................................. 19
Figure 3: Schematic Overview of the Study for the Revaccination/Durability Cohorts: Cohort 3
(Arms 11a, 11b and 12) and Cohort 4...................................................................................... 20
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
6
Status: Approved,  Date: 22 December 2021
1. 
PROTOCOL SUMMARY
1.1. 
Synopsis
A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity
Evaluations of various RSV.preF-based Vaccine Formulations in Adults Aged 60 Years and Older
The respiratory syncytial virus (RSV) vaccine that will be investigated in the current study is a combination
of adenovirus type 26 (Ad26)-based and/or preF protein-based vaccine components derived from RSV A
and B subtypes, administered as intramuscular (IM) injections:
 
Ad26.RSV.preF (JNJ-64400141; referred to in this document as Ad26.RSV-A.preF), a replication-
incompetent Ad26 containing a deoxyribonucleic acid (DNA) transgene that encodes the prefusion
conformation-stabilized F protein derived from the RSV A subtype.
 
Ad26.RSV-B.preF2 (JNJ-86051823), a replication-incompetent Ad26 containing a DNA transgene
that encodes the prefusion conformation-stabilized F protein derived from the RSV B subtype.
 
RSV preF protein (JNJ-64213175; referred to in this document as RSV-A preF protein) is a prefusion
conformation-stabilized F protein derived from the RSV A subtype.
 
RSV-B preF protein (JNJ-78991172) is a prefusion conformation-stabilized F protein derived from
the RSV B subtype.
OBJECTIVES AND ENDPOINTS
INITIAL SAFETY COHORT OBJECTIVE (COHORT 1): To determine in small numbers of participants aged
60 years and older the safety of a vaccine formulation comprising a combination of Ad26.RSVA.preF and/or
Ad26.RSVB.preF2 and/or RSVA preF and/or RSVB preF proteins before progression to vaccine components
selection in a larger number of participants for further assessment of the safety and immunogenicity
Objectives 
Endpoints
PRIMARY
 To assess the safety and reactogenicity of various
combinations of RSV vaccine components
 Serious adverse events (SAEs) and adverse events
of special interest (AESIs) from first dose
administration until 6 months after vaccination
 Solicited local and systemic adverse events (AEs)
for 7 days after vaccine administration
 Unsolicited AEs from the time of vaccine
administration through the following 28 days
VACCINE COMPONENTS SELECTION OBJECTIVE (COHORTS 1 and 2): To select an optimal RSV.preF
based vaccine based on assessment of the safety and immunogenicity in participants aged 60 years and older
receiving a vaccine formulation comprising a combination of Ad26.RSVA.preF and/or Ad26.RSVB.preF2 and/or
RSVA preF and/or RSVB preF proteins.
Objectives 
Endpoints
PRIMARY
 To assess the safety and reactogenicity of 
various combinations of RSV vaccine 
components 
 SAEs and AESIs from first dose administration until
6 months after vaccination
 Solicited local and systemic AEs for 7 days after
vaccine administration
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
7
Status: Approved,  Date: 22 December 2021
Objectives 
Endpoints
 Unsolicited AEs from the time of vaccine
administration through the following 28 days
 To assess humoral immune responses elicited 
by various combinations of RSV vaccine
components
 RSV neutralization antibody titers
SECONDARY
 To assess humoral and cellular immune 
responses elicited by various combinations of 
RSV vaccine components using other
immunological assays
 F protein binding antibodies (pre-F and/or post-F),
and antigen-specific T-cell responses*
EXPLORATORY
 To further explore vaccine-elicited immune 
responses after single vaccination with various 
combinations of RSV vaccine components 
 
Exploratory endpoints may include the following, but
are not limited to: RSV neutralization antibody titers
against additional A and/or B strains, anti-F protein
antibody specificity and functionality characterization,
adenovirus neutralization antibody titers, molecular
antibody characterization (eg, avidity, Fc cell
interaction, 
antibody-dependent 
cell-mediated
cytotoxicity 
[ADCC], 
antibody-dependent 
cell-
mediated phagocytosis [ADCP], antibody isotyping,
antibody sequencing for repertoire), including but not
limited to immunoglobulin (Ig)A and IgG, chemokines
and cytokines in serum samples, transcriptome analysis
and sequencing of the T-cell receptor (TCR) and/or B-
cell receptor (BCR) or heavy/light chain (VH/VL)
characterization, evaluation of the cellular immune
response and the functional and memory immune
response by intracellular cytokine staining (ICS)*,
cellular phenotyping and memory B-cell ELISpot*
 To assess the durability of the immune 
response in selected groups 
 Endpoints may include the following, but are not
limited to: RSV neutralization antibody titers against
RSV subtype A and B, RSV neutralization antibody
titers against additional A and/or B strains, RSV F
protein binding antibodies (pre-F and/or post-F),
antigen-specific T-cell responses*, anti-F protein
antibody specificity and functionality characterization,
adenovirus neutralization antibody titers, molecular
antibody characterization (eg, avidity, Fc cell
interaction, ADCC, ADCP, antibody isotyping,
antibody sequencing for repertoire), including but not
limited to immunoglobulin (Ig)A and IgG, chemokines
and cytokines in serum, transcriptome analysis and
sequencing of the TCR and/or BCR or VH/VL
characterization, evaluation of the cellular immune
response and the functional and memory immune
response by ICS*, cellular phenotyping and memory
B-cell ELISpot*
* Only applicable for participants with blood draws for cellular responses.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
8
Status: Approved,  Date: 22 December 2021
EXPANDED SAFETY COHORT OBJECTIVE (COHORT 3): To determine the safety and immunogenicity of the
selected RSV.preF based vaccine in an expanded cohort of participants aged 60 years and older, comparing the
formulation of the selected combination of RSV vaccine components (2x1mL formulation, based on Cohort 1 and 2
results) and the formulation to be used for future clinical development (1x1mL formulation); and to assess
durability of the selected RSV.preF based vaccine and determine the effect ofrevaccination.
Objectives 
Endpoints
PRIMARY
 To assess the safety and reactogenicity of the 
selected RSV.preF-based vaccine formulation 
(based on Cohort 1 and 2 results), compared to
the formulation to be used for future clinical
development
 SAEs and AESIs from first administration until
6 months after the last vaccination
 Solicited local and systemic AEs for 7 days after
each vaccine administration
 Unsolicited AEs from the time of each vaccine
administration through the following 28 days
SECONDARY
 To assess immune responses to the selected 
RSV.preF-based vaccine formulation (based on
Cohort 1 and 2 results), compared to the
formulation to be used for future clinical
development
 RSV neutralization antibody titers
 To assess the durability of the immune response 
to the selected RSV.preF-based vaccine
formulation in groups with and without
revaccination
 RSV neutralization antibody titers
EXPLORATORY
 Additional exploratory analyses may be performed 
to further investigate humoral and cellular 
vaccine-elicited immune responses to the selected 
RSV.preF-based 
vaccine 
formulation  
and 
durability  
 Endpoints may include the following, but are not
limited to: RSV neutralization antibody titers
against additional A and/or B strains, F protein
binding antibodies (pre-F and/or post-F), and
antigen-specific T-cell responses*, anti-F protein
antibody specificity and functionality
characterization, adenovirus neutralization
antibody titers, molecular antibody characterization
(eg, avidity, Fc cell interaction, ADCC, ADCP,
antibody isotyping, antibody sequencing for
repertoire), including but not limited to
immunoglobulin (Ig)A and IgG, chemokines and
cytokines in serum, transcriptome analysis and
sequencing of the TCR and/or BCR or VH/VL
characterization, evaluation of the cellular immune
response and the functional and memory immune
response by ICS*, cellular phenotyping and
memory B-cell ELISpot*
 To further assess immune responses to the selected 
RSV.preF-based vaccine formulation (based on 
Cohort 1 and 2 results), the formulation to be used 
for future clinical development, and the current 
Ad26/protein preF RSV vaccine 
 Endpoints may include the following, but are not
limited to: RSV neutralization antibody titers, RSV
neutralization antibody titers against additional A
and/or B strains, F protein binding antibodies (pre-
F and/or post-F), and antigen-specific T-cell
responses*, anti-F protein antibody specificity and
functionality characterization, adenovirus
neutralization antibody titers, molecular antibody
characterization (eg, avidity, Fc cell interaction,
ADCC, ADCP, antibody isotyping, antibody
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
9
Status: Approved,  Date: 22 December 2021
Objectives 
Endpoints
sequencing for repertoire), including but not
limited to immunoglobulin (Ig)A and IgG,
chemokines and cytokines in serum, transcriptome
analysis and sequencing of the TCR and/or BCR or
VH/VL characterization, evaluation of the cellular
immune response and the functional and memory
immune response by ICS*, cellular phenotyping
and memory B-cell ELISpot*
* Only applicable for participants with blood draws for cellular responses.
REVACCINATION AND DURABILITY COHORT OBJECTIVE (COHORT 4): To assess durability of the
selected RSV.preF based vaccine, to determine the effect ofrevaccination; and to determine the safety and
immunogenicity of the selected formulation for future clinical development in a cohort of participants aged 60
years and older
Objectives 
Endpoints
PRIMARY
 To assess immune responses, including durability 
to the selected RSV.preF-based vaccine
formulation (formulation for future clinical
development)in groups with and without
revaccination
 RSV neutralization antibody titers
SECONDARY
 To assess the safety and reactogenicity of the 
selected RSV.preF-based vaccine formulation 
(formulation for future clinical development)
 SAEs and AESIs from first administration until
6 months after the last vaccination
 Solicited local and systemic AEs for 7 days after
each vaccine administration
 Unsolicited AEs from the time of each vaccine
administration through the following 28 days
EXPLORATORY
 Additional exploratory analyses may be performed 
to further investigate humoral and cellular 
vaccine-elicited immune responses to the selected 
RSV.preF-based 
vaccine 
formulation 
and 
durability  
 Endpoints may include the following, but are not
limited to: RSV neutralization antibody titers
against additional A and/or B strains, F protein
binding antibodies (pre-F and/or post-F), anti-F
protein antibody specificity and functionality
characterization, adenovirus neutralization
antibody titers, molecular antibody characterization
(eg, avidity, Fc cell interaction, ADCC, ADCP,
antibody isotyping, antibody sequencing for
repertoire), and nasal antibodies to RSV, including
but not limited to immunoglobulin (Ig)A and IgG,
chemokines and cytokines in serum and/or nasal
samples, transcriptome analysis and sequencing of
the TCR and/or BCR or VH/VL characterization
Hypothesis
No formal statistical testing of safety and immunogenicity data is planned.
Data will be analyzed descriptively.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
10
Status: Approved,  Date: 22 December 2021
OVERALL DESIGN
This is a multicenter, randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate safety and
immunogenicityof various Ad26.RSV.preF and/or RSV preF protein combinations followed by expanded
safety evaluation and durability/revaccination evaluation of the selected RSV.preF-based vaccine
formulation in participants aged≥60years in stable health.
The study design includes 4 cohorts: an initial dose escalation safety cohort (Cohort 1 in a total of
132 participants), an extension of Cohort 1 for vaccine components selection (Cohort 2 in a total of
528 participants), an expanded safety cohort (Cohort 3 in a total of 400 participants), and a
revaccination/durability cohort (Cohort 4 in a total of 540 participants). Data from Cohorts 1 and 2 will be
combined to select the components of the RSV.preF-based vaccine formulation to be used in Cohorts 3 and
4, and further clinical development.
The end of the study is defined as the last participant’s last visit.
An internal data review committee (DRC) will be commissioned for this study to evaluate safety and
reactogenicity data. If any of the pre-specified study vaccination pausing rules is met, further study
vaccination will be paused and a DRC meeting will be convened.
Initial Safety Cohort (Cohort 1)
In the initial safety cohort, participants will be randomized progressively to 1 of 4 groups with additional
safety checks in place in a sentinel subgroup before extending enrollment to the next group (Table 1).
Sentinel participants in the same group will be enrolled at the same site. Vaccine components evaluated in
Cohorts 1 and 2 will be administered as 2 IM injections of 1 mL in the same deltoid muscle.
 
Group 1: Initially, 4 sentinel participants will be enrolled: 2 participants in Arm 1a, 1 participant in
Arm 1b, and 1 participant in Arm 1c. (Note: The 2:1:1 distribution in the sentinel participants is applied
to facilitate further randomization). Enrollment will be paused to allow for 24-hour safety assessments
in these 4 sentinel participants by the principal investigator(s) (PI), the sponsor’s study responsible
physician/scientist (SRP/S), and the sponsor’s medical leader (ML). In the absence of any clinical
safety concerns over the 24-hour assessment, the remaining 14 participants will be randomized in a
5:1:1 ratio and vaccinated. Seven days after vaccination available safety data will be reviewed by the
PI(s), SRP/S, ML, and the sponsor’s medical safety officer (MSO) before proceeding to Group 2.
 
Group 2: Initially, 12 sentinel participants will be enrolled; 2 participants in Arms 2, 3, 4, 5, and 6;
1 participant in Arm 1b; and 1 participant in Arm 1c. (Note: The 2:2:2:2:2:1:1 distribution in the
sentinel participants is applied to facilitate further randomization). Enrollment will be paused to allow
for 24-hour safety assessments in the 12 sentinel participants by the PI(s), SRP/S, and ML. In the
absence of any clinical safety concerns over the 24-hour assessment, the remaining 54 participants will
be randomized in a 5:5:5:5:5:1:1 ratio and vaccinated. Seven days after vaccination, available safety
data will be reviewed by the PI(s), SRP/S, ML, and MSO before proceeding to Group 3.
 
Group 3: Initially, 6 sentinel participants will be enrolled; 2 participants in Arms 7 and 8; 1 participant
in Arm 1b; and 1 participant in Arm 1c. (Note: The 2:2:1:1 distribution in the sentinel participants is
applied to facilitate further randomization). Enrollment will be paused to allow for 24-hour safety
assessments in these 6 sentinel participants by the PI(s), SRP/S, and ML. In the absence of any clinical
safety concerns over the 24-hour assessment, the remaining 24 participants will be randomized in a
5:5:1:1 ratio and vaccinated. Seven days after vaccination, available safety data will be reviewed by
the PI(s), SRP/S, ML, and MSO before proceeding to Group 4.
 
Group 4: Initially, 4 sentinel participants will be enrolled; 2 participants in Arm 9; 1 participant in Arm
1b; and 1 participant in Arm 1c. (Note: The 2:1:1 distribution in the sentinel participants is applied to
facilitate further randomization). These sentinel participants will be dosed at least 1 hour apart.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
11
Status: Approved,  Date: 22 December 2021
Enrollment will be paused to allow 24-hour safety assessments in the 4 sentinel participants by the
PI(s), SRP/S, and ML. In the absence of any clinical safety concerns over the 24-hour assessment, the
remaining 14 participants will be randomized in a 5:1:1 ratio and vaccinated.
Sentinel participants will be contacted by telephone 24 hours post-vaccination to collect safety information.
Progression to Cohort 2 will be based on  acceptable safety in the initial safety cohort (Cohort 1), as
determined by DRC review of Day 8 safety data in all Cohort 1 participants. If there are clinically relevant
safety findings in any of the study arms in Cohort 1, further evaluation of these study arms will not be
continued in Cohort 2.
Table 1: 
Study Design: Initial Safety Cohort (Cohort 1)
Group  Arm  
N
Vaccine Components in 2×1 mL Formulation Day 1
Ad26.RSV-A.preF Ad26.RSV-B.preF2 RSV-A preF protein RSV-B preF protein 
Placebo
1 
1a 
12 
1×1011 vp 
150µg
1b 
3 
1×1011 vp 
150µg
1c 
3 
Placebo
2 
2 
12 
150µg 
150µg
3 
12 
2.5×1010 vp 
2.5×1010 vp 
150µg 
150µg
4 
12 
5×1010 vp 
5×1010 vp 
150µg 
150µg
5 
12 
1×1011 vp 
300µg
6 
12 
1×1011 vp 
150µg 
150µg
1b 
3 
1×1011 vp 
150µg
1c 
3 
Placebo
3
7 
12 
1×1011 vp 
5×1010 vp 
150µg 
150µg
8 
12 
1.5×1011 vp 
300µg
1b 
3 
1×1011 vp 
150µg
1c 
3 
Placebo
4 
9 
12 
1×1011 vp 
1×1011 vp 
150µg 
150µg
1b 
3 
1×1011 vp 
150µg
1c 
3 
Placebo
COHORT 1
TOTAL
132
N  number of participants; vp  virus particles
Vaccine Components Selection Cohort (Cohorts 1 and 2)
The safety and immunogenicity data obtained from Cohort 1 will be combined with those obtained in
Cohort 2 to support vaccine components selection. In Cohort 2, approximately 528 participants will be
randomized in parallel to 1 of 11 arms (in a 1:1:1:1:1:1:1:1:1:1:1 ratio to Arms 1a to 9; Table 2). No pauses
for safety assessments during enrollment are planned.
For a subset of the participants, additional cellular immunogenicity assessments will be performed. This
subset will be referred to as the Cellular Immuno Subset and will consist of approximately 50 active study
vaccine participants per arm (all participants in Cohort 1 and approximately 38 participants per arm in
Cohort 2). The Cellular Immuno Subset will be recruited in study sites that have PBMC collection
capability.
Participants in Cohorts 1 and 2 will continue follow-up up to 3 years post vaccination.
Based on safety and immunogenicity results available at the time of primary analysis, the sponsor will
decide on the optimal vaccine composition to be used in the expanded safety cohort (Cohort 3), the
revaccination/durability cohort (Cohort 4), and further clinical development. Additional factors such as
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
12
Status: Approved,  Date: 22 December 2021
manufacturability and ease of administration may be taken into account to select the optimal vaccine
formulation for the expanded safety phase.
Table 2: 
Study Design: Supporting Vaccine Components Selection Cohort (Cohort 2)
Arm  
N
Vaccine Components in 2×1 mL Formulation
Day 1
Ad26.RSV-A.preF Ad26.RSV-B.preF2 RSV-A preF protein 
RSV-B preF protein 
Placebo
1a 
48 
1×1011 vp 
150µg
1b 
48 
1×1011 vp 
150µg
1c 
48 
Placebo
2 
48 
150µg 
150µg
3 
48 
2.5×1010 vp 
2.5×1010 vp 
150µg 
150µg
4 
48 
5×1010 vp 
5×1010 vp 
150µg 
150µg
5 
48 
1×1011 vp 
300µg
6 
48 
1×1011 vp 
150µg 
150µg
7 
48 
1×1011 vp 
5×1010 vp 
150µg 
150µg
8 
48 
1.5×1011 vp 
300µg
9 
48 
1×1011 vp 
1×1011 vp 
150µg 
150µg
COHORT 2
TOTAL
528
N  number of participants; vp  virus particles
Notes: Data from Cohort 1 and Cohort 2 will be pooled for safety and immunogenicity analysis.
Expanded Safety Cohort (Cohort 3)
In the expanded safety cohort, approximately 400 participants will be randomized in parallel to 1 of5 arms
(in a 6:3:3:2:2 ratio to Arms 10, 11a, 11b, 12 and 13; Table 3). No pauses in enrollment for safety
assessments are planned. Participants will receive either the selected 2×1 mL formulation based on the
results from Cohorts 1 and 2, the selected 1mL formulation for future clinical development, placebo, or the
current Ad26/protein preF RSV vaccine (1×1011 vp Ad26.RSV-A.preF/150 µg RSV-A preF protein).
Vaccine components evaluated in Cohorts 1 and 2 will be administered as 2 IM injections of 1 mL in the
same deltoid muscle. However, once the optimal composition is selected, manufacturing formulation will
be adjusted to ensure the administration of a single 1 mL vaccine dose in subsequent cohorts. Participants
in Arms 11a and 11b will receive the selected vaccine in a 1 mL formulation and a second injection with
placebo (1 mL) for blinding purposes. Cohort 3 thus will compare the 2×1 mL formulation of the selected
combination of RSV vaccine components from Cohorts 1 and 2 (Arm 10) with the 1 mL formulation to be
used for future clinical development (Arms 11a and 11b) with follow-up for 1 year post-vaccination in a
double-blind placebo-controlled fashion. Participants in Arm 13 will receive the current Ad26/protein preF
RSV vaccine (1×1011 vp Ad26.RSV-A.preF/150 µg RSV-A preF protein) in a 1 mL formulation and a
second injection with placebo (1 mL) for blinding purposes. Participants in Arms 11a, 11b and 12 will
continue the study to assess durability and the effect of revaccination with follow-up up to 5 years post
first vaccination. The timing of revaccination (at least 12 months relative to the first dose) will be based on
Ad26/protein preF RSV vaccine clinical data.
For a subset of the participants, additional cellular immunogenicity assessments will be performed. This
subset will be referred to as the Cellular Immuno Subset and will consist of approximately 240 participants:
40 participants per arm in Arms 10, 12 and 13, and 60 participants per arm in Arms 11a and 11b. The
Cellular Immuno Subset will be recruited in study sites that have PBMC collection capability.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
13
Status: Approved,  Date: 22 December 2021
Table 3: 
Study Design: Expanded Safety Cohort (Cohort 3)
Arm  
N 
Day 1 
Day X*
10** 
150 Selected 2×1 mL formulation (based on 
Cohort 1 and 2 results)
-
11a 
75
Selected formulation for future clinical 
development (1 mL) + placebo (1 mL) 
Selected formulation for future clinical
development
11b 
75
Selected formulation for future clinical 
development (1 mL) + placebo (1 mL)
Placebo
12 
50 Placebo (2×1 mL)
Selected formulation for future clinical
development
13** 
50
1×1011 vp Ad26.RSV-A.preF/150 µg RSV-A 
preF protein (1 mL) + placebo (1 mL)
-
COHORT 3
TOTAL
400
*Timing of revaccination to be defined based on Ad26/protein preF RSV vaccine clinical data (Studies
VAC18193RSV1004, VAC18193RSV2001, and VAC18193RSV3001)
** Arms 10 and 13 will be completed after 1 year of follow-up
Revaccination and Durability Cohort (Cohort 4)
In the revaccination and durability cohort, approximately 540 participants will be randomized in parallel to
1 of3 arms (in a 5:5:2 ratio to Arms 14, 15 and 16; Table 4). No pauses in enrollment for safety assessments
are planned. Participants in Arms 14 and 15 will receive the selected formulation for future clinical
development on Day 1 and participants in Arm 16 will receive placebo on Day 1. Participants in Arm 14
(revaccination arm) and Arm 16 will receive the selected formulation at the same revaccination timepoint
as participants in Arm 11a and 12 of Cohort 3. Participants in Arm 15 will receive placebo at the same
revaccination timepoint as participants in Arm 11b of Cohort 3.
Table 4: 
Study Design: Revaccination and Durability Cohort (Cohort 4)
Arm  
N 
Day 1 
Day Xa
14 
225
Selected formulation for future clinical 
development 
Selected formulation for future clinical
development
15 
225
Selected formulation for future clinical 
development
Placebo
16 
90 Placebo
Selected formulation for future clinical
development
COHORT 4
TOTAL
540
a Timing of revaccination to be defined based on Ad26/protein preF RSV vaccine clinical data (Studies
VAC18193RSV1004, VAC18193RSV2001, and VAC18193RSV3001)
NUMBER OF PARTICIPANTS
A target of 1,600 participants will be enrolled in the study.
INTERVENTION GROUPS AND DURATION
Thestudydurationwillbe approximately 1,095 days (3 years) per participant in Cohorts 1 and 2; 365 days
(1 year) per participant in Cohort 3, Arms 10 and 13; and 5 years per participant in Cohort 3, Arms 11a,
11b, and 12 and Cohort 4. The study comprises a maximum 28-day screening period, administration of
study vaccine (active or placebo), a minimum 28-day follow-up period after vaccination, and a follow-up
period up to 3 years after vaccination for Cohorts 1 and 2; 1 year after vaccination for Cohort 3, Arms 10
and 13; and up to 5 years after the first vaccination for Cohort 3, Arms 11a, 11b and 12, and Cohort 4.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
14
Status: Approved,  Date: 22 December 2021
Study Vaccine Administration
The investigational medicinal products (IMPs) to be administered to participants in this study are
Ad26/protein preF RSV vaccine, Ad26.RSV-B.preF2 mixed with RSV-B preF protein, RSV-A preF protein
mixed with RSV-B preF protein, Ad26/protein preF RSV vaccine mixed with RSV-B preF protein,
Ad26/protein preF RSV vaccine mixed with Ad26.RSV-B.preF2 and RSV-B preF protein. All IMPs will
be administered IM into the deltoid muscle:
 Ad26.RSV-A.preF (JNJ-64400141) will be used at a dose level of 2.5×1010 vp, 5×1010 vp, 1×1011 vp,
or 1.5×1011 vp.
 RSV-A preF protein (JNJ-64213175) will be used at a dose level of 150 μg or 300 μg.
 Ad26.RSV-B.preF2 (JNJ-86051823) will be used at a dose level of 2.5×1010 vp, 5×1010 vp or
1×1011 vp.
 RSV-B preF protein (JNJ-78991172) will be used at a dose level of 150 μg.
Placebo will be 0.9% saline.
IMMUNOGENICITY EVALUATIONS
Blood samples will be collected for the determination of immune responses.
Possible immunogenicity evaluations may include (but are not limited to) the assays summarized in the
table below:
Assay 
Purpose
Primary Endpoints*
RSV neutralization assay  
Analysis of neutralizing antibodies against the RSV A2 strain
Analysis of neutralizing antibodies against an RSV B strain
Secondary Endpoints
F protein antibodies 
(ELISA; pre-F and/or post-F) 
Analysis of antibodies binding to RSV F protein in prefusion and/or
post-fusion form
IFN-γ ELISpot**  
T-cell IFN-γ responses to RSV F proteinpeptides
Exploratory Endpoints
RSV neutralization assay  
Analysis of neutralizing antibodies against additional A and/or
B strains
F protein antibody specificity 
characterization  
Pre- and post-F specificity by binding or functional assays as ELISA,
and/or competition ELISA. Adsorption of serum or plasma with pre-
F and post-F protein before any antibody assay, epitope mapping,
functional VNAs
G and/or N protein antibodies (ELISA) 
Analysis of antibodies binding to RSV G and/or N protein
Adenovirus neutralization assay  
Analysis of neutralizing antibodies to adenovirus
Functional and molecular antibody 
characterization  
Analysis of antibody characteristics may include, but not limited to,
ADCC, ADCP, avidity, Fc cell interaction, other respiratory viral
neutralizing or binding assays, Ig isotype, and antibody assessments
for antibody repertoire
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
15
Status: Approved,  Date: 22 December 2021
ICS and/or cellular phenotyping and/or
cellular function characterization**
Analysis of T-cell responses to RSV F proteinpeptide-stimulated
PBMCs (including, but not limited to, CD4+/CD8+, IL-2, IFN-γ,
TNF-α, activation markers and memory markers), cellular
phenotyping by extracellular markers for several immune cells
including but not limited to B-cells and T-cells, and B-cell memory
ELISpot for B-cell memory formation analysis
Transcriptome analysis 
Regulation of genes (clusters), expression patterns, that for example
could predict specific immune responses after vaccination
Chemokine/cytokine analysis 
Levels of chemokines and cytokines in serum
Sequencing ofT-cells and/or B-cells 
Including but not limited to sequencing of TCR and BCR including
VH/VL (heavy/light chain) characterization
* Analysis of neutralizing antibodies against the RSV A2 and RSV B strain is a primary endpoint in the vaccine components
selection cohort (Cohorts 1 and 2)and in the revaccination and durability cohort (Cohort 4), and a secondary endpoint in the
expanded safety cohort objective (Cohort 3).
** Only applicable for participants with blood draws for cellular responses.
ADCC: antibody dependent cell mediated cytotoxicity; ADCP: antibody dependent cell mediated phagocytosis; BCR: B cell
receptor; ELISA: enzyme linked immunosorbent assay; ELISpot: enzyme linked immunospot; F: fusion; ICS: intracellular
cytokine staining; IFN γ: interferon gamma; IL 2: interleukin 2, Ig: immunoglobulin; PBMC: peripheral blood mononuclear cell;
RSV: respiratory syncytial virus; TCR: T cell receptor; VH: heavy chain variable domain; VL: light chain variable domain;
VNA: virus neutralizing antibody
SAFETY EVALUATIONS
Key safety assessments will include the monitoring of AEs, vital signs, physical examinations (all cohorts),
and safety laboratory assessments (Cohorts 1 and 2 only).
AEs and special reporting situations, whether serious or non-serious, that are related to study procedures or
that are related to non-investigational sponsor products will be reported from the time a signed and dated
informed consent form (ICF) is obtained until the end of the study/early withdrawal. Solicited AEs,
collected through a participant diary, will be recorded for each vaccination from the time of vaccination
until 7 days post-vaccination.
All other unsolicited AEs and special reporting situations, whether serious or non-serious, will be reported
for each vaccination from the time of vaccination until 28 days post-vaccination. All SAEs and AEs leading
to discontinuation from the study (regardless of the causal relationship) and all AESIs are to be reported
from the moment of vaccination until 6 months post vaccination. All COVID-19 cases will be collected for
all participants for the duration of the study. All AEs will be followed until resolution or until clinically
stable.
STATISTICAL METHODS
Sample Size Determination
For Cohort 1, a sample size of 12 participants per arm is considered sufficient for an initial safety evaluation.
For Cohort 2, the objective is to compare immunomarker levels, including virus neutralizing antibody
(VNA) levels, of the various combinations of vaccine components (Arms 1a, and Arms 2 to 9) to Arm 1b
(1×1011 vp Ad26.RSV-A.preF/150 µg RSV-A preF protein), based on the estimated geometric mean titer
(GMT) ratios and corresponding 95% confidence intervals (CIs). With a sample size of 55 evaluable
participants per arm, and assuming a standard deviation for RSV-A2 VNA of 1.3a on the log2 scale, the
a Based on Day 29 VNA results from study VAC18193RSV1004: Cohort 2, Groups 14+17 and Cohort 3,
Groups 19+20
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
16
Status: Approved,  Date: 22 December 2021
precision of the estimated GMTs will be ~0.36 on the log2 scale. To account for approximately 10%
dropout, a sample size of 60 participants per arm will be used. The table below shows the estimated 95%
CIs for several GMT ratios, assuming a standard deviation for RSV-A2 VNA of 1.3 on the log2 scale for
55 participants for immunogenicity evaluation per arm.
Note: Per arm, immunogenicity data from the initial safety cohort (Cohort 1) will be combined with those
from Cohort 2 to support vaccine components selection, as applicable.
N per Arm  
Observed GMT Ratio 
Corresponding 95% CI
55 
1 
[0.71; 1.41]
1.2 
[0.85; 1.69]
1.5 
[1.07; 2.11]
CI = confidence interval; GMT = geometric mean titer; N = number of participants.
The expanded safety cohort (Cohort 3) should provide sufficient safety data on the selected vaccine
formulation to support late-stage development if the immunogenicity results of Cohort 2 are satisfactory.
The revaccination and durability cohort (Cohort 4) should provide sufficient data on the selected vaccine
formulation to support future clinical development. To have approximately 150 participants available per
arm for evaluating durability of immune response at end of the 5-year study period, and assuming a dropout
rate of 10% per year, approximately 300 participants per arm are needed.
Corresponding arms of Cohort 3 and 4 will be combined (Arm 11a [Cohort 3] + Arm 14 [Cohort 4], and
Arm 11b [Cohort 3] + Arm 15 [Cohort 4], respectively) for the evaluation of durability of the immune
response. Having 75 participants in Arm 11a and 11b in Cohort 3 requires enrollment of 225 participants
in Arms 14 and 15 in Cohort 4. Enrollment of 90 participants in Arm 16 (placebo) results in enrollment of
in total 540 participants in Cohort 4. Placebo arms from Cohort 3 and 4, Arm 12 and Arm 16, respectively,
will be combined in the analyses, as applicable.
Populations for Analysis Sets
The Full Analysis (FA) Set will include all participants who received the study vaccine, regardless of the
occurrence of protocol deviations. All safety and participant information analyses will be based on the FA
Set.
The Per-protocol Immunogenicity (PPI) Set will include all randomized participants who received the
planned study vaccine(s) and for whom immunogenicity data are available. Samples taken after a
participant experiences a major protocol deviation expected to impact the immunogenicity outcomes will
be excluded from the PPI analysis.
The analysis of all immunogenicity endpoints will be based on the PPI Set. For key tables, sensitivity
immunogenicity analyses might also be performed on the FA Set.
Immunogenicity Analyses
Continuous variables will be summarized descriptively. For continuous parameters, descriptive statistics of
the actual values will be calculated at all timepoints, including geometric mean with 95% CI, median and
quartiles, as applicable. Additionally, geometric mean fold rises from baseline and corresponding 95% CIs
might be calculated. For combined primary endpoint data of Cohort 1 and Cohort 2, geometric mean ratios
between each active arm and Arm 1b will be calculated at all available timepoints, with corresponding 95%
CI, as applicable. For Cohort 3, Arms 11a and 11b will be combined and the active arms will be compared
to each other at all available timepoints up to 1 year after vaccination on Day 1, by means of geometric
mean ratios with corresponding 95% CI. For durability and revaccination evaluation Arm 11a (Cohort 3)
and Arm 14 (Cohort 4) will be combined, Arm 11b (Cohort 3) and Arm 15 (Cohort 4) will be combined,
and Arm 12 (Cohort 3) and Arm 16 (Cohort 4) will be combined. For immunogenicity analyses, baseline
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
17
Status: Approved,  Date: 22 December 2021
is considered as the last assessment pre-vaccination. Graphical representations of immunologic parameters
will be made as applicable.
Geometric means per arm, and geometric mean ratios between active arms, with corresponding 95% CIs
will be estimated via an analysis of variance (ANOVA) including all active arms, using log-transformed
post-vaccination immune parameter response as dependent variable and study arm as independent variable.
The means and differences in mean and CIs will be back-transformed (by exponentiation) to CIs around a
GMT or geometric mean titer ratio (GMR). This analysis will be performed for all available assays and all
time points, separately  per assay. Data of the same arms form different cohorts will be combined, as
applicable.
As a sensitivity analysis, the ANOVA may also be performed adjusting for the respective baseline titers,
by including baseline titer as additional covariate.
For categorical variables, frequency tables will be presented.
Safety Analyses
No formal statistical testing of safety data is planned. Safety data will be analyzed descriptively by cohort
and study arm, and by group (pooled over cohorts, as applicable). All safety analyses will be made on the
FA Set.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
18
Status: Approved,  Date: 22 December 2021
1.2. 
Schema
Figure 1: 
Schematic Overview of the Study for Cohorts 1 and 2
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
19
Status: Approved,  Date: 22 December 2021
Figure 2: 
Schematic Overview of the Study for Cohort 3, Arms 10 and 13
* Safety only visits will be by telephone.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
20
Status: Approved,  Date: 22 December 2021
Figure 3: 
Schematic Overview of the Study for the Revaccination/Durability Cohorts: Cohort 3 (Arms
11a, 11b and 12) and Cohort 4
* Safety only visits will be by telephone.
** Timing of revaccination to be defined based on Ad26/protein preF RSV vaccine clinical data (Studies
VAC18193RSV1004, VAC18193RSV2001, and VAC18193RSV3001)
NCT05327816


NCT05327816


NCT05327816


NCT05327816


NCT05327816


NCT05327816


NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
27
Status: Approved,  Date: 22 December 2021
Table footnotes for all cohorts:
a. 
For visits more than 3 months apart, sites will be encouraged to make quarterly phone calls prior to the indicated visit timing to ensure participant engagement.
b. 
Safety only visits will be by telephone (Cohorts 3 and 4).
c. 
An early exit visit will be conducted as soon as possible for those participants who are unable to continue participation in the study, for whom consent is not
withdrawn. Participants who wish to withdraw consent from participation in the study will be offered an early exit visit (prior to formal withdrawal of consent).
d. 
In addition, sentinel participants will be contacted by telephone 24 hours post-dose to collect safety information.
e. 
Signing of the ICF should be done before any study-related activity.
f. 
Medical history of all participants will be recorded in the eCRF, including whether each condition places the participant at increased risk for severe RSV disease.
The conditions placing a participant at increased risk of severe RSV disease include congestive heart failure, coronary artery disease (such as angina pectoris,
ischemic cardiomyopathy, history of myocardial infarct, or history of coronary artery bypass graft or coronary artery stent), and chronic lung disease (such as
asthma and chronic obstructive pulmonary disease). Baseline information on risk factors for thrombosis and/or thrombocytopenia should also be recorded, as well
as history of past COVID-19 infection.
g. 
Prestudy therapies administered up to 30 days pre-vaccination must be recorded on Day 1.
h. 
A physical examination, including height and body weight, will be carried out at on Day 1. At all other visits, an abbreviated, symptom-directed examination will
be performed if deemed necessary by the investigator based on any clinically relevant issues, clinically relevant symptoms, and medical history.
i. 
Sitting systolic and diastolic blood pressure, heart rate, and respiratory rate after at least 5 minutes rest on Day 1. At non-vaccination visits, vital signs will be
measured if deemed necessary by the investigator.
j. 
Investigator must check for clinically significant acute illness at the time of vaccination or body temperature of ≥38.0°C (≥100.4ºF) within 24 hours prior to the
planned time of vaccination. In such cases, the participant may be vaccinated up to, and no later than 10 days after the scheduled vaccination, or be withdrawn at
the discretion of the investigator.
k. 
Blood sample volumes are approximate. Refer to the laboratory manual for additional details.
l. 
Aliquots of serums samples collected for immunogenicity test can be reconverted for participant’s safety purposes upon sponsor request. Please refer to
Appendix 2 for a non-exhaustive list oftests that will be requested on these sample in case of potential AESI reporting.
m. Blood for humoral immune responses will be drawn from all participants. Blood for cellular immune responses will be drawn from a subset of participants (from
Cohorts 1, 2, and 3; not applicable to Cohort 4).
n. 
Based on results available at the time of primary analysis, the sponsor will decide which arms will continue with blood sampling for cellular immune responses
beyond 6 months post vaccination in Cohorts 1 and 2.
o. 
After vaccination, participants will remain under observation at the study site for at least 30 minutes for presence of any acute reactions and solicited events. Any
unsolicited AEs, solicited local (injection site) or systemic AEs, and vital signs (sitting systolic and diastolic blood pressure, heart rate, and respiratory rate after at
least 5 minutes rest, and body temperature) will be documented by the study site personnel following this observation period.
p. 
All (S)AEs and special reporting situations related to study procedures or to non-investigational (concomitant) Janssen products will be collected from ICF
signature onwards until the end of the study for all participants. All other SAEs and AESIs will be collected from administration of study vaccine (Day 1) until
6 months after the last study vaccination. AEs leading to discontinuation from vaccination and/or study will be collected for the duration of the study.
q. 
AESIs, including potential AESIs, are to be reported from the moment of vaccination until 6 months after the last study vaccination.
r. 
Concomitant therapies will be collected from the time of study vaccination through 28 days post-vaccination when associated with an AE, and from ICF signature
until 6 months after the last study vaccination when associated with an SAE or AESI.
s. 
Any history of SARS-CoV-2 vaccination (name/manufacturer of the vaccine and date of administration, whenever possible) prior to and during the study will be
collected in the eCRF.
t. 
All COVID-19 cases will be collected for all participants for the duration of the study. COVID-19 cases reported by the participant will be reported in the eCRF by
the investigator.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
28
Status: Approved,  Date: 22 December 2021
u. 
Rulers and thermometers will be distributed at these visits.
v. 
Participants will be contacted by telephone 2 to 4 days post-vaccination to remind them to fill in the participant diaries and to check that they are entering
information correctly.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
29
Status: Approved,  Date: 22 December 2021
2. 
INTRODUCTION
The respiratory syncytial virus (RSV) vaccine that will be investigated in the current study is a
combination of adenovirus type 26 (Ad26)-based and/or preF protein-based vaccine components
derived from RSV A and B subtypes, administered as intramuscular (IM) injections:
 
Ad26.RSV.preF (JNJ-64400141; referred to in this document as Ad26.RSV-A.preF), a
replication-incompetent Ad26 containing a deoxyribonucleic acid (DNA) transgene that
encodes the prefusion conformation-stabilized F protein derived from the RSV A subtype.
 
Ad26.RSV-B.preF2 (JNJ-86051823), a replication-incompetent Ad26 containing a DNA
transgene that encodes the prefusion conformation-stabilized F protein derived from the RSV
B subtype.
 
RSV preF protein (JNJ-64213175; referred to in this document as RSV-A preF protein) is a
prefusion conformation-stabilized F protein derived from the RSV A subtype.
 
RSV-B preF protein (JNJ-78991172) is a prefusion conformation-stabilized F protein derived
from the RSV B subtype.
A combination of Ad26.RSV-A.preF and RSV-A preF protein, referred to as Ad26/protein preF
RSV vaccine, was shown to be efficacious against RSV-A and RSV-B in preventing RSV-
mediated lower respiratory tract disease (LRTD) in humans in the ongoing Phase 2b study
VAC18193RSV2001. The efficacy of the Ad26/protein preF RSV vaccine will be further
evaluated in an ongoing Phase 3 study (VAC18193RSV3001). The current study will be the first-
in-human (FIH) study for Ad26.RSV-B.preF2, RSV-B preF protein, the Ad26.RSV-
B.preF2/RSV-B preF protein combination, and the various combinations of RSV-A and RSV-B
components. After initial safety assessments, the study will continue with vaccine components and
dose selection followed by expanded safety evaluation and evaluation of durability of immune
responses of the selected vaccine formulation and the effect ofrevaccination.
Both Ad26.RSV-B.preF2 and RSV-B preF protein have been evaluated in nonclinical
pharmacology studies that have shown improved humoral immune responses and protective
efficacy against circulating RSV B strains compared with the Ad26.RSV-A.preF and RSV-A preF
protein components, respectively, in rodent models.
For the most comprehensive nonclinical and clinical information regarding Ad26.RSV-A.preF and
RSV-A preF protein, refer to the latest version of the Investigator's Brochure (IB)and Addenda (if
applicable) (IB Ad26/protein preF RSV vaccine 2021).
For the most comprehensive nonclinical and clinical information regarding Ad26.RSV-B.preF2
and RSV-B preF protein, refer to the latest version of the IB  and addenda (if applicable)
(IB VAC18195 2021).
A briefsummary ofthe clinical information available at the time ofprotocol writing is provided
below.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
30
Status: Approved,  Date: 22 December 2021
The term “study vaccine” throughout the protocol, refers to Ad26.RSV-A.preF, RSV-A preF
protein, Ad26.RSV-B.preF2, RSV-B preF protein, or placebo as defined in Section 6.1.
The term "sponsor" used throughout this document refers to the entities listed in the Contact
Information page(s), which will be provided as a separate document.
2.1. 
Study Rationale
Study VAC18193RSV2001 showed that the Ad26/protein preF RSV vaccine could prevent RSV-
mediated LRTD with 80% efficacy. 
 Two strategies to improve protection against RSV B subtypes will be explored in the
current study: 1) increase the dose of the Ad26/protein preF RSV vaccine; 2) introduce additional
components based on the preF protein of the RSV B subtype (Ad26.RSV-B.preF2 and/or RSV-B
preF protein). This RSV-B F protein is based on the consensus sequence of RSV B subtype
sequences present in the public database. Following these 2 strategies, various combinations of
vaccine components will be evaluated in this study.
This study is designed to evaluate the safety and immunogenicity of different formulations of
RSV.preF-based vaccines in adults aged 60 years and older, to select the optimal dose based on
safety and immunogenicity data, and to assess durability of immune responses of the selected
vaccine formulation as well as the effect of revaccination. The RSV.preF-based vaccines to be
evaluated in the current study include various combinations of 2 or more of the following
components: Ad26.RSV-A.preF, Ad26.RSV-B.preF2, RSV-A preF protein and RSV-B preF
protein. The details on the combinations of RSV vaccine components to be evaluated in each group
are described in Section 4.
2.2. 
Background
RSV is a negative-sense, single stranded RNA virus that belongs to the family of Paramyxoviridae.
RSV is traditionally classified into 2 subtypes, RSV A and RSV B, which diverged approximately
350 years ago and are mainly based on antigenic variations in the RSV G protein (Pandya 2019).
Adults infected with RSV usually experience mild, cold-like symptoms of upper respiratory tract
infection and recover within 2 weeks. However, infection can progress to severe LRTD causing
substantial morbidity and mortality in vulnerable populations, such as adults with underlying
comorbidities and the elderly, ie, aged 60 years and older. In long-term care facilities, RSV is
estimated to infect 5% to 10% of the residents per year with significant rates of pneumonia (10%
to 20%) and death (2% to 5%) (Falsey 2000). In one epidemiology study of RSV burden, it was
estimated that 11,000 elderly persons die annually of RSV in the United States (Thompson 2003).
Despite this high disease burden, there are currently no licensed preventive vaccines against RSV
infection.
To address this unmet medical need, the sponsor is developing the Ad26/protein preF RSV vaccine
for use in adults, which is currently in clinical evaluation. This vaccine contains the combination
CCI
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
31
Status: Approved,  Date: 22 December 2021
of an Ad26 viral vector expressing the RSV A2 preF protein (Ad26.RSV-A.preF) and the preF
protein of RSV A2 (RSV-A preF protein). The F protein is highly similar between RSV A and B
subtypes and its prefusion form has been shown to be immunogenic (Sullender 2000, Williams
2020). Antibodies against preF protein have also been suggested as correlates of protection for
RSV (Mazur 2019). Results showed that the vaccine containing Ad26.RSV-A.preF and RSV-
A preF protein components has a favorable reactogenicity profile as well as induced durable
humoral and cellular immune responses (IB Ad26/protein preF RSV vaccine 2021). In a currently
ongoing Phase 2b clinical study (VAC18193RSV2001), this vaccine has been shown to prevent
RSV-mediated LRTD due to both RSV A and B infection. However, further exploratory analyses
suggested that the observed VE against RSV B subtypes was lower compared to VE against RSV
A subtypes. In case these findings would be confirmed in larger studies, there might be opportunity
to identify possibilities to improve the VE of the current vaccine against RSV B subtypes.
Nonclinical Studies
For the most comprehensive nonclinical information regarding the Ad26/protein preF RSV
vaccine, refer to the latest version of the IB and addenda (if applicable) (IB Ad26/protein preF
RSV vaccine 2021).
For the most comprehensive nonclinical information regarding Ad26.RSV-B.preF2 and RSV-B
preF protein, refer to the latest version of the IB and addenda (if applicable) (IB VAC18195 2021).
Clinical Studies
The immunological benefit of combining Ad26.RSV-A.preF with RSV-A preF protein was first
shown in study VAC18193RSV1004. A significant increase in virus neutralizing titers was
observed at 28 days post-dose 1 in the groups combining Ad26.RSV-A.preF and RSV-A preF
protein compared to Ad26.RSV-A.preF 1×1011 viral particles (vp) alone. Based on this study, the
current Ad26/protein preF RSV vaccine, based on the RSV-A subtype, at a dose level of
1×1011 vp/150 µg was selected for future clinical development.
The Ad26/protein preF RSV vaccine is currently being evaluated in studyVAC18193RSV2001, a
multicenter, randomized, double-blind, placebo-controlled Phase 2b proof-of-concept efficacy
study in ~5,800 participants aged ≥65 years, with and without comorbidities. The study was
designed to demonstrate efficacy of the Ad26.RSV.preF/ RSV preF protein  vaccine
(1×1011 vp/150µg) for at least 1 of the 3 case definitions of RSV-mediated LRTD. The primary
analysis after the end of the first RSV season showed high, statistically significant VE against
RSV-mediated LRTD for all case definitions, ranging from 80% for the most severe endpoint (case
definition #1) to 69.8% for the mildest endpoint (case definition #3). The vaccine was safe and
well tolerated. Study VAC18193RSV2001 is currently ongoing to evaluate the duration of
protection beyond the first season and immune responses after revaccination in a subset of
participants. Additionally, the Ad26/protein preF RSV vaccine is also being evaluated in study
VAC18193RSV3001, a multicenter, randomized, double-blind, placebo-controlled Phase 3
efficacy study in participants aged 60 years and older, with or without comorbidities.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
32
Status: Approved,  Date: 22 December 2021
The Ad26/protein preF RSV vaccine was also evaluated in study VAC18193RSV2005, an
ongoing, multicenter, randomized, double-blind, placebo-controlled Phase 2a study to explore the
dose-response relationship, safety, and immunogenicity of a range of dose levels of the
Ad26.RSV.preF component in the Ad26/protein preF RSV vaccine in participants aged 60 years
and older who are in stable health, with and without comorbidities. The primary analysis has been
completed. All Ad26.RSV.preF dose levels evaluated in the study, ranging from 3.7×109 vp to
1.6×1011 vp, in combination with the 150 µg dose of RSV preF protein evaluated in this study
showed comparable vaccine induced humoral and cellular immune responses and an acceptable
safety and reactogenicity profile.
For the most comprehensive clinical information regarding the Ad26/protein preF RSV vaccine,
refer to the latest version of the IB and addenda (if applicable) (IB Ad26/protein preF RSV vaccine
2021).
This will be the first-in-human study to collect clinical information regarding Ad26.RSV-B.preF2,
RSV-B preF protein, the Ad26.RSV-B.preF2/RSV-B preF protein combination, or the various
combinations of RSV A and RSV B components.
Clinical Safety Experience with Ad26-based Vaccines
Safety data of Ad26-vectored vaccines from the Adenoviral Vaccine Safety Database V6.0 (cut-
off date: 31 December 2020) (AdVac Safety Database 2021), including vaccines against Ebola
virus (Ad26.ZEBOV), HIV (Ad26.ENVA.01, Ad26.Mos.HIV, and Ad26.Mos4.HIV), malaria
(Ad26.CS.01), RSV (Ad26.RSV.FA2 and Ad26.RSV.preF), filovirus (Ad26.Filo), Zika virus
(Ad26.ZIKV.001), and HPV (Ad26.HPV16 and Ad26.HPV18) have been evaluated in adults.
Studies with Ad26.COV2.S (COVID-19 vaccine program) were still blinded at the cut-off date
and therefore only blinded SAE data and blinded pregnancy data from the Janssen Global Safety
Database were included in the AdVac Safety Database.
No significant safety issues have been identified from the data available in the current adenoviral
vaccine safety database. Overall, the Ad26-based vaccines were well tolerated, without significant
safety issues identified.
Thrombosis With Thrombocytopenia Syndrome
In the context of worldwide vaccination following Emergency Use Authorization (EUA),
conditional licensure, or approval by health authorities, thrombosis in combination with
thrombocytopenia (thrombosis with thrombocytopenia syndrome [TTS]), in some cases
accompanied by internal bleeding, has been observed following vaccination with the Janssen
COVID-19 (Ad26.COV2.S) vaccine. As of 31 August 2021, out of 33,584,049 doses of
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
33
Status: Approved,  Date: 22 December 2021
Ad26.COV2.S administered post-marketing, the following spontaneous reported/solicited reports
of probable TTS cases were identified. a
 
A total of 104 post-marketing events that met the Brighton TTS Case Definition Criteria
Level 1 to 3 (Brighton Collaboration 2021). This corresponds to a reporting ratio of 3.1 per
million doses overall.
 
A total of 67 post-marketing events that met the CDC TTS Case Definition Criteria Tier 1 to 2
(Shimabukuro 2021). This corresponds to a reporting ratio 2 per million doses overall.
Reports include severe cases of venous thrombosis at unusual sites such as cerebral venous sinus
thrombosis (CVST), splanchnic vein thrombosis and arterial thrombosis, in combination with
thrombocytopenia. Venous thrombosis cases have also been reported at more common sites, eg,
in the lower extremities. The onset of associated symptoms has usually been 1 to 4 weeks, but
sometimes even later following vaccination. TTS cases have been reported mostly in women under
60 years of age although some cases of TTS have also been reported in men and in individuals
older than 60 years of age. Thrombosis in combination with thrombocytopenia has been fatal in
some cases. The exact pathophysiology of TTS is unclear. This event has not been observed to
date with any other Janssen Ad26-based vaccines. Participants should be instructed to seek
immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg
pain or leg swelling, persistent abdominal pain, severe or persistent headaches, blurred vision, skin
bruising and/or petechiae beyond the site of vaccination, changes in mental status or the occurrence
of seizures.
2.3. 
Benefit-Risk Assessment
More detailed information about the known and expected benefits and risks of Ad26.RSV-A.preF
and RSV-A preF protein may be found in the IB and addenda (if applicable) (IB Ad26/protein
preF RSV vaccine 2021).
More detailed information about the known and expected benefits and risks of Ad26.RSV-B.preF2
and RSV-B preF protein may be found in the IB and addenda (ifapplicable)(IB VAC18195 2021).
2.3.1. 
Risks for Study Participation
The following potential risks for the Ad26/protein preF RSV vaccine will be monitored during the
study:
Risks Related to Ad26/protein preF RSV Vaccine
The Ad26/protein preF RSV vaccine is currently being studied in 4 ongoing studies in more than
6,500 participants aged 60 years and older, including participants with comorbidities, to assess
safety and immunogenicity and to investigate whether the vaccine prevents RSV disease. In these
studies, the most commonly reported solicited local adverse events (AEs) were injection site
a Probable TTS is defined as a thrombotic/thromboembolic event reported in combination with a low platelet count
[thrombocytopenia]
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
34
Status: Approved,  Date: 22 December 2021
pain/tenderness and swelling (mild to moderate). The most frequently reported solicited systemic
AEs were fatigue, muscle pain, headache, chills, joint pain, and nausea, which were mild to
moderate in severity. These solicited AEs were short-lived and resolved within a few days. Overall,
available results from these studies show the vaccine to be well-tolerated with no safety concerns.
Risks Related to RSV-B Components
This study will be the FIH study for Ad26.RSV-B.preF2, RSV-B preF protein, and the various
combinations of RSV A and RSV B components. No clinical data are available to date.
For the most comprehensive nonclinical information regarding Ad26.RSV-B.preF2 and RSV-B
preF protein, refer to the latest version of the Investigator’s Brochure (IB VAC18195 2021).
General Risks Related to Vaccination
In general, IM injection may cause local itching, warmth, pain, tenderness, erythema/redness,
induration, swelling, arm discomfort, or bruising of the skin. Participants may exhibit general signs
and symptoms associated with IM injection of a vaccine, including fever, chills, rash, myalgia,
nausea/vomiting, headache, dizziness, arthralgia, general itching, and fatigue. These side effects
will be monitored, but are generally short-term and do not require treatment.
Syncope can occur in association with  administration of injectable vaccines. Syncope can be
accompanied by falls. Procedures should be in place to avoid falling injury. If syncope develops,
participants should be observed until the symptoms resolve. Fear of injection might lead to fainting
and fast breathing.
Participants may have an allergic reaction to the vaccination. An allergic reaction may cause a
rash, urticaria, or even anaphylaxis. Severe reactions are rare. Participants with a known or
suspected allergy, or with a history of anaphylaxis or other serious adverse reactions to vaccines
or vaccine excipients (specifically the excipients of the study vaccine), will be excluded from the
study.
After vaccination, participants will remain at the study site for at least 30 minutes and will be
closely observed by study staff. Necessary emergency equipment and medications must be
available in the clinic to treat severe allergic reactions.
Pregnancy and Birth Control
The effect of the study vaccine on a fetus or nursing baby is unknown. Participants may therefore
only participate if they are postmenopausal (defined as no menses for 12 months without an
alternative medical cause) and not intending to conceive by any methods. Participants who are
surgically sterile are also eligible for the study. Follow-up information regarding the outcome of
the pregnancy will be required.
Because the effect on sperm is unknown, participants must inform the study-site personnel if their
partner becomes pregnant during the study. Follow-up information regarding the outcome of the
pregnancy will be requested upon the consent provided by the partner.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
35
Status: Approved,  Date: 22 December 2021
Participants with Immunosuppression/Reduced Immune Response
Participants with abnormal function of the immune system will be excluded from the study.
Limited evidence indicates that inactivated vaccines (or nonreplicating viral vaccines) generally
have the same safety profile in immunocompromised patients as in immunocompetent individuals.
However, the magnitude, breadth, and persistence of the immune response to vaccination may be
reduced or absent in immunocompromised persons.
Risks from Blood Draws
Blood draws may cause pain, tenderness, bruising, bleeding, dizziness, vasovagal response,
syncope, and rarely, infection at the site where the blood is taken. Participants with
contraindications to IM injections and blood draws (eg, bleeding disorders) will be excluded.
Risks from Genetic Testing
Genetic test results could indicate risks for certain diseases, which could potentially lead to
discrimination or other problems for the participant. However, the results are for exploratory
research purposes only and will not be provided to the participant.
Concomitant Vaccination
Concomitant vaccination might have an influence on both the safety profile and immunogenicity
of the Ad26/protein preF RSV vaccine. Likewise, the Ad26/protein preF RSV vaccine might have
an influence on both the safety profile and immunogenicity of any concomitant vaccination. As a
result, licensed live attenuated vaccines should be given at least 28 days before or after vaccination.
Other licensed (not live) vaccines (eg, influenza, tetanus, hepatitis A, hepatitis B, rabies) should
be given at least 14 days before or after vaccination to avoid potential confusion of adverse
reactions and potential immune interference. If a vaccine is indicated in a postexposure setting (eg,
rabies or tetanus), it must take priority over the study vaccine.
For Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) vaccines licensed or
available under Emergency Use Authorization: live attenuated vaccines should be given at least
28 days before or after vaccination; non-live vaccines should be given at least 14 days before or
after vaccination. A viral-vectored SARS-CoV-2 vaccine is not to be given within 6 months prior
to randomization or during the study period until 28 days after study vaccination.
Unknown Risks
There may be other risks that are not known. If any significant new risks are identified, the
investigators and participants will be informed.
2.3.2. 
Benefits for Study Participation
Participants may benefit from clinical testing and physical examination.
The clinical benefits of the Ad26/protein preF RSV vaccine have yet to be confirmed.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
36
Status: Approved,  Date: 22 December 2021
The Ad26/protein preF RSV vaccine (combination of Ad26.RSV-A.preF and RSV-A preF protein)
is under development for prophylaxis of RSV disease and vaccine efficacy is being evaluated in
ongoing studies. Results from the primary analysis of study VAC18193RSV2001 with
approximately 5,800 participants showed the potential for the vaccine to prevent lower respiratory
tract disease caused by RSV in participants 65 years and older.
This study will be the FIH study for Ad26.RSV-B.preF2, RSV-B preF protein, and the various
combinations of RSV A and RSV B components. No clinical data are available to date.
2.3.3. 
Benefit-Risk Assessment for Study Participation
Based on the available data and proposed safety measures, the overall benefit-risk assessment for
this clinical study is considered acceptable for the following reasons:
 
The dose levels of Ad26.RSV-A.preF and RSV-A preF protein used in the current study were
determined from the primary analysis of Cohort 2 in study VAC18193RSV1004 and are
currently under further evaluation in studies VAC18193RSV1004, VAC18193RSV2001 and
VAC18193RSV3001. Additional dose levels of Ad26.RSV.preF were evaluated in studies
VAC18193RSV1004 and VAC18193RSV2005. The available safety data from all studies
show the vaccine to be well-tolerated with no safety concerns. For details on the justification
for dose levels selected for this study, see Section 4.3. In the primary analysis of study
VAC18193RSV2001, vaccine efficacy was demonstrated for the 1×1011 vp/150 µg dose level
in adults aged 65 years and above, for the prevention of LRTD caused by RSV.
 
Only participants who meet all inclusion criteria and none of the exclusion criteria (specified
in Section 5) will be allowed to participate in this study. The selection criteria include adequate
provisions to minimize the risk and protect the well-being of participants in the study.
 
Safety will be closely monitored throughout the study:
 
In general, safety evaluations will be performed at scheduled visits during the study, as
indicated in the Schedule of Activities.
 
After each vaccination, participants will remain at the study site for at least 30 minutes
and will be closely observed by study staff. Necessary emergency equipment and
medications must be available in the clinic to treat severe allergic reactions. Participants
will use a participant diary to document solicited signs and symptoms. Details are
provided in Section 8.2.
 
The investigator or the designee will document unsolicited AEs, SAEs, and AESIs as
indicated in Sections 8.2 and 8.3 and Appendix 4.
 
Any clinically significant abnormalities will be followed by the investigator until
resolution or until clinically stable.
 
After vaccination, participants will enter a 6-month safety follow-up period for collection
of SAEs and AESIs.
 
All AEs, SAEs, and AESIs will be followed by the investigator until clinical resolution
or until a clinically stable condition is reached, or until the participant has been deemed
lost to follow-up after demonstration of due diligence of follow-up efforts. An early exit
visit will be conducted for those participants who are unable to continue participation in
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
37
Status: Approved,  Date: 22 December 2021
the study and withdraw from the study before the end of the study, but who do not
withdraw consent. Participants who wish to withdraw consent from participation in the
study will be offered an early exit visit (prior to formal withdrawal of consent) (Section
7.2).
 
Several safety measures are included in this protocol to minimize the potential risk to
participants, including the following:
 
Clinical laboratory assessments will be performed at screening. Details are provided in
Section 10.2, Appendix 2, Clinical Laboratory Tests.
 
In Cohort 1, sentinel participants will be evaluated for safety before extending enrollment
to the next group. In Group 4, the sentinel participants will be dosed at least 1 hour apart.
A telephone call will be made to each of the sentinel participants on Day 2 (approximately
24 hours post-vaccination) to collect safety data. The blinded 24-hour post-vaccination
safety data in these sentinel participants will be reviewed by the principal investigator
(PI) and sponsor’s study responsible physician/scientist (SRP/S). Randomization and
vaccination of additional participants will be halted until this 24-hour sentinel safety
evaluation is completed. Refer to Section 4.1 for further details.
 
Prior to progression to Cohort 2, an internal DRC will review blindeda Day 8 safety data
following administration of the first vaccination to all Cohort 1 participants. Refer to
Section 4.1 for further details.
 
There are pre-specified rules for all participants, that if met would result in pausing of
further vaccinations, preventing exposure of new participants to study vaccine until the
Data Review Committee (DRC) reviews all safety data (see Committee Structure in
Appendix 3).
 
Study vaccinations will be discontinued in participants for the reasons described in
Section 7.1.
 
Temporary contraindications to study vaccination are described in Section 5.5.
3. 
OBJECTIVES AND ENDPOINTS
The current study has an adaptive design to determine a combination of vaccine components for
further clinical development in adults aged ≥60 years based on safety and immunogenicity. The
selected RSV.preF-based vaccine formulation  should improve immune responses to RSV B
subtypes with no adverse effect on immune responses to RSV A subtypes compared to the
Ad26/protein preF RSV vaccine.
a The DRC will review blinded data first but may review unblinded data if deemed necessary.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
38
Status: Approved,  Date: 22 December 2021
INITIAL SAFETY COHORT OBJECTIVE (COHORT 1): To determine in small numbers of participants aged
60 years and older the safety of a vaccine formulation comprising a combination of Ad26.RSVA.preF and/or
Ad26.RSVB.preF2 and/or RSVA preF and/or RSVB preF proteins before progression to vaccine components
selection in a larger number of participants for further assessment ofthe safety and immunogenicity
Objectives 
Endpoints
PRIMARY
 To assess the safety and reactogenicity of various 
combinations of RSV vaccine components 
 Serious adverse events (SAEs) and adverse events
of special interest (AESIs) from first dose
administration until 6 months after vaccination
 Solicited local and systemic adverse events (AEs)
for 7 days after vaccine administration
 Unsolicited AEs from the time of vaccine
administration through the following 28 days
VACCINE COMPONENTS SELECTION OBJECTIVE (COHORTS 1 and 2): To select an optimal RSV.preF
based vaccine based on assessment of the safety and immunogenicity in participants aged 60 years and older
receiving a vaccine formulation comprising a combination of Ad26.RSVA.preF and/or Ad26.RSVB.preF2 and/or
RSVA preF and/or RSVB preF proteins.
Objectives 
Endpoints
PRIMARY
 To assess the safety and reactogenicity of 
various combinations of RSV vaccine 
components 
 SAEs and AESIs from first dose administration until
6 months after vaccination
 Solicited local and systemic AEs for 7 days after
vaccine administration
 Unsolicited AEs from the time of vaccine
administration through the following 28 days
 To assess humoral immune responses elicited 
by various combinations of RSV vaccine
components
 RSV neutralization antibody titers
SECONDARY
 To assess humoral and cellular immune 
responses elicited by various combinations of 
RSV 
vaccine 
components 
using 
other
immunological assays
 F protein binding antibodies (pre-F and/or post-F),
and antigen-specific T-cell responses*
EXPLORATORY
 To further explore vaccine-elicited immune 
responses after single vaccination with various 
combinations of RSV vaccine components 
 
Exploratory endpoints may include the following, but
are not limited to: RSV neutralization antibody titers
against additional A and/or B strains, anti-F protein
antibody specificity and functionality characterization,
adenovirus neutralization antibody titers, molecular
antibody characterization (eg, avidity, Fc cell
interaction, 
antibody-dependent 
cell-mediated
cytotoxicity 
[ADCC], 
antibody-dependent 
cell-
mediated phagocytosis [ADCP], antibody isotyping,
antibody sequencing for repertoire), including but not
limited to immunoglobulin (Ig)A and IgG, chemokines
and cytokines in serum samples, transcriptome analysis
and sequencing of the T-cell receptor (TCR) and/or B-
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
39
Status: Approved,  Date: 22 December 2021
Objectives 
Endpoints
cell receptor (BCR) or heavy/light chain (VH/VL)
characterization, evaluation of the cellular immune
response and the functional and memory immune
response by intracellular cytokine staining (ICS)*,
cellular phenotyping and memory B-cell ELISpot*
 To assess the durability of the immune 
response in selected groups 
 Endpoints may include the following, but are not
limited to: RSV neutralization antibody titers against
RSV subtype A and B, RSV neutralization antibody
titers against additional A and/or B strains, RSV F
protein binding antibodies (pre-F and/or post-F),
antigen-specific T-cell responses*, anti-F protein
antibody specificity and functionality characterization,
adenovirus neutralization antibody titers, molecular
antibody characterization (eg, avidity, Fc cell
interaction, ADCC, ADCP, antibody isotyping,
antibody sequencing for repertoire), including but not
limited to immunoglobulin (Ig)A and IgG, chemokines
and cytokines in serum, transcriptome analysis and
sequencing of the TCR and/or BCR or VH/VL
characterization, evaluation of the cellular immune
response and the functional and memory immune
response by ICS*, cellular phenotyping and memory
B-cell ELISpot*
* Only applicable for participants with blood draws for cellular responses.
EXPANDED SAFETY COHORT OBJECTIVE (COHORT 3): To determine the safety and immunogenicity of the
selected RSV.preF based vaccine in an expanded cohort of participants aged 60 years and older, comparing the
formulation of the selected combination of RSV vaccine components (2x1mL formulation, based on Cohort 1 and 2
results) and the formulation to be used for future clinical development (1x1mL formulation); and to assess
durability of the selected RSV.preF based vaccine and determine the effect of revaccination.
Objectives 
Endpoints
PRIMARY
 To assess the safety and reactogenicity of the 
selected RSV.preF-based vaccine formulation 
(based on Cohort 1 and 2 results), compared to
the formulation to be used for future clinical
development
 SAEs and AESIs from first administration until
6 months after the last vaccination
 Solicited local and systemic AEs for 7 days after
each vaccine administration
 Unsolicited AEs from the time of each vaccine
administration through the following 28 days
SECONDARY
 To assess immune responses to the selected 
RSV.preF-based vaccine formulation (based on
Cohort 1 and 2 results), compared to the
formulation to be used for future clinical
development
 RSV neutralization antibody titers
 To assess the durability of the immune response 
to the selected RSV.preF-based vaccine
formulation in groups with and without
revaccination
 RSV neutralization antibody titers
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
40
Status: Approved,  Date: 22 December 2021
Objectives 
Endpoints
EXPLORATORY
 Additional exploratory analyses may be performed
to further investigate humoral and cellular
vaccine-elicited immune responses to the selected
RSV.preF-based 
vaccine 
formulation  
and
durability
 Endpoints may include the following, but are not
limited to: RSV neutralization antibody titers
against additional A and/or B strains, F protein
binding antibodies (pre-F and/or post-F), and
antigen-specific T-cell responses*, anti-F protein
antibody specificity and functionality
characterization, adenovirus neutralization
antibody titers, molecular antibody characterization
(eg, avidity, Fc cell interaction, ADCC, ADCP,
antibody isotyping, antibody sequencing for
repertoire), including but not limited to
immunoglobulin (Ig)A and IgG, chemokines and
cytokines in serum, transcriptome analysis and
sequencing of the TCR and/or BCR or VH/VL
characterization, evaluation of the cellular immune
response and the functional and memory immune
response by ICS*, cellular phenotyping and
memory B-cell ELISpot*
 To further assess immune responses to the selected
RSV.preF-based vaccine formulation (based on
Cohort 1 and 2 results), the formulation to be used
for future clinical development, and the current
Ad26/protein preF RSV vaccine
 Endpoints may include the following, but are not
limited to: RSV neutralization antibody titers, RSV
neutralization antibody titers against additional A
and/or B strains, F protein binding antibodies (pre-
F and/or post-F), and antigen-specific T-cell
responses*, anti-F protein antibody specificity and
functionality characterization, adenovirus
neutralization antibody titers, molecular antibody
characterization (eg, avidity, Fc cell interaction,
ADCC, ADCP, antibody isotyping, antibody
sequencing for repertoire), including but not
limited to immunoglobulin (Ig)A and IgG,
chemokines and cytokines in serum, transcriptome
analysis and sequencing of the TCR and/or BCR or
VH/VL characterization, evaluation of the cellular
immune response and the functional and memory
immune response by ICS*, cellular phenotyping
and memory B-cell ELISpot*
* Only applicable for participants with blood draws for cellular responses.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
41
Status: Approved,  Date: 22 December 2021
REVACCINATION AND DURABILITY COHORT OBJECTIVE (COHORT 4): To assess durability of the
selected RSV.preF based vaccine, to determine the effect of revaccination; and to determine the safety and
immunogenicity of the selected formulation for future clinical development in a cohort of participants aged 60
years and older
Objectives 
Endpoints
PRIMARY
 To assess immune responses, including durability 
to the selected RSV.preF-based vaccine
formulation (formulation for future clinical
development)in groups with and without
revaccination
 RSV neutralization antibody titers
SECONDARY
 To assess the safety and reactogenicity of the 
selected RSV.preF-based vaccine formulation 
(formulation for future clinical development)
 SAEs and AESIs from first administration until
6 months after the last vaccination
 Solicited local and systemic AEs for 7 days after
each vaccine administration
 Unsolicited AEs from the time of each vaccine
administration through the following 28 days
EXPLORATORY
 Additional exploratory analyses may be performed 
to further investigate humoral and cellular 
vaccine-elicited immune responses to the selected 
RSV.preF-based 
vaccine 
formulation 
and 
durability  
 Endpoints may include the following, but are not
limited to: RSV neutralization antibody titers
against additional A and/or B strains, F protein
binding antibodies (pre-F and/or post-F), anti-F
protein antibody specificity and functionality
characterization, adenovirus neutralization
antibody titers, molecular antibody characterization
(eg, avidity, Fc cell interaction, ADCC, ADCP,
antibody isotyping, antibody sequencing for
repertoire), and nasal antibodies to RSV, including
but not limited to immunoglobulin (Ig)A and IgG,
chemokines and cytokines in serum and/or nasal
samples, transcriptome analysis and sequencing of
the TCR and/or BCR or VH/VL characterization
Refer to Section 8 for evaluations related to endpoints.
HYPOTHESIS
No formal statistical testing of safety and immunogenicity data is planned.
Data will be analyzed descriptively.
4. 
STUDY DESIGN
4.1. 
Overall Design
This is a multicenter, randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate
safety and immunogenicity of various Ad26.RSV.preF and/or RSV preF protein combinations
followed by expanded safety evaluation and durability/revaccination evaluation of the selected
RSV.preF-based vaccine formulation in participants aged≥60 years in stable health.
The study design includes 4 cohorts: an initial dose escalation safety cohort (Cohort 1 in a total of
132 participants), an extension of Cohort 1 for vaccine components selection (Cohort 2 in a total
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
42
Status: Approved,  Date: 22 December 2021
of 528 participants), an expanded safety cohort (Cohort 3 in a total of 400 participants), and a
revaccination/durability cohort (Cohort 4 in a total of 540 participants). Data from Cohorts 1 and
2 will be combined to select the components of the RSV.preF-based vaccine formulation to be
used in Cohorts 3 and 4, and further clinical development. Overall, the total number of participants
will be approximately1,600.
The studydurationwill be approximately 1,095 days (3 years) per participant in Cohorts 1 and 2;
365 days (1 year) per participant in Cohort 3, Arms 10 and 13; and 5 years per participant in
Cohort 3, Arms 11a, 11b, and 12 and Cohort 4. The study comprises a maximum 28-day screening
period, administration of study vaccine (active or placebo), a minimum 28-day follow-up period
after vaccination, and a follow-up period up to 3 years after vaccination for Cohorts 1 and 2; 1 year
after vaccination for Cohort 3, Arms 10 and 13; and up to 5 years after the first vaccination for
Cohort 3, Arms 11a, 11b and 12, and Cohort 4. The end of the study is defined as the last
participant’s last visit.
After vaccination with study vaccine on Day 1, participants will remain under observation at the
study site for at least 30 minutes for presence of any acute reactions and solicited events. Any
unsolicited AEs, solicited local (injection site) or systemic AEs, and vital signs (sitting systolic
and diastolic blood pressure, heart rate, respiratory rate, and body temperature) will be documented
by study site personnel following this observation period. In addition, participants will record
temperature and solicited signs and symptoms in a participant diary beginning on the evening of
the day of vaccination and on a daily basis for 7 days post-vaccination.
Blood will be collected from all participants to assess immune responses pre-vaccination and at
the timepoints indicated in the Schedule of Activities.
An internal DRC will be commissioned for this study to evaluate safety and reactogenicity data.
If any of the pre-specified study vaccination pausing rules is met, further study vaccination will be
paused and a DRC meeting will be convened (See Section 6.9). Refer to Committees Structure in
Appendix 3.
Initial Safety Cohort (Cohort 1)
In the initial safety cohort, participants will be randomized progressively to 1 of 4 groups with
additional safety checks in place in a sentinel subgroup before extending enrollment to the next
group (Table 5). Sentinel participants in the same group will be enrolled at the same site. Vaccine
components evaluated in Cohorts 1 and 2 will be administered as 2 IM injections of 1 mL in the
same deltoid muscle.
 
Group 1: Initially, 4 sentinel participants will be enrolled: 2 participants in Arm 1a,
1 participant in Arm 1b, and 1 participant in Arm 1c. (Note: The 2:1:1 distribution in the
sentinel participants is applied to facilitate further randomization). Enrollment will be paused
to allow for 24-hour safety assessments in these 4 sentinel participants by the principal
investigator(s) (PI), the sponsor’s study responsible physician/scientist (SRP/S), and the
sponsor’s medical leader (ML). In the absence of any clinical safety concerns over the 24-
hour assessment, the remaining 14 participants will be randomized in a 5:1:1 ratio and
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
43
Status: Approved,  Date: 22 December 2021
vaccinated. Seven days after vaccination available safety data will be reviewed by the PI(s),
SRP/S, ML, and the sponsor’s medical safety officer (MSO) before proceeding to Group 2.
 
Group 2: Initially, 12 sentinel participants will be enrolled; 2 participants in Arms 2, 3, 4, 5,
and 6; 1 participant in Arm 1b; and 1 participant in Arm 1c. (Note: The 2:2:2:2:2:1:1
distribution in the sentinel participants is applied to facilitate further randomization).
Enrollment will be paused to allow for 24-hour safety assessments in the 12 sentinel
participants by the PI(s), SRP/S, and ML. In the absence of any clinical safety concerns over
the 24-hour assessment, the remaining 54 participants will be randomized in a 5:5:5:5:5:1:1
ratio and vaccinated. Seven days after vaccination, available safety data will be reviewed by
the PI(s), SRP/S, ML, and MSO before proceeding to Group 3.
 
Group 3: Initially, 6 sentinel participants will be enrolled; 2 participants in Arms 7 and 8;
1 participant in Arm 1b; and 1 participant in Arm 1c. (Note: The 2:2:1:1 distribution in the
sentinel participants is applied to facilitate further randomization). Enrollment will be paused
to allow for 24-hour safety assessments in these 6 sentinel participants by the PI(s), SRP/S,
and ML. In the absence of any clinical safety concerns over the 24-hour assessment, the
remaining 24 participants will be randomized in a 5:5:1:1 ratio and vaccinated. Seven days
after vaccination, available safety data will be reviewed by the PI(s), SRP/S, ML, and MSO
before proceeding to Group 4.
 
Group 4: Initially, 4 sentinel participants will be enrolled; 2 participants in Arm 9;
1 participant in Arm 1b; and 1 participant in Arm 1c. (Note: The 2:1:1 distribution in the
sentinel participants is applied to facilitate further randomization). These sentinel participants
will be dosed at least 1 hour apart. Enrollment will be paused to allow 24-hour safety
assessments in the 4 sentinel participants by the PI(s), SRP/S, and ML. In the absence of any
clinical safety concerns over the 24-hour assessment, the remaining 14 participants will be
randomized in a 5:1:1 ratio and vaccinated.
Sentinel participants will be contacted by telephone 24 hours post-vaccination to collect safety
information.
Progression to Cohort 2 will be based on acceptable safety in the initial safety cohort (Cohort 1),
as determined by DRC review of Day 8 safety data in all Cohort 1 participants. If there are
clinically relevant safety findings in any of the study arms in Cohort 1, further evaluation of these
study arms will not be continued in Cohort 2.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
44
Status: Approved,  Date: 22 December 2021
Table 5: 
Study Design: Initial Safety Cohort (Cohort 1)
Group  Arm  
N
Vaccine Components 2×1 mL Formulation Day 1
Ad26.RSV-A.preF Ad26.RSV-B.preF2 RSV-A preF protein RSV-B preF protein 
Placebo
1 
1a 
12 
1×1011 vp 
150µg
1b 
3 
1×1011 vp 
150µg
1c 
3 
Placebo
2 
2 
12 
150µg 
150µg
3 
12 
2.5×1010 vp 
2.5×1010 vp 
150µg 
150µg
4 
12 
5×1010 vp 
5×1010 vp 
150µg 
150µg
5 
12 
1×1011 vp 
300µg
6 
12 
1×1011 vp 
150µg 
150µg
1b 
3 
1×1011 vp 
150µg
1c 
3 
Placebo
3
7 
12 
1×1011 vp 
5×1010 vp 
150µg 
150µg
8 
12
1.5×1011 vp 
300µg
1b 
3 
1×1011 vp 
150µg
1c 
3 
Placebo
4 
9 
12 
1×1011 vp 
1×1011 vp 
150µg 
150µg
1b 
3 
1×1011 vp 
150µg
1c 
3 
Placebo
COHORT 1
TOTAL
132
N  number of participants; vp  virus particles
Vaccine Components Selection Cohort (Cohorts 1 and 2)
The safety and immunogenicity data obtained from Cohort 1 will be combined with those obtained
in Cohort 2 to support vaccine components selection. In Cohort 2, approximately 528 participants
will be randomized in parallel to 1 of 11 arms (in a 1:1:1:1:1:1:1:1:1:1:1 ratio to Arms 1a to 9;
Table 6). No pauses for safety assessments during enrollment are planned.
For a subset of the participants, additional cellular immunogenicity assessments will be performed.
This subset will be referred to as the Cellular Immuno Subset and will consist of approximately
50 active study vaccine participants per arm (all participants in Cohort 1 and approximately 38
participants per arm in Cohort 2). The Cellular Immuno Subset will be recruited in study sites that
have PBMC collection capability.
Participants in Cohorts 1 and 2 will continue follow-up up to 3 years post vaccination.
Based on safety and immunogenicity results available at the time of primary analysis, the sponsor
will decide on the optimal vaccine composition to be used in the expanded safety cohort
(Cohort 3), the revaccination/durability cohort (Cohort 4), and further clinical development.
Additional factors such as manufacturability and ease ofadministration may be taken into account
to select the optimal vaccine formulation for the expanded safety phase.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
45
Status: Approved,  Date: 22 December 2021
Table 6: 
Study Design: Supporting Vaccine Components Selection Cohort (Cohort 2)
Arm  
N
Vaccine Components in 2×1 mL Formulation Day 1
Ad26.RSV-A.preF Ad26.RSV-B.preF2 RSV-A preF protein 
RSV-B preF protein 
Placebo
1a 
48 
1×1011 vp 
150µg
1b 
48 
1×1011 vp 
150µg
1c 
48 
Placebo
2 
48 
150µg 
150µg
3 
48 
2.5×1010 vp 
2.5×1010 vp 
150µg 
150µg
4 
48 
5×1010 vp 
5×1010 vp 
150µg 
150µg
5 
48 
1×1011 vp 
300µg
6 
48 
1×1011 vp 
150µg 
150µg
7 
48 
1×1011 vp 
5×1010 vp 
150µg 
150µg
8 
48 
1.5×1011 vp 
300µg
9 
48 
1×1011 vp 
1×1011 vp 
150µg 
150µg
COHORT 2
TOTAL
528
N  number of participants; vp  virus particles
Notes: Data from Cohort 1 and Cohort 2 will be pooled for safety and immunogenicity analysis.
Expanded Safety Cohort (Cohort 3)
In the expanded safety cohort, approximately 400 participants will be randomized in parallel to
1 of5 arms (in a 6:3:3:2:2 ratio to Arms 10, 11a, 11b, 12, and 13; Table 7). No pauses in enrollment
for safety assessments are planned. Participants will receive either the selected 2×1 mL
formulation based on the results from Cohorts 1 and 2, the selected 1 mL formulation for future
clinical development, placebo, or the current Ad26/protein preF RSV vaccine (1×1011 vp
Ad26.RSV-A.preF/150 µg RSV-A preF protein).
Vaccine components evaluated in Cohorts 1 and 2 will be administered as 2 IM injections of 1 mL
in the same deltoid muscle. However, once the optimal composition is selected, manufacturing
formulation will be adjusted to ensure the administration of a single 1 mL vaccine dose in
subsequent cohorts. Participants in Arms 11a and 11b will receive the selected vaccine in a 1 mL
formulation and a second injection with placebo (1 mL) for blinding purposes. Cohort 3 thus will
compare the 2×1 mL formulation of the selected combination of RSV vaccine components from
Cohorts 1 and 2 (Arm 10) with the 1 mL formulation to be used for future clinical development
(Arms 11a and 11b) with follow-up for 1 year post-vaccination in a double-blind placebo-
controlled fashion. Participants in Arm 13 will receive the current Ad26/protein preF RSV vaccine
(1×1011 vp Ad26.RSV-A.preF/150 µg RSV-A preF protein) in a 1 mL formulation and a second
injection with placebo (1 mL) for blinding purposes. Participants in Arms 11a, 11b and 12 will
continue the study to assess durability and the effect ofrevaccination with follow-up up to 5 years
post first vaccination. The timing of revaccination (at least 12 months relative to the first dose)
will be based onAd26/protein preF RSV vaccine clinical data.
For a subset of the participants, additional cellular immunogenicity assessments will be performed.
This subset will be referred to as the Cellular Immuno Subset and will consist of approximately
240 participants: 40 participants per arm in Arms 10, 12 and 13, and 60 participants per arm in
Arms 11a and 11b. The Cellular Immuno Subset will be recruited in study sites that have PBMC
collection capability.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
46
Status: Approved,  Date: 22 December 2021
Table 7: 
Study Design: Expanded Safety Cohort (Cohort 3)
Arm  
N 
Day 1 
Day X*
10** 
150 Selected 2×1 mL formulation (based on 
Cohort 1 and 2 results)
-
11a 
75
Selected formulation for future clinical 
development (1 mL) + placebo (1 mL) 
Selected formulation for future clinical
development
11b 
75
Selected formulation for future clinical 
development (1 mL) + placebo (1 mL)
Placebo
12 
50 Placebo (2×1 mL)
Selected formulation for future clinical
development
13** 
50
1×1011 vp Ad26.RSV-A.preF/150 µg RSV-A 
preF protein (1 mL) + placebo (1 mL)
-
COHORT 3
TOTAL
400
*Timing of revaccination to be defined based on Ad26/protein preF RSV vaccine clinical data (Studies
VAC18193RSV1004, VAC18193RSV2001, and VAC18193RSV3001)
** Arms 10 and 13 will be completed after 1 year of follow-up
Revaccination and Durability Cohort (Cohort 4)
In the revaccination and durability cohort, approximately 540 participants will be randomized in
parallel to 1 of3 arms (in a 5:5:2 ratio to Arms 14, 15 and 16; Table 8). No pauses in enrollment
for safety assessments are planned. Participants in Arms 14  and 15 will receive the selected
formulation for future clinical development on Day 1 and participants in Arm 16 will receive
placebo on Day 1. Participants in Arm 14 (revaccination arm) and Arm 16 will receive the selected
formulation at the same revaccination timepoint as participants in Arm 11a and 12 of Cohort 3.
Participants in Arm 15 will receive placebo at the same revaccination timepoint as participants in
Arm 11b of Cohort 3.
Table 8: 
Study Design: Revaccination and Durability Cohort (Cohort 4)
Arm  
N 
Day 1 
Day Xa
14 
225
Selected formulation for future clinical 
development 
Selected formulation for future clinical
development
15 
225
Selected formulation for future clinical 
development
Placebo
16 
90 Placebo
Selected formulation for future clinical
development
COHORT 4
TOTAL
540
a Timing of revaccination to be defined based on Ad26/protein preF RSV vaccine clinical data (Studies
VAC18193RSV1004, VAC18193RSV2001, and VAC18193RSV3001)
A diagram of the study design is provided in Section 1.2, Schema.
4.2. 
Scientific Rationale for Study Design
For the study rationale, refer to Section 2.1.
Dose Selection
The rationale behind the selection of the doses is described in Section 4.3, Justification for Dose.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
47
Status: Approved,  Date: 22 December 2021
Blinding, Control, Study Phase/Periods, Intervention Groups
A placebo control will be used to establish the frequency and magnitude of changes in endpoints
that may occur in the absence of active vaccine. Randomization will be used to minimize bias in
the assignment of participants to vaccination groups, to increase the likelihood that known and
unknown participant attributes (eg, demographic and baseline characteristics) are evenly balanced
across vaccination groups, and to enhance the validity of statistical comparisons across vaccination
groups. Blinded intervention  will be used to reduce potential bias during data collection and
evaluation of endpoints.
Biomarker Collection
For all participants, additional biomarker analysis may be performed to explore potentially
informative biomarkers related to vaccine-elicited immune responses.
4.2.1. 
Study-Specific Ethical Design Considerations
Potential participants will be fully informed of the risks and requirements of the study and, during
the study, participants will be given any new information that may affect their decision to continue
participation. They will be told that their consent to participate in the study is voluntary and may
be withdrawn at any time with no reason given and without penalty or loss of benefits to which
they would otherwise be entitled. Only participants who are fully able to understand the risks,
benefits, and potential AEs of the study, and provide their consent voluntarily will be enrolled.
Written consent/assent may be obtained through various sources (eg, paper or electronic such as
eConsent, eSignature, or digital signature) as determined by regulations as well as study and/or
patient preferences.
The primary ethical concern is that this study will be performed in adult participants who will
receive no benefit from participation in the study, except for compensation for the time and
inconveniences that may arise from participation in the study.
See Section 2.3 for Benefit-Risk Assessment.
The total blood volume to be collected is considered to be an acceptable amount of blood to be
collected over this time period from the population in this study based upon the standard of the US
Department of Health and Human Services Office for Human Research Protections, and US FDA
guidelines of 550 mL in any 8-week period (OHRP 1998; FDA 1998).
The results of this study may be made available to all participants through a plain language
summary at the conclusion of the study according to local standards/restrictions.
4.3. 
Justification for Dose
Ad26.RSV-A.preF at dose levels of 5×1010 vp and 1×1011 vp (Phase 1/2a study
VAC18193RSV1004), and at dose levels of 1×1011 vp, 1.3×1011 vp, and 1.6×1011 vp (Phase 2a
study VAC18193RSV2005), combined with RSV-A preF protein showed an acceptable safety and
reactogenicity profile in a population aged 60 years and older. Ad26.RSV-A.preF administered
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
48
Status: Approved,  Date: 22 December 2021
alone at dose levels of 5×1010 vp and1×1011 vp and RSV-A preF protein administered alone at a
dose level of 150 μg has also been evaluated in study VAC18193RSV1004 and did not reveal any
safety concerns. The Ad26/protein preF RSV vaccine containing a combination of 1×1011 vp
Ad26.RSV-A.preF and 150 μg RSV-A preF protein has been evaluated in the Phase 2b study
VAC18193RSV2001 and showed efficacy in preventing RSV-mediated LRTD.
Based on encouraging nonclinical immunogenicity and efficacy data, and available clinical data
on the reactogenicity, immunogenicity, and efficacy of Ad26.RSV-A.preF and RSV-A preF
protein, a range of vaccine formulations including Ad26.RSV-B.preF2 and RSV-B preF protein
components was selected to be evaluated in the current study. As RSV preF protein at a dose level
of 300 μg and Ad26 up to a dose level of 2×1011 vp will be evaluated for the first time in the current
study, the safety and reactogenicity profile will be monitored closely. These dose levels have been
evaluated in a nonclinical toxicity study and were shown to be well tolerated with no adverse
vaccine-related findings observed.
4.4. 
End of Study Definition
End of Study Definition
The end of study is considered as the last visit or contact for the last participant in the study. The
final data from the study site will be sent to the sponsor (or designee) after completion of the final
participant’s assessment at that study site, in the time frame specified in the clinical trial agreement.
Participant Study Completion Definition
A participant will be considered to have completed the study if the participant has completed
assessments at the Month 12 visit (Cohort 3, Arms 10 and 13), Month 36 visit (Cohort 1 and 2) or
Month 60 visit (Cohort 3, Arms 11a, 11b, 12, and Cohort 4).
5. 
STUDYPOPULATION
Screening for eligible participants will be performed within 28 days before administration of the
study vaccine.a Refer to Section 5.4 for conditions under which the repeat of any screening
procedures are allowed.
The inclusion and exclusion criteria for enrolling participants in this study are described below. If
there is a question about these criteria, the investigator must consult with the appropriate sponsor
representative and resolve any issues before enrolling a participant in the study. Waivers are not
allowed.
For a discussion of the statistical considerations of participant selection, refer to Section 9.2.
a If screening is performed on the day of vaccination (recommended), Visit 1 and Visit 2 will coincide on Day 1. In
that case, assessments should only be done once. Screening must be completed and all eligibility criteria must be
fulfilled prior to randomization and vaccination.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
49
Status: Approved,  Date: 22 December 2021
5.1. 
Inclusion Criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1. 
must sign an informed consent form (ICF) indicating that the participant understands
the purpose, procedures, and potential risks and benefits of the study, and is willing to
participate in the study.
2. 
willing and able to adhere to the prohibitions and restrictions specified in this protocol.
3. 
aged 60 years or older on the day of signing the ICF and expected to be available for
the duration of the study.
4. 
before randomization, a participant must be:
 
postmenopausal (postmenopausal state is defined as no menses for 12 months
without an alternative medical cause); and
 
not intending to conceive by any methods.
Note: Surgically sterile participants are also eligible for the study.
5. 
in the investigator’s clinical judgment, participant must be in stable health at the time
of vaccination. Participants may have underlying illnesses such as hypertension,
congestive heart failure, COPD, Type 2 diabetes mellitus, hyperlipoproteinemia, or
hypothyroidism, as long as their symptoms and signs are stable at the time of
vaccination, and these conditions receive routine follow-up by the participant’s
healthcare provider. Participants will be included on the basis of physical examination,
medical history, and vital signsa performed between ICF signature and vaccination.
6. 
For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of
clinical laboratory tests performed at screening. If the results of the laboratory screening
tests are outside the laboratory normal reference ranges and additionally within the
limits of toxicity Grade 2 according to the US FDA toxicity tables (ie, for tests in the
FDA tableb), the participant may be included only if the investigator judges the
abnormalities or deviations from normal to be not clinically significant and appropriate
and reasonable for the population under study. This determination must be recorded in
the participant’s source documents and initialed by the investigator.
Note: If laboratory screening tests are out of laboratory normal ranges and deemed
clinically significant, repeat of screening tests is permitted once, using an unscheduled
visit during the screening period to assess eligibility. Screening laboratory tests are to
be done within 28 days of randomization.
a Participants can be enrolled with Grade 1 or Grade 2 values for vital signs measurements (refer to Appendix 6).
b For the FDA toxicity grading tables, refer to Appendix 6.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
50
Status: Approved,  Date: 22 December 2021
7. 
agrees not to donate blood from the time of vaccination through 3 months after
vaccination.
8. 
must be willing to provide verifiable identification, has means to be contacted and to
contact the investigator during the study.
5.2. 
Exclusion Criteria
Any potential participant who meets any of the following criteria will be excluded from
participating in the study:
1. 
history of malignancy within 5 years before screening not in the following
categories:
a. Participants with squamous and basal cell carcinomas of the skin and carcinoma
in situ of the cervix may be enrolled at the discretion of the investigator.
b. Participants with a history of malignancy within 5 years before screening, with
minimal risk of recurrence per investigator’s judgment, can be enrolled.
2. 
known or suspected allergy or history of anaphylaxis or other serious adverse
reactions to vaccines or vaccine components (including any of the constituents of the
study vaccine) (IB Ad26/protein preF RSV vaccine 2021, IB VAC18195 2021).
Note: participants with egg allergies can be enrolled.
3. 
abnormal function of the immune system resulting from:
a. Clinical conditions (eg, autoimmune disease or immunodeficiency) expected to
have an impact on the immune response elicited by the study vaccine.
Participants with autoimmune disease (eg, autoimmune-mediated thyroid
disease, autoimmune inflammatory rheumatic disease such as rheumatoid
arthritis, and Type 1 diabetes) that is stable and inactive without the use of
systemic immunomodulators and glucocorticoids may be enrolled at the
discretion of the investigator.
b. Chronic or recurrent use of systemic corticosteroids within 2 months before
administration of study vaccine and during the study. A substantially
immunosuppressive steroid dose is considered to be ≥2 weeks of daily receipt of
20 mg of prednisone or equivalent.
Note: Ocular, topical, intra-articular, or inhaled steroids are allowed.
c. Administration of antineoplastic and immunomodulating agents, eg, cancer
chemotherapeutic agents, or radiotherapy within 6 months before administration
of study vaccine and during the study.
Note: Topical immunomodulating agents may be allowed upon sponsor
approval.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
51
Status: Approved,  Date: 22 December 2021
4. 
per medical history, participant has chronic active hepatitis B or hepatitis C infection.
5. 
per medical history, participant has HIV type 1 or type 2 infection.
6. 
history of acute polyneuropathy (eg, Guillain-Barré syndrome) or chronic idiopathic
demyelinating polyneuropathy.
7. 
received hematopoietic stem cell transplant in medical history, treatment with
immunoglobulins expected to impact the vaccine-induced immune response
(including monoclonal antibodies for chronic underlying conditions) in the 2
months, immunoglobulins specific to RSV, human metapneumovirus, or
parainfluenza viruses in the 12 months, apheresis therapies in the 4 months, or blood
products in the 4 months before the planned administration of the first study vaccine
or has any plans to receive such treatment during the study.
Note: Locally administered monoclonal antibodies (for example, intra-ocular) may
be allowed upon sponsor approval. The investigator is encouraged to contact the
sponsor to discuss eligibility of participants on immunoglobulin treatment.
8. 
history of TTS or heparin-induced thrombocytopenia and thrombosis (HITT).
9. 
received or plans to receive:
a. Licensed live attenuated vaccines within 28 days before or after planned
administration of study vaccination
b. Other licensed (not live) vaccines within 14 days before or after planned
administration of study vaccination.
10. 
received or plans to receive a SARS-CoV-2 vaccine:
a. Live attenuated SARS-CoV-2 vaccine within 28 days before or after planned
administration of the first or subsequent study vaccines.
b. Non-live SARS-CoV-2 vaccine within 14 days before or after planned
administration of the first or subsequent study vaccines.
c. A viral-vectored SARS-CoV-2 vaccine within 6 months prior to
randomization or during the study period until 28 days after the last study
vaccination.
11. 
received an RSV vaccine in a previous RSV vaccine study at any time prior to
randomization.
12. 
received or plans to receive an Ad26-vectored vaccine at any time prior to
randomization until 28 days after the last study vaccination (for exclusion criteria
related to SARS-CoV-2 vaccines; please refer to Exclusion Criterion 10).
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
52
Status: Approved,  Date: 22 December 2021
13. 
has taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy,
before vaccination.
14. 
received an investigational drug or used an invasive investigational medical device
within 30 days or received an investigational vaccine within 6 months before the
planned administration of the study vaccine or is currently enrolled or plans to
participate in another investigational study during this study.
Note: Participation in an observational clinical study (ie, without intervention) or in
the observational phase of interventional studies is allowed upon approval of the
sponsor or its delegate.
15. 
has a serious chronic disorder, eg, severe chronic obstructive pulmonary disease or
severe congestive heart failure, end-stage renal disease with or without dialysis,
clinically unstable cardiac disease, Alzheimer’s disease, or has any condition for
which, in the opinion of the investigator, participation would not be in the best
interest of the participant (eg, compromise the well-being) or that could prevent,
limit, or confound the protocol-specified assessments.
16. 
had major surgery (per the investigator’s judgment) within  4 weeks before
vaccination, or will not have fully recovered from surgery at time of vaccination (in
the opinion of the investigator), or has major surgery planned during the time the
participant is expected to participate in the study.
17. 
contraindication to IM injections and blood draws (eg, bleeding disorders).
18. 
employee of the investigator or study site, with direct involvement in the proposed
study or other studies under the direction of that investigator or study site, as well as
family members of the employees or the investigator, or an employee of the sponsor.
19. 
has had major psychiatric illness and/or drug or alcohol abuse which in the
investigator’s opinion would compromise the participant’s safety and/or compliance
with the study procedures.
20. 
cannot communicate reliably with the investigator.
21. 
who, in the opinion of the investigator, is unlikely to adhere to the requirements of
the study, or is unlikely to complete the full course of vaccination and observation.
22. 
who have significant scarring, tattoos, abrasions, cuts, or infections over the deltoid
region of both arms that, in the investigator’s opinion, could interfere with evaluation
of injection site local reactions.
NOTE: Investigators must ensure that all study enrollment criteria have been met at screening. If
a participant's clinical status changes (including any available laboratory results or receipt of
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
53
Status: Approved,  Date: 22 December 2021
additional medical records) after screening but before the first dose of study vaccine is given such
that the participant no longer meets all eligibility criteria, then the participant must be excluded
from participation in the study. Section 5.4, describes options for retesting. The required source
documentation to support meeting the enrollment criteria are noted in Appendix 3.
5.3. 
Lifestyle Considerations
Potential participants must be willing and able to adhere to the following lifestyle restrictions
during the study to be eligible for participation:
1. 
refer to Section 6.8 for details regarding prohibited and restricted therapy during the
study.
2. 
agree to follow all requirements that must be met during the study as noted in the
Inclusion and Exclusion Criteria (eg, contraceptive requirements).
5.4. 
Screen Failures
Participant Identification, Enrollment, and Screening Logs
The investigator agrees to complete a participant identification and enrollment log to permit easy
identification of each participant during and after the study. This document will be reviewed by
the sponsor study site contact for completeness.
The participant identification and enrollment log will be treated as confidential and will be filed
by the investigator in the study file. To ensure participant confidentiality, no copy will be made.
All reports and communications relating to the study will identify participants by participant
identification and age at initial informed consent. In cases where the participant is not randomized
into the study, the date seen and age at initial informed consent will be used.
Individuals who do not meet the criteria for participation in this study (screen failure) may be
rescreened once. Individuals who are rescreened will be assigned a new participant number and
will undergo the informed consent process, and then restart a new screening phase.
5.5. 
Criteria for Temporarily Delaying Administration of Study Vaccine
The following events constitute a temporary contraindication to study vaccination:
 
Clinically significant acute illness at the time of vaccination. This does not include minor
illnesses, such as diarrhea or mild upper respiratory tract infection.
 
Fever (body temperature ≥38.0°C [≥100.4°F]) within 24 hours prior to the planned time of
vaccination.
 
Medically indicated vaccinations, including SARS-CoV-2 vaccine boosters
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
54
Status: Approved,  Date: 22 December 2021
If any of these events occur at the scheduled time for vaccination, randomization at a later date
within the screening window (allowed window up to 10 days) is permitted at the discretion of the
investigator and after consultation with the sponsor. If randomization cannot occur within the
screening window, rescreening is required. If any of these events occur at the scheduled time for
the second vaccination, the vaccination can be rescheduled, as long as this is in agreement with
the allowed windows (refer to the Schedule of Activities).
If the vaccination visit cannot be rescheduled within the allowed window or the contraindications
to vaccination persist, the sponsor should be contacted for further guidance.
6. 
STUDY VACCINE(S) AND CONCOMITANT THERAPY
6.1. 
Study Vaccine(s) Administered
The investigational medicinal products (IMPs) to be administered to participants in this study are
Ad26/protein preF RSV vaccine, Ad26.RSV-B.preF2 mixed with RSV-B preF protein, RSV-A
preF protein mixed with RSV-B preF protein, Ad26/protein preF RSV vaccine mixed with RSV-
B preF protein, Ad26/protein preF RSV vaccine mixed with Ad26.RSV-B.preF2 and RSV-B preF
protein. All IMPs will be administered IM into the deltoid muscle according to the schedules
shown in Table 5, Table 6, Table 7, and Table 8. Various dose levels will be evaluated:
 Ad26.RSV-A.preF (JNJ-64400141) will be used at a dose level of 2.5×1010 vp, 5×1010 vp,
1×1011 vp, or 1.5×1011 vp.
 RSV-A preF protein (JNJ-64213175) will be used at a dose level of 150 μg or 300 μg.
 Ad26.RSV-B.preF2 (JNJ-86051823) will be used at a dose level of 2.5×1010 vp, 5×1010 vp or
1×1011 vp.
 RSV-B preF protein (JNJ-78991172) will be used at a dose level of 150 μg.
Placebo will be 0.9% saline.
For Cohorts 1 and 2, and Arm 10 in Cohort 3, study vaccine will be prepared in a 2×1 mL
formulation. Each component will be provided in a separate vial and components will be mixed
according to treatment assignment. The total 2 mL volume will be divided into 2 injections of
1 mL, which will be administered IM in the same deltoid muscle. Arms 11a and 11b in Cohort 3
will be used to evaluate the formulation of the selected vaccine for future clinical development in
comparison to the initial formulations administered as 2 separate injections of 1 mL. On Day 1,
the participants in Arms 11a and 11b will receive the selected vaccine in a 1 mL formulation and
a second injection with placebo (1 mL) for blinding purposes; participants in Arm 13 will receive
the current Ad26/protein preF RSV vaccine (1×1011 vp Ad26.RSV-A.preF/150 µg RSV-A preF
protein) in a 1 mL formulation and a second injection with placebo (1 mL) for blinding purposes.
The participants in Cohort 4 will receive the selected vaccine in the 1 mL formulation for future
clinical development. Full details of vaccine preparation, including mixing of components, are
provided in the Investigational Product Preparation Instructions.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
55
Status: Approved,  Date: 22 December 2021
Study vaccine administration must be captured in the source documents and the electronic case
report form (eCRF).
All study vaccines will be manufactured and provided under the responsibility of the sponsor.
Refer to the IB’s for a list of excipients (IB Ad26/protein preF RSV vaccine 2021 and IB
VAC18195 2021).
For a definition of study vaccine overdose, refer to Section 6.7.
6.2. 
Preparation/Handling/Storage/Accountability
Preparation/Handling/Storage
Vials must be stored in a secured location under controlled temperature with no access for
unauthorized personnel. The study refrigerator/freezer must be equipped with a continuous
temperature monitor and alarm and should be equipped with back-up power systems. If the study
vaccine components are exposed to temperatures outside the specified temperature range, all
relevant data will be sent to the sponsor to determine if the affected study vaccine components can
be used or will be replaced. The affected study vaccine components must be quarantined and not
used until further instruction from the sponsor is received.
An unblinded study-site pharmacist, or other qualified individual will prepare the appropriate vials
and syringes, labeled with the participant’s identification number, and provide the syringes for
Ad26/protein preF RSV vaccine in a blinded manner to the blinded study vaccine administrator
who will perform the injection.
Refer to the Investigational Product Preparation Instructions and Study Site Investigational
Product and Procedures Manual for additional guidance on study vaccine preparation, handling,
and storage.
Accountability
The investigator is responsible for ensuring that all study vaccine received at the site is inventoried
and accounted for throughout the study. The study vaccine administered to the participant must be
documented on the intervention accountability form. All study vaccine will be stored and disposed
of according to the sponsor's instructions.
Study vaccine must be handled in strict accordance with the protocol and as indicated on the
container label, and must be stored at the study site in a limited-access area or in a locked cabinet
under appropriate environmental conditions. Unused study vaccine must be available for
verification by the sponsor's study site monitor during on-site monitoring visits. The return to the
sponsor of unused study vaccine will be documented on the intervention return form. When the
study site is an authorized destruction unit and study vaccine supplies are destroyed on-site, this
must also be documented on the intervention return form.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
56
Status: Approved,  Date: 22 December 2021
Potentially hazardous materials containing hazardous liquids, such as used ampules, needles,
syringes and vials, must be disposed of immediately in a safe manner and therefore will not be
retained for intervention accountability purposes.
Study vaccine must be dispensed under the supervision of the investigator or a qualified member
of the study site personnel. Study vaccine will be supplied only to participants participating in the
study. Study vaccine may not be relabeled or reassigned for use by other participants. The
investigator agrees neither to dispense the study vaccine from, nor store it at, any site other than
the study sites agreed upon with the sponsor.
Refer to the Investigational Product Preparation  Instructions and Study Site Investigational
Product and Procedures Manual for additional guidance on the final disposition of unused study
vaccines.
6.3. 
Measures to Minimize Bias: Randomization and Blinding
Study Vaccine Allocation
Procedures for Randomization
Central randomization will be implemented in this study. Participants will be randomly assigned
to a vaccination group, as described in Section 4.1, based on a computer-generated randomization
schedule prepared before the study by or under the supervision of the sponsor. The randomization
will be balanced by using randomly permuted blocks.
Sites will be split into 2 categories based on their PBMC collection capabilities for enrolment in
the Cellular Immuno Subset.
For Cohorts 2 and 3, sites collecting PBMC samples will randomize participants in the Cellular
Immuno Subset of the respective cohort in a ratio as described in Section 4.1. These sites may
enroll participants without PBMC sampling on the same day once their daily PBMC capacity has
been reached. PBMC samples will be collected for all participants in Cohort 1 and for 38
participants per arm in Cohort 2. In Cohort 3 PBMC samples will be collected for approximately
240 participants: 40 participants per arm in Arms 10, 12, and 13, and 60 participants per arm in
Arms 11a and 11b. When the Cellular Immuno Subset has been completed for a cohort, the sites
will continue randomizing the remaining participants without PBMC sampling. Sites with no
PBMC sample collection capabilities will randomize participants that are not part of the Cellular
Immuno Subset. Separate randomization lists will be used for the Cellular Immuno Subset and for
the participants that are not part of the Cellular Immuno Subset.
The interactive web response system (IWRS) will assign a unique intervention code, which will
dictate the intervention assignment and matching study vaccine kit for the participant. The
requestor must use his or her own user identification and personal identification number when
contacting the IWRS, and will then give the relevant participant details to uniquely identify the
participant.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
57
Status: Approved,  Date: 22 December 2021
Blinding
The investigator will not be provided with randomization codes. The codes will be maintained
within the IWRS, which has the functionality to allow the investigator to break the blind for an
individual participant.
For the sponsor, unblinding (at the participant level) of Cohort 1 and 2 will occur at the time of the
primary analysis (Section 9.5). From the primary analysis onwards, group level results of Cohort 1
and 2 may be shared as needed, however, efforts will be made to preserve the blinding to the
individual participant allocation. Sponsor unblinding (at the participant level) of Cohort 3 will
occur at the time of the interim analysis when all participants in Cohort 3 have completed their 28-
day post-first vaccination visit (Section 9.5). From this interim analysis onwards, group level
results from Cohort 3 may be shared as needed, however, efforts will be made to preserve the
blinding to the individual participant allocation  (for participants in Arms 11a, 11b, and 12).
Sponsor unblinding (at the participant level) of Cohort 4 will occur at the time of the interim
analysis when all participants in Cohort 4 have completed their 28 days post-first vaccination visit
(Section 9.5). From this interim analysis onwards, group level results from Cohort 4 may be shared
as needed, however, efforts will be made to preserve the blinding to the individual participant
allocation.
Data that may potentially unblind the randomization group assignment (eg, immunogenicity data,
study vaccine preparation/accountability data, study vaccine allocation) will be handled with
special care to ensure that the integrity of the blind is maintained and the potential for bias is
minimized. This can include making special provisions, such as segregating the data in question
from view by the investigators, clinical team, or others as appropriate until the time of database
lock and unblinding.
Under normal circumstances, the blind must not be broken for a cohort until all participants in that
cohort have completed the study and the database is finalized for the cohort, except for Cohort 3:
the blind will be broken for participants in Arms 10 and 13 once all participants in these arms have
completed their last visit after 1 year of follow-up post-vaccination. The investigator may, in an
emergency, determine the identity of the randomization group by contacting the IWRS. While the
responsibility to break the intervention  code in emergency situations resides solely with the
investigator, it is recommended that the investigator contact the sponsor or its designee if possible,
to discuss the particular situation, before breaking the blind. Telephone contact with the sponsor
or its designee will be available 24 hours per day, 7 days per week. In the event the blind is broken,
the sponsor must be informed as soon as possible. The date, time, and reason for the unblinding
must be documented by the IWRS, in the appropriate section of the eCRF, and in the source
document. The documentation received from the IWRS indicating the code break must be retained
with the participant's source documents in a secure manner.
Participants who have had their intervention assignment unblinded should continue to return for
scheduled evaluations.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
58
Status: Approved,  Date: 22 December 2021
In general, randomization codes will be disclosed fully only if the study is completed and the
clinical database is closed. However, if an interim analysis is specified (Section 9.5), the
randomization codes and, if required, the translation of randomization codes into vaccine and
control groups will be disclosed to the sponsor and only for those participants included in the
interim analysis.
Participants who withdraw will not be replaced.
6.4. 
Study Vaccine Compliance
Study vaccine will be administered IM by blinded qualified study-site personnel at the study site.
Details of each administration will be recorded in the eCRF (including date and time of injection,
and site of administration). For blinding procedures, see Section 6.3.
6.5. 
Dose Modification
Not applicable.
6.6. 
Continued Access to Study Vaccine After the End of the Study
Participants will be instructed that study vaccine will not be made available to them after they have
completed/discontinued study vaccination.
6.7. 
Treatment of Overdose
For this study, any dose of study vaccine greater than the protocol-specified dose will be
considered an overdose. The sponsor does not recommend specific treatment for an overdose.
In the event of an overdose, the investigator or treating physician should:
 
Contact the Medical Monitor immediately.
 
Closely monitor the participant for AE/SAE/AESIs until resolution.
 
Document the quantity of the excess dose in the eCRF.
 
Report as a special reporting situation.
6.8. 
Concomitant Therapy
Prestudy therapies administered up to 30 days before vaccination must be recorded either during
screening or on Day 1. Additionally, any history of SARS-CoV-2 vaccination (name/manufacturer
of the vaccine and date of administration, whenever possible) prior to and during the study will be
collected in the eCRF.
Concomitant therapies associated with solicited AEs will be collected by the participants in the
participant diary from the time of study vaccination through 7 days after vaccination. Concomitant
therapies associated with unsolicited AEs will be collected and recorded in the eCRF from the time
of study vaccination through 28 days after vaccination. Concomitant therapies associated with
SAEs or AESIs will be collected and recorded in the eCRF from ICF signature until 6 months after
study vaccination.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
59
Status: Approved,  Date: 22 December 2021
Analgesic/antipyretic medications and non-steroidal anti-inflammatory drugs may be used post-
vaccination only in cases of medical need (eg, fever or pain) and their use must be documented.
Use of these medications as routine prophylaxis prior to study vaccination is discouraged.
Information on concomitant use of herbal supplements or vitamins will not be collected.
Use of any experimental medication (including experimental vaccines other than the study
vaccine) during the study is not allowed.
Vaccination with licensed live attenuated vaccines within 28 days of a study vaccination (ie, before
or after) is prohibited. Other licensed (not live) vaccines (eg, influenza, tetanus, hepatitis A,
hepatitis B, rabies) should be given at least 14 days before (or at least 14 days after) administration
of study vaccine in order to avoid potential confusion of adverse reactions and potential immune
interference. If a vaccine is indicated in a post-exposure setting (eg, rabies or tetanus), it must take
priority over the study vaccine.
For SARS-CoV-2 vaccines either licensed or available under Emergency Use Authorization: live
attenuated vaccines should be given at least 28 days before or after vaccination; non-live vaccines
should be given at least 14 days before or after vaccination. A viral-vectored SARS-CoV-2 vaccine
is not to be given within 6 months prior to randomization or during the study period until 28 days
after the last study vaccination.
Use of systemic corticosteroidsa must be documented throughout the study. Antineoplastic and
immunomodulating agents administered parenterally, eg, cancer chemotherapeutic agents or
systemic corticosteroids, or radiotherapy are prohibited throughout the study. If the use of systemic
corticosteroids, antineoplastic or immunomodulating agents or any therapy described in Exclusion
Criterion 7 becomes medically indicated during the study for any participant, the sponsor should
be notified.
The sponsor must be notified in advance (or as soon as possible thereafter) of any instances in
which prohibited therapies are administered.
6.9. 
Study Pausing Rules
For Cohort 1, randomization and vaccination of participants will be suspended during review of
the 24-hour data following the first administration of study vaccine to sentinel participants in each
group (see Section 4.1).
If a study vaccination is considered to raise significant safety concerns (and a specific set of
pausing criteria have been met), further vaccination of participants will be paused. The concerned
data will be reviewed by the DRC, after which the DRC will recommend whether the pause can
be lifted or not, or whether other steps are needed.
a Note: Ocular, topical, intra-articular or inhaled steroids are allowed.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
60
Status: Approved,  Date: 22 December 2021
The DRC will review blinded data first but has the right to request the randomization codes and
review unblinded data if deemed necessary. The DRC will make recommendations regarding the
continuation of the study to the sponsor study team. The sponsor study team will communicate
conclusions regarding study continuation to the investigator, the Independent Ethics Committee
(IEC) / Institutional Review Board (IRB), and applicable health authorities as appropriate.
After the first DRC meeting triggered by the occurrence of a given pausing rule, the DRC will
convene thereafter for each additional participant meeting that pausing rule.
The occurrence of any of the following events will lead to a pause in further study vaccination.
This list is only applicable for concerned AEs that occur up to 4 weeks after each vaccination and
to concerned SAEs and AESIs.
1. 
Death of a participant, considered related to study vaccine or if the causal relationship
to the study vaccine cannot be excluded; OR
Note: All cases of death will be sent for DRC information. Upon their review, DRC
may then decide whether a study pause is required.
2. 
One or more participants per cohort experience an SAE, AESI (ie, confirmed TTS), or
a Grade 4 (solicited or unsolicited) adverse event or a persistent (upon repeat testing)
Grade 4 laboratory abnormality that is determined to be related to study vaccine (in
Cohorts 1 and 2 only); OR
3. 
One or more participants per cohort experience anaphylaxis or generalized urticaria
within 24 hours of vaccination, clearly not attributable to other causes than vaccination
with study vaccine; OR
4. 
Two or more participants per cohort experience a Grade 3 or 4 unsolicited AE of the
same type (as per medical judgment of the sponsor), that is determined to be related to
study vaccine, that persists for 72 hours or longer; OR
5. 
Two or more participants per cohort (in Cohorts 1 and 2 only) experience a persistent
(upon repeat testing) Grade 3 or 4 laboratory abnormality related to the same laboratory
parameter and considered related to study vaccine, that persists for 72 hours or longer;
OR
6. 
Two or more participants per cohort experience a Grade 3 or 4 solicited AE of the same
type, determined to be related to study vaccine, that persists for 72 hours or longer.
For number 2 and number 5: to assess abnormal laboratory values, the test must be repeated at
least once, within 48 hours of the site becoming aware of the abnormal value.
For number 4, number 5, and number 6: after each DRC review of similar AEs, the Committee
will indicate the conditions under which it requires further notification and review of the
subsequent similar AEs.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
61
Status: Approved,  Date: 22 December 2021
To enable prompt response to a situation that could trigger pausing rules, the investigator should
notify the sponsor’s medical monitor or designee (AND fax or email serious adverse event form
to Global Medical Safety Operations, if applicable), immediately and no later than 24 hours after
becoming aware of any related adverse event of Grade 3 or above AND update the eCRF with
relevant information on the same day the adverse event information is collected. A thorough
analysis of all Grade 3 (or above) cases will be carried out by the sponsor’s medical monitor or
designee, irrespective of whether the criteria for pausing the study are met. Based on the pausing
criteria, the sponsor’s medical monitor or designee then decides whether a study pause is
warranted. All sites will be notified immediately in case of a study pause. The sponsor’s medical
monitor or designee is responsible for the immediate notification of DRC members and
coordination of a DRC meeting in case of a study pause.
Vaccinations for an individual participant may be suspended for safety concerns other than those
described in the pausing criteria, at the discretion of the investigator if he/she feels the participant’s
safety may be threatened. The sponsor’s medical monitor or designee or the investigator(s) (upon
consultation with the sponsor’s medical monitor or designee) may initiate DRC review for any
single event or combination of multiple events which, in their professional opinion, could
jeopardize the safety of the participants or the reliability of the data.
Vaccinations for the study may be suspended for safety concerns other than those described above,
or before pausing rules are met, if, in the judgment of the DRC, participant safety may be
threatened.
Resumption of vaccinations paused by the DRC will start only upon receipt of written
recommendations by the DRC. The clinical site(s) will be allowed to resume activities upon receipt
of a written notification from the sponsor. The communications from the DRC will be forwarded
by the investigator to the IRB/IEC and by the sponsor to the relevant health authorities, according
to local standards and regulations.
7. 
DISCONTINUATION OF STUDY VACCINATION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
7.1. 
Discontinuation of Study Vaccination
Study vaccinations will be withheld for the reasons listed below. These participants must not
receive any further doses of study vaccine but should remain on study for follow-up with
assessments of safety and immunogenicity as indicated in the as indicated in the Schedule of
Activities. Additional unscheduled visits may be performed for safety/reactogenicity reasons, if
needed. In case of questions, the investigator is encouraged to contact the sponsor.
 
Any related adverse event, worsening of health status or intercurrent illnesses that, in the
opinion of the investigator, requires discontinuation from study vaccine
 
Unblinding on the participant level that, in the opinion of the sponsor, would compromise the
integrity of the data
 
Anaphylactic reaction following vaccination
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
62
Status: Approved,  Date: 22 December 2021
 
Serious adverse event or other potentially life-threatening (Grade 4) event that is determined
to be related to study vaccine
 
Administration of antineoplastic and immunomodulating agents or radiotherapy prior to
14 days after the second study vaccination
 
Withdrawal of consent
 
The investigator believes that for safety reasons or reactogenicity reasons (eg, AE) it is in the
best interest of the participant to discontinue study vaccination
 
Participant previously experienced TTS, including CVST or HIT
Study vaccine assigned to the participant who discontinued study vaccination may not be assigned
to another participant.
7.2. 
Participant Discontinuation/Withdrawal From the Study
A participant will be withdrawn from the study for any of the following reasons:
 
Lost to follow-up
 
Withdrawal of consent
 
Death
 
Any AE that requires discontinuation from the study
 
Repeated failure to comply with protocol requirements
When a participant withdraws before study  completion, the reason for withdrawal is to be
documented in the eCRF and in the source document. If the reason for withdrawal from the study
is withdrawal ofconsent then no additional assessments are allowed.
An early exit visit (site visit or by telephone) will be conducted for those participants who are
unable to continue participation in the study and withdraw from the study before end of study, but
who do not withdraw consent (see Schedule of Activities). Participants who wish to withdraw
consent from participation in the study will be offered an early exit visit (prior to formal withdrawal
of consent; site visit or by telephone). They have the right to refuse.
Withdrawal of Consent
A participant declining to return for scheduled visits does not necessarily constitute withdrawal of
consent. Alternate follow-up mechanisms that the participant agreed to when signing the consent
form apply (eg, consult with family members, contacting the participant’s other physicians,
medical records, database searches, use of locator agencies at study completion,) as local
regulations permit.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
63
Status: Approved,  Date: 22 December 2021
7.2.1. 
Withdrawal From the Use of Research Samples
Withdrawal From the Use of Samples in Future Research
The participant may withdraw consent for use of samples for research (refer to Long-Term
Retention of Samples for Additional Future Research in Appendix 3). In such a case, samples will
be destroyed after they are no longer needed for the clinical study. Details of the sample retention
for research are presented in the main ICF.
7.3. 
Lost to Follow-up
A participant will be considered lost to follow-up if the participant repeatedly fails to return for
scheduled visits and is unable to be contacted by the study site. A participant cannot be deemed
lost to follow-up until all reasonable efforts made by the study  site personnel to contact the
participant are deemed futile. The following actions must be taken if a participant fails to return to
the study site for a required study visit:
 
The study site personnel must attempt to contact the participant to reschedule the missed visit
as soon as possible, to counsel the participant on the importance of maintaining the assigned
visit schedule, to ascertain whether the participant wishes to or should continue in the study.
 
Before a participant is deemed lost to follow-up, the investigator or designee must make every
reasonable effort to regain contact with the participant (where possible, 3 telephone calls,
emails, fax, and, if necessary, a certified letter to the participant’s last known mailing address,
or local equivalent methods). These contact attempts should be documented in the
participant’s medical records.
 
Should the participant continue to be unreachable, they will be considered to have withdrawn
from the study.
Should a study site close, eg, for operational, financial, or other reasons, and the investigator cannot
reach the participant to inform them, their contact information will be transferred to another study
site.
8. 
STUDY ASSESSMENTS AND PROCEDURES
Overview
The Schedule of Activities summarizes the frequency and timing of study visits and of
immunogenicity and safety assessments applicable to this study.
If multiple assessments are scheduled for the same timepoint, it is recommended that procedures
be performed in the following sequence: vital signs, other safety assessments, blood draws. If
needed, assessments may be performed at another day within the applicable visit window. Actual
dates and times of assessments will be recorded in the source documentation and/or the eCRF.
Participants will be provided a thermometer (to measure body temperature), ruler (to measure local
injection site reactions), and participant diary to record body temperature and solicited local (at
injection site) and systemic signs and symptoms.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
64
Status: Approved,  Date: 22 December 2021
The diary includes instructions on how to capture the data and grading scales to assess severity of
the signs and symptoms. The study staff is responsible for providing appropriate training to the
participant to avoid missing or incorrect data. The diary will be reviewed by the study personnel
at visits indicated in the Schedule of Activities. If the diary review is missed, the diary will be
reviewed during the following visit. If a participant misses a vaccination, the diary covering the
period after the missed vaccination does not have to be completed.
Over the entire study, the total blood volume to be collected from each participant will be:
 
In Cohort 1 and the participants in Cohort 2 that are part of the Cellular Immuno Subset:
approximately 648 mL;
 
In the remaining participants in Cohort 2: approximately 228 mL;
 
In participants in Cohort 3, Arms 10 and 13 that are part of the Cellular Immuno Subset:
approximately 456 mL;
 
In the remaining participants in Cohort 3, Arms 10 and 13: approximately 156 mL;
 
In participants in Cohort 3, Arms 11a, 11b and 12 that are part of the Cellular Immuno Subset:
approximately 1,084 mL;
 
In the remaining participants in Cohort 3, Arms 11a, 11b and 12 and all participants in
Cohort 4: approximately 364 mL.
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the
samples.
Visit Windows
Windows are allowed for the following visits as indicated in Table 9, Table 10, and Table 11:
Table 9: 
Visit Windows: Cohort 1 and 2
Clinic Visit # 
Visit Day  
Visit Window  Primary Purpose
3 
8 
+ 3 days 
7 days post study vaccination, Safety visit
4 
15 
+ 3 days 
14 days post study vaccination, Immunogenicity and Safety visit
5 
29 
+ 7 days 
28 days post study vaccination, Immunogenicity and Safety visit
6 
85 
+ 7 days
3 months post study vaccination, Immunogenicity and Safety
visit
7 
183 
± 14 days
6 months post study vaccination, Immunogenicity and Safety
visit
8 
365 
± 1 month  
1 year post study vaccination, Immunogenicity visit
9 
730 
± 1 month  
2 years post study vaccination, Immunogenicity visit
10 
1095 
± 1 month  
3 years post study vaccination, Immunogenicity visit
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
65
Status: Approved,  Date: 22 December 2021
Table 10: 
Visit Windows: Cohort 3 (Arms 10 and 13)
Clinic Visit # 
Visit Day  
Visit Window  Primary Purpose
3 
8 
+ 3 days 
7 days post study vaccination, Safety visit
4 
15 
+ 3 days 
14 days post study vaccination, Immunogenicity and Safety visit
5 
29 
+ 7 days 
28 days post study vaccination, Immunogenicity and Safety visit
6 
85 
+ 7 days
3 months post study vaccination, Immunogenicity and Safety
visit
7 
183 
± 14 days
6 months post study vaccination, Immunogenicity and Safety
visit
8 
365 
± 1 month  
1 year post study vaccination, Immunogenicity visit
Table 11: 
Visit Windows: Cohort 3 (Arms 11a, 11b and 12) and Cohort 4
Clinic Visit # 
Visit Day  
Visit Window  Primary Purpose
3 
8 
+ 3 days 
7 days post first study vaccination, Safety visit
4 
15 
+ 3 days
14 days post first study vaccination, Immunogenicity and Safety
visit
5 
29 
+ 7 days
28 days post first study vaccination, Immunogenicity and Safety
visit
6 
85 
+ 7 days
3 months post first study vaccination, Immunogenicity and Safety
visit
7 
183 
± 14 days
6 months post first study vaccination, Immunogenicity and Safety
visit
8 
X 
± 1 month  
Vaccination 2
9 
X+7 
+ 3 days 
7 days post second study vaccination, Safety visit
10 
X+14  
+ 3 days
14 days post second study vaccination, Immunogenicity and
Safety visit
11 
X+28 
+ 7 days
28 days post second study vaccination, Immunogenicity and
Safety visit
12 
X+84 
+ 7 days
3 months post second study vaccination, Immunogenicity and
Safety visit
13 
X+183 
± 14 days
6 months post second study vaccination, Immunogenicity and
Safety visit
14 
730 
± 1 month  
2 years post first study vaccination, Immunogenicity visit
15 
1095 
± 1 month  
3 years post first study vaccination, Immunogenicity visit
16 
1460 
± 1 month  
4 years post first study vaccination, Immunogenicity visit
17 
1825 
± 1 month  
5 years post first study vaccination, Immunogenicity visit
* Timing of revaccination to be defined based on Ad26/protein preF RSV vaccine clinical data (Studies
VAC18193RSV1004, VAC18193RSV2001, and VAC18193RSV3001)
The timings of the post-vaccination visits will be determined relative to the actual day of the
corresponding vaccination. If a participant misses a vaccination, the post-vaccination visits will be
calculated from the imputative vaccination date according to protocol.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
66
Status: Approved,  Date: 22 December 2021
Screening
The study will include a screening phase of up to 28 days. If possible, screening may also be
performed prior to randomization on the day of vaccination. In that case, Visits 1 and 2 will
coincide on Day 1. Screening must be completed, and all eligibility criteria must be fulfilled prior
to randomization and vaccination.
Sample Collection and Handling
The actual dates and times of sample collection must be recorded in the eCRF and laboratory
requisition form.
Refer to the Schedule of Activities for the timing and frequency of all sample collections.
For samples collected using a central laboratory, instructions for the collection, handling, storage,
and shipment of samples are found in the laboratory manual that will be provided. Collection,
handling, storage, and shipment of samples must be under the specified, and where applicable,
controlled temperature conditions as indicated in the laboratory manual.
Study-Specific Materials
The investigator will be provided with the following supplies:
 
IB (IB Ad26/protein preF RSV vaccine 2021, IB VAC18195 2021)
 
Study site investigational product and procedures manual
 
Laboratory manual
 
Investigational Product Preparation Instructions
 
IWRS Manual
 
Electronic data capture (eDC) Manual/eCRF completion guidelines
 
Sample ICF
 
Participant diaries and instructions for use
 
Thermometer
 
Ruler (to measure diameter of any erythema and swelling)
 
Laboratory kits
 
Contact Information page(s)
 
