Clinical trial NCT05242432: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Prevention
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2022-02-16
Enrollment: 2192
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Cohort 2: Neutralizing Antibody Titers Against RSV A Strain as Measured by Virus Neutralizing Antibody (VNA) Assay
timeFrame: Day 15
measure: 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
timeFrame: Until end of RSV season (up to 11.5 months)
Secondary outcomes:
measure: Cohort 1 (Immuno Subset): Neutralizing Antibody Titers Against RSV A Strain
timeFrame: Day 1, 15, 85, and 169
measure: 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)
timeFrame: Cohort 1: Day 1, 15, 85, and 169; Cohort 2: 14 days after vaccination (Day 15)
measure: Cohorts 1 and 2: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: 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
measure: Cohorts 1 and 2: Number of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: 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
measure: Cohort 1 (Safety Subset) and Cohort 2: Number of Participants with Solicited Systemic AEs After Vaccination
timeFrame: 7 Days after vaccination (Day 1 to Day 8)
measure: Cohort 1 (Safety Subset) and Cohort 2: Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination
timeFrame: 7 Days after vaccination (Day 1 to Day 8)
measure: Cohort 1 (Safety Subset) and Cohort 2: Number of Participants with Unsolicited AEs After Vaccination
timeFrame: 28 days after vaccination (Day 1 to Day 29)
measure: Cohort 2: Neutralizing Antibody Titers Against RSV A Strain iso RSV A2 as Measured by VNA Assay in terms of Seroresponse rate
timeFrame: 14 days after vaccination (Day 15)
measure: Cohort 1: Number of Participants with First Occurrence of RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI) Over one RSV Season
timeFrame: Until end of RSV season (up to 11.5 months)
Other outcomes:
Locations:
city: Akashi-shi
country: Japan
facility: Shohokai Toda Internal Medicine and Neurology Clinic
city: Chiyoda-ku
country: Japan
facility: Doujin Memorial Meiwa Hospital
city: Chuo City
country: Japan
facility: Fukuwa Clinic
city: Chuo-Ku
country: Japan
facility: Tokyo-Eki Center-Building Clinic
city: Chuo-ku
country: Japan
facility: Tokyo Asbo Clinic
city: Fukuoka-shi
country: Japan
facility: Tenjin Sogo Clinic
city: Hachioji-shi
country: Japan
facility: Seikoukai New Medical Research System Clinic
city: Hiroshima-shi
country: Japan
facility: Hiroshima Station Clinic
city: Hiroshima-shi
country: Japan
facility: Medical Corporation JR Hiroshima Hospital
city: Hokkaido
country: Japan
facility: Teine Keijinkai Hospital
city: Iizuka
country: Japan
facility: Aso Co.,Ltd Iizuka Hospital
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
city: Kusatsu-shi
country: Japan
facility: Seikokai Omi Medical Center
city: Mizunami-shi
country: Japan
facility: Tohno Chuo Clinic
city: Nagoya
country: Japan
facility: Kojunkai Daido Hospital
city: Nakagami-gun
country: Japan
facility: Chubu Tokushukai Hospital
city: Nerima-ku
country: Japan
facility: Hanabusakai Shimamura Memorial Hospital
city: Osaka-shi
country: Japan
facility: Yotsubashi Clinic
city: Osaki-shi
country: Japan
facility: Satou Hospital Miyagi
city: Ota-ku
country: Japan
facility: Jakushikai Banno Clinic
city: Setagaya-ku
country: Japan
facility: Keichikai Shimokitazawa Tomo Clinic
city: Shimajiri-Gun
country: Japan
facility: Nanbu Tokushukai Hospital
city: Shinjuku-ku
country: Japan
facility: Clinical Research Hospital Tokyo
city: Shinjyuku-ku
country: Japan
facility: Ishinkai Oda Clinic
city: Suginami-ku
country: Japan
facility: Hanabusakai Shinei Clinic
city: Takamatsu-shi
country: Japan
facility: Josuikai Olive Takamatsu Medical Clinic
city: Tokyo-To
country: Japan
facility: Ikebukuro Metropolitan Clinic
city: Toshima-ku
country: Japan
facility: Kouwakai Kouwa Clinic
city: Toyonaka-shi
country: Japan
facility: Senrichuo Ekimae Clinic
city: Tsuchiura-shi
country: Japan
facility: Tsuchiura Beryl Clinic
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: