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

NCT ID: NCT05242432

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-03-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Ad26/protein preF RSV Vaccine

Intervention Type: BIOLOGICAL

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

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching Placebo will be administered as an IM injection

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

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

Group Type: EXPERIMENTAL

Ad26/protein preF RSV Vaccine

Intervention Type: BIOLOGICAL

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

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching Placebo will be administered as an IM injection

Interventions

Ad26/protein preF RSV Vaccine

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

Intervention Type: BIOLOGICAL

Placebo

Matching Placebo will be administered as an IM injection

Intervention Type: OTHER

Other Intervention Names

VAC18193

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Shohokai Toda Internal Medicine and Neurology Clinic

Akashi-shi, , Japan

Doujin Memorial Meiwa Hospital

Chiyoda-ku, , Japan

Fukuwa Clinic

Chūō, , Japan

Tokyo-Eki Center-Building Clinic

Chūōku, , Japan

Tokyo Asbo Clinic

Chūōku, , Japan

Tenjin Sogo Clinic

Fukuoka, , Japan

Seikoukai New Medical Research System Clinic

Hachioji-shi, , Japan

Hiroshima Station Clinic

Hiroshima, , Japan

Medical Corporation JR Hiroshima Hospital

Hiroshima, , Japan

Teine Keijinkai Hospital

Hokkaido, , Japan

Aso Co.,Ltd Iizuka Hospital

Iizuka, , Japan

Kishiwada Tokushukai Hospital

Kishiwada, , Japan

Seikokai Omi Medical Center

Kusatsu-shi, , Japan

Tohno Chuo Clinic

Mizunami-shi, , Japan

Kojunkai Daido Hospital

Nagoya, , Japan

Chubu Tokushukai Hospital

Nakagami-gun, , Japan

Hanabusakai Shimamura Memorial Hospital

Nerima-ku, , Japan

Yotsubashi Clinic

Osaka, , Japan

Satou Hospital Miyagi

Osaki-shi, , Japan

Jakushikai Banno Clinic

Ōta-ku, , Japan

Keichikai Shimokitazawa Tomo Clinic

Setagaya-ku, , Japan

Nanbu Tokushukai Hospital

Shimajiri-Gun, , Japan

Clinical Research Hospital Tokyo

Shinjuku-ku, , Japan

Ishinkai Oda Clinic

Shinjyuku-ku, , Japan

Hanabusakai Shinei Clinic

Suginami-ku, , Japan

Josuikai Olive Takamatsu Medical Clinic

Takamatsu, , Japan

Ikebukuro Metropolitan Clinic

Tokyo-To, , Japan

Kouwakai Kouwa Clinic

Toshima-ku, , Japan

Senrichuo Ekimae Clinic

Toyonaka-shi, , Japan

Tsuchiura Beryl Clinic

Tsuchiura-shi, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 40319702 (View on PubMed)

Other Identifiers

VAC18193RSV3007

Identifier Type: OTHER

Identifier Source: secondary_id

CR109164

Identifier Type: -

Identifier Source: org_study_id