Study protocol
 
Wallet card
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
67
Status: Approved,  Date: 22 December 2021
8.1. 
Immunogenicity Assessments
Blood samples will be collected for the determination of immune responses at the timepoints
indicated in the Schedule of Activities. Sample collection and processing will be performed by the
study site personnel according to current versions of approved standard operating procedures.
Possible immunogenicity evaluations may include (but are not limited to) the assays summarized
in Table 12.
Table 12: 
Summary of Immunogenicity Assays
Assay 
Purpose
Primary Endpoints*
RSV neutralization assay  
Analysis of neutralizing antibodies against the RSV A2 strain
Analysis of neutralizing antibodies against an RSV B strain
Secondary Endpoints
F protein antibodies 
(ELISA; pre-F and/or post-F) 
Analysis of antibodies binding to RSV F protein in prefusion and/or
post-fusion form
IFN-γ ELISpot**  
T-cell IFN-γ responses to RSV F proteinpeptides
Exploratory Endpoints
RSV neutralization assay  
Analysis of neutralizing antibodies against additional A and/or
B strains
F protein antibody specificity 
characterization  
Pre- and post-F specificity by binding or functional assays as ELISA,
and/or competition ELISA. Adsorption of serum or plasma with pre-
F and post-F protein before any antibody assay, epitope mapping,
functional VNAs
G and/or N protein antibodies (ELISA) 
Analysis of antibodies binding to RSV G and/or N protein
Adenovirus neutralization assay  
Analysis of neutralizing antibodies to adenovirus
Functional and molecular antibody 
characterization  
Analysis of antibody characteristics may include, but not limited to,
ADCC, ADCP, avidity, Fc cell interaction, other respiratory viral
neutralizing or binding assays, Ig isotype, and antibody assessments
for antibody repertoire
ICS and/or cellular phenotyping and/or 
cellular function characterization**  
Analysis of T-cell responses to RSV F proteinpeptide-stimulated
PBMCs (including, but not limited to, CD4+/CD8+, IL-2, IFN-γ,
TNF-α, activation markers and memory markers), cellular
phenotyping by extracellular markers for several immune cells
including but not limited to B-cells and T-cells, and B-cell memory
ELISpot for B-cell memory formation analysis
Transcriptome analysis 
Regulation of genes (clusters), expression patterns, that for example
could predict specific immune responses after vaccination
Chemokine/cytokine analysis 
Levels of chemokines and cytokines in serum
Sequencing ofT-cells and/or B-cells 
Including but not limited to sequencing of TCR and BCR including
VH/VL (heavy/light chain) characterization
* Analysis of neutralizing antibodies against the RSV A2 and RSV B strain is a primary endpoint in the vaccine components
selection cohort (Cohorts 1 and 2) and in the revaccination and durability cohort (Cohort 4), and a secondary endpoint in the
expanded safety cohort objective (Cohort 3).
** Only applicable for participants with blood draws for cellular responses.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
68
Status: Approved,  Date: 22 December 2021
ADCC: antibody dependent cell mediated cytotoxicity; ADCP: antibody dependent cell mediated phagocytosis; BCR: B cell
receptor; ELISA: enzyme linked immunosorbent assay; ELISpot: enzyme linked immunospot; F: fusion; ICS: intracellular
cytokine staining; IFN γ: interferon gamma; IL 2: interleukin 2, Ig: immunoglobulin; PBMC: peripheral blood mononuclear cell;
RSV: respiratory syncytial virus; TCR: T cell receptor; VH: heavy chain variable domain; VL: light chain variable domain;
VNA: virus neutralizing antibody
8.2. 
Safety Assessments
Key safety assessments will include the monitoring of AEs, vital signs, physical examinations (all
cohorts), and safety laboratory assessments (Cohorts 1 and 2 only).
Details regarding the DRC are provided in Committees Structure in Appendix 3.
Adverse events will be reported and followed by the investigator as specified in Section 8.3 and
Appendix 4.
Any clinically significant abnormalities persisting at the end of the study/early withdrawal will be
followed by the investigator until clinical resolution (return to baseline) or until a clinically stable
condition is reached, or until the participant has been deemed lost to follow-up after demonstration
of due diligence of follow-up efforts.
The study will include the following evaluations of safety and reactogenicity according to the time
points provided in the Schedule of Activities.
8.2.1. 
Physical Examinations
A physical examination, including height and body weight, will be carried out pre-vaccination
during the screening period and, if deemed necessary by investigator, also on Day 1. At all other
visits, an abbreviated, symptom-directed examination will be performed if deemed necessary by
the investigator based on any clinically relevant issues, clinically relevant symptoms, and medical
history. Symptom-directed physical examination may also be performed if deemed necessary by
the investigator.
Physical examinations will be performed by the investigator or appropriately trained delegate. Any
clinically relevant abnormalities or changes in severity noted during the review of body systems
should be documented in the eCRF as an AE or SAE if it meets the criteria for an AE or SAE
according to the protocol reporting requirements.
8.2.2. 
Vital Signs
Body temperature (oral route preferred), heart rate (beats per minute), respiratory rate (breaths per
minute), and systolic and diastolic blood pressure (mm Hg) will be assessed.
Blood pressure and pulse/heart rate measurements will be assessed, if possible, with a completely
automated device. Manual techniques will be used only if an automated device is not available.
Sitting systolic and diastolic blood pressure and heart and respiratory rate measurements should
be preceded by at least 5 minutes of rest in a quiet setting without distractions (eg, television, cell
phones). Vital signs evaluation is recommended before blood sampling.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
69
Status: Approved,  Date: 22 December 2021
Confirmatory vital signs measurement can be performed if inconsistent with a prior measurement.
Any abnormalities or changes in severity noted during the review of vital signs should be
documented in the eCRF.
Participants will utilize a diary to record body temperature measurements post-vaccination (see
Section 8).
8.2.3. 
Clinical Safety Laboratory Assessments
For participants in Cohorts 1 and 2, blood samples for serum chemistry and hematology will be
collected at screening, on Day 1, and 7 days after vaccination (or at the exit visit if early exit is
within 7 days after vaccination and the participant terminates from the study without withdrawing
consent) as noted in  Appendix 2: Clinical Laboratory Tests. The investigator must review the
laboratory results, document this review, and record any clinically relevant changes occurring
during the study in the AE section of the eCRF. The laboratory reports must be filed with the
source documents.
8.3. 
Adverse Events, Serious Adverse Events, Adverse Events of Special
Interest and Other Safety Reporting
Timely, accurate, and complete reporting and analysis of safety information, including AEs, SAEs,
AESIs (including potential AESIs, refer to Section 8.3.6) and PQCs, from clinical studies are
crucial for the protection of participants, investigators, and the sponsor, and are mandated by
regulatory agencies worldwide. The sponsor has established Standard Operating Procedures in
conformity with regulatory requirements worldwide to ensure appropriate reporting of safety
information; all clinical studies conducted by the sponsor or its affiliates will be conducted in
accordance with those procedures.
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate,
or the participant's legally acceptable representative) for the duration of the study.
Further details on AEs, SAEs, AESIs, and PQCs can be found in Appendix 4.
8.3.1. 
Time Period and Frequency for Collecting Adverse Event, Serious
Adverse Event and Adverse Event of Special Interest Information
All Adverse Events
AEs and special reporting situations, whether serious or non-serious, that are related to study
procedures or that are related to non-investigational sponsor products will be reported from the
time a signed and dated ICF is obtained until the end of the study/early withdrawal.
Clinically relevant medical events not meeting the above criteria and occurring between signing
of ICF and moment of first vaccination will be collected on the Medical History eCRF page as
pre-existing conditions.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
70
Status: Approved,  Date: 22 December 2021
Solicited AEs, collected through a participant diary, will be recorded for each vaccination from
the time of vaccination until 7 days post-vaccination.
All other unsolicited AEs and special reporting situations, whether serious or non-serious, will be
reported for each vaccination from the time of vaccination until 28 days post-vaccination.
Unsolicited AEs with the onset date outside the timeframe defined above (>28 days after previous
study vaccination), which are ongoing on the day of the subsequent vaccination, should be
recorded as such.
All SAEs and AEs leading to discontinuation from the study (regardless of the causal relationship)
and all AESIs are to be reported from the moment of vaccination until 6 months post vaccination.
The sponsor will evaluate any safety information that is spontaneously reported by an investigator
beyond the time frame specified in the protocol.
All COVID-19 cases will be collected for all participants for the duration of the study.
See Section 7.2 for procedures associated with withdrawal of consent.
All AEs will be followed until resolution or until clinically stable.
Serious Adverse Events
All SAEs occurring during the study must be reported to the appropriate sponsor contact person
by study site personnel immediately, but no later than within 24 hours of their knowledge of the
event.
Information regarding SAEs will be transmitted to the sponsor using the Serious Adverse Event
Form and Safety Report Form of the eCRF, which must be completed and reviewed by a physician
from the study site, and transmitted to the sponsor immediately, but no later than within 24 hours.
The initial and follow-up reports of an SAE should be transmitted electronically or by facsimile
(fax). Telephone reporting should be the exception and the reporter should be asked to complete
the appropriate form(s) first.
AESIs
TTS is considered to be an AESI. Thrombotic events and/or thrombocytopenia (defined as platelet
count below the lower limit of normal [LLN] range for the testing laboratory) are considered to be
potential AESIs. All AESIs, including potential AESIs, will be reported to the sponsor from the
moment of study vaccination until 6 months after the study vaccination (see Section 8.3.6).
8.3.2. 
Method of Detecting Adverse Events and Serious Adverse Events
and Adverse Events of Special Interest
Care will be taken not to introduce bias when detecting AEs, SAEs or AESIs. Open-ended and
nonleading verbal questioning of the participant is the preferred method to inquire about AE
occurrence.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
71
Status: Approved,  Date: 22 December 2021
Solicited Adverse Events
Solicited AEs are used to assess the reactogenicity of the study vaccine and are predefined local
(at the injection site) and systemic events for which the participant is specifically questioned and
which are noted by participants in their diary (see Section 8).
After vaccination, participants will remain under observation at the study site for at least
30 minutes for presence of any acute reactions and solicited events.
In addition, participants will record solicited signs and symptoms in a participant diary for 7 days
post-vaccination. All participants will be provided with a participant diary and instructions on how
to complete the participant diary (see Overview in Section 8). If a paper diary is used for this study,
the study staff will transcribe the information provided by the participant into the relevant sections
of the eCRF. If an e-diary is used, diary information will be transferred to the sponsor. After review
and verbal discussion of the initial diary entries with the participant, the investigator will complete
their own assessment in the relevant sections of the eCRF. Once a solicited sign or symptom from
a participant diary is considered to be of severity Grade 1 or above, it will be recorded as a solicited
AE.
Solicited Local (Injection Site) AEs
Participants will be asked to note in the participant diary occurrences of injection site
pain/tenderness, erythema and swelling at the study vaccine injection site daily for 7 days post-
vaccination (day of vaccination and the subsequent 7 days). The extent (largest diameter) of any
erythema and swelling should be measured (using the ruler supplied) and recorded daily. The case
definitions for solicited injection site events can be found in the references (Gidudu 2012; Kohl
2007).
Solicited Systemic AEs
Participants will be instructed on how to record daily temperature using a thermometer provided
for home use. Participants should record the temperature (oral route preferred) in the participant
diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at
the same time each day. If more than 1 measurement is made on any given day, the highest
temperature of that day will be used in the eCRF.
Fever is defined as endogenous elevation of body temperature ≥38.0°C (≥100.4°F), as recorded in
at least 1 measurement (Marcy 2004).
Participants will also be instructed on how to note signs and symptoms in the participant diary on
a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days), for the
following events: fatigue, headache, nausea, and myalgia.
Unsolicited Adverse Events
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the
participant diary.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
72
Status: Approved,  Date: 22 December 2021
For details regarding AESIs, refer to Section 8.3.6.
8.3.3. 
Follow-up of Adverse Events, Serious Adverse Events and Adverse
Events of Special Interest
The investigator is obligated to perform or arrange for the conduct of supplemental measurements
and evaluations as medically indicated to elucidate the nature and causality of the AE, SAE, AESI,
or PQC as fully as possible. This may include additional laboratory tests or investigations,
histopathological examinations, or consultation with other health care professionals.
Adverse events, and the special reporting situation of pregnancy, will be followed by the
investigator as specified in Appendix 4.
8.3.4. 
Regulatory Reporting Requirements for Serious Adverse Events
The sponsor assumes responsibility for appropriate reporting of AEs to the regulatory authorities.
The sponsor will also report to the investigator (and the head of the investigational institute where
required) all suspected unexpected serious adverse reactions (SUSARs). The investigator (or
sponsor where required) must report SUSARs to the appropriate Independent Ethics
Committee/Institutional Review Board (IEC/IRB) that approved the protocol unless otherwise
required and documented by the IEC/IRB. A SUSAR will be reported to regulatory authorities
unblinded. Participating investigators and IEC/IRB will receive a blinded SUSAR summary,
unless otherwise specified.
8.3.5. 
Pregnancy
All initial reports of pregnancy in participants or partners of male participants must be reported to
the sponsor by the study site personnel within 24 hours of their knowledge of the event using the
appropriate pregnancy notification form. Abnormal pregnancy outcomes (eg, spontaneous
abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) are considered SAEs and
must be reported using an SAE reporting form. If a participant becomes pregnant during the study,
a determination regarding study vaccination discontinuation must be made by the investigator in
consultation with the sponsor.
Follow-up information regarding the outcome of the pregnancy will be required.
If the partner of a male participant becomes pregnant during the study, follow-up information
regarding the outcome of the pregnancy will be requestedupon the consent provided by the partner.
8.3.6. 
Adverse Events of Special Interest
AESIs (including potential AESIs) are significant AEs that are judged to be of special interest
because of clinical importance, known or suspected class effects, or based on nonclinical signals.
AESIs and potential AESIs will be carefully monitored during the study by the sponsor.
AESIs and potential AESIs must be reported to the sponsor within 24 hours of awareness
irrespective of seriousness (ie, serious and nonserious AEs) or causality following the procedure
described above for SAEs.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
73
Status: Approved,  Date: 22 December 2021
AESIs must be reported using the AESI form in the eCRF using the eCRF completion guidelines.
Specific requirements for the AESI are described below.
8.3.6.1. 
Thrombosis with Thrombocytopenia Syndrome
As described in Section 2.2, TTS has been observed following vaccination with Janssen COVID
vaccine and is considered to be an AESI in this study. TTS is a syndrome characterized by a
combination of both a thrombotic event and thrombocytopenia. (American Society of Hematology
2021; Brighton Collaboration 2021)
Because this syndrome is rare and not completely understood, all cases of thrombosis and/or
thrombocytopenia will be considered a potential case of TTS and should be reported to the sponsor
within 24 hours of awareness using the AESI form. Each potential AESI will be reviewed to
identify a TTS case. A potential TTS case is defined as:
 
Thrombotic events: suspected deep vessel venous or arterial thrombotic events as detailed in
Section 10.7, Appendix 7,
and/or
 
Thrombocytopenia, defined as platelet count below LLN for the testing laboratory
Symptoms, signs, or conditions suggestive of a thrombotic event or thrombocytopenia should be
recorded and reported as a potential AESI even if the final or definitive diagnosis has not yet been
determined, and alternative diagnoses have not yet been eliminated or shown to be less likely.
Follow-up information and final diagnoses, if applicable, should be submitted to the sponsor as
soon as they become available.
In the event of thrombocytopenia, study site personnel should report the absolute value for the
platelet count and the reference range for the laboratory test used.
For either a thrombotic event or thrombocytopenia, complete blood count including platelet count
and a coagulation profile available from participant’s medical records should be entered in the
eCRF. In case these results are not available at the time of the event report in the eCRF, the study
site is required to obtain a complete blood count including platelet count and a coagulation profile.
Tests should be performed at the local laboratory. Repeat testing may be requested for
confirmation upon sponsor discretion.
Aliquots of serum samples collected for immunogenicity test can be reconverted for participant’s
safety purposes upon sponsor request.
Refer to Appendix 2, Table 20 for a non-exhaustive list of required tests.
In addition, the sponsor requires additional blood samples to be obtained as soon as possible after
the potential AESI onset, either during an ad hoc unscheduled visit or the next scheduled visit,
whichever comes first. Refer to Appendix 2, Table 21 for a non-exhaustive list of laboratory tests
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
74
Status: Approved,  Date: 22 December 2021
that may be requested by the sponsor in case of potential AESI reporting for which these additional
samples may be used.
AESIs, including potential AESIs, will require enhanced data collection and evaluation. Every
effort should be made to report as much information as possible about the event to the sponsor in
a reasonable timeframe. Relevant laboratory results can be entered on the AESI form in the eCRF,
using the eCRF completion guidelines.
If the investigator is not the treating physician, every effort should be made to collect the
information requested in the form from the treating physician and enter the available information
in the eCRF.
If an event meets the criteria for an SAE (Section 10.4.1), it should be reported using the same
process as for other SAEs.
Treatment and Follow-up Recommendation
The medical management of thrombotic events with thrombocytopenia is different from the
management of isolated thromboembolic diseases. Study site personnel and/or treating physicians
should follow available guidelines for treatment of thrombotic thrombocytopenia (eg, American
Society of Hematology 2021; British Society for Haematology 2021; CDC 2021). The use of
heparin may be harmful and alternative treatments may  be needed. Consultation with a
hematologist is strongly recommended.
8.4. 
Pharmacokinetics
Pharmacokinetics are not evaluated in this study.
8.5. 
Genetics and Pharmacogenomics
Genetics and pharmacogenomics are not evaluated in this study.
8.6. 
Biomarkers
Blood will be drawn at selected timepoints during the study for evaluation of biomarkers (may
include, but not limited to RNA-seq including TCR and BCR sequencing) related to vaccine
immunogenicity, as indicated in the Schedule of Activities. Analyses of biomarkers may be
conducted at the sponsor’s discretion and may be reported separately from this study.
8.7. 
Medical Resource Utilization and Health Economics
Medical Resource Utilization and Health Economics parameters are not evaluated in this study.
9. 
STATISTICAL CONSIDERATIONS
Statistical analysis will be done by the sponsor or under the authority of the sponsor. A general
description of the statistical methods to be used to analyze the immunogenicity and safety data is
outlined below. Specific details will be provided in the statistical analysis plan.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
75
Status: Approved,  Date: 22 December 2021
9.1. 
Statistical Hypotheses
No formal hypothesis will be tested.
9.2. 
Sample Size Determination
9.2.1. 
Initial Safety Cohort (Cohort 1)
The number of participants chosen for the initial safety cohort will provide a preliminary safety
assessment. Participants receiving placebo and participants receiving the Ad26/protein preF RSV
vaccine as used in studies VAC18193RSV2001 and VAC18193RSV3001 are included for
blinding and safety purposes and will provide additional control specimens for immunogenicity
assays.
While mild to moderate vaccine reactions (local injection site, systemic responses) are expected,
AEs that preclude further vaccine administration or more serious ones that would limit product
development are not anticipated.
Table 13 provides the probability of observing at least one AE in a group of the considered sample
size given several true AE rates.
Table 13: 
Probability of Observing at Least One AE in a Group of the Considered Sample Size Given
Several True AE Rates
True AE Rate (%)
Probability of Observing at Least One AE in N Participants (%)
N=2 
N=3 
N=4 
N=12
0.5 
1.0%  
1.5%  
2.0%  
5.8%
1 
2.0%  
3.0% 
3.9% 
11.4%
2.5 
4.9% 
7.3% 
9.6% 
26.2%
10 
19.0%  
27.1% 
34.3% 
71.8%
25 
43.8% 
57.8%  
68.4%  
96.8%
50 
75.0%  
87.5%  
93.8%  
100%
AE = adverse event; N = number of participants.
9.2.2. 
Vaccine Components Selection Cohort (Cohorts 1 and 2)
The objective is to compare immunomarker levels, including virus neutralizing antibody (VNA)
levels, of the various combinations of vaccine components (Arms 1a, and Arms 2 to 9) to Arm 1b
(1×1011 vp Ad26.RSV-A.preF/150 µg RSV-A preF protein), based on the estimated geometric
mean titer (GMT) ratios and corresponding 95% confidence intervals (CIs). With a sample size of
55 evaluable participants per arm, and assuming a standard deviation for RSV-A2 VNA of 1.3a on
the log2 scale, the precision of the estimated GMTs will be ~0.36 on the log2 scale. To account for
approximately 10% dropout, a sample size of 60 participants per arm will be used.
a Based on Day 29 VNA results from study VAC18193RSV1004: Cohort 2, Groups 14+17 and Cohort 3,
Groups 19+20
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
76
Status: Approved,  Date: 22 December 2021
Table 14 shows the estimated 95% CIs for several GMT ratios, assuming a standard deviation for
RSV-A2 VNA of 1.3 on the log2 scale for 55 participants for immunogenicity evaluation per arm.
Note: Per arm, immunogenicity data from the initial safety cohort (Cohort 1) will be combined
with those from Cohort 2 to support vaccine components selection, as applicable.
Table 14: 
Estimated 95% CIs, by Observed GMT Ratio of VNA Levels.
N per Arm  
Observed GMT Ratio 
Corresponding 95% CI
55 
1 
[0.71; 1.41]
1.2 
[0.85; 1.69]
1.5 
[1.07; 2.11]
CI = confidence interval; GMT = geometric mean titer; N = number of participants.
9.2.3. 
Expanded Safety Cohort (Cohort 3)
The expanded safety cohort (Cohort 3) should provide sufficient safety data on the selected vaccine
formulation to support late-stage development if the immunogenicity results of Cohort 2 are
satisfactory.
Table 15 shows the probabilities of observing at least one AE in the expanded safety cohort with
150 participants per vaccine formulation, 50 participants receiving placebo, and 50 participants
receiving 1×1011 vp Ad26.RSV-A.preF/ 150 µg RSV-A preF protein, at given true AE rates. This
table shows that the current numbers give a reasonable probability to also observe less frequent
events in the active arms in this cohort. Combining the 60 participants from Cohorts 1 and 2 and
150 participants from Cohort 3 for the selected vaccine formulation results in 210 participants for
this formulation.
Table 15: 
Probability of Observing at Least One Adverse Event in the Expanded Safety Cohort (Cohort 3)
at a Given True Adverse Event Rate
True AE Rate (%)
Probability of Observing at Least One AE in N Participants (%)
N=50 
N=60 
N=150 
N=210
0.5 
22.2% 
26.0%  
52.9%  
65.1%
1 
39.5%  
45.3% 
77.9% 
87.9%
2.5 
71.8%  
78.1%  
97.8% 
99.5%
10 
99.5%  
99.8% 
100.0%  
100.0%
25 
100.0%  
100.0%  
100.0%  
100.0%
50 
100.0%  
100.0%  
100.0%  
100.0%
AE = adverse event; N = number of participants.
The observation of 0 events (eg, SAEs) is associated with 95% confidence that the true event rate
is below the rates specified in Table 16 for the considered number of participants.
Table 16: 
Upper Limit of the 1-sided 95% CI if no Cases are Observed for Different Sample Sizes
Sample Size 
N=50 
N=60 
N=150 
N=210
Upper Limit 1-sided 95% CI 
5.8%  
4.9% 
2.0%  
1.4%
CI = confidence interval; N = number of participants.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
77
Status: Approved,  Date: 22 December 2021
9.2.4. 
Revaccination and Durability Cohort (Cohort 4)
The revaccination and durability cohort (Cohort 4) should provide sufficient data on the selected
vaccine formulation to support future clinical development. To have approximately 150
participants available per arm for evaluating durability of immune response at end of the 5-year
study period, and assuming a dropout rate of 10% per year, approximately 300 participants per
arm are needed.
Corresponding arms of Cohort 3 and 4 will be combined (Arm 11a [Cohort 3] + Arm 14 [Cohort 4],
and Arm 11b [Cohort 3] + Arm 15 [Cohort 4], respectively) for the evaluation of durability of the
immune response. Having 75 participants in Arm 11a and 11b in Cohort 3 requires enrollment of
225 participants in Arms 14 and 15 in Cohort 4. Enrollment of 90 participants in Arm 16 (placebo)
results in enrollment of in total 540 participants in Cohort 4. Placebo arms from Cohort 3 and 4,
Arm 12 and Arm 16, respectively, will be combined in the analyses, as applicable.
Table 17 shows the probabilities of observing at least one AE for the selected formulation for
future clinical development, at given true AE rates. This table shows that the current numbers give
a reasonable probability to also observe less frequent events in the active arms in this cohort.
Table 17: 
Probability of Observing at Least One Adverse Event for the Selected Formulation for Future
Clinical Development, at a Given True Adverse Event Rate
True AE Rate (%)
Probability of Observing at Least One AE in N Participants (%)
N=150 
N=225 
N=300 
N=450 
N=600
0.5 
52.9%  
67.6%  
77.8% 
89.5%  
95.1%
1 
77.9% 
89.6% 
95.1%  
98.9% 
99.8%
2.5 
97.8% 
99.7% 
99.9% 
100.0%  
100.0%
10 
100.0%  
100.0%  
100.0%  
100.0%  
100.0%
25 
100.0%  
100.0%  
100.0%  
100.0%  
100.0%
50 
100.0%  
100.0%  
100.0%  
100.0%  
100.0%
AE = adverse event; N = number of participants.
The observation of 0 events (eg, SAEs) is associated with 95% confidence that the true event rate
is below the rates specified in Table 18 for the considered number of participants.
Table 18: 
Upper Limit of the 1-sided 95% CI if no Cases are Observed for Different Sample Sizes
Sample Size 
N=150 
N=225 
N=300 
N=450 
N=600
Upper Limit 1-sided 95% CI 
2.0%  
1.3%  
1.0%  
0.7% 
0.5%
CI = confidence interval; N = number of participants.
9.3. 
Populations for Analysis Sets
Vaccine assignment will follow the as-treated principle.
For purposes of analysis, the following populations are defined:
The Full Analysis (FA) Set will include all participants who received the study vaccine, regardless
of the occurrence of protocol deviations. All safety and participant information analyses will be
based on the FA Set.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
78
Status: Approved,  Date: 22 December 2021
The Per-protocol Immunogenicity (PPI) Set will include all randomized participants who received
the planned study vaccine(s)and for whom immunogenicity data are available. Samples taken after
a participant experiences a major protocol deviation expected to impact the immunogenicity
outcomes will be excluded from the PPI analysis.
The analysis of all immunogenicity endpoints will be based on the PPI Set. For key tables,
sensitivity immunogenicity analyses might also be performed on the FA Set.
9.4. 
Statistical Analyses
The statistical analysis plan will be finalized prior to sponsor unblinding of the locked database
for the primary analysis and it will include a more technical and detailed description of the
statistical analyses described in this section. This section is a summary of the planned statistical
analyses of the most important endpoints including primary and key secondary endpoints.
9.4.1. 
General Considerations
The primary analysis will be performed when all participants in Cohort 1 and Cohort 2 have
completed their 28-day post-vaccination visit or discontinued earlier.
Analysis populations are defined in Section 9.3. Planned analyses are defined in Section 9.5.
9.4.2. 
Participant Information
For all participants, demographic characteristics (eg, age, height, body weight, body mass index,
race, and gender) and other baseline characteristics will be tabulated and summarized
descriptively.
9.4.3. 
Immunogenicity Analyses
Immunogenicity data of corresponding arms from Cohort 1 and Cohort 2 will be combined in all
analyses. Immunogenicity data of corresponding arms from Cohort 3 and Cohort 4 will be
combined as applicable.
Continuous variables will be summarized descriptively. For continuous parameters, descriptive
statistics of the actual values will be calculated at all timepoints, including geometric mean with
95% CI, median and quartiles, as applicable. Additionally, geometric mean fold rises from baseline
and corresponding 95% CIs might be calculated.
For combined primary endpoint data of Cohort 1 and Cohort 2, geometric mean ratios between
each active arm and Arm 1b will be calculated at all available timepoints, with corresponding 95%
CI, as applicable. For Cohort 3, Arms 11a and 11b will be combined and the active arms will be
compared to each other at all available timepoints up to 1 year after vaccination on Day 1, by
means of geometric mean ratios with corresponding 95% CI. For durability and revaccination
evaluation Arm 11a (Cohort 3) and Arm 14 (Cohort 4) will be combined, Arm 11b (Cohort 3) and
Arm 15 (Cohort 4) will be combined, and Arm 12 (Cohort 3) and Arm 16 (Cohort 4) will be
combined.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
79
Status: Approved,  Date: 22 December 2021
For immunogenicity analyses, baseline is considered as the last assessment pre-vaccination.
Graphical representations of immunologic parameters will be made as applicable.
Geometric means per arm, and geometric mean ratios between active arms, with corresponding
95% CIs will be estimated via an analysis of variance (ANOVA) including all active arms, using
log-transformed post-vaccination immune parameter response as dependent variable and study
arm as independent variable. The means and differences in mean and CIs will be back-transformed
(by exponentiation) to CIs around a GMT or geometric mean titer ratio (GMR). This analysis will
be performed for all available assays and all time points, separately per assay. Data of the same
arms form different cohorts will be combined, as applicable.
As a sensitivity analysis, the ANOVA may also be performed adjusting for the respective baseline
titers, by including baseline titer as additional covariate.
For categorical variables, frequency tables will be presented.
9.4.4. 
Safety Analyses
No formal statistical testing of safety data is planned. Safety data will be analyzed descriptively
by cohort and study arm, and by group (pooled over cohorts, as applicable). All safety analyses
will be made on the FA Set.
Adverse Events
The verbatim terms used in the eCRF by investigators to identify AEs will be coded using the
Medical Dictionary for Regulatory Activities (MedDRA). All reported AEs with onset during the
active phase (ie, AEs occurring after vaccination up to 28 days post-vaccination) or AEs present
before the active phase but worsening during the active phase, and all SAEs and AESIs will be
included in the analysis. For each AE, the percentage of participants who experience at least
1 occurrence of the given event will be summarized by intervention group.
Summaries, listings, datasets, or participant narratives may be provided, as appropriate, for those
participants who die, who discontinue intervention due to an AE, or who experience a severe AE,
an AESI, an SAE or a COVID-19 infection.
Solicited local (at injection site) and systemic AEs will be summarized descriptively. The number
and percentages of participants with at least one solicited local (at injection site) or systemic
adverse event will be presented. The frequencies by vaccine group as well as frequencies according
to severity and duration will be described for solicited AEs. Frequencies of unsolicited AEs,
separately for all and vaccination-related only, will be presented by System Organ Class and
preferred term, while those of solicited AEs will be presented only by preferred term.
Clinical Laboratory Tests
Laboratory abnormalities will be determined according to the FDA toxicity grading tables (see
Appendix 6), or in accordance with the normal ranges for the clinical laboratory parameter if no
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
80
Status: Approved,  Date: 22 December 2021
grades are available. Any laboratory value shown as a “graded” value in the FDA table that is
within laboratory normal ranges will not be graded for severity.
Vital Signs
Vital signs including temperature, heart rate, respiratory rate, and blood pressure (systolic and
diastolic) will be summarized over time, using descriptive statistics and/or graphically. The
percentage of participants with values beyond clinically important limits will be summarized.
Physical Examinations
Physical examination findings pre-vaccination will be summarized per vaccine administration. A
listing of the abnormalities will be made.
9.4.5. 
Other Analyses
Biomarker data analysis may be conducted at the sponsor’s discretion and may be reported
separately from this study.
9.5. 
Planned Analyses
The following analyses are planned:
 
Primary analysis: 28 days post-vaccination safety and immunogenicity analysis. This analysis
will be performed when all participants in Cohort 1 and Cohort 2 have completed their 28-day
post-vaccination visit. Data from corresponding arms from the 2 cohorts will be combined.
The goal of this analysis will be to select the vaccine formulation to be used in Cohort 3.
 
Interim analyses:
 
6-month post-vaccination safety and immunogenicity analysis for Cohorts 1 and 2.
Available safety and immunogenicity data of all participants in Cohort 1 and Cohort 2 up
to the Day 185 follow-up visit post-vaccination will be included in the analysis. This
analysis may include immunogenicity data available from additional timepoints.
 
1-year post-vaccination immunogenicity analysis for Cohorts 1 and 2. Immunogenicity
data of all participants in Cohort 1 and Cohort 2 up to (and including) the 1-year follow-
up visit post-vaccination will be included in the analysis.
 
28 days post-vaccination safety and immunogenicity analysis for Cohort 3. This analysis
will be performed when all participants in Cohort 3 have completed their 28-day post-
vaccination visit.
 
28 days post-vaccination safety and immunogenicity analysis for Cohort 4. This analysis
will be performed when all participants in Cohort 4 have completed their 28-day post-
vaccination visit.
 
6-month post first vaccination safety and immunogenicity analysis for Cohorts 3 and 4.
This interim analysis will include all safety and immunogenicity data from all participants
in Cohorts 3 and 4, collected up to (and including) the 6-months follow-up visit post
Day 1 vaccination.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
81
Status: Approved,  Date: 22 December 2021
 
28 days post revaccination safety and immunogenicity analysis for Cohorts 3 and 4. This
interim analysis will include all safety and immunogenicity data from all participants in
Cohorts 3 and 4, collected up to (and including) the 28-day post-revaccination visit.
 
Yearly follow-up analyses until 3 years post first vaccination in Cohorts 1 and 2 and until
5 years post first vaccination in Cohort 3 (Arms 11a, 11b and 12) and Cohort 4. These
analyses will include immunogenicity and safety data up to the 2-year follow-up visit
post Day 1 vaccination, the 3-year follow-up visit post Day 1 vaccination, the 4-year
follow-up visit post-Day 1 vaccination (applicable for Cohort 3 [Arms 11a, 11b and 12]
and Cohort 4 only), and 5-year follow-up visit post Day 1 vaccination (applicable for
Cohort 3 [Arms 11a, 11b and 12] and Cohort 4 only).
 
Final analysis: immunogenicity analysis and safety data up to study end. This analysis will be
performed on unblinded data.
Additional interim analyses may be performed during the study for the purpose of informing future
vaccine development-related decisions in a timely manner, or upon health authority request. If they
occur, these unplanned interim analyses may replace or be combined with planned analyses,
depending on the timing.
For any planned or additional analysis performed before the final analysis, the sponsor will be
unblinded at the time of the analysis, while study site personnel and participants will remain
blinded until the end of the study.
The statistical analysis plan will describe the planned interim analyses in greater detail.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
82
Status: Approved,  Date: 22 December 2021
10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Abbreviations
Ad26 
adenovirus type 26
ADCC  
antibody-dependent cell-mediated cytotoxicity
ADCP  
antibody-dependent cell-mediated phagocytosis
AE 
adverse event
AESI 
adverse event of special interest
ANOVA  
analysis of variance
BCR  
B-cell receptor
CI 
confidence interval
COVID-19 
coronavirus disease-2019
CTM  
Clinical Trial Manager
CVST  
cerebral venous sinus thrombosis
DNA  
deoxyribonucleic acid
DRC 
Data Review Committee
eCRF  
electronic case report form
eDC  
electronic data capture
ELISA  
enzyme-linked immunosorbent assay
ELISpot 
enzyme-linked immunospot
F protein  
fusion protein
FA 
Full Analysis
FDA  
(United States) Food and Drug Administration
FOIA  
Freedom of Information Act
GCP  
Good Clinical Practice
GMR  
geometric mean titer ratio
GMT  
geometric mean titer
HITT  
heparin-induced thrombocytopenia and thrombosis
HIV  
human immunodeficiency virus
IB  
Investigator’s Brochure
ICF  
informed consent form
ICH  
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use
ICMJE 
International Committee of Medical Journal Editors
IEC  
Independent Ethics Committee
Ig 
immunoglobulin
IM  
intramuscular
IMP  
Investigational Medicinal Product
IRB  
Institutional Review Board
IWRS  
interactive web response system
LLN  
lower limit of normal
LRTD  
lower respiratory tract disease
LTM  
Local Trial Manager
MedDRA  
Medical Dictionary for Regulatory Activities
ML 
medical leader
MSO  
medical safety officer
PBMC  
peripheral blood mononuclear cell
PCC  
protocol clarification communication
PI 
principal investigator
post-F 
post-fusion
PPI 
Per-protocol Immunogenicity
PQC  
Product Quality Complaint
pre-F 
prefusion conformation-stabilized F protein
RSV  
respiratory syncytial virus
SAE 
serious adverse event
SAP  
statistical analysis plan
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
83
Status: Approved,  Date: 22 December 2021
SARS-CoV-2 
Severe Acute Respiratory Syndrome Coronavirus-2
SoA  
Schedule of Activities
SRP  
study responsible physician
SRS  
study responsible scientist
SUSAR  
suspected unexpected serious adverse reaction
TCR  
T-cell receptor
TTS  
thrombosis with thrombocytopenia syndrome
VH  
heavy chain variable domain
VL 
light chain variable domain
VNA  
virus neutralizing antibody
vp 
viral particles
NCT05327816


NCT05327816


NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
86
Status: Approved,  Date: 22 December 2021
10.3. Appendix 3: Regulatory, Ethical, and Study Oversight Considerations
10.3.1. 
Regulatory and Ethical Considerations
Investigator Responsibilities
The investigator is responsible for ensuring that the study is performed in accordance with the
protocol, current ICH guidelines on Good Clinical Practice (GCP), and applicable regulatory and
country-specific requirements.
Good Clinical Practice is an international ethical and scientific quality standard for designing,
conducting, recording, and reporting studies that involve the participation of human participants.
Compliance with this standard provides public assurance that the rights, safety, and well-being of
study participants are protected, consistent with the principles that originated in the Declaration of
Helsinki, and that the study data are credible.
Protocol Clarification Communications
If text within a final approved protocol requires clarification (eg, current wording is unclear or
ambiguous) that does not change any aspect of the current study conduct, a protocol clarification
communication (PCC) may be prepared. The PCC Document will be communicated to the
Investigational Site, Site Monitors, Local Trial Managers (LTMs), Clinical Trial Managers
(CTMs), and/or Contract Research Organizations (CROs) who will ensure that the PCC
explanations are followed by the investigators.
The PCC Document may be shared by the sites with Independent Ethics Committees/Institutional
Review Boards (IECs/IRBs) per local regulations.
The PCC Documents must NOT be used in place of protocol amendments, but the content of the
PCC Document must be included in any future protocol amendments.
Protocol Amendments
Neither the investigator nor the sponsor will modify this protocol without a formal amendment by
the sponsor. All protocol amendments must be issued by the sponsor, and signed and dated by the
investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or
when the relevant competent authority has raised any grounds for non-acceptance, except when
necessary to eliminate immediate hazards to the participants, in which case the amendment must
be promptly submitted to the IEC/IRB and relevant competent authority. Documentation of
amendment approval by the investigator and IEC/IRB must be provided to the sponsor. When the
change(s) involve only logistic or administrative aspects of the study, the IEC/IRB (where
required) only needs to be notified.
During the study, in situations where a departure from the protocol is unavoidable, the investigator
or other physician in attendance will contact the appropriate sponsor representative listed in the
Contact Information page(s), which will be provided as a separate document. Except in emergency
situations, this contact must be made before implementing any departure from the protocol. In all
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
87
Status: Approved,  Date: 22 December 2021
cases, contact with the sponsor must be made as soon as possible to discuss the situation and agree
on an appropriate course of action. The data recorded in the eCRF and source documents will
reflect any departure from the protocol, and the source documents will describe this departure and
the circumstances requiring it.
Regulatory Approval/Notification
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities
in each respective country, if applicable. A study may not be initiated until all local regulatory
requirements are met.
Required Prestudy Documentation
The following documents must be provided to the sponsor before shipment of study vaccine to the
study site:
 
Protocol and amendment(s), if any, signed and dated by the principal investigator
 
A copy of the dated and signed (or sealed, where appropriate per local regulations), written
IEC/IRB approval of the protocol, amendments, ICF, any recruiting materials, and if
applicable, participant compensation programs. This approval must clearly identify the
specific protocol by title and number and must be signed (or sealed, where appropriate per
local regulations) by the chairman or authorized designee.
 
