Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease PreventionPhase 1/2NCT05327816

A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older

A Phase 1/2 study testing RSV preF-based Vaccine in people with Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention, run by Janssen Vaccines & Prevention B.V. at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention
What is being tested?: RSV preF-based Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 132 participants
Where: 11 sitesUnited States
Study dates: 13 Apr 2022to 14 Feb 2023
Phase: Phase 1/2
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, participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease (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 signs performed between informed consent form (ICF) signature and vaccination
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 United States Food and Drug Administration (US FDA) toxicity tables (that is, for tests in the FDA table), 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
Agrees not to donate blood from the time of vaccination through 3 months after vaccination
Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study

Who cannot join

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
Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components
Per medical history, participant has chronic active hepatitis B or hepatitis C infection, human immunodeficiency viruses (HIV) type 1 or type 2 infection, acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
Participant is in receipt of, or planning to receive, licensed live attenuated vaccine within 28 days before and after study vaccinations; other licensed vaccines (that is, not live such as, influenza, tetanus, hepatitis A or B, rabies) within 14 days before and after study vaccinations
Received treatment with immunoglobulins expected to impact the vaccine-induced immune response (including monoclonal antibodies [MAbs] for chronic underlying conditions) in the 2 months; immunoglobulins specific to respiratory syncytial virus (RSV), human metapneumovirus, or parainfluenza viruses in the 12 months; apheresis therapies in the 4 months; or blood products in the 4 months prior to study vaccination or has any plans to receive such treatment during the study

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Tekton Research Inc.
Austin, Texas, 78745
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212
Meridian Clinical Research, LLC
Cincinnati, Ohio, 45246
Accel Research Sites
DeLand, Florida, 32720
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
Ark Clinical Research
Long Beach, California, 90815
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
Floridian Clinical Research LLC
Miami Lakes, Florida, 33016
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Heartland Research Associates, an AMR Company
Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention
Being tested: RSV preF-based Vaccine, Placebo

What participants receive

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

RSV preF-based VaccineBiological
RSV preF-based vaccine will be administered as intramuscular injection.
PlaceboDrug
Placebo will be administered as intramuscular injection.

Study groups in NCT05327816
Study group	Role	What they receive
Arm 1a: Respiratory Syncytial Virus (RSV) preFusion (preF) Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 1b: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 1c: Placebo	Experimental	Participants will receive single dose of placebo in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1. Receives: Drug: Placebo
Arm 2: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 3: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 4: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 5: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 6: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 7: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 8: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 9: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 10: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 11a: RSV preF Based Vaccine and Placebo	Experimental	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. Receives: Biological: RSV preF-based Vaccine; Drug: Placebo
Arm 11b: RSV preF Based Vaccine and Placebo	Experimental	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. Receives: Biological: RSV preF-based Vaccine; Drug: Placebo
Arm 12: RSV preF Based Vaccine and Placebo	Experimental	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. Receives: Biological: RSV preF-based Vaccine; Drug: Placebo
Arm 13: RSV preF Based Vaccine	Experimental	Participants in C 3 will receive the mixture of RSV preF-based vaccine plus placebo on Day 1 through intramuscular injection. Receives: Biological: RSV preF-based Vaccine; Drug: Placebo
Arm 14: RSV preF Based Vaccine	Experimental	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. Receives: Biological: RSV preF-based Vaccine
Arm 15: RSV preF Based Vaccine and Placebo	Experimental	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. Receives: Biological: RSV preF-based Vaccine; Drug: Placebo
Arm 16: RSV preF Based Vaccine and Placebo	Experimental	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. Receives: Biological: RSV preF-based Vaccine; Drug: Placebo

What is being measured

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

Number of Participants With Serious Adverse Events (SAEs)
An AE is 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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measured: From Day 1 up to 6 months post vaccination (up to Day 183)
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of participants with AESIs were reported. Thrombosis with thrombocytopenia syndrome (TTS) were considered as potential AESIs.
Measured: From Day 1 up to 6 months post vaccination (up to Day 183)
Number of Participants With Solicited Local and Systemic Adverse Events (AEs)
Number of participants with solicited local and systemic AEs were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: 7 days post vaccination (Day 8)
Number of Participants With Unsolicited Adverse Events (AEs)
Number of participants with unsolicited AEs were reported. An AE is 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 are all AEs for which the participant were not specifically questioned in the participant diary.
Measured: 28 days post vaccination (Day 29)

Timeline

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

13 Apr 202214 Feb 2023

First posted14 Apr 2022
Study start13 Apr 2022
Primary completion16 Jan 2023
Study completion14 Feb 2023

Why it stopped: Based on recent study data from VAC18193, it was decided to terminate the study. There are no underlying safety concerns to terminate VAC18195RSV1001

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.
Other trials for Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease PreventionStudies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05327816
Sponsor's protocol ID: CR109184
Other IDs: VAC18195RSV1001, 2022-001015-14
Status last verified: May 2025
First submitted: 13 Apr 2022
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

