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

NCT05242432 | Terminated Phase 3 DMC

• 2 other identifiers: CR109164VAC18193RSV3007
• Study Type: interventional
• Target: 2,192
• Locations: 1 country
• Sites: 30

Brief 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 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.

Conditions

Respiratory Syncytial Virus Prevention

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 15

• 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.

  Until end of RSV season (up to 11.5 months)

Secondary Outcomes (9)

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

  Day 1, 15, 85, and 169

• 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)

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

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

  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

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

  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

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

  7 Days after vaccination (Day 1 to Day 8)

Study Arms (4)

Cohort (C)1 Group (G)1: Adults, 60 years and older (Ad26/protein preF RSV Vaccine)

EXPERIMENTAL

Participants 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.

Biological: Ad26/protein preF RSV Vaccine

C1 G2: Adults, 60 years and older (Placebo)

PLACEBO COMPARATOR

Participants will receive a single IM injection of matching placebo on Day 1.

Other: Placebo

C2 G3: Adults Aged 20 to 59 years at High-risk of Severe RSV Disease (Ad26/protein preF RSV Vaccine)

EXPERIMENTAL

Participants will receive a single IM injection of Ad26/protein preF RSV vaccine on Day 1.

Biological: Ad26/protein preF RSV Vaccine

C2 G4: Adults Aged 20 to 59 years at High-risk of Severe RSV Disease (Placebo)

PLACEBO COMPARATOR

Participants will receive a single IM injection of matching placebo on Day 1.

Other: Placebo

Interventions

Ad26/protein preF RSV Vaccine BIOLOGICAL

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

Also known as: VAC18193

C2 G3: Adults Aged 20 to 59 years at High-risk of Severe RSV Disease (Ad26/protein preF RSV Vaccine); Cohort (C)1 Group (G)1: Adults, 60 years and older (Ad26/protein preF RSV Vaccine)

Placebo OTHER

Matching Placebo will be administered as an IM injection

C1 G2: Adults, 60 years and older (Placebo); C2 G4: Adults Aged 20 to 59 years at High-risk of Severe RSV Disease (Placebo)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (30)

Shohokai Toda Internal Medicine and Neurology Clinic

Akashi-shi, 674-0081, Japan

Location

Doujin Memorial Meiwa Hospital

Chiyoda-ku, 101-0041, Japan

Location

Fukuwa Clinic

Chūō, 104-0031, Japan

Location

Tokyo-Eki Center-Building Clinic

Chūōku, 103-0027, Japan

Location

Tokyo Asbo Clinic

Chūōku, 104-0031, Japan

Location

Tenjin Sogo Clinic

Fukuoka, 810-0021, Japan

Location

Seikoukai New Medical Research System Clinic

Hachioji-shi, 192-0046, Japan

Location

Hiroshima Station Clinic

Hiroshima, 732-0053, Japan

Location

Medical Corporation JR Hiroshima Hospital

Hiroshima, 732-0057, Japan

Location

Teine Keijinkai Hospital

Hokkaido, 006-8555, Japan

Location

Aso Co.,Ltd Iizuka Hospital

Iizuka, 820-8501, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, 5960042, Japan

Location

Seikokai Omi Medical Center

Kusatsu-shi, 525-8585, Japan

Location

Tohno Chuo Clinic

Mizunami-shi, 509-6134, Japan

Location

Kojunkai Daido Hospital

Nagoya, 4578511, Japan

Location

Chubu Tokushukai Hospital

Nakagami-gun, 901-2393, Japan

Location

Hanabusakai Shimamura Memorial Hospital

Nerima-ku, 177-0051, Japan

Location

Yotsubashi Clinic

Osaka, 550-0013, Japan

Location

Satou Hospital Miyagi

Osaki-shi, 989-6143, Japan

Location

Jakushikai Banno Clinic

Ōta-ku, 146-0085, Japan

Location

Keichikai Shimokitazawa Tomo Clinic

Setagaya-ku, 155-0031, Japan

Location

Nanbu Tokushukai Hospital

Shimajiri-Gun, 9010493, Japan

Location

Clinical Research Hospital Tokyo

Shinjuku-ku, 162-0053, Japan

Location

Ishinkai Oda Clinic

Shinjyuku-ku, 169-0072, Japan

Location

Hanabusakai Shinei Clinic

Suginami-ku, 166-0003, Japan

Location

Josuikai Olive Takamatsu Medical Clinic

Takamatsu, 760-0076, Japan

Location

Ikebukuro Metropolitan Clinic

Tokyo-To, 171-0021, Japan

Location

Kouwakai Kouwa Clinic

Toshima-ku, 170-0003, Japan

Location

Senrichuo Ekimae Clinic

Toyonaka-shi, 560-0082, Japan

Location

Tsuchiura Beryl Clinic

Tsuchiura-shi, 300-0062, Japan

Location

Related Publications (1)

• 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.

  PMID: 40319702 DERIVED

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort 1: adults aged 60 years and older Cohort 2: adults aged 20 to 59 years at high-risk of severe RSV disease

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 16, 2022
• Study Start: April 1, 2022
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (30)