Name and address of the IEC/IRB, including a current list of the IEC/IRB members and their
function, with a statement that it is organized and operates according to GCP and the
applicable laws and regulations. If accompanied by a letter of explanation, or equivalent, from
the IEC/IRB, a general statement may be substituted for this list. If an investigator or a
member of the study site personnel is a member of the IEC/IRB, documentation must be
obtained to state that this person did not participate in the deliberations or in the vote/opinion
of the study.
 
Regulatory authority approval or notification, if applicable
 
Signed and dated statement of investigator (eg, Form FDA 1572), if applicable
 
Documentation of investigator qualifications (eg, curriculum vitae)
 
Completed investigator financial disclosure form from the principal investigator, where
required
 
Signed and dated clinical trial agreement, which includes the financial agreement
 
Any other documentation required by local regulations
The following documents must be provided to the sponsor before enrollment of the first
participant:
 
Completed investigator financial disclosure forms from all subinvestigators
 
Documentation of subinvestigator qualifications (eg, curriculum vitae)
 
Name and address of any local laboratory conducting tests for the study, and a dated copy of
current laboratory normal ranges for these tests, if applicable
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
88
Status: Approved,  Date: 22 December 2021
 
Local laboratory documentation demonstrating competence and test reliability
(eg, accreditation/license), if applicable
Independent Ethics Committee or Institutional Review Board
Before the start of the study, the investigator (or sponsor where required) will provide the IEC/IRB
with current and complete copies of the following documents (as required by local regulations):
 
Final protocol and, if applicable, amendments
 
Sponsor-approved ICF (and any other written materials to be provided to the participants)
 
IB (or equivalent information) and amendments/addenda
 
Sponsor-approved participant recruiting materials
 
Information on compensation for study-related injuries or payment to participants for
participation in the study, if applicable
 
Investigator's curriculum vitae or equivalent information (unless not required, as documented
by the IEC/IRB)
 
Information regarding funding, name of the sponsor, institutional affiliations, other potential
conflicts of interest, and incentives for participants
 
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after the IEC/IRB has given full approval of the final protocol,
amendments (if any, excluding the ones that are purely administrative, with no consequences for
participants, data or study conduct, unless required locally), the ICF, applicable recruiting
materials, and participant compensation programs, and the sponsor has received a copy of this
approval. This approval letter must be dated and must clearly identify the IEC/IRB and the
documents being approved.
During the study the investigator (or sponsor where required) will send the following documents
and updates to the IEC/IRB for their review and approval, where appropriate:
 
Protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or study conduct)
 
Revision(s) to ICF and any other written materials to be provided to participants
 
If applicable, new or revised participant recruiting materials approved by the sponsor
 
Revisions to compensation for study-related injuries or payment to participants for
participation in the study, if applicable
 
New edition(s) of the IB and amendments/addenda
 
Summaries of the status of the study at intervals stipulated in guidelines of the IEC/IRB (at
least annually)
 
Reports of AEs that are serious, unlisted/unexpected, and associated with the study vaccine
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
89
Status: Approved,  Date: 22 December 2021
 
New information that may adversely affect the safety of the participants or the conduct of the
study
 
Deviations from or changes to the protocol to eliminate immediate hazards to the participants
 
Report of deaths of participants under the investigator's care
 
Notification if a new investigator is responsible for the study at the site
 
Development Safety Update Report and Line Listings, where applicable
 
Any other requirements of the IEC/IRB
For all protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or study conduct), the amendment and applicable ICF revisions
must be submitted promptly to the IEC/IRB for review and approval before implementation of the
change(s).
At least once a year, the IEC/IRB will be asked to review and reapprove this study, where required.
At the end of the study, the investigator (or sponsor where required) will notify the IEC/IRB about
the study completion.
Country Selection
This study will only be conducted in those countries where the intent is to launch or otherwise help
ensure access to the developed product if the need for the product persists, unless explicitly
addressed as a specific ethical consideration in Section  4.2.1, Study-Specific Ethical Design
Considerations.
Other Ethical Considerations
For study-specific ethical design considerations, refer to Section 4.2.1.
10.3.2. 
Financial Disclosure
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial
information in accordance with local regulations to allow the sponsor to submit complete and
accurate financial certification or disclosure statements to the appropriate regulatory authorities.
Investigators are responsible for providing information on financial interests during the study and
for 1 year after completion of the study.
Refer to Required Prestudy Documentation (above) for details on financial disclosure.
10.3.3. 
Informed Consent Process
Each participant must give consent according to local requirements after the nature of the study
has been fully explained. The ICF(s) must be signed before performance of any study-related
activity. The ICF(s) that is/are used must be approved by both the sponsor and by the reviewing
IEC/IRB and be in a language that the participant can read and understand. The informed consent
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
90
Status: Approved,  Date: 22 December 2021
must be in accordance with principles that originated in the Declaration of Helsinki, current ICH
and GCP guidelines, applicable regulatory requirements, and sponsor policy.
Before enrollment in the study, the investigator or an authorized member of the study site personnel
must explain to potential participants the aims, methods, reasonably anticipated benefits, and
potential hazards of the study, and any discomfort participation in the study may entail. Participants
will be informed that their participation is voluntary and that they may withdraw consent to
participate at any time. They will be informed that choosing not to participate will not affect the
care the participant will receive. Finally, they will be told that the investigator will maintain a
participant identification register for the purposes of long-term follow-up if needed and that their
records may be accessed by health authorities and authorized sponsor personnel without violating
the confidentiality of the participant, to the extent permitted by the applicable law(s) or regulations.
By signing the ICF the participant is authorizing such access. It also denotes that the participant
agrees to allow his or her study physician to recontact the participant for the purpose of obtaining
consent for additional safety evaluations, if needed.
The participant will be given sufficient time to read the ICF and the opportunity to ask questions.
After this explanation and before entry into the study, consent must be appropriately recorded by
means of the participant's personally dated signature. After having obtained the consent, a copy of
the ICF must be given to the participant.
Participants who are rescreened are required to sign a new ICF.
If the participant is unable to read or write, an impartial witness should be present for the entire
informed consent process (which includes reading and explaining all written information) and
must personally date and sign the ICF after the oral consent of the participant is obtained.
10.3.4. 
Data Protection
Privacy of Personal Data
The collection and processing of personal data from participants enrolled in this study will be
limited to those data that are necessary to fulfill the objectives of the study.
These data must be collected and processed with adequate precautions to ensure confidentiality
and compliance with applicable data privacy protection laws and regulations. Appropriate
technical and organizational measures to protect the personal data against unauthorized disclosures
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place.
Sponsor personnel whose responsibilities require access to personal data agree to keep the identity
of participants confidential.
The informed consent obtained from the participant includes information about, and where
required per applicable regulations, explicit consent for the processing of personal data and for the
investigator/institution to allow direct access to his or her original medical records (source
data/documents) for study-related monitoring, audit, IEC/IRB review, and regulatory inspection.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
91
Status: Approved,  Date: 22 December 2021
The informed consent also provides information to address the lawful transfer of the data to other
entities and to other countries.
The participant has the right to request through the investigator access to his or her personal data
and the right to request rectification of any data that are not correct or complete, or make requests
concerning his or her personal data in accordance with applicable data protection law. Reasonable
steps will be taken to respond to such a request, taking into consideration the nature of the request,
the conditions of the study, and the applicable laws and regulations.
In the event of a data security breach, the sponsor will apply measures to adequately manage and
mitigate possible adverse effects taking into consideration the nature of the data security breach as
necessary to address other obligations such as notifying appropriate authorities in accordance with
applicable data protection law.
10.3.5. 
Long-Term Retention of Samples for Additional Future Research
Samples collected in this study may be stored for up to 15 years (or according to local regulations)
for additional research. Samples will only be used to understand Ad26.RSV-A.preF, RSV-A preF
protein, Ad26.RSV-B.preF2, and RSV-B preF protein, to understand RSV and other respiratory
pathogens, and to develop tests/assays related to understand Ad26.RSV-A.preF, RSV-A preF
protein, Ad26.RSV-B.preF2, and RSV-B preF protein, to understand RSV and other respiratory
pathogens. The research may begin at any time during the study or the post-study storage period.
Stored samples will be coded throughout the sample storage and analysis process and will not be
labeled with personal identifiers. Participants may withdraw their consent for their samples to be
stored for research (refer to Section 7.2.1, Withdrawal From the Use of Research Samples).
10.3.6. 
Committees Structure
All potential AESI cases will be reviewed to determine if they meet the definition of TTS (see
Section 8.3.6.1). A Charter will be developed to describe the roles and responsibilities of the
Committee appointed to perform this review.
Data Review Committee
An internal DRC will be established to evaluate safety and reactogenicity data, including interim
safety and reactogenicity data of Cohort 1, to ensure the continuing safety of the participants
enrolled in this study. Ad-hoc meetings will be convened in case any of the pre-specified study
vaccination pausing rules are met. This committee will consist of at least one medical expert in the
relevant therapeutic area and at least one statistician; committee membership responsibilities,
authorities, and procedures will be documented in its charter. After the review, the DRC will make
recommendations regarding the continuation of the study.
10.3.7. 
Publication Policy/Dissemination of Clinical Study Data
All information, including but not limited to information regarding Ad26.RSV-A.preF, RSV-A
preF protein, Ad26.RSV-B.preF2, and RSV-B preF protein or the sponsor's operations (eg, patent
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
92
Status: Approved,  Date: 22 December 2021
application, formulas, manufacturing processes, basic scientific data, prior clinical data,
formulation information) supplied by the sponsor to the investigator and not previously published,
and any data, generated as a result of this study, are considered confidential and remain the sole
property of the sponsor. The investigator agrees to maintain this information in confidence and use
this information only to accomplish this study and will not use it for other purposes without the
sponsor's prior written consent.
The investigator understands that the information developed in the study will be used by the
sponsor in connection with the continued development of Ad26.RSV-A.preF, RSV-A preF
protein, Ad26.RSV-B.preF2, and RSV-B preF protein and thus may be disclosed as required to
other clinical investigators or regulatory agencies. To permit the information derived from the
clinical studies to be used, the investigator is obligated to provide the sponsor with all data obtained
in the study.
The results of the study will be reported in a Clinical Study Report generated by the sponsor and
will contain data from all study sites that participated in the study as per protocol. Recruitment
performance or specific expertise related to the nature and the key assessment parameters of the
study will be used to determine a coordinating investigator for the study. Results of analyses
performed after the Clinical Study Report has been issued will be reported in a separate report and
will not require a revision of the Clinical Study Report.
Study participant identifiers will not be used in publication of results. Any work created in
connection with performance of the study and contained in the data that can benefit from copyright
protection (except any publication by the investigator as provided for below) shall be the property
of the sponsor as author and owner of copyright in such work.
Consistent with Good Publication Practices and International Committee of Medical Journal
Editors (ICMJE) guidelines, the sponsor shall have the right to publish such primary (multicenter)
data and information without approval from the investigator. The investigator has the right to
publish study site-specific data after the primary data are published. If an investigator wishes to
publish information from the study, a copy of the manuscript must be provided to the sponsor for
review at least 60 days before submission for publication or presentation. Expedited reviews will
be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in
writing, the investigator will withhold such publication for up to an additional 60 days to allow for
filing of a patent application. In the event that issues arise regarding scientific integrity or
regulatory compliance, the sponsor will review these issues with the investigator. The sponsor will
not mandate modifications to scientific content and does not have the right to suppress information.
For multicenter study designs and sub-study approaches, secondary results generally should not
be published before the primary endpoints of a study have been published. Similarly, investigators
will recognize the integrity of a multicenter study by not submitting for publication data derived
from the individual study site until the combined results from the completed study have been
submitted for publication, within 18 months after the study end date, or the sponsor confirms there
will be no multicenter study publication. Authorship of publications resulting from this study will
be based on the guidelines on authorship, such as those described in the ICMJE Recommendations
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
93
Status: Approved,  Date: 22 December 2021
for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, which
state that the named authors must have made a significant contribution to the conception or design
of the work; or the acquisition, analysis, or interpretation of the data for the work; and drafted the
work or revised it critically for important intellectual content; and given final approval of the
version to be published; and agreed to be accountable for all aspects of the work in ensuring that
questions related to the accuracy or integrity of any part of the work are appropriately investigated
and resolved.
Registration of Clinical Studies and Disclosure of Results
The sponsor will register and disclose interim results of clinical studies as required by law. The
disclosure of the study results will be performed after the end of study in order to ensure the
statistical analyses are relevant.
10.3.8. 
Data Quality Assurance
Data Quality Assurance/Quality Control
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified
investigators and appropriate study sites, review of protocol procedures with the investigator and
study site personnel before the study, and periodic monitoring visits by the sponsor. Written
instructions will be provided for collection, handling, storage, and shipment of samples.
Guidelines for eCRF completion will be provided and reviewed with study site personnel before
the start of the study.
The sponsor may review the eCRF for accuracy and completeness during on-site monitoring visits
and after transmission to the sponsor; any discrepancies will be resolved with the investigator or
designee, as appropriate. After upload of the data into the study database they will be verified for
accuracy and consistency with the data sources.
10.3.9. 
Case Report Form Completion
Case report forms are prepared and provided by the sponsor for each participant in electronic
format. All data relating to the study must be recorded in the eCRF. All eCRF entries, corrections,
and alterations must be made by the investigator or authorized study site personnel. The
investigator must verify that all data entries in the eCRF are accurate and correct.
The study data will be transcribed by study site personnel from the source documents onto an
eCRF, if applicable. Study-specific data will be transmitted in a secure manner to the sponsor.
Worksheets may be used for the capture of some data to facilitate completion of the eCRF. Any
such worksheets will become part of the participant's source documents. Data must be entered into
the eCRF in English. The eCRF must be completed as soon as possible after a participant visit and
the forms must be available for review at the next scheduled monitoring visit.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
94
Status: Approved,  Date: 22 December 2021
If necessary, queries will be generated in the eDC tool. If corrections to a eCRF are needed after
the initial entry into the eCRF, this can be done in either of the following ways:
 Investigator and study site personnel can make corrections in the eDC tool at their own
initiative or as a response to an auto query (generated by the eDC tool).
 Sponsor or sponsor delegate can generate a query for resolution by the investigator and study
site personnel.
10.3.10. 
Source Documents
At a minimum, source documents consistent in the type and level of detail with that commonly
recorded at the study site as a basis for standard medical care must be available for the following:
participant identification, eligibility, and study identification; study discussion and date of signed
informed consent; dates of visits; results of safety and efficacy parameters as required by the
protocol; record of all AEs and follow-up of AEs; concomitant medication; intervention
receipt/dispensing/return records; study vaccine administration information; and date of study
completion and reason for early discontinuation of study vaccination or withdrawal from the study,
if applicable.
The author of an entry in the source documents must be identifiable.
The participant’s diary used to collect information regarding solicited signs and symptoms after
vaccination will be considered source data.
Specific details required as source data for the study and source data collection methods will be
reviewed with the investigator before the study and will be described in the monitoring guidelines
(or other equivalent document).
An eSource system may be utilized, which contains data traditionally maintained in a hospital or
clinic record to document medical care (eg, electronic source documents) as well as the clinical
study-specific data fields as determined by the protocol. This data is electronically extracted for
use by the sponsor. If eSource is utilized, references made to the eCRF in the protocol include the
eSource system but information collected through eSource may not be limited to that found in the
eCRF.
10.3.11. 
Monitoring
The sponsor will use a combination of monitoring techniques (central, remote, or on-site
monitoring)to monitor this study.
The sponsor will perform on-site monitoring visits as frequently as necessary. The monitor will
record dates of the visits in a study site visit log that will be kept at the study site. The first post-
initiation visit will be made as soon as possible after enrollment has begun. At these visits, the
monitor may  compare the data entered into the eCRF with the source documents
(eg, hospital/clinic/physician’s office medical records); a sample may be reviewed. The nature and
location of all source documents will be identified to ensure that all sources of original data
required to complete the eCRF are known to the sponsor and study site personnel and are accessible
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
95
Status: Approved,  Date: 22 December 2021
for verification by the sponsor study site contact. If electronic records are maintained at the study
site, the method of verification must be discussed with the study site personnel.
Direct access to source documents (medical records) must be allowed for the purpose of verifying
that the recorded data are consistent with the original source data. Findings from this review will
be discussed with the study site personnel. The sponsor expects that, during monitoring visits, the
relevant study site personnel will be available, the source documents will be accessible, and a
suitable environment will be provided for review of study-related documents. The monitor will
meet with the investigator on a regular basis during the study to provide feedback on the study
conduct.
In addition to on-site monitoring visits, remote contacts can occur. It is expected that during these
remote contacts, study site personnel will be available to provide an update on the progress of the
study at the site.
Central monitoring will take place for data identified by the sponsor as requiring central review.
10.3.12. 
On-Site Audits
Representatives of the sponsor's clinical quality assurance department may visit the study site at
any time during or after completion of the study to conduct an audit of the study in compliance
with regulatory guidelines and company policy. These audits will require access to all study
records, including source documents, for inspection. Participant privacy must, however, be
respected. The investigator and study site personnel are responsible for being present and available
for consultation during routinely scheduled study site audit visits conducted by the sponsor or its
designees.
Similar auditing procedures may also be conducted by agents of any regulatory body, either as part
of a national GCP compliance program or to review the results of this study in support of a
regulatory submission. The investigator must immediately notify the sponsor if he or she has been
contacted by a regulatory agency concerning an upcoming inspection.
10.3.13. 
Record Retention
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all eCRF
and all source documents that support the data collected from each participant, as well as all study
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical
Trial, and all study documents as specified by the applicable regulatory requirement(s). The
investigator/institution will take measures to prevent accidental or premature destruction of these
documents.
Essential documents must be retained until at least 2 years after the last approval of a marketing
application in an ICH region and until there are no pending or contemplated marketing applications
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical
development of the investigational product. These documents will be retained for a longer period
if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
96
Status: Approved,  Date: 22 December 2021
responsibility of the sponsor to inform the investigator/institution as to when these documents no
longer need to be retained.
If the responsible investigator retires, relocates, or for other reasons withdraws from the
responsibility of keeping the study records, custody must be transferred to a person who will accept
the responsibility. The sponsor must be notified in writing of the name and address of the new
custodian. Under no circumstance shall the investigator relocate or dispose of any study documents
before having obtained written approval from the sponsor.
If it becomes necessary for the sponsor or the appropriate regulatory authority to review any
documentation relating to this study, the investigator/institution must permit access to such reports.
10.3.14. 
Study and Site Start and Closure
First Act of Recruitment
The first participant screened is considered the first act of recruitment and it becomes the study
start date.
Study/Site Termination
The sponsor reserves the right to close the study site or terminate the study at any time for any
reason at the sole discretion of the sponsor. Study sites will be closed upon study completion. A
study site is considered closed when all required documents and study supplies have been collected
and a study site closure visit has been performed.
The investigator may initiate study site closure at any time, provided there is reasonable cause and
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the sponsor or investigator may include but are not
limited to:
 Failure of the investigator to comply with the protocol, the requirements of the IEC/IRB or
local health authorities, the sponsor's procedures, or GCP guidelines
 Inadequate recruitment of participants by the investigator
 Discontinuation of further study vaccine development
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
97
Status: Approved,  Date: 22 December 2021
10.4. Appendix 4: Adverse Events, Serious Adverse Events, Product Quality
Complaints, and Other Safety Reporting: Definitions and Procedures for
Recording, Evaluating, Follow-up, and Reporting
10.4.1. 
Adverse Event Definitions and Classifications
Adverse Event
An AE is any untoward medical occurrence in a clinical study participant administered a
pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have
a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended
sign (including an abnormal finding), symptom, or disease temporally associated with the use of a
medicinal (investigational or non-investigational) product, whether or not related to that medicinal
(investigational or non-investigational) product. (Definition per International Council on
Harmonisation [ICH])
This includes any occurrence that is new in onset or aggravated in severity or frequency from the
baseline condition, or abnormal results of diagnostic procedures, including laboratory test
abnormalities.
Note: For time period of sponsor’s AE collection, see All Adverse Events under Section 8.3.1.
Serious Adverse Event
An  SAE based on ICH and EU Guidelines on Pharmacovigilance for Medicinal Products for
Human Use is any untoward medical occurrence that at any dose:
 
Results in death
 
Is life-threatening
(The participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might have caused death if it were more severe.)
 
Requires inpatient hospitalization or prolongation of existing hospitalization
 
Results in persistent or significant disability/incapacity
 
Is a congenital anomaly/birth defect
 
Is a suspected transmission of any infectious agent via a medicinal product
 
Is Medically Important*
*Medical and scientific judgment must be exercised in deciding whether expedited reporting
is also appropriate in other situations, such as important medical events that may not be
immediately life-threatening or result in death or hospitalization but may jeopardize the
participant or may require intervention to prevent one of the other outcomes listed in the
definition above. These should usually be considered serious.
If a serious and unexpected AE occurs for which there is evidence suggesting a causal relationship
between the study vaccine and the event (eg, death from anaphylaxis), the event must be reported
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
98
Status: Approved,  Date: 22 December 2021
as a SUSAR by the sponsor to health authorities and by the investigator to the IEC/IRB according
to regulatory and local requirements.
Unlisted (Unexpected) Adverse Event/Reference Safety Information
An AE is considered unlisted if the nature or severity is not consistent with the applicable product
reference safety information. Ad26.RSV-A.preF, RSV-A preF protein, Ad26.RSV-B.preF2, and
RSV-B preF protein, the expectedness of an AE will be determined by whether or not it is listed
in the IB (IB Ad26/protein preF RSV vaccine 2021, IB VAC18195 2021).
10.4.2. 
Attribution Definitions
Assessment of Causality
The causal relationship to study vaccine is assessed by the investigator. The following selection
must be used to assess all AEs.
Related
There is a reasonable causal relationship between study vaccine administration and the AE.
Not Related
There is not a reasonable causal relationship between study vaccine administration and the AE.
The term "reasonable causal relationship" means there is evidence to support a causal relationship.
By definition, all solicited AEs at the injection site (local) will be considered related to the study
vaccine administration.
10.4.3. 
Severity Criteria
All AEs and laboratory data will be coded for severity using a modified version of the FDA grading
table, based on version of September 2007 (FDA 2007), included in Appendix 6, Toxicity Grading
Scale.
For AEs not identified in the grading table, the following guidelines will be applied:
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
99
Status: Approved,  Date: 22 December 2021
Grade 1 
Mild 
Symptoms causing no or minimal interference with usual social
and functional activities
Grade 2 
Moderate 
Symptoms causing greater than minimal interference with usual
social and functional activities
Grade 3 
Severe 
Symptoms causing inability to perform usual social and
functional activities and requires medical intervention
Grade 4 
Potentially 
life- 
threatening 
Symptoms causing inability to perform basic self-care functions
OR medical or operative intervention indicated to prevent
permanent impairment, persistent disability OR ER visit or
hospitalization
The severity of solicited signs and symptoms will be graded in the diary by the participant based
on the severity assessment provided in the diary and then verified by the investigator using the
toxicity grading scale in Appendix 6. (Note: severity of the measured events will be derived from
the diameter [for erythema and swelling] and the temperature measurements [for fever])
10.4.4. 
Special Reporting Situations
Safety events of interest on a sponsor study vaccine in an interventional study that may require
expedited reporting or safety evaluation include, but are not limited to:
 
Overdose of a sponsor study vaccine
 
Suspected abuse/misuse of a sponsor study vaccine
 
Accidental or occupational exposure to a sponsor study vaccine
 
Medication error, intercepted medication error, or potential medication error involving a
Johnson & Johnson medicinal product (with or without patient exposure to the Johnson &
Johnson medicinal product, eg, product name confusion, product label confusion, intercepted
prescribing or dispensing errors)
 
Exposure to a sponsor study vaccine from breastfeeding
 
Reporting of participant pregnancy or participant partner(s) pregnancy
Special reporting situations must be recorded in the eCRF. Any special reporting situation that
meets the criteria of an SAE must be recorded on the SAE page of the eCRF.
10.4.5. 
Procedures
All Adverse Events
All AEs, regardless of seriousness, severity, or presumed relationship to study vaccine, must be
recorded using medical terminology in the source document and the eCRF. Whenever possible,
diagnoses should be given when signs and symptoms are due to a common etiology (eg, cough,
runny nose, sneezing, sore throat, and head congestion should be reported as "upper respiratory
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
100
Status: Approved,  Date: 22 December 2021
infection"). Investigators must record in the eCRF their opinion concerning the relationship of the
AE to study therapy. All measures required for AE management must be recorded in the source
document and reported according to sponsor instructions.
For all studies with an outpatient phase, including open-label studies, the participant must be
provided with a "wallet (study) card" and instructed to carry this card with them for the duration
of the study indicating the following:
 
Study number
 
Statement, in the local language(s), that the participant is participating in a clinical study
 
Investigator's name and 24-hour contact telephone number
 
Local sponsor's name and 24-hour contact telephone number (for medical personnel only)
 
Site number
 
Participant number
 
Any other information that is required to do an emergency breaking of the blind
Serious Adverse Events
All SAEs that have not resolved by the end of the study, or that have not resolved upon  the
participant's discontinuation from the study, must be followed until any of the following occurs:
 
The event resolves
 
The event stabilizes
 
The event returns to baseline, if a baseline value/status is available
 
The event can be attributed to agents other than the study vaccine or to factors unrelated to
study conduct
 
It becomes unlikely that any additional information can be obtained (participant or health care
practitioner refusal to provide additional information, lost to follow-up after demonstration of
due diligence with follow-up efforts)
Any event requiring hospitalization (or prolongation of hospitalization) that occurs during
participation in the study must be reported as an SAE, except hospitalizations for the following:
 
Hospitalizations not intended to treat an acute illness or AE (eg, social reasons such as pending
placement in long-term care facility)
 
Surgery or procedure planned before entry into the study (must be documented in the eCRF).
Note: Hospitalizations that were planned before the signing of the ICF, and where the
underlying condition for which the hospitalization was planned has not worsened, will not be
considered SAEs. Any AE that results in a prolongation of the originally planned
hospitalization is to be reported as a new SAE.
The cause of death of a participant in a study during the entire study period, whether or not the
event is expected or associated with the study vaccine, is considered an SAE.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
101
Status: Approved,  Date: 22 December 2021
Information regarding SAEs will be transmitted to the sponsor using an SAE reporting form and
safety report form of the eCRF, which must be completed and reviewed by a physician from the
study site, and transmitted in a secure manner to the sponsor within 24 hours. The initial and
follow-up reports of an SAE should be transmitted in a secure manner electronically or by
facsimile (fax). Telephone reporting should be the exception and the reporter should be asked to
complete the appropriate form(s) first.
Adverse Events of Special Interest
AESIs, including potential AESIs, will be carefully monitored during the study by the sponsor and
must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (ie,
serious and nonserious AEs) or causality assessment, following the procedure described above for
SAEs and will require enhanced data collection.
10.4.6. 
Product Quality Complaint Handling
Definition
A product quality complaint (PQC) is defined as any suspicion of a product defect related to
manufacturing, labeling, or packaging, ie, any dissatisfaction relative to the identity, quality,
durability, reliability, or performance of a distributed product, including its labeling, drug delivery
system, or package integrity. A PQC may have an impact on the safety and efficacy of the product.
In addition, it includes any technical complaints, defined as any complaint that indicates a potential
quality issue during manufacturing, packaging, release testing, stability monitoring, dose
preparation, storage or distribution of the product or the drug delivery system.
Procedures
All initial PQCs must be reported to the sponsor by the study site personnel within 24 hours after
being made aware of the event.
A sample of the suspected product should be maintained under the correct storage conditions until
a shipment request is received from the sponsor.
10.4.7. 
Contacting Sponsor Regarding Safety, Including Product Quality
The names (and corresponding telephone numbers) of the individuals who must be contacted
regarding safety issues, PQC, or questions regarding the study are listed in the Contact Information
page(s), which will be provided as a separate document.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
102
Status: Approved,  Date: 22 December 2021
10.5. Appendix 5: Contraceptive Guidance and Collection of Pregnancy
Information
Participants must follow contraceptive measures as outlined in Section 5.1. Pregnancy information
will be collected and reported as noted in Section 8.3.5, Pregnancy and Appendix 4.
Definition of Woman of Childbearing Potential
Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal unless
permanently sterile (see below).
Woman Not of Childbearing Potential
 
premenarchal
A premenarchal state is one in which menarche has not yet occurred.
 
postmenopausal
A postmenopausal state is defined as no menses for 12 months without an alternative medical
cause.
 
permanently sterile (for the purpose of this study)
 
Permanent sterilization methods include hysterectomy, or bilateral salpingectomy, or
bilateral oophorectomy.
 
