HealthyPhase 2NCT04453202

A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults

A Phase 2 study testing RSV Vaccine in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3). Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: RSV Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 459 participants
Where: 9 sitesUnited States
Study dates: 16 Jul 2020to 9 Apr 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
Agree to not donate blood from the time of vaccination until 3 months after vaccination
Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)
Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study

Who cannot join

Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
Has hepatitis B or C infection, including history of treated hepatitis C infection
Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Clinical Research of South Florida, an AMR Company
Coral Gables, Florida, 33134
Heartland Research Associates, an AMR Company
El Dorado, Kansas, 67042
The Center for Pharmaceutical Research (CPR)
Kansas City, Missouri, 64114
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, 37920
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
Meridian Clinical Research - Omaha
Omaha, Nebraska, 68134
Optimal Research
Rockville, Maryland, 20850
Optimal Research
San Diego, California, 92108
Tekton Research Inc.
Yukon, Oklahoma, 73099

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older

Conditions: Healthy
Being tested: RSV Vaccine, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSV VaccineBiological
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
PlaceboOther
Participants will receive a single IM injection of placebo on Day 1.

Study groups in NCT04453202
Study group	Role	What they receive
Cohort 1 Group 1: RSV Vaccine	Experimental	Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1. Receives: Biological: RSV Vaccine
Cohort 1 Group 2: RSV Vaccine	Experimental	Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1. Receives: Biological: RSV Vaccine
Cohort 1 Group 3: RSV Vaccine	Experimental	Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1. Receives: Biological: RSV Vaccine
Cohort 1 Group 4: RSV Vaccine	Experimental	Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1. Receives: Biological: RSV Vaccine
Cohort 1 Group 5: Placebo	Placebo comparator	Participants will receive IM injection of placebo on Day 1. Receives: Other: Placebo
Cohort 2 Group 6: RSV Vaccine	Experimental	Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1. Receives: Biological: RSV Vaccine
Cohort 2 Group 7: RSV Vaccine	Experimental	Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1. Receives: Biological: RSV Vaccine
Cohort 2 Group 8: Placebo	Placebo comparator	Participants will receive IM injection of placebo on Day 1. Receives: Other: Placebo
Cohort 3 Group 9: RSV Vaccine	Experimental	Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1. Receives: Biological: RSV Vaccine
Cohort 3 Group 10: RSV Vaccine	Experimental	Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1. Receives: Biological: RSV Vaccine
Cohort 3 Group 11: Placebo	Experimental	Participants will receive IM injection of placebo on Day 1. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination
Geometric mean antibody titers (ELISA units per liter [EU/L]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.
Measured: 14 days after vaccination on Day 1 (Day 15)
Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Measured: Until 7 days after Vaccination on Day 1 (Day 8)
Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree celsius).
Measured: Until 7 days after Vaccination on Day 1 (Day 8)
Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Measured: Until 28 days after Vaccination on Day 1 (Day 29)

Secondary outcomes (11)

Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 3 and 6 months after vaccination on Day 1 were reported.
Measured: At 3 and 6 months after vaccination on Day 1
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
RSV A2 strain neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% inhibitory concentration (IC50) units.
Measured: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by enzyme-linked immunospot (ELISpot) assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
Measured: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Measured: Baseline (Day1) up to 6 months
Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Measured: Until 7 days after vaccination on Day 1 (Day 8)
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree celsius).
Measured: Until 7 days after vaccination on Day 1 (Day 8)
Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Measured: Until 28 days after vaccination on Day 1 (Day 29)
Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 14 days and 3 and 6 months after vaccination on Day 1 were reported.
Measured: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
RSV A2 neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% IC50 units.
Measured: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
Measured: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Measured: Baseline (Day1 ) up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 20209 Apr 2021

First posted1 Jul 2020
Study start16 Jul 2020
Primary completion24 Sep 2020
Study completion9 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 459 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04453202
Sponsor's protocol ID: CR108835
Other IDs: VAC18193RSV2005
Status last verified: May 2025
First submitted: 29 Jun 2020
Last updated: 25 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

van Heesbeen R, Bastian AR, Omoruyi E, Rosen J, Comeaux CA, Callendret B, Heijnen E. Immunogenicity and safety of different dose levels of Ad26.RSV.preF/RSV preF protein vaccine in adults aged 60 years and older: A randomized, double-blind, placebo-controlled, phase 2a study. Vaccine. 2024 Dec 2;42(26):126273. doi: 10.1016/j.vaccine.2024.126273. Epub 2024 Sep 13.
PubMed 39276619

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older
ClinicalTrials.gov ID: NCT04453202
Acronym / sponsor ID: CR108835
Conditions: Healthy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 459 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Study start: 16 Jul 2020 (actual)
Primary completion: 24 Sep 2020 (actual)
Study completion: 9 Apr 2021 (actual)
First posted: 1 Jul 2020 (actual)
Results: Posted 3 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 11

Arm	Type	Receives
Cohort 1 Group 1: RSV Vaccine	Experimental	Biological: RSV VaccineParticipants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.
Cohort 1 Group 2: RSV Vaccine	Experimental	Biological: RSV VaccineParticipants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.
Cohort 1 Group 3: RSV Vaccine	Experimental	Biological: RSV VaccineParticipants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.
Cohort 1 Group 4: RSV Vaccine	Experimental	Biological: RSV VaccineParticipants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.
Cohort 1 Group 5: Placebo	Placebo comparator	Other: PlaceboParticipants will receive IM injection of placebo on Day 1.
Cohort 2 Group 6: RSV Vaccine	Experimental	Biological: RSV VaccineParticipants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Cohort 2 Group 7: RSV Vaccine	Experimental	Biological: RSV VaccineParticipants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.
Cohort 2 Group 8: Placebo	Placebo comparator	Other: PlaceboParticipants will receive IM injection of placebo on Day 1.
Cohort 3 Group 9: RSV Vaccine	Experimental	Biological: RSV VaccineParticipants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Cohort 3 Group 10: RSV Vaccine	Experimental	Biological: RSV VaccineParticipants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.
Cohort 3 Group 11: Placebo	Experimental	Other: PlaceboParticipants will receive IM injection of placebo on Day 1.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
Agree to not donate blood from the time of vaccination until 3 months after vaccination
Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)
Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study

Key exclusion criteria (5 listed)

Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
Has hepatitis B or C infection, including history of treated hepatitis C infection
Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RSV VaccineParticipants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.	Biological	Cohort 1 Group 1: RSV Vaccine, Cohort 1 Group 2: RSV Vaccine, Cohort 1 Group 3: RSV Vaccine, Cohort 1 Group 4: RSV Vaccine, Cohort 2 Group 6: RSV Vaccine, Cohort 2 Group 7: RSV Vaccine, Cohort 3 Group 10: RSV Vaccine, Cohort 3 Group 9: RSV Vaccine
PlaceboParticipants will receive a single IM injection of placebo on Day 1.	Other	Cohort 1 Group 5: Placebo, Cohort 2 Group 8: Placebo, Cohort 3 Group 11: Placebo

Primary outcome

Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination
Time frame: 14 days after vaccination on Day 1 (Day 15)
Geometric mean antibody titers (ELISA units per liter [EU/L]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.
Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Time frame: Until 7 days after Vaccination on Day 1 (Day 8)
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Time frame: Until 7 days after Vaccination on Day 1 (Day 8)
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree celsius).
Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Time frame: Until 28 days after Vaccination on Day 1 (Day 29)
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).

