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Respiratory Syncytial Virus PreventionPhase 3NCT05242432

A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention of Respiratory Syncytial Virus (RSV) Mediated- Lower Respiratory Tract Disease (LRTD) in Japanese Participants

A Phase 3 study testing Ad26/protein preF RSV Vaccine in people with Respiratory Syncytial Virus Prevention, run by Janssen Pharmaceutical K.K. at 30 sites in Japan.

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 the efficacy of study vaccine in the prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-confirmed RSV mediated- lower Respiratory Tract Disease (LRTD) over one RSV season when compared to placebo in adults aged 60 years and above and to demonstrate the… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Respiratory Syncytial Virus Prevention
What is being tested?
Ad26/protein preF RSV Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,192 participants
Where
30 sitesJapan
Study dates
1 Apr 2022to 20 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For Participants in Cohort 1 only
  • Must be greater than or equal to (>=60) years old on the day of signing the informed consent form (ICF) and expected to be available for the duration of the study
  • 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
  • Participants may have underlying illnesses such as hypertension, congestive heart failure (CHF), Chronic obstructive pulmonary disease (COPD), type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable and medically controlled in the judgement of the investigator at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider
  • For Participants in Cohort 2 only
  • Must be aged 20 to 59 years (inclusive) on the day of signing the ICF and expected to be available for the duration of the study
  • Has an existing chronic heart or lung condition, without hospitalizations or major medication class change (that is, new or stopped medications) within 30 days prior to screening
  • Participant may have other underlying illnesses 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

Who cannot join

  • Has a serious clinically unstable condition like, (example, end-stage renal disease with or without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent or limit the protocol-specified assessments
  • History of malignancy within 5 years before screening or revaccination 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, which is considered cured with minimal risk of recurrence per investigator's judgement, can be enrolled
  • Had major surgery (example, major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study
  • Has an acute illness (including acute respiratory illnesses) or body temperature of >=38.0 degree Celsius (ºC) (>=100.4 Fahrenheit [ºF ] within 24 hours prior to administration of study vaccine)
  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Japan30 sites

  • Shohokai Toda Internal Medicine and Neurology Clinic

    Akashi-shi, 674-0081

  • Doujin Memorial Meiwa Hospital

    Chiyoda-ku, 101-0041

  • Fukuwa Clinic

    Chūō, 104-0031

  • Tokyo-Eki Center-Building Clinic

    Chūōku, 103-0027

  • Tokyo Asbo Clinic

    Chūōku, 104-0031

  • Tenjin Sogo Clinic

    Fukuoka, 810-0021

  • Seikoukai New Medical Research System Clinic

    Hachioji-shi, 192-0046

  • Hiroshima Station Clinic

    Hiroshima, 732-0053

  • Medical Corporation JR Hiroshima Hospital

    Hiroshima, 732-0057

  • Teine Keijinkai Hospital

    Hokkaido, 006-8555

  • Aso Co.,Ltd Iizuka Hospital

    Iizuka, 820-8501

  • Kishiwada Tokushukai Hospital

    Kishiwada, 5960042

  • Seikokai Omi Medical Center

    Kusatsu-shi, 525-8585

  • Tohno Chuo Clinic

    Mizunami-shi, 509-6134

  • Kojunkai Daido Hospital

    Nagoya, 4578511

  • Chubu Tokushukai Hospital

    Nakagami-gun, 901-2393

  • Hanabusakai Shimamura Memorial Hospital

    Nerima-ku, 177-0051

  • Yotsubashi Clinic

    Osaka, 550-0013

  • Satou Hospital Miyagi

    Osaki-shi, 989-6143

  • Jakushikai Banno Clinic

    Ōta-ku, 146-0085

  • Keichikai Shimokitazawa Tomo Clinic

    Setagaya-ku, 155-0031

  • Nanbu Tokushukai Hospital

    Shimajiri-Gun, 9010493

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, 162-0053

  • Ishinkai Oda Clinic

    Shinjyuku-ku, 169-0072

  • Hanabusakai Shinei Clinic

    Suginami-ku, 166-0003

  • Josuikai Olive Takamatsu Medical Clinic

    Takamatsu, 760-0076

  • Ikebukuro Metropolitan Clinic

    Tokyo-To, 171-0021

  • Kouwakai Kouwa Clinic

    Toshima-ku, 170-0003

  • Senrichuo Ekimae Clinic

    Toyonaka-shi, 560-0082

  • Tsuchiura Beryl Clinic

    Tsuchiura-shi, 300-0062

Other trials in Japan

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Efficacy, Safety, Reactogenicity, and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Japanese Adults Aged 60 Years and Older, and Safety, Reactogenicity, and Immunogenicity of the Vaccine in Japanese Adults Aged 20 to 59 Years at High-risk of RSV Disease

The purpose of the study is to evaluate the efficacy of study vaccine in the prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-confirmed RSV mediated- lower Respiratory Tract Disease (LRTD) over one RSV season when compared to placebo in adults aged 60 years and above and to demonstrate the non-inferiority of the vaccine in high-risk adults aged 20 to 59 years versus in adults aged 60 years and older in terms of humoral immune response.

Being tested
Ad26/protein preF RSV Vaccine, Placebo

What participants receive

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

  • Ad26/protein preF RSV VaccineBiological

    Also called VAC18193

    Ad26/protein preF RSV vaccine will be administered as an IM injection.