Has congenital abnormalities resulting in sterility.
Note: If the childbearing potential changes after start of the study (eg, a premenarchal woman
experiences menarche) or the risk of pregnancy changes (eg, a woman who is not heterosexually
active becomes active), a woman must begin an acceptable effective method of contraception, as
described throughout the inclusion criteria.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
103
Status: Approved,  Date: 22 December 2021
10.6. Appendix 6: Toxicity Grading Scale
Adapted from the FDA Guidance document “Toxicity Grading Scale for Healthy Adult and
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials” (September 2007) (FDA
2007)
A: Tables for Clinical Abnormalities
Local Reaction to 
Injectable Product 
Mild (Grade 1) 
Moderate (Grade 2) Severe (Grade 3) 
Potentially Life
Threatening
(Grade 4)
Pain/Tenderness# 
Aware of symptoms 
but easily tolerated; 
Does not interfere 
with activity; 
Discomfort only to 
touch  
Notable symptoms; 
Requires modification 
in activity or use of 
medications; 
Discomfort with 
movement 
Incapacitating 
symptoms; 
Inability to do work, 
school, or usual 
activities; Use of 
narcotic pain reliever
Hospitalization;
Pain/tenderness
causing inability to
perform basic self-
care function
Erythema# 
25 –50 mm  
51 –100 mm  
> 100 mm  
Hospitalization;
Necrosis or
exfoliative dermatitis
Swelling# 
25 –50 mm  
51 –100 mm  
> 100 mm  
Hospitalization;
Necrosis
# Revised by the sponsor.
Vital Signs * 
Mild (Grade 1) 
Moderate (Grade 2) Severe (Grade 3) 
Potentially Life
Threatening
(Grade 4)
Fever (°C) ** 
           (°F)** 
38.0 - 38.4 
100.4 - 101.1 
38.5 - 38.9 
101.2 - 102.0 
39.0 - 40.0 
102.1 - 104.0 
> 40 
> 104.0
Tachycardia - beats 
per 
minute
101 –115 
116 –130 
> 130 
Hospitalization for
arrhythmia#
Bradycardia - beats 
per 
minute***
50 –54 
45 –49 
< 45 
Hospitalization for
arrhythmia#
Hypertension 
(systolic) - mm Hg 
141 –150 
151 –155 
> 155 
Hospitalization for
malignant
hypertension#
Hypertension 
(diastolic) - mm Hg 
91 –95 
96 –100 
> 100 
Hospitalization for
malignant
hypertension#
Hypotension 
(systolic) –mm Hg 
85 –89 
80 –84 
< 80 
Hospitalization for
hypotensive shock#
Respiratory Rate – 
breaths per minute
17 –20 
21 –25 
> 25 
Intubation
* Participant should be at rest for all vital sign measurements.
** For oral temperature: no recent hot or cold beverages or smoking.
*** When resting heart rate is between 60 –100 beats per minute. Use clinical judgment when characterizing
bradycardia among some healthy participant populations, for example, conditioned athletes.
# Revised by the sponsor.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
104
Status: Approved,  Date: 22 December 2021
Systemic (General) Mild (Grade 1) 
Moderate (Grade 2) Severe (Grade 3) 
Potentially Life
Threatening
(Grade 4)
Vomiting# 
No interference 
with activity or 1 –2 
episodes/24 hours 
Some interference 
with activity or > 2 
episodes/24 hours 
Prevents daily  
activity, requires 
outpatient IV
hydration
Hospitalization;
Hypotensive shock
Nausea# 
Minimal symptoms; 
causes minimal or no 
interference with 
work, school, or self- 
care activities 
Notable symptoms; 
Requires modification 
in activity or use of 
medications; 
Does NOT result in 
loss of work, school, 
or cancellation of 
social activities
Incapacitating 
symptoms; 
Requires bed rest 
and/or results in loss 
of work, school, or
cancellation of social
activities
Hospitalization;
Inability to perform
basic self-care
functions
Diarrhea# 
2 –3 loose stools or 
< 400 gms/24 hours 
4 –5 stools or 
400 –800 gms/24 
hours 
6 or more watery  
stools or 
> 800 gms/24 hours 
or oral rehydration 
necessary
Hospitalization;
Hypotensive shock
OR IV fluid
replacement indicated
Headache# 
Minimal symptoms;
causes minimal or no
interference with
work, school, or self-
care activities
Notable symptoms; 
Requires modification 
in activity or use of 
medications; 
Does NOT result in 
loss of work, school, 
or cancellation of 
social activities 
Incapacitating
symptoms;
Requires bed rest
and/or results in loss
of work, school, or
cancellation of social
activities;
Use of narcotic pain
reliever
Hospitalization;
Inability to perform
basic self-care
functions
Fatigue# 
Minimal symptoms;
causes minimal or no
interference with
work, school, or self-
care activities
Notable symptoms; 
Requires modification 
in activity or use of 
medications; 
Does NOT result in 
loss of work, school, 
or cancellation of 
social activities 
Incapacitating
symptoms;
Requires bed rest
and/or results in loss
of work, school, or
cancellation of social
activities;
Use of narcotic pain
reliever
Hospitalization;
Inability to perform
basic self-care
functions
Myalgia# 
Minimal symptoms;
causes minimal or no
interference with
work, school, or self-
care activities
Notable symptoms; 
Requires modification 
in activity or use of 
medications; 
Does NOT result in 
loss of work, school, 
or cancellation of 
social activities 
Incapacitating
symptoms;
Requires bed rest
and/or results in loss
of work, school, or
cancellation of social
activities;
Use of narcotic pain
reliever
Hospitalization;
Inability to perform
basic self-care
functions
# Revised by the sponsor.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
105
Status: Approved,  Date: 22 December 2021
Systemic Illness 
Mild (Grade 1) 
Moderate (Grade 2) Severe (Grade 3) 
Potentially Life
Threatening
(Grade 4)
Illness or clinical 
adverse 
event (as defined 
according to 
No interference with  
activity  
Some interference 
with activity not 
requiring medical 
intervention 
Prevents daily  
activity and
requires medical
intervention
Hospitalization#
# Revised by the sponsor.
B: Tables for Laboratory Abnormalities
The laboratory values provided in the tables below serve as guidelines and are dependent upon
institutional normal parameters. Institutional normal reference ranges should be provided to
demonstrate that they are appropriate.
Serum * 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially Life
Threatening
(Grade 4)**
Sodium –Hyponatremia mEq/L 
132 –134 
130 –131 
125 –129 
< 125
Sodium –Hypernatremia mEq/L 
144 –145 
146 –147 
148 –150 
> 150
Potassium –Hyperkalemia mEq/L 
5.1 –5.2 
5.3 –5.4 
5.5 –5.6 
> 5.6
Potassium –Hypokalemia mEq/L 
3.5 –3.6 
3.3 –3.4 
3.1 –3.2 
< 3.1
Glucose –Hypoglycemia mg/dL 
65 –69 
55 –64 
45 –54 
< 45
Glucose –Hyperglycemia 
  Fasting mg/dL 
  Random –mg/dL 
100 –110 
110 –125 
111 –125 
126 –200 
>125 
>200 
Insulin
requirements or
hyperosmolar
coma
Blood Urea Nitrogen  
BUN mg/dL
23 –26 
27 –31 
> 31  
Requires dialysis
Creatinine –mg/dL 
1.5 –1.7 
1.8 –2.0 
2.1 –2.5 
> 2.5 or requires
dialysis
Calcium –hypocalcemia mg/dL 
8.0 –8.4 
7.5 –7.9 
7.0 –7.4 
< 7.0
Calcium –hypercalcemia mg/dL 
10.5 –11.0 
11.1 –11.5 
11.6 –12.0 
> 12.0
Magnesium –hypomagnesemia mg/dL 
1.3 –1.5 
1.1 –1.2 
0.9 –1.0 
< 0.9
Phosphorous –hypophosphatemia mg/dL 2.3 –2.5 
2.0 –2.2 
1.6 –1.9 
< 1.6
CPK –mg/dL 
1.25 –1.5 x  
ULN***
1.6 –3.0 x ULN  3.1 –10 x ULN  
> 10 x ULN
Albumin –Hypoalbuminemia g/dL 
2.8 –3.1 
2.5 –2.7 
< 2.5 
--
Total Protein –Hypoproteinemia g/dL 
5.5 –6.0 
5.0 –5.4 
< 5.0 
--
Alkaline phosphate – 
increase by factor
1.1 –2.0 x ULN  2.1 –3.0 x ULN  3.1 –10 x ULN  > 10 x ULN
Liver Function Tests –ALT, AST  
increase by factor
1.1 –2.5 x ULN  2.6 –5.0 x ULN  5.1 –10 x ULN  > 10 x ULN
Bilirubin –when accompanied 
by any increase in Liver Function Test 
increase by factor
1.1 –1.25 x 
ULN  
1.26 –1.5 x 
ULN  
1.51 –1.75 x 
ULN
> 1.75 x ULN
Bilirubin –when Liver Function Test 
is normal; increase by factor
1.1 –1.5 x ULN  1.6 –2.0 x ULN  2.0 –3.0 x ULN  > 3.0 x ULN
Cholesterol 
201 –210 
211 –225 
> 226 
---
Pancreatic enzymes –amylase, lipase 
1.1 –1.5 x ULN 1.6 –2.0 x ULN 2.1 –5.0 x ULN > 5.0 x ULN
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
106
Status: Approved,  Date: 22 December 2021
Serum * 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially Life
Threatening
(Grade 4)**
* The laboratory values provided in the tables serve as guidelines and are dependent upon institutional normal
parameters. Institutional normal reference ranges should be provided to demonstrate that they are appropriate.
** The clinical signs or symptoms associated with laboratory abnormalities might result in characterization of the
laboratory abnormalities as potentially life-threatening (Grade 4). For example. a low sodium value that falls
within a Grade 3 parameter (125-129 mE/L) should be recorded as a Grade 4 hyponatremia event ifthe
participant had a new seizure associated with the low sodium value.
***ULN is the upper limit ofthe normal range.
Hematology * 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially Life
Threatening
(Grade 4)
Hemoglobin (Female)- gm/dL 
11.0 –12.0 
9.5 –10.9 
8.0 –9.4 
< 8.0
Hemoglobin (Female) 
change from baseline value -  gm/dL
Any decrease –1.5 1.6 –2.0 
2.1 –5.0 
> 5.0
Hemoglobin (Male) - gm/dL 
12.5 –13.5 
10.5 –12.4 
8.5 –10.4 
< 8.5
Hemoglobin (Male) 
change from baseline value –gm/dL
Any decrease –1.5 1.6 –2.0 
2.1 –5.0 
> 5.0
WBC Increase - cell/mm3 
10,800 –15,000 
15,001 –20,000 20,001 –25, 000 > 25,000
WBC Decrease - cell/mm3 
2,500 –3,500 
1,500 –2,499 
1,000 –1,499 
< 1,000
Lymphocytes Decrease - cell/mm3 
750 –1,000 
500 –749 
250 –499 
< 250
Neutrophils Decrease - cell/mm3 
1,500 –2,000 
1,000 –1,499 
500 –999 
< 500
Eosinophils - cell/mm3 
650 –1500 
1501 - 5000 
> 5000 
Hypereosinophilic
Platelets Decreased - cell/mm3 
125,000 –140,000 100,000 – 
124,000
25,000 –99,000 
< 25,000
PT –increase by factor 
(prothrombin time) 
1.0 –1.10 x  
ULN** 
1.11 –1.20 x 
ULN
1.21 –1.25 x ULN > 1.25 ULN
PTT –increase by factor 
(partial thromboplastin time) 
1.0 –1.2 x ULN  
1.21 –1.4 x 
ULN
1.41 –1.5 x ULN  > 1.5 x ULN
Fibrinogen increase - mg/dL 
400 –500 
501 –600 
> 600 
--
Fibrinogen decrease - mg/dL 
150 –200 
125 –149 
100 –124 
< 100 or associated
with gross bleeding
or disseminated
intravascular
coagulation (DIC)
* The laboratory values provided in the tables serve as guidelines and are dependent upon institutional normal
parameters. Institutional normal reference ranges should be provided to demonstrate that they are appropriate.
** ULN is the upper limit ofthe normal range.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
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107
Status: Approved,  Date: 22 December 2021
Urine * 
Mild  
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially Life
Threatening (Grade 4)
Protein  
Trace 
1+  
2+ 
Hospitalization or
dialysis
Glucose 
Trace 
1+  
2+ 
Hospitalization for
hyperglycemia
Blood (microscopic) – 
red blood cells per 
high power field (rbc/hpf) 
1 - 10 
11 –50 
> 50 and/or gross 
blood 
Hospitalization or
packed red blood cells
(PRBC) transfusion
* The laboratory values provided in the tables serve as guidelines and are dependent upon institutional normal
parameters. Institutional normal reference ranges should be provided to demonstrate that they are appropriate.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
108
Status: Approved,  Date: 22 December 2021
10.7. Appendix 7: Thrombotic Events to be Reported as Potential AESIs
At the time of protocol writing, the list of thrombotic events to be reported to the sponsor as
potential AESIs is provided below. Further guidance may become available on thrombotic events
of interest.
 
MedDRA PTs for large vessel thrombosis and embolism
 
Aortic embolus, aortic thrombosis, aseptic cavernous sinus thrombosis, brain stem
embolism, brain stem thrombosis, carotid arterial embolus, carotid artery thrombosis,
cavernous sinus thrombosis, cerebral artery thrombosis, cerebral venous sinus
thrombosis, cerebral venous thrombosis, superior sagittal sinus thrombosis, transverse
sinus thrombosis, mesenteric artery embolism, mesenteric artery thrombosis, mesenteric
vein thrombosis, splenic artery thrombosis, splenic embolism, splenic thrombosis,
thrombosis mesenteric vessel, visceral venous thrombosis, hepatic artery embolism,
hepatic artery thrombosis, hepatic vein embolism, hepatic vein thrombosis, portal vein
embolism, portal vein thrombosis, portosplenomesenteric venous thrombosis, splenic
vein thrombosis, spontaneous heparin-induced thrombocytopenia syndrome, femoral
artery embolism, iliac artery embolism, jugular vein embolism, jugular vein thrombosis,
subclavian artery embolism, subclavian vein thrombosis, obstetrical pulmonary
embolism, pulmonary artery thrombosis, pulmonary thrombosis, pulmonary venous
thrombosis, renal artery thrombosis, renal embolism, renal vein embolism, renal vein
thrombosis, brachiocephalic vein thrombosis, vena cava embolism, vena cava
thrombosis, truncus coeliacus thrombosis
 
MedDRA PTs for more common thrombotic events
 
Axillary vein thrombosis, deep vein thrombosis, pulmonary embolism, MedDRA PTs for
acute myocardial infarction*, MedDRA PTs for stroke*
Source: Shimabukuro T. CDC COVID-19 Vaccine Task Force. Thrombosis with thrombocytopenia syndrome (TTS)
following Janssen COVID-19 vaccine. Advisory Committee on Immunization Practices (ACIP). April 23, 2021.
https://www.cdc.gov/vaccines/acip/meetings/slides-2021-04-23.html.
*Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (as of 29 January
2021) https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
109
Status: Approved,  Date: 22 December 2021
10.8. Appendix 8: Study Conduct During a Natural Disaster
GUIDANCE ON STUDY CONDUCT DURING THE COVID-19 PANDEMIC
It is recognized that the CORONAVIRUS DISEASE 2019 (COVID-19) may have an impact on
the conduct of this clinical study due to, for example, isolation or quarantine of participants and 
study site personnel; travel restrictions/limited access to public places, including hospitals; study
site personnel being unavailable, isolated, or reassigned to critical tasks.
The sponsor is providing options for study-related participant management in the event of
disruption to the conduct of the study. This guidance does not supersede any local or government
requirements or the clinical judgement of the investigator to protect the health and well-being of
participants and site staff. If, at any time, a participant’s travel to the study site is considered to be
dangerous, study participation may be interrupted, and study follow-up conducted. If it becomes
necessary to discontinue participation in the study, the procedures outlined in the protocol for
discontinuing study intervention will be followed.
If, as a result of the COVID-19 pandemic scheduled visits cannot be conducted in person at the
study site, they will be performed to the extent possible remotely/virtually or delayed until such
time that on-site visits can be resumed. At each contact, participants will be interviewed to collect
safety data. Key immunogenicity endpoint assessments should be performed if required and as
feasible. Participants will also be questioned regarding general health status to fulfill any physical
examination requirement.
Every effort should be made to adhere to protocol-specified assessments for participants on study
intervention, including follow-up. Modifications to protocol-required assessments may be
permitted after consultation with the participant, investigator, and the sponsor. Missed
assessments/visits will be captured in the clinical trial management system for protocol deviations.
Discontinuations of study interventions and withdrawal from the study should be documented with
the prefix “COVID-19-related” in the
If the participant has tested positive for COVID-19, the investigator should contact the sponsor’s
responsible medical officer to discuss plans for administration of study intervention, performing.
study assessments, and follow-up. Modifications made to the study conduct as a result of the
COVID-19 pandemic should be summarized in the Clinical Study Report.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
110
Status: Approved,  Date: 22 December 2021
GUIDANCE SPECIFIC TO THIS PROTOCOL:
Screening and Randomization
 Enrollment of new participants may continue based on the investigator’s assessment of risks
versus benefits, depending on the situation at a particular site, and the ability to monitor
participant safety.
Site Visits
 
When site visits are not possible due to local/national guidelines, sites should collect the
assessments via telephone visits or home-based visits, if the participant allows. The actual
visit date and the type of visit (ie, telephone or home-based visit) should be captured in the
eCRF according to the eCRF completion guidelines. Procedures that cannot be performed
during a home-based visit (eg, blood samples), should be excluded. 
Vaccine Administration
 
When planning for vaccination visits, local/national or institutional guidelines will be
followed. The study vaccine must be administered by a blinded qualified individual at the
study site. If this is not possible, a solution may be considered in consultation with the sponsor
and taking into consideration participant safety.
Informed Consent Form
 
Consenting and re-consenting of participants for the measures taken (including also remote
consenting by phone or video consultation) will be performed as applicable and according to
local guidance for informed consent applicable during the COVID-19 pandemic. The process
is to be documented in the source documents.
Source Data Verification/Monitoring
 
In case on-site monitoring visits are not possible, the site monitor may contact the investigator
to arrange monitoring visits and activities remotely (in accordance with site and local
requirements). Additional on-site monitoring visits may be needed in the future to catch up on
source data verification.
Site Audits
 
During the COVID-19 pandemic and at the impacted sites, study site GCP audits with direct
impact/engagement from the investigator and study site personnel would not be conducted in
order to comply with national, local, and/or organizational social distancing restrictions.
Additional quality assurance activities such as remote audits or focused review of study-
related documents may take place with limited impact/engagement if possible.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
111
Status: Approved,  Date: 22 December 2021
10.9. Appendix 9: Protocol Amendment History
This is an original protocol.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
112
Status: Approved,  Date: 22 December 2021
11. 
REFERENCES
Adenoviral Vaccine Safety Database - Report V6.0. Janssen Vaccines & Prevention B.V. (April 2021).
American Society of Hematology. COVID-19 resources. Thrombosis with Thrombocytopenia Syndrome (also
termed Vaccine-induced Thrombotic Thrombocytopenia). Updated 6 May 2021. https://www.hematology.org/covid-
19/vaccine-induced-immune-thrombotic-thrombocytopenia. Accessed: 27 August 2021.
Brighton Collaboration. Updated Proposed Brighton Collaboration process for developing a standard case definition
for study of new clinical syndrome X, as applied to Thrombosis with Thrombocytopenia Syndrome (TTS). 18 May
2021. https://brightoncollaboration.us/wp-content/uploads/2021/05/TTS-Interim-Case-Definition-v10.16.3-May-23-
2021.pdf. Accessed 02 September 2021.
British Society for Haematology. Guidance produced from the Expert Haematology Panel (EHP) focused on Covid-
19 Vaccine induced Thrombosis and Thrombocytopenia (VITT). https://b-s-h.org.uk/media/19530/guidanceversion-
13-on-mngmt-of-thrombosis-with-thrombocytopenia-occurring-after-c-19-vaccine 20210407.pdf. Version 1.3; 7
April 2021. Accessed: 27 April 2021.
Centers for Disease Control and Prevention (CDC) (2021). Cases of cerebral venous sinus thrombosis with
thrombocytopenia after receipt of the Johnson & Johnson COVID-19 Vaccine. 13 April 2021. Available at:
https://emergency.cdc.gov/han/2021/han00442.asp. Accessed 29 April 2021.
Falsey AR, Walsh EE. Respiratory syncytial virus infection in adults. Clin Microbiol Rev. 2000;13(3):371-384.
Gidudu JK, Walco GA, Taddio A, et al./The Brighton Immunization Site Pain Working Group. Immunization site
pain: Case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine.
2012;30(30):4558-4577.
Investigator's Brochure: Ad26/protein preF RSV vaccine (JNJ-64400141/JNJ-64213175). Edition 2. Janssen
Vaccines & Prevention B.V. (April 2021).
Investigator's Brochure: VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172). Edition 1.
Janssen Vaccines & Prevention B.V. (December 2021).
Kohl KS, Walop W, Gidudu J, et al. The Brighton Collaboration Local Reaction Working Group for Swelling at or
near Injection Site. Swelling at or near injection site: Case definition and guidelines for collection, analysis and
presentation of immunization safety data. Vaccine. 2007;25(31):5858-5874.
Marcy SM, Kohl KS, Dagan R, et al. Fever as an adverse event following immunization: case definition and
guidelines of data collection, analysis, and presentation. Vaccine 2004:22;551-556.
Mazur NI, Horsley NM, Englund JA, et al. Breast milk prefusion F immunoglobulin G as a correlate of protection
against respiratory syncytial virus acute respiratory illness. J Infect Dis. 2019;219(1):59-67.
Pandya MC, Callahan SM, Savchenko KG, Stobart CC. A contemporary view of respiratory syncytial virus (Rsv)
biology and strain-specific differences. Pathogens. 2019;8(2).
Shimabukuro T. Update: Thrombosis with thrombocytopenia syndrome (TTS) following COVID-19 vaccination.
Centers for Disease Control & Prevention Advisory Committee on Immunization Practices (ACIP) meeting 12 May
2021. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-05-12/07-COVID-Shimabukuro-508.pdf.
(accessed 18 May 2021).
Sullender WM. Respiratory syncytial virus genetic and antigenic diversity. Clin Microbiol Rev. 2000;13(1):1-15.
Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in
the United States. JAMA. 2003;289(2):179-186.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation
and Research. September 2007. Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent
Volunteers Enrolled in Preventive Vaccine Clinical Trials. Available at:
https://www.fda.gov/media/73679/download. Accessed 15 June 2020.
U.S. Department of Health and Human Services, Office for Human Research Protections. March 2016. OHRP
Expedited Review Categories (1998). Available at: http://www.hhs.gov/ohrp/regulations-and-
policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html. Accessed 15 March 2021.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
113
Status: Approved,  Date: 22 December 2021
US Food and Drug Administration. Conditions for IRB Use of Expedited Review. Federal Register: November 9,
1998 (Volume 63, Number 216). https://www.hhs.gov/ohrp/news/federal-register-notices/federal-register-11-09-
1998-vol-63-no-216/index.html. Accessed 17 February 2021
Williams K, Bastian AR, Feldman RA, et al. Phase 1 safety and immunogenicity study of a respiratory syncytial
virus vaccine with an adenovirus 26 vector encoding prefusion f (Ad26.RSV.preF) in adults aged ≥60 years. J Infect
Dis. 2020;222(6):979-988.
NCT05327816


VAC18195  (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Clinical Protocol VAC18195RSV1001 Original
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
114
Status: Approved,  Date: 22 December 2021
INVESTIGATOR AGREEMENT
I have read this protocol and agree that it contains all necessary details for carrying out this study. I will
conduct the study as outlined herein and will complete the study within the time designated.
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who
assist in the conduct of this study. I will discuss this material with them to ensure that they are fully informed
regarding the study intervention, the conduct of the study, and the obligations of confidentiality.
Coordinating Investigator (where required):
Name (typed or printed):
Institution and Address:
Signature: 
Date:
(Day Month Year)
Principal (Site) Investigator:
Name (typed or printed):
Institution and Address:
Telephone Number:
Signature: 
Date:
(Day Month Year)
Sponsor's Responsible Medical Officer:
Name (typed or printed): 
Institution: 
Janssen Vaccines & Prevention B.V.
Signature: 
electronic signature appended at the end of the protocol 
Date:
(Day Month Year)
Note: If the address or telephone number of the investigator changes during the study, written notification will be
provided by the investigator to the sponsor, and a protocol amendment will not be required.
PPD
NCT05327816


Signature
User 
Date 
Reason
22-Dec-2021
16:16:22
(GMT)
Document Approval
PPD
NCT05327816

SAP_001.pdf: 
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
1
Status: Final, Date: 23-Jun-2022
Janssen Vaccines & Prevention B.V.*
Statistical Analysis Plan
A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and 
Immunogenicity Evaluations of various RSV.preF-based Vaccine Formulations in Adults 
Aged 60 Years and Older
Protocol VAC18195RSV1001; Phase 1/2a
VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
* Janssen Vaccines & Prevention B.V. is a Janssen pharmaceutical company of Johnson & Johnson and is
hereafter referred to as the sponsor of the study. The sponsor is identified on the Contact Information page
that accompanies the protocol.
Status:
Final
Date:
23-Jun-2022
Prepared by:
Janssen Vaccines & Prevention B.V.  
Document No.: EDMS-RIM-653275
Compliance: The study described in this report was performed according to the principles of Good Clinical Practice (GCP). 
Confidentiality Statement
The information provided herein contains Company trade secrets, commercial or financial information that the Company 
customarily holds close and treats as confidential.  The information is being provided under the assurance that the recipient
will maintain the confidentiality of the information under applicable statutes, regulations, rules, protective orders or 
otherwise.
NCT05327816


VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
2
Status: Final, Date: 23-Jun-2022
TABLE OF CONTENTS
TABLE OF CONTENTS ............................................................................................................................... 2
VERSION HISTORY..................................................................................................................................... 3
1.
INTRODUCTION.................................................................................................................................. 4
1.1.
Objectives and Endpoint .................................................................................................................. 4
1.2.
Study Design.................................................................................................................................... 4
2.
STATISTICAL HYPOTHESES............................................................................................................ 4
3.
SAMPLE SIZE DETERMINATION...................................................................................................... 4
4.
POPULATIONS (ANALYSIS SETS) FOR ANALYSIS....................................................................... 4
5.
STATISTICAL ANALYSES................................................................................................................. 5
5.1.
General Considerations ................................................................................................................... 5
5.1.1.
Study phases ................................................................................................................................ 5
5.1.2.
Phase definition ............................................................................................................................ 5
5.1.3.
Immunogenicity Visit Windows ..................................................................................................... 6
5.2.
Participant Dispositions.................................................................................................................... 7
5.3.
Primary Endpoint(s) Analysis........................................................................................................... 8
5.3.1.
Definition of Endpoints.................................................................................................................. 8
5.3.2.
Analysis Methods for the Primary Safety endpoints..................................................................... 8
5.3.2.1.
Definitions of Adverse Events.................................................................................................... 8
5.3.2.2.
Analysis of Adverse Events....................................................................................................... 9
5.3.2.3.
Phase Allocation of Adverse Events ....................................................................................... 10
5.3.2.4.
Missing Data............................................................................................................................ 13
5.3.3.
Analysis Methods for the Primary Immunogenicity endpoint(s) ................................................. 13
5.4.
Secondary Immunogenicity Endpoint(s) Analysis.......................................................................... 14
5.5.
Exploratory Endpoints Analysis ..................................................................................................... 15
5.5.1.
ICS.............................................................................................................................................. 15
5.5.2.
VNA against Ad26 vector............................................................................................................ 16
5.6.
Handling of Missing and/or Unquantifiable Immune Response Data ............................................ 16
5.7.
Other Safety Analyses ................................................................................................................... 16
5.7.1.
Clinical Laboratory Tests ............................................................................................................ 17
5.7.2.
Vital Signs................................................................................................................................... 17
5.7.3.
Physical Examinations................................................................................................................ 17
5.8.
Other Analyses............................................................................................................................... 17
5.8.1.
Pharmacokinetics ....................................................................................................................... 17
5.8.2.
Pharmacodynamics .................................................................................................................... 17
5.8.3.
Biomarkers.................................................................................................................................. 17
5.8.4.
Definition of Subgroups .............................................................................................................. 17
5.9.
Planned Analyses .......................................................................................................................... 17
5.9.1.
Data Review Committee (DRC).................................................................................................. 19
6.
SUPPORTING DOCUMENTATION .................................................................................................. 20
6.1.
Appendix 1 List of Abbreviations.................................................................................................... 20
6.2.
Appendix 2 Changes to Protocol-Planned Analyses ..................................................................... 21
6.3.
Appendix 3 Demographics and Baseline Characteristics.............................................................. 22
6.4.
Appendix 4 Protocol Deviations ..................................................................................................... 23
6.5.
Appendix 5 Prior and Concomitant Medications............................................................................ 24
7.
REFERENCES................................................................................................................................... 25
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VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
3
Status: Final, Date: 23-Jun-2022
VERSION HISTORY
Table 1 – SAP Version History Summary
SAP Version
Approval Date
Change
Rationale
1.0
23-Jun-2022
Not Applicable
Initial release
NCT05327816


VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
4
Status: Final, Date: 23-Jun-2022
1.
INTRODUCTION
This statistical analysis plan (SAP) contains information needed to perform the complete safety 
and immunogenicity analysis of the VAC18195RSV1001 trial. It applies to all the analyses 
described in Section 9.4 of the clinical trial protocol (CTP). The specifications of individual tables, 
listings, and figures to be generated in each analysis will be described in a separate data 
presentation specifications (DPS) document.
1.1.
Objectives and Endpoint
Refer to Section 3 of the CTP.
1.2.
Study Design
Please refer to Section 4.1 of the CTP for more details on the study design, and Section 6.3 of the 
CTP for details on randomization and procedures for maintaining the blind.
2.
STATISTICAL HYPOTHESES
No formal hypothesis will be tested. All the statistical analyses will be performed descriptively.
3.
SAMPLE SIZE DETERMINATION
Refer to Section 9.2 of the CTP.
4.
POPULATIONS (ANALYSIS SETS) FOR ANALYSIS
For vaccine studies, study intervention assignment will follow the as-treated principle. The 
analysis sets are defined in the Table 2.
Table 2 – Analysis sets
Analysis Sets
Description
All screened
This analysis set includes all participants screened for 
the study, regardless of whether they were screen 
failures or they got enrolled in the study.
Rescreened participants are counted only once.
Randomized
The randomized analysis set includes all participants 
who were randomized in the study.
Full Analysis Set (FAS)
The full analysis set (FAS) will include all participants 
who received the study vaccine, regardless of the 
occurrence of protocol deviations. 
All safety and participant information analyses will be 
based on the FAS.
Per-protocol Immunogenicity (PPI) Set
The Per-protocol Immunogenicity (PPI) Set will include 
all randomized participants who received the planned 
study vaccine(s) and for whom immunogenicity data are 
available. Samples taken after a participant experiences 
a major protocol deviation expected to impact the 
immunogenicity outcomes will be excluded from the 
PPI analysis.
The list of major protocol deviations that would lead to 
elimination from the immunogenicity analysis will be 
specified in the major protocol deviation criteria 
NCT05327816


VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
5
Status: Final, Date: 23-Jun-2022
Analysis Sets
Description
document, which will be finalized before database lock 
and unblinding.
The analysis of all immunogenicity endpoints will be 
based on the PPI Set. For key tables, sensitivity 
immunogenicity analyses might also be performed on 
the FAS.
5.
STATISTICAL ANALYSES
5.1.
General Considerations
5.1.1.
Study phases
A baseline (or reference) value will be defined as the value of the last available assessment prior 
to vaccination on Day 1. If there was no immunogenicity assessment done pre-vaccination, the 
earliest assessment post-vaccination on Day 1 (but not exceeding Day 1) can be used as the 
baseline value for the immunogenicity analysis, if available.
The results of the safety analysis will be presented by phase. Immunogenicity results will be
presented per scheduled time point as appropriate. Listings will be shown per phase and time point.
Study day or relative day is defined as follows:

Study Day = visit date – date of Day 1 + 1; if visit date >= date of Day 1 (date of vaccination).