11 secondary outcomes

Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1
Time frame: At 3 and 6 months after vaccination on Day 1
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Baseline (Day1) up to 6 months
Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Time frame: Until 7 days after vaccination on Day 1 (Day 8)
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Time frame: Until 7 days after vaccination on Day 1 (Day 8)
Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Time frame: Until 28 days after vaccination on Day 1 (Day 29)
Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Baseline (Day1 ) up to 6 months

Results and safety

Results posted to the registry on 3 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)	51	50
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)	51	48
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)	51	50
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)	48	45
Cohort 1: Placebo	25	24
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)	49	47
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)	49	48
Cohort 2: Placebo	26	26
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)	27	27
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)	51	48
Cohort 3: Placebo	26	25

Primary outcome: Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination

Time frame: 14 days after vaccination on Day 1 (Day 15). Geometric mean (95% Confidence Interval). Unit: EU/L

Measure	Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) n = 44	Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) n = 46	Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) n = 45	Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) n = 45	Cohort 1: Placebo n = 24
Value	4907 (4030 to 5976)	4681 (3696 to 5928)	4038 (3042 to 5361)	5238 (4070 to 6743)	272 (212 to 350)

Population analysed: Per-protocol Immunogenicity (PPI) set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Primary outcome: Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1

Time frame: Until 7 days after Vaccination on Day 1 (Day 8). Count of participants. Unit: Participants

Measure	Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) n = 49	Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg) n = 49	Cohort 2: Placebo n = 26	Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) n = 27	Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg) n = 50	Cohort 3: Placebo n = 26
Value	37	42	3	23	37	2

Population analysed: Full Analysis Set (FAS) included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Primary outcome: Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1

Time frame: Until 7 days after Vaccination on Day 1 (Day 8). Count of participants. Unit: Participants

Measure	Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) n = 49	Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg) n = 49	Cohort 2: Placebo n = 26	Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) n = 27	Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg) n = 50	Cohort 3: Placebo n = 26
Value	39	43	8	19	41	7

Population analysed: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Primary outcome: Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1

Time frame: Until 28 days after Vaccination on Day 1 (Day 29). Count of participants. Unit: Participants

Measure	Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) n = 49	Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg) n = 49	Cohort 2: Placebo n = 26	Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) n = 27	Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg) n = 51	Cohort 3: Placebo n = 26
Value	13	8	7	3	8	2

Population analysed: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Day 1) up to 6 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)	3 of 51 (5.9%)	42 of 51 (82.4%)	0 of 51
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)	0 of 51 (0%)	36 of 51 (70.6%)	0 of 51
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)	0 of 51 (0%)	25 of 51 (49%)	0 of 51
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)	1 of 48 (2.1%)	23 of 48 (47.9%)	0 of 48
Cohort 1: Placebo	0 of 25 (0%)	7 of 25 (28%)	0 of 25
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)	1 of 49 (2%)	44 of 49 (89.8%)	0 of 49
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)	1 of 49 (2%)	48 of 49 (98%)	0 of 49
Cohort 2: Placebo	1 of 26 (3.8%)	13 of 26 (50%)	0 of 26
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)	0 of 27 (0%)	25 of 27 (92.6%)	0 of 27
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)	2 of 51 (3.9%)	44 of 51 (86.3%)	1 of 51
Cohort 3: Placebo	1 of 26 (3.8%)	8 of 26 (30.8%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39276619van Heesbeen R, Bastian AR, Omoruyi E, Rosen J, Comeaux CA, Callendret B, Heijnen E. Immunogenicity and safety of different dose levels of Ad26.RSV.preF/RSV preF protein vaccine in adults aged 60 years and older: A randomized, double-blind, placebo-controlled, phase 2a study. Vaccine. 2024 Dec 2;42(26):126273. doi: 10.1016/j.vaccine.2024.126273. Epub 2024 Sep 13.
Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Vaccines & Prevention B.V. Clinical Trial study director

Janssen Vaccines & Prevention B.V.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RSV Vaccine in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination (time frame: 14 days after vaccination on Day 1 (Day 15)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04453202, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.