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 1/2a Study for Safety and Immunogenicity Evaluations of Various RSV.preF-based Vaccine Formulations in Adults Aged 60 Years and Older
ClinicalTrials.gov ID: NCT05327816
Acronym / sponsor ID: CR109184
Conditions: Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Based on recent study data from VAC18193, it was decided to terminate the study. There are no underlying safety concerns to terminate VAC18195RSV1001
Enrolment: 132 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Study start: 13 Apr 2022 (actual)
Primary completion: 16 Jan 2023 (actual)
Study completion: 14 Feb 2023 (actual)
First posted: 14 Apr 2022 (actual)
Results: Posted 2 Jan 2024

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 19

Arm	Type	Receives
Arm 1a: Respiratory Syncytial Virus (RSV) preFusion (preF) Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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 1b: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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 1c: Placebo	Experimental	Drug: PlaceboParticipants will receive single dose of placebo in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1.
Arm 2: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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 3: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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 4: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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 8: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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 9: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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 10: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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 11a: RSV preF Based Vaccine and Placebo	Experimental	Biological: RSV preF-based Vaccine, Drug: PlaceboParticipants 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 11b: RSV preF Based Vaccine and Placebo	Experimental	Biological: RSV preF-based Vaccine, Drug: PlaceboParticipants 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 12: RSV preF Based Vaccine and Placebo	Experimental	Biological: RSV preF-based Vaccine, Drug: PlaceboParticipants 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 13: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based Vaccine, Drug: PlaceboParticipants in C 3 will receive the mixture of RSV preF-based vaccine plus placebo on Day 1 through intramuscular injection.
Arm 14: RSV preF Based Vaccine	Experimental	Biological: RSV preF-based VaccineParticipants 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 15: RSV preF Based Vaccine and Placebo	Experimental	Biological: RSV preF-based Vaccine, Drug: PlaceboParticipants 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 16: RSV preF Based Vaccine and Placebo	Experimental	Biological: RSV preF-based Vaccine, Drug: PlaceboParticipants 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.

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, participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease (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 signs performed between informed consent form (ICF) signature and vaccination
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 United States Food and Drug Administration (US FDA) toxicity tables (that is, for tests in the FDA table), 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
Agrees not to donate blood from the time of vaccination through 3 months after vaccination
Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study

Key exclusion criteria (5 listed)

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
Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components
Per medical history, participant has chronic active hepatitis B or hepatitis C infection, human immunodeficiency viruses (HIV) type 1 or type 2 infection, acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
Participant is in receipt of, or planning to receive, licensed live attenuated vaccine within 28 days before and after study vaccinations; other licensed vaccines (that is, not live such as, influenza, tetanus, hepatitis A or B, rabies) within 14 days before and after study vaccinations
Received treatment with immunoglobulins expected to impact the vaccine-induced immune response (including monoclonal antibodies [MAbs] for chronic underlying conditions) in the 2 months; immunoglobulins specific to respiratory syncytial virus (RSV), human metapneumovirus, or parainfluenza viruses in the 12 months; apheresis therapies in the 4 months; or blood products in the 4 months prior to study vaccination or has any plans to receive such treatment during the study

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 preF-based VaccineRSV preF-based vaccine will be administered as intramuscular injection.	Biological	Arm 10: RSV preF Based Vaccine, Arm 11a: RSV preF Based Vaccine and Placebo, Arm 11b: RSV preF Based Vaccine and Placebo, Arm 12: RSV preF Based Vaccine and Placebo, Arm 13: RSV preF Based Vaccine, Arm 14: RSV preF Based Vaccine, Arm 15: RSV preF Based Vaccine and Placebo, Arm 16: RSV preF Based Vaccine and Placebo, Arm 1a: Respiratory Syncytial Virus (RSV) preFusion (preF) Based Vaccine, Arm 1b: RSV preF Based Vaccine, Arm 2: RSV preF Based Vaccine, Arm 3: RSV preF Based Vaccine, Arm 4: RSV preF Based Vaccine, Arm 5: RSV preF Based Vaccine, Arm 6: RSV preF Based Vaccine, Arm 7: RSV preF Based Vaccine, Arm 8: RSV preF Based Vaccine, Arm 9: RSV preF Based Vaccine
PlaceboPlacebo will be administered as intramuscular injection.	Drug	Arm 11a: RSV preF Based Vaccine and Placebo, Arm 11b: RSV preF Based Vaccine and Placebo, Arm 12: RSV preF Based Vaccine and Placebo, Arm 13: RSV preF Based Vaccine, Arm 15: RSV preF Based Vaccine and Placebo, Arm 16: RSV preF Based Vaccine and Placebo, Arm 1c: Placebo

Primary outcome

Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 up to 6 months post vaccination (up to Day 183)
An AE is 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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: From Day 1 up to 6 months post vaccination (up to Day 183)
Number of participants with AESIs were reported. Thrombosis with thrombocytopenia syndrome (TTS) were considered as potential AESIs.
Number of Participants With Solicited Local and Systemic Adverse Events (AEs)
Time frame: 7 days post vaccination (Day 8)
Number of participants with solicited local and systemic AEs were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: 28 days post vaccination (Day 29)
Number of participants with unsolicited AEs were reported. An AE is 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 are all AEs for which the participant were not specifically questioned in the participant diary.