Study Day = visit date – date of Day 1; if visit date < date of Day 1 (date of vaccination).
5.1.2.
Phase definition
The phases in the study will be constructed as follows:
Table 3 – Phase definitions
Phase
Phase 
#
Period
Period 
#
Interval
From
To
Screening
1
Date and time of 
signing
One minute prior to start of the Post-dose 
period
Regimen
2
Post-dose
1
1
Date and time of the 
first vaccination
Minimum of:
a) 23:59 at the date of last contact (for 
early discontinuation)
b) 23:59 at the database cut-off date for 
analyses conducted before the final 
analysis
c) maximum of (28 days after
vaccination at 23:59, scheduled visit 28 
days after vaccination at 23:59)
NCT05327816


VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
6
Status: Final, Date: 23-Jun-2022
Follow-
up 1
3
One minute after 
Post-dose 1 period 
end
Minimum of:
a) 23:59 at the date of last contact (for 
early discontinuation or participants that 
completed the study)
b) 23:59 at the database cut-off date for 
analyses conducted
before the final 
analysis
c) End of Study Visit day at 23:59
d) date/time of second vaccination
Regimen
2
Post-dose
2
2
Date and time of the 
second vaccination
Minimum of:
a) 23:59 at the date of last contact (for 
early discontinuation)
b) 23:59 at the database cut-off date for 
analyses conducted before the final 
analysis
c) maximum of (28 days after
vaccination at 23:59, scheduled visit 28 
days after vaccination at 23:59)
Follow-
up 2
4
One minute after 
Post-dose 2 period 
end
Minimum of:
a) 23:59 at the date of last contact (for 
early discontinuation or participants that 
completed the study)
b) 23:59 at the database cut-off date for 
analyses conducted
before the final 
analysis
c) maximum of (End of Study Visit, 
scheduled visit 182 days after vaccination 
at 23:59)
5.1.3.
Immunogenicity Visit Windows
For the immunogenicity analysis, assessments will be allocated to an analysis visit based on the
planned visit as captured in the CRF. Visits that are out of the protocol-defined visit windows (see
the table below) will not be included in the per-protocol immunogenicity analysis. However, they 
may be included in sensitivity analyses.
Table 4 – Immunogenicity timepoints 
Analysis time point label 
(Relative to Day 1)
Reference day
Target day (from 
reference day)
Window of target day 
(days)
Cohorts 1 and 2
Day 1
Day of vaccination 1
1
(-∞, 1]
Day 15
Day of vaccination 1
15
[12, 18]
Day 29
Day of vaccination 1
29
[22, 36]
Day 85
Day of vaccination 1
85
[78, 92]
Day 183
Day of vaccination 1
183
[169, 197]
Day 365
Day of vaccination 1
365
[335, 395]
Day 730
Day of vaccination 1
730
[700, 760]
Day 1095
Day of vaccination 1
1095
[1065, 1125]
Cohorts 3 (Arms 10 and 13)
Day 1
Day of vaccination 1
1
(-∞, 1]
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Day 15
Day of vaccination 1
15
[12, 18]
Day 29
Day of vaccination 1
29
[22, 36]
Day 85
Day of vaccination 1
85
[78, 92]
Day 183
Day of vaccination 1
183
[169, 197]
Day 365
Day of vaccination 1
365
[335, 395]
Cohorts Cohort 3 (Arms 11a, 11b and 12) and Cohort 4
Day 1
Day of vaccination 1
1
(-∞, 1]
Day 15
Day of vaccination 1
15
[12, 18]
Day 29
Day of vaccination 1
29
[22, 36]
Day 85
Day of vaccination 1
85
[78, 92]
Day 183
Day of vaccination 1
183
[169, 197]
Day X
Day of vaccination 1
X
[X-30, X+30]
Day X+14
Day of vaccination 2*
15
[12, 18]
Day X+28
Day of vaccination 2*
29
[22, 36]
Day X+84
Day of vaccination 2*
85
[78, 92]
Day X+182
Day of vaccination 2*
183
[169, 197]
Day 730
Day of vaccination 1
730
[700, 760]
Day 1095
Day of vaccination 1
1095
[1065, 1125]
Day 1460
Day of vaccination 1
1460
[1430, 1490]
Day 1825
Day of vaccination 1
1825
[1795, 1855]
Notes: * in case of missed vaccination 2, the actual date of missed vaccination 2 (i.e. the date of the day X visit) is 
used as a reference day.
5.2.
Participant Dispositions
Participant information will be shown for the FAS. The number of participants in the following
disposition categories will be summarized throughout the study by intervention group and overall:

participants screened

participants not randomized and not vaccinated

participants not randomized and vaccinated

participants randomized and not vaccinated

participants randomized and vaccinated

participants in the FAS

participants in the PPI Set

participants who discontinued study vaccine with reasons for discontinuation

participants who discontinued the study with reasons for discontinuation
Also, the number of participants and percentage per phase will be tabulated.
Other participant information variables: demographics and baseline characteristics, major protocol 
deviations, and prior and concomitant medications will be analyzed as described in Sections 6.3, 
6.4 and 6.5, respectively. Medical history and concomitant diseases will be tabulated by body 
system class and preferred term.
NCT05327816


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Status: Final, Date: 23-Jun-2022
5.3.
Primary Endpoint(s) Analysis
5.3.1.
Definition of Endpoints
For cohort 1 to 3 the primary safety endpoints are defined as:

Serious adverse events (SAEs) and adverse events of special interest (AESIs) from first dose 
administration until 6 months after vaccination

Solicited local and systemic adverse events (AEs) for 7 days after vaccine administration

Unsolicited AEs from the time of vaccine administration through the following 28 days
In addition, for cohorts 1 and 2, and cohort 4 the primary immunogenicity endpoint is defined as 
RSV neutralization antibody titers.
5.3.2.
Analysis Methods for the Primary Safety endpoints
No formal statistical testing of safety data is planned. Safety data will be analyzed descriptively 
by cohort (or pooled over cohorts, as applicable) and study arm, and by group (cohort 1), as 
applicable, per phase and across the entire study period. All safety analyses will be made on the 
FAS.
The verbatim terms used in the eCRF by investigators to identify AEs will be coded using the 
Medical Dictionary for Regulatory Activities (MedDRA). Any AE occurring at or after the first 
vaccination is considered to be treatment emergent. All reported AEs with onset during the active 
phase (ie, AEs occurring after vaccination up to 28 days post-vaccination) or AEs present before 
the active phase but worsening during the active phase, and all SAEs, AEs leading to study or 
vaccine discontinuation during the study, potential AESIs and AESIs (up to 6 months after 
vaccination) will be included in the analysis. For each AE, the percentage of participants who 
experience at least 1 occurrence of the given event will be summarized. All other unsolicited 
adverse events collected outside the 28-day period will be presented through listings.
AESIs (as determined in Section 5.3.2.1) will be reported until 6 months post vaccination and 
additionally by different time periods:

0 – 28 days post dose, 

29 days – 56 days post dose, 

0 – 56 days post dose, 

57 days – 6 months post dose,

0 – 6 months post-dose.
5.3.2.1.
Definitions of Adverse Events
Solicited AEs shown in the tables will be extracted from the investigator assessment pages (CE) 
of the CRF. Solicited administration site symptoms by definition will be considered as related to 
the study vaccine.
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The severity of the AEs will be classified as grade 1 to 4. Solicited events of grade 0, not reported
in the CE domain, will therefore not be reported in the AE analysis.
In addition to the potential AESIs as identified by the investigator in the database, potential AESIs 
will also be selected programmatically. Those will include all reported AEs that are identified by 
the selection rule: SMQ (Standardised MedDRA Queries) = “EMBOLIC AND THROMBOTIC 
EVENTS (SMQ)” or (SUB_SMQ1 = “HAEMATOPOIETIC THROMBOCYTOPENIA (SMQ)” 
and SCOPE in (“BROAD”, ”NARROW”)) or HLT (higher level term)=“Thrombocytopenias”.
5.3.2.2.
Analysis of Adverse Events
Number and percentage of participants with at least one particular AE (unsolicited/solicited) will
be tabulated. Unsolicited AEs will be summarized by System Organ Class (SOC) and Preferred 
Term (PT).
Solicited AEs will be summarized by class (administration site, systemic) and Derived Term. The 
number and percentages of participants with at least one solicited local (at injection site) or 
systemic adverse event will be presented. For solicited AEs, the following tables will be provided: 
overall summary, by worst severity grade, at least grade 3, related (systemic only), time to onset 
(in days) and duration (in days). Note: Duration is defined as number of days from the start of the 
event until resolution of the event. The time to first onset is defined as date of first onset – reference 
date + 1. The reference date is the start date of the post-dose period. For solicited AEs, the 
denominator for the percentages is the number of participants with solicited event data assessed 
by the investigator in the considered population, phase and arm (incidence per 100 
participants/phase).
A tabulation of the distribution of temperatures per half degree intervals will also be provided.
Frequencies of unsolicited AEs, separately for all and vaccination-related only, will be presented 
by SOC and PT. The following tables will be provided: overall summary, all AEs, most frequent
AEs, AEs with at least grade 3, related AEs, AEs leading to death, AEs leading to study 
discontinuation, SAEs, related SAEs, potential AESIs and AESIs, COVID-19 related AEs.
AESIs, AEs flagged by the investigator as potential AESI and AESIs identified via a programmed 
selection will be summarized by Interest Category and PT. Denominator for the percentages is the 
number of participants in the considered population, phase and arm (incidence per 100 
participants/phase). 
Potential AESIs selected programmatically will be tabulated by categories: ‘Embolic and 
thrombotic events (SMQ)’ and ‘Haematopoietic Thrombocytopenias (SMQ) (broad) or HLT = 
Thrombocytopenias’. Potential AESI determined programmatically, related to study vaccine 
(investigator assessment), will be tabulated similarly. 
Potential AESIs as identified by the investigator, will be tabulated by categories: ‘Embolic and 
thrombotic events (SMQ)’ and ‘Haematopoietic Thrombocytopenias (SMQ) (broad) or HLT = 
NCT05327816


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Thrombocytopenias’, and ‘Other’. Potential AESI as identified by the investigator, related to study 
vaccine (investigator assessment), will be tabulated similarly.
AESIs (as confirmed by review) will be tabulated by categories: ‘Embolic and thrombotic events 
(SMQ)’ and ‘Haematopoietic Thrombocytopenias (SMQ) (broad) or HLT=Thrombocytopenias’. 
All AESI analyses will be presented by phase as well as by time interval. The definition of the 
different time intervals can be found in Section 5.3.2.3.
For AESIs, potential AESIs as identified by the investigator and potential AESIs determined 
programmatically, attribution to the intervals will be done similarly to the unsolicited AEs as 
described in Section 5.3.2.3. For Step 2 of phase allocation of adverse events, the ‘0 - 28 days post-
dose’ interval should be treated similar to active periods and the rest as non-active periods.
Summaries, listings, datasets, or participant narratives may be provided, as appropriate, for those 
participants who die, who discontinue the study vaccination due to an AE, who discontinue the 
study due to an AE, or who experience a severe AE, an AESI, an SAE or a COVID-19 infection.
5.3.2.3.
Phase Allocation of Adverse Events
As the analysis of solicited events will be based on the overall assessment of the investigator,
which is documented in the CE domain, the Analysis Data Model (ADaM) dataset will be based
on the CE domain. Solicited events are allocated to the phases as described below, however they
are always allocated to Post-dose period and will never be attributed to the screening phase. Time
of day is not considered while attributing solicited AEs to phases.
For unsolicited AEs, the steps below are followed as well.
Step 1: Allocation of events to the periods:
Adverse events in the SDTM database are allocated to periods based on their start date/time. If the
start date/time of an event falls between (or on) the start and stop date/time of a period, the AE is
attributed to that period (treatment-emergent principle).

In case of partial start or stop dates (i.e., time and/or day and/or month and/or year missing), 
the events are allocated to the periods using the available partial information on start and end 
date; no imputation will be done. If, for instance, the AE start date only month and year are 
available, these data are compared to the month and year information of the periods. This rule 
may lead to multiplication of the event as a consequence of its assignment to multiple periods.

In case of a completely missing end date, the date is imputed by the cut-off date of the analysis
for participants still ongoing in the study, and by the end date of the last period for participants
who discontinued or completed the trial. The imputed end dates will not be shown in the data
listings.

In case of a completely missing start date, the event is allocated to the first active phase
(Post-dose period), except if the end date of the AE falls before the start of the first active 
phase (Post-dose period).
NCT05327816


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Step 2: Combination of events:
Overlapping/consecutive events are defined as events of the same participant with the same
preferred term which have at least 1 day overlap or for which the start date of an event is 1 day
after the end date of the preceding event. Overlapping/consecutive events may be combined into
one AE or not, according to the following rules:
1. If overlapping/consecutive events start in one of the following phases/periods - Screening 
or Follow-up (defined as non-active periods) - followed by an AE in - Post-dose period 
(defined as active period) - they are allocated to their respective phases/periods and are 
considered as separate events.
2. In case overlapping/consecutive events start within a single period, they are considered as 
one and the same AE. The individual events which contribute to this AE are retained as 
individual records in the ADaM database but are assigned the same onset, period, and total 
duration. All related attributes to the AE/phase/period should also be consistent with the 
new event.
3. In case overlapping/consecutive events start in both an active period followed by a 
consecutive non-active period, they are allocated to the active period only and are 
considered as one and the same AE. The individual events which contribute to this AE are 
retained as individual records in the ADaM database but are assigned the same onset, 
treatment period, and total duration. All related attributes to the AE/phase/period should 
also be consistent with the new event.
4. In case an active period is followed by another active period, and the 
overlapping/consecutive events start in both periods, they are allocated to their respective 
period and are considered as separate AEs. In case overlapping/consecutive events start in 
non-consecutive periods (regardless of active or non-active), they are allocated to their 
respective period and are considered as separate AEs.
5. In case a non-active period is followed by another non-active period, and the 
overlapping/consecutive events start in both periods, they are allocated to the first period 
and they are considered as one and the same AE. The individual events which contribute 
to this AE are retained as individual records in the ADaM database but are assigned the 
same onset, period, and total duration. All related attributes to the AE/phase/period should 
also be consistent with the new event.
Remarks:
1. Events can only be combined into one and the same AE if their start and stop dates are 
known.
2. In case the completely missing end date is imputed (for period allocation), this date is also
considered as a complete date.
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3. Time is not considered when determining overlap of events.
The AESIs will be presented by phase as well as by time interval. The definition of the different 
time intervals can be found below. Attribution to the intervals will be done similarly to the 
unsolicited AEs as described above. For Step 2 of phase allocation of adverse events, the ‘0 - 28 
days post-dose’ intervals should be treated similar to ‘active’ periods and the rest as ‘non-active’ 
periods.
The definition of the time intervals is shown in the table below. Additionally, in the tables a ‘0-56 
days post-dose’ interval and a ‘0-6 months post-dose’ interval should also be shown. The ‘0-56 
days post-dose’ interval is the combination of the ‘0 - 28 days post-dose’ interval and the ‘29 - 56 
days post-dose’ interval. The ‘0-6 months post-dose’ interval is the combination of the ‘0 - 28 days 
post-dose’, ‘29 - 56 days post-dose’ and ‘57 days - 6 months post-dose’ intervals.
Definition of intervals:
Dose
Interval
From
to
Post-vaccination 
1
0-28 days post 
dose
Date time of the 
1st vaccination
Min of:

23:59 at the date of last contact 
(for discontinuations)

23:59 at date of DB cut-off for 
interim analyses

Maximum(Date of Vaccination 1 
+ 28 days at 23:59, date of 
scheduled visit 4 weeks after 1st
vaccination at 23:59)
29-56 days 
post dose
One minute after 
the end of the 
interval 0-28 
days post dose
Min of:

23:59 at date of last contact (for 
discontinuations)

23:59 at date of DB cut-off for 
interim analyses

Date of Vaccination 1 + 56 
days at 23:59
57 days - 6 
months post-
dose
One minute after 
the end of the 
interval 29-56 
days post dose
Min of:

23:59 at date of last contact (for 
discontinuations)

23:59 at date of DB cut-off for 
interim analyses

Maximum of (Date of 
Vaccination 1 + 183 days at 
23:59, date of scheduled visit 
183 days post 1st vaccination at 
23:59)
>6 months 
post-dose
One minute after 
the end of the 
interval 57 days -
6 months post-
dose
Min of:

23:59 at the date of last contact 
(for discontinuations)

23:59 at the date of DB cut-off 
for interim analyses
NCT05327816


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
1 min prior to date time of 
vaccination 2
Post-vaccination 
2
0-28 days post 
dose
Date time of the 
2nd vaccination
Min of:

23:59 at the date of last contact 
(for discontinuations)

23:59 at date of DB cut-off for 
interim analyses

Maximum(Date of Vaccination 2 
+ 28 days at 23:59, date of 
scheduled visit 4 weeks after 2nd 
vaccination at 23:59)
29-56 days 
post dose
One minute after 
the end of the 
interval 0-28 
days post dose
Min of:

23:59 at date of last contact (for 
discontinuations)

23:59 at date of DB cut-off for 
interim analyses

Date of Vaccination 2 + 56 
days at 23:59
57 days - 6 
months post-
dose
One minute after 
the end of the 
interval 29-56 
days post dose
Min of:

23:59 at date of last contact (for 
discontinuations)

23:59 at date of DB cut-off for 
interim analyses

Maximum (Date of Vaccination 
2 + 183 days at 23:59, day 547 
visit at 23:59) 
>6 months 
post-dose
One minute after 
the end of the 
interval 57 days -
6 months post-
dose
Min of:

23:59 at the date of last contact 
(for discontinuations)

23:59 at the date of DB cut-off 
for interim analyses 
The combination of the ‘0 - 28 days post-dose’ interval and the ‘29 - 56 days post-dose’ interval 
will be referred as ‘0 - 56 days post-dose’.  
The combination of the ‘0 - 28 days post-dose’, ‘29 - 56 days post-dose’ and ‘57 days - 6 months 
post-dose’ intervals will be referred as ‘0-6 months post-dose’.
5.3.2.4.
Missing Data
Missing data will not be imputed. Participants who do not report an event will be considered as
participants without an event. An AE with a missing severity or relationship will be considered as
an AE reported but will be considered as not reported for the severity or relationship. For example,
an AE with missing severity will be considered as an AE reported for the analysis of any grade but
will be considered as not reported for the analysis of at least grade 3. 
5.3.3.
Analysis Methods for the Primary Immunogenicity endpoint(s)
For Cohort 1, 2 and 4 the primary endpoint will be RSV neutralization antibody titers measured 
for RSV-A and RSV-B. In Cohort 3, RSV neutralization antibody titers are a secondary endpoint.
NCT05327816


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Data of corresponding arms from Cohort 1 and Cohort 2 will be combined in all analyses. 
Immunogenicity data of corresponding arms from Cohort 3 and Cohort 4 will be combined as 
applicable, too.
Descriptive statistics will be used for all arms to analyze the actual values (geometric mean, 95% 
CI, minimum, maximum, median and quartiles) and fold increase from baseline at all timepoints, 
as well as the percentage of participants with 2- and 4-fold increases from baseline. Additionally, 
the RSV-A/RSV-B antibody ratio will be reported by time points and the fold increase of RSV-
A/RSV-B antibody ratio from baselines will be calculated at all timepoints.
For combined data from Cohort 1 and Cohort 2, geometric mean ratios for each active arm 
relatively to control Arm 1a and relatively to control Arm 1b, as well as relatively to each other 
will be calculated at all available timepoints along with corresponding 95% CI as applicable.
For Cohort 3, Arms 11a and 11b will be combined and the active arms (10, 11a+11b, 13) will be 
compared to each other at all available timepoints up to 1 year after vaccination on Day 1 by 
calculating the geometric mean ratios along with corresponding 95% CIs. 
For durability and revaccination evaluation analyses, the following arms will be combined and 
compared to each other for all timepoints:

Arm 11a (Cohort 3) combined with Arm 14 (Cohort 4);

Arm 11b (Cohort 3) combined with Arm 15 (Cohort 4);

Arm 12 (Cohort 3) combined with Arm 16 (Cohort 4).
Geometric means per arm of values for RSV-A, RSV-B and the ratio of RSV-A/RSV-B, geometric 
mean ratios for RSV-A, RSV-B and the ratio of RSV-A/RSV-B between all active arms along 
with corresponding 95% CIs will be estimated via an analysis of variance (ANOVA) using log-
transformed post-vaccination immuno parameter response as dependent variable and study arm as 
independent variable. The means and differences in mean and CIs will be back transformed (by 
exponentiation) to CIs around a geometric mean or geometric mean ratio. This analysis will be 
performed by time points, separately per parameter. As a sensitivity analysis, the ANOVA may 
also be performed adjusting for baseline titer, age and sex.
Graphical presentation of actual values, fold increase from baseline and geometric mean ratios 
(between active arms) will be presented in scatterplots, boxplots, dot-plots, spaghetti plots etc. as 
applicable. In addition, plots of geometric mean titers (GMT) over time, combining the regimens 
in one graph (without individual participant dots) will be created. Reverse distribution curves of 
the actual values will be provided, for baseline and the different timepoints. In the graphs, original 
values will be displayed on the log2 scale.
5.4.
Secondary Immunogenicity Endpoint(s) Analysis
Key secondary endpoints (for Cohorts 1 and 2) include F protein binding antibodies (pre-F and/or 
post-F), and antigen-specific T-cell responses (as defined by IFN-γ ELISpot).
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The data on titers of F protein binding antibodies for RSV-A and RSV-B and antigen-specific T-
cell responses will be analyzed similarly as described in Section 5.3.3 but using log2 or log10 
transformation as applicable. For ELISpot, only the following descriptive statistics will be 
calculated: N, median, quartiles, minimum and maximum.
5.5.
Exploratory Endpoints Analysis
Exploratory endpoints may include the following, but are not limited to: RSV neutralization 
antibody titers against additional A and/or B strains, anti-F protein antibody specificity and 
functionality characterization, adenovirus neutralization antibody titers, molecular antibody 
characterization (eg, avidity, Fc cell interaction, antibody-dependent cell-mediated cytotoxicity 
[ADCC], antibody-dependent cell-mediated phagocytosis [ADCP], antibody isotyping, antibody 
sequencing for repertoire), including but not limited to immunoglobulin (Ig)A and IgG, 
chemokines and cytokines in serum samples, transcriptome analysis and sequencing of the T-cell 
receptor (TCR) and/or B-cell receptor (BCR) or heavy/light chain (VH/VL) characterization, 
evaluation of the cellular immune response and the functional and memory immune response by 
intracellular cytokine staining (ICS), cellular phenotyping and memory B-cell ELISpot.
Scatterplot with humoral and cellular assays may be provided for the most important time points. 
Alternatively, in case of no quantitative data available or in case of sparse data, the results may be 
summarized by frequency and proportions along with 95 CIs.
5.5.1.
ICS
For ICS, if available, analyses may include: 
Total Cytokine response: the % of subsets expressing at least IFNγ, TNFa or IL2 will be calculated 
for CD4 and CD8 separately (IFNγ and/or TNFa and/or IL2). Here, at least one cytokine should 
be positive. For total cytokine responses, tables with number of observations, median, first and 
third interquartile per timepoint will be provided. Subject profiles of the actual values over time 
will be graphically presented. Actual values are shown as box plots with dots for subject values, 
and the corresponding median and the first and third quartile (Q1, Q3) per time point. 
Total CD8 cytotoxic response: the % of subsets expressing cytotoxic markers such as Perforin, 
Granzyme B and/or CD107a will be calculated for CD8. Tables with number of observations, 
median, first and third interquartile per timepoint will be provided. Subject profiles of the actual 
values over time will be graphically presented. Actual values are shown as box plots with dots for 
subject values, and the corresponding median and the first and third quartile (Q1, Q3) per time 
point. 
Polyfunctionality analysis will be assessing the possible cytokine combinations with at least one 
cytokine being positive  (for example, IFNγ+TNFa+ IL2+, IFNγ+TNFa+IL2-, IFNγ+TNFa-IL2-
etc). For the polyfunctionality analysis bar charts reflecting the median magnitude and/or the 
mean±SD of each combination may be graphically presented. In that case, tables with the 
corresponding descriptive statistics will also be provided.
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Status: Final, Date: 23-Jun-2022
Th1 and Th2: Th1 is defined as all CD4+ IFNγ and/or TNFa and/or IL2 and Th2 as all CD4+ as 
IL4 and/or IL13 and CD40L+ cells. Subject profiles and graphs of the actual values over time 
(box-plot type including individual scatterplots) will be created. In addition, at time points of 
interest, scatterplots of Th1 vs Th2 might be created. For the graphs, original values will be 
displayed on the log10 scale. 
The technical details for the calculation of the ICS values to be used in the graphs will be outlined 
in the data presentation specifications (DPS) document.
5.5.2.
VNA against Ad26 vector
For VNA against the Ad26 vector, if available following statistics will be calculated: N, geometric 
mean and corresponding 95% CI of the actual values. Subject profiles of the assays against the 
insert (RSV-A and RSV-B) will be repeated, highlighting subjects with pre-existing immunity at 
baseline against the vectors. Scatterplots of the Adeno assay versus the assays against the inserts 
may be provided for the most important time points. In these scatterplots the actual values will be 
shown, even if they are below the LLOQ.
5.6.
Handling of Missing and/or Unquantifiable Immune Response Data
Missing immune response data will not be imputed. Values below the lower limit of quantification 
(LLOQ) will be imputed based on the type of analysis:

For the calculation of the geometric mean titer, values below LLOQ will be imputed to 
LLOQ/2. While for the calculation of the geometric mean of the increase from baseline, values 
below LLOQ will be imputed to LLOQ.

Data above the ULOQ will be imputed with the ULOQ.
The ULOQ and LLOQ values per assay will be available in the database.
For ICS: if no LLOQ is available at the time of analysis, a provisional lower limit will be used to 
impute as described above. The provisional lower limit will be provided in the data base.
5.7.
Other Safety Analyses
The analysis of Adverse Events is described in Section 5.3.2. Other safety analyses include 
laboratory tests, vital signs and physical examination data. All these safety analyses will be based 
on the FAS using actual intervention received, unless otherwise specified. All the summary tables 
will be presented by cohort (or pooled over cohorts, as applicable) and study arm, and by group 
(cohort 1), as applicable.
For all continuous safety variables, descriptive statistics will include the N, mean, standard 
deviation, median, minimum, maximum, and interquartile range. Categorical variables will be 
summarized using frequency counts and percentages.
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VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
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Status: Final, Date: 23-Jun-2022
5.7.1.
Clinical Laboratory Tests
Laboratory abnormalities will be determined according to the FDA toxicity grading tables (see 
Appendix 6 of CTP), or in accordance with the normal ranges for the clinical laboratory parameter: 
any laboratory value shown as a “graded” value in the FDA table that is within laboratory normal 
ranges will not be graded for severity. All the abnormalities will be summarized and listed.
5.7.2.
Vital Signs
Vital signs including temperature, heart rate, respiratory rate, and blood pressure (systolic and 
diastolic) will be summarized over time, using descriptive statistics and/or graphical
representations. The percentage of participants with values beyond clinically important limits will 
be summarized. Baseline and emerging vital sign abnormalities will be listed based on the 
abnormality gradings in Appendix 6 of the CTP. An abnormality will be considered as emerging 
if it is worse than the baseline value. If the baseline is missing, the abnormality is always 
considered emerging.
5.7.3.
Physical Examinations
Physical examination findings pre-vaccination will be summarized per vaccine administration. A 
summary table as well as listing of the abnormalities will be presented.
5.8.
Other Analyses
5.8.1.
Pharmacokinetics
Not applicable.
5.8.2.
Pharmacodynamics
Not applicable.
5.8.3.
Biomarkers
Biomarker data analysis may be conducted at the sponsor’s discretion and may be detailed and 
reported separately.
5.8.4.
Definition of Subgroups
No subgroup analysis is planned for this study.
5.9.
Planned Analyses
The following analyses are planned: 

Primary analysis: 28 days post-vaccination safety and immunogenicity analysis up to D15 for 
humoral antibodies. This analysis will be performed when all participants in Cohort 1 and 
Cohort 2 have completed their 28-day post-vaccination visit. For primary analysis humoral 
immunogenicity will include baseline and Day 15 data, while safety analysis will be included 
the data up to Day 29 visit. Data from corresponding arms from the two cohorts will be 
combined. The goal of this analysis will be to select the vaccine formulation to be used in 
Cohort 3.
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VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
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Status: Final, Date: 23-Jun-2022

Interim analyses: 
o
84 days post-vaccination immunogenicity analysis for Cohorts 1 and 2. Available 
immunogenicity data of all participants in Cohort 1 and Cohort 2 up to the Day 85 
will be included in the analysis.6-month post-vaccination safety and immunogenicity 
analysis for Cohorts 1 and 2. Available safety and immunogenicity data of all 
participants in Cohort 1 and Cohort 2 up to the Day 185 follow-up visit post-
vaccination will be included in the analysis. This analysis may include 
immunogenicity data available from additional timepoints.
o
1-year post-vaccination immunogenicity analysis for Cohorts 1 and 2. 
Immunogenicity data of all participants in Cohort 1 and Cohort 2 up to (and 
including) the 1-year follow-up visit post-vaccination will be included in the 
analysis. 
o
28 days post-vaccination safety and immunogenicity analysis for Cohort 3. This 
analysis will be performed when all participants in Cohort 3 have completed their 
28-day post-vaccination visit.
o
28 days post-vaccination safety and immunogenicity analysis for Cohort 4. This 
analysis will be performed when all participants in Cohort 4 have completed their 
28-day post-vaccination visit. 
o
6-month post first vaccination safety and immunogenicity analysis for Cohorts 3 and 
4. This interim analysis will include all safety and immunogenicity data from all 
participants in Cohorts 3 and 4, collected up to (and including) the 6-months follow-
up visit post Day 1 vaccination.
o
28 days post revaccination safety and immunogenicity analysis for Cohorts 3 and 4. 
This interim analysis will include all safety and immunogenicity data from all 
participants in Cohorts 3 and 4, collected up to (and including) the 28-day post-
revaccination visit.
o
Yearly follow-up analyses until 3 years post first vaccination in Cohorts 1 and 2 and 
until 5 years post first vaccination in Cohort 3 (Arms 11a, 11b and 12) and Cohort 4. 
These analyses will include immunogenicity and safety data up to the 2-year follow-
up visit post Day 1 vaccination, the 3-year follow-up visit post Day 1 vaccination, 
the 4-year follow-up visit post-Day 1 vaccination (applicable for Cohort 3 [Arms 
11a, 11b and 12] and Cohort 4 only), and 5-year follow-up visit post Day 1 
vaccination (applicable for Cohort 3 [Arms 11a, 11b and 12] and Cohort 4 only). 

Final analysis: immunogenicity analysis and safety data up to study end. 
Additional interim analyses may be performed during the study for the purpose of informing future 
vaccine development-related decisions in a timely manner, or upon health authority request. If they 
occur, these unplanned interim analyses may replace or be combined with planned analyses, 
depending on the timing. 
For any planned or additional analysis performed before the final analysis, the sponsor will be 
unblinded at the time of the analysis, while study site personnel and participants will remain 
blinded until the end of the study.
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VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
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Status: Final, Date: 23-Jun-2022
5.9.1.
Data Review Committee (DRC)
An internal DRC will be established to evaluate safety and reactogenicity data, including interim 
safety and reactogenicity data of Cohort 1, to ensure the continuing safety of the participants 
enrolled in this study. The DRC will review blinded data but may request unblinded data if deemed 
necessary. Ad-hoc meetings will be convened in case any of the pre-specified study vaccination 
pausing rules are met. This committee will consist of at least one medical expert in the relevant 
therapeutic area and at least one statistician; committee membership responsibilities, authorities, 
and procedures will be documented in its charter. After the review, the DRC will make 
recommendations regarding the continuation of the study.
NCT05327816


VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
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Status: Final, Date: 23-Jun-2022
6.
SUPPORTING DOCUMENTATION
6.1.
Appendix 1 List of Abbreviations
ADA
anti-drug antibody
ADaM
Analysis Data Model
AE
adverse event
ANCOVA
analysis of covariance
ATC
anatomic and therapeutic class
Analysis Data Model
Analysis Data Model
BMI
body mass index
CI
confidence interval
CRF
case report form
CSR
Clinical Study Report
CTCAE
Common Terminology Criteria for Adverse Events
DMC
Data Monitoring Committee
DPS
Data Presentation Specifications
ELISA
enzyme-linked immunosorbent assay
eCRF
electronic case report form
FAS
full analysis set
FDA
Food and Drug Administration
ICH
International Conference on Harmonisation
IQ
Interquartile
IWRS
interactive web response system
LLOQ
lower limit of quantification
MedDRA
Medical Dictionary for Regulatory Activities
MRD
minimum required dilution
NAb
neutralizing antibodies
PPI
per protocol immunogenicity analysis set
Pre F
prefusion conformation-stabilized F protein
PT
Preferred term
RSV
respiratory syncytial virus
QTL
Quality Tolerance Limit
SAE
serious adverse event
SAP
Statistical Analysis Plan
SD
standard deviation
SMQs
standardized MedDRA queries
SOC
System organ class
TEAE
treatment-emergent adverse event
VNA
virus neutralization antibody
WHO
World Health Organization
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VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
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Status: Final, Date: 23-Jun-2022
6.2.
Appendix 2 Changes to Protocol-Planned Analyses
The safety laboratory data are planned to be assessed according to both local laboratory normal 
ranges as well as FDA toxicities grades.
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VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
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Status: Final, Date: 23-Jun-2022
6.3.
Appendix 3 Demographics and Baseline Characteristics
The following demographic and baseline characteristics will be summarized. Table 5 presents a 
list of the demographic variables that will be summarized by cohort and vaccine regimen and 
overall, for the FAS.
Table 5 – Demographic Variables
Continuous Variables:
Summary Type
Age (years)
Descriptive statistics (N, mean, 
standard deviation [SD], median 
and range [minimum and 
maximum], and IQ range).
Weight (kg)
Height (cm)
Body Mass Index (BMI) (kg/m2)
Categorical Variables
Sex (male, female, undifferentiated)
Frequency distribution with the 
number and percentage of 
participants in each category.
Racea (American Indian or Alaska Native, Asian, Black or African 
American, Native Hawaiian or other Pacific Islander, White, Multiple)
Ethnicity (Hispanic or Latino, not Hispanic or Latino)
BMI (<18.5 kg/m2 (underweight), 18.5-24.9 kg/m2 (Normal or Healthy 
Weight), 25-29.9 kg/m2 (Overweight), ≥30 kg/m2 (Obese))
Risk level of severe RSV disease (Increased risk / Non-increased risk) as
collected (CDC definition)
aIf multiple race categories are indicated, the Race is recorded as 'Multiple'
NCT05327816


VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
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Status: Final, Date: 23-Jun-2022
6.4.
Appendix 4 Protocol Deviations
Major protocol deviations will be summarized.
In general, a list of major protocol deviations that may have the potential to impact participants’
rights, safety or well-being, or the integrity and/or result of the clinical study will be specified in a
major protocol violation criteria document. Participants with major protocol deviations will be
identified prior to database lock and the participants with major protocol deviations will be
summarized by category. In addition, minor and major protocol deviations related to COVID-19
will be tabulated.
NCT05327816


VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
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Status: Final, Date: 23-Jun-2022
6.5.
Appendix 5 Prior and Concomitant Medications
The analysis of concomitant therapies will be done using the WHO drug coded terms. Based on 
their start and stop date, concomitant therapies will be reported in each applicable phase. If a 
concomitant therapy record misses components of its start and/or stop dates (time, day and/or
month and/or year):

In case of partial start or stop dates, the concomitant therapy records will be allocated to
periods using the available partial information, without imputations. If, for example, only
month and year are available, these will be compared to the month and the year of the periods,
and the concomitant therapy record will be allocated to the period(s) where these date parts
match. This rule may lead to assignment to multiple periods. The same rule applies for
identifying whether a concomitant therapy was administered during 8 days following
vaccination. If for example, the vaccination was administered on the 30 December 2021 and
the concomitant therapy start date is January 2022, then the concomitant therapy will be
assumed to have started within 8 days of the vaccination.

In case of a completely missing start date, the concomitant therapy will be considered as
having started before the study.

In case of a completely missing end date, the concomitant therapy will be considered as
ongoing at the end of the trial.
There will be special attention to any systemic use of analgesics/antipyretics, started during 8 days
following each vaccination (00:00 of day of vaccination + 7 days). Following ATC/DD codes will
be used for this: N02A (OPIOIDS) and N02B (OTHER ANALGESICS AND ANTIPYRETICS),
M01A (ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS)
and M01B (ANTIINFLAMMATORY/ANTIRHEUMATIC AGENTS IN COMBINATION)
(ATC/DD Index). The classes will be added in a footnote in all related tables and listings. For the
use of analgesics/antipyretics which are taken on the day of vaccination, an exception is made in
case the time is before vaccination. In this case, the concomitant medication is also allocated to
the Post-dose period. Tables will be created for all concomitant medication and concomitant
medications of special interest.
Prior medications will be summarized by cohort and vaccine regimen and overall and ATC term.
NCT05327816


VAC18195 (JNJ 64400141/ JNJ 64213175/ JNJ-86051823/ JNJ 78991172)
Statistical Analysis Plan VAC18195RSV1001
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Status: Final, Date: 23-Jun-2022
7.
REFERENCES
Clinical study protocol VAC18195RSV1001, v 1.0, 22-Dec-2021.
NCT05327816