  • PlaceboOther

    Matching Placebo will be administered as an IM injection

Study groups in NCT05242432
Study groupRoleWhat they receive
Cohort (C)1 Group (G)1: Adults, 60 years and older (Ad26/protein preF RSV Vaccine)ExperimentalParticipants will receive a single intramuscular (IM) injection of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26/protein preF RSV) vaccine on Day 1.
Receives: Biological: Ad26/protein preF RSV Vaccine
C1 G2: Adults, 60 years and older (Placebo)Placebo comparatorParticipants will receive a single IM injection of matching placebo on Day 1.
Receives: Other: Placebo
C2 G3: Adults Aged 20 to 59 years at High-risk of Severe RSV Disease (Ad26/protein preF RSV Vaccine)ExperimentalParticipants will receive a single IM injection of Ad26/protein preF RSV vaccine on Day 1.
Receives: Biological: Ad26/protein preF RSV Vaccine
C2 G4: Adults Aged 20 to 59 years at High-risk of Severe RSV Disease (Placebo)Placebo comparatorParticipants will receive a single IM injection of matching placebo on Day 1.
Receives: Other: Placebo

What is being measured

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

  1. Cohort 2: Neutralizing Antibody Titers Against RSV A Strain as Measured by Virus Neutralizing Antibody (VNA) Assay

    Neutralizing antibody titers against RSV A strain as measured by VNA Assay will be reported.

    Measured: Day 15

  2. Cohort 1: Number of Participants with First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV) Mediated-lower Respiratory Tract Disease (LRTD) Over one RSV Season

    Number of participants with first occurrence of RT-PCR confirmed RSV Mediated LRTD over one RSV season will be reported.

    Measured: Until end of RSV season (up to 11.5 months)

Secondary outcomes (9)

  1. Cohort 1 (Immuno Subset): Neutralizing Antibody Titers Against RSV A Strain

    Neutralizing antibody titers against RSV A strain will be reported.

    Measured: Day 1, 15, 85, and 169

  2. Cohort 1 (Immuno Subset) and 2: RSV A F protein in pre-fusion form Binding Antibodies as Assessed by Enzyme linked Immuno Sorbent Assay (ELISA)

    Antibodies binding to RSV A F protein in pre-fusion form as assessed by ELISA will be reported

    Measured: Cohort 1: Day 1, 15, 85, and 169; Cohort 2: 14 days after vaccination (Day 15)

  3. Cohorts 1 and 2: Number of Participants with Serious Adverse Events (SAEs)

    A 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.

    Measured: Cohort 1: Up to 6 months after vaccination or end of RSV season, whichever comes later (up to 11.5 months); Cohort 2: Up to 6 months after vaccination

  4. Cohorts 1 and 2: Number of Participants with Adverse Events of Special Interest (AESIs)

    Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.

    Measured: Cohort 1: Up to 6 months after vaccination or end of RSV season, whichever comes later (up to 11.5 months); Cohort 2: Up to 6 months after vaccination

  5. Cohort 1 (Safety Subset) and Cohort 2: Number of Participants with Solicited Systemic AEs After Vaccination

    Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary for 7 days post-vaccination.

    Measured: 7 Days after vaccination (Day 1 to Day 8)

  6. Cohort 1 (Safety Subset) and Cohort 2: Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination

    An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary for 7 days post-vaccination.

    Measured: 7 Days after vaccination (Day 1 to Day 8)

  7. Cohort 1 (Safety Subset) and Cohort 2: Number of Participants with Unsolicited AEs After Vaccination

    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

    Measured: 28 days after vaccination (Day 1 to Day 29)

  8. Cohort 2: Neutralizing Antibody Titers Against RSV A Strain iso RSV A2 as Measured by VNA Assay in terms of Seroresponse rate

    Neutralizing antibody titers against RSV A strain as measured by VNA assay in terms of seroresponse rate will be reported. Seroresponse is defined as a 4-fold increase from baseline in Day 15 antibody titers.

    Measured: 14 days after vaccination (Day 15)

  9. Cohort 1: Number of Participants with First Occurrence of RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI) Over one RSV Season

    Number of participants with first occurrence of any RT-PCR confirmed RSV-mediated ARI over one RSV season will be reported.

    Measured: Until end of RSV season (up to 11.5 months)

Timeline

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

  1. First posted16 Feb 2022
  2. Study start1 Apr 2022
  3. Primary completion20 Mar 2023
  4. Study completion20 Mar 2023

Why it stopped: Terminated (Janssen made the strategic decision to discontinue the RSV3007 study. This decision is not based on any safety concerns.)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cohort 1: adults aged 60 years and older Cohort 2: adults aged 20 to 59 years at high-risk of severe RSV disease
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05242432
Sponsor's protocol ID
CR109164
Other IDs
VAC18193RSV3007
Status last verified
May 2025
First submitted
15 Feb 2022
Last updated
23 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
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

  • Tamura H, Momose A, Takato Y, Richuan Z, Bastian AR, Callendret B, Heijnen E. Phase 3 study of an Ad26.RSV.preF/RSV preF protein vaccine to evaluate the prevention efficacy of RSV-mediated lower tract disease, immunogenicity and safety in Japanese adults. Respir Investig. 2025 Jul;63(4):560-568. doi: 10.1016/j.resinv.2025.04.016. Epub 2025 May 3.

    PubMed 40319702

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ad26/protein preF RSV Vaccine in people with Respiratory Syncytial Virus Prevention, run by Janssen Pharmaceutical K.K. at 30 sites in Japan.

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 8 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 23 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 30 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early (reason given: Terminated (Janssen made the strategic decision to discontinue the RSV3007 study. This decision is not based on any safety concerns.)). Results are not available in the source record.

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 2: Neutralizing Antibody Titers Against RSV A Strain as Measured by Virus Neutralizing Antibody (VNA) Assay (time frame: Day 15). The study lists 2 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 NCT05242432, 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 23 May 2025.

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