Results and safety

Results posted to the registry on 2 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg	12	0
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg	12	0
Arm 1c (Cohort 1): Pooled Placebo	12	0
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg	12	0
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg	12	0
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg	12	0
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg	12	0
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg	12	0
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 110^11vp/Ad26.RSV-B.preF2 510^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg	12	0
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg	12	0
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg	12	0

Primary outcome: Number of Participants With Serious Adverse Events (SAEs)

Time frame: From Day 1 up to 6 months post vaccination (up to Day 183). Count of participants. Unit: Participants

Measure	Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg n = 12	Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg n = 12	Arm 1c (Cohort 1): Pooled Placebo n = 12	Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg n = 12	Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg n = 12	Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg n = 12	Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg n = 11	Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg n = 11	Arm 7 (Cohort 1):Ad26.RSV-A.PreF 110^11vp/Ad26.RSV-B.preF2 510^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg n = 11	Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg n = 12	Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg n = 12
Value	0	0	1	1	0	0	1	1	1	0	0

Population analysed: The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.

Primary outcome: Number of Participants With Adverse Events of Special Interest (AESIs)

Time frame: From Day 1 up to 6 months post vaccination (up to Day 183). Count of participants. Unit: Participants

Measure	Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg n = 12	Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg n = 12	Arm 1c (Cohort 1): Pooled Placebo n = 12	Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg n = 12	Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg n = 12	Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg n = 12	Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg n = 11	Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg n = 11	Arm 7 (Cohort 1):Ad26.RSV-A.PreF 110^11vp/Ad26.RSV-B.preF2 510^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg n = 11	Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg n = 12	Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg n = 12
Value	0	0	0	0	0	0	1	0	1	0	0

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

Primary outcome: Number of Participants With Solicited Local and Systemic Adverse Events (AEs)

Time frame: 7 days post vaccination (Day 8). Count of participants. Unit: Participants

Measure	Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg n = 12	Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg n = 12	Arm 1c (Cohort 1): Pooled Placebo n = 12	Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg n = 12	Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg n = 12	Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg n = 12	Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg n = 11	Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg n = 11	Arm 7 (Cohort 1):Ad26.RSV-A.PreF 110^11vp/Ad26.RSV-B.preF2 510^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg n = 11	Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg n = 12	Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg n = 12
Solicited Local AEs	6	8	5	7	8	10	7	8	9	11	7
Solicited Systemic AEs	9	8	7	8	9	10	7	10	10	10	7

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

Primary outcome: Number of Participants With Unsolicited Adverse Events (AEs)

Time frame: 28 days post vaccination (Day 29). Count of participants. Unit: Participants

Measure	Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg n = 12	Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg n = 12	Arm 1c (Cohort 1): Pooled Placebo n = 12	Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg n = 12	Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg n = 12	Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg n = 12	Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg n = 11	Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg n = 11	Arm 7 (Cohort 1):Ad26.RSV-A.PreF 110^11vp/Ad26.RSV-B.preF2 510^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg n = 11	Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg n = 12	Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg n = 12
Value	5	2	4	3	4	0	2	1	4	5	2

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

Adverse events

Time frame: From Day 1 up to 6 months post vaccination (up to Day 183). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Arm 1c (Cohort 1): Pooled Placebo	1 of 12 (8.3%)	10 of 12 (83.3%)	0 of 12
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg	1 of 12 (8.3%)	10 of 12 (83.3%)	0 of 12
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg	1 of 11 (9.1%)	8 of 11 (72.7%)	0 of 11
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg	1 of 11 (9.1%)	11 of 11 (100%)	0 of 11
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 110^11vp/Ad26.RSV-B.preF2 510^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg	1 of 11 (9.1%)	10 of 11 (90.9%)	0 of 11
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12

Limitations and caveats (from the sponsor): Study was terminated on sponsor's decision, hence, participants were enrolled in Cohort 1 only. Cohorts 2, 3, and 4 were not initiated. Participants enrolled in Cohort 1 completed visit up to Day 183 (6-months post vaccination) and safety evaluations were performed only for Cohort 1. Since the study was terminated prior to Cohort 2 enrolment and the data was planned for combined Cohorts 1 and 2, samples collected in Cohort 1 alone were not tested and no immunogenicity testing was performed.

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.
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

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.

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

Questions about this trial

What is this clinical trial studying?

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: stopped early, 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 11 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 2 Jan 2024). 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?

Number of Participants With Serious Adverse Events (SAEs) (time frame: From Day 1 up to 6 months post vaccination (up to Day 183)). 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 NCT05327816.

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.