A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
Brief Summary:
The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
Detailed Description:
RSV is an important cause of serious respiratory infections in adults aged 60 years and older, immunocompromised individuals, and those with underlying chronic cardiopulmonary conditions. The current study assess the safety and immunogenicity of the RSV vaccine in adults 18 to 59 years of age, including those who are at risk for severe RSV disease. The study comprises screening (pre-vaccination) and vaccination for each participant on Day 1, and a 6- month safety and immunogenicity follow-up period. The study duration will be up to 6 months per participant. Assessments like immunogenicity (such as humoral and cellular immune responses), safety (such as monitoring of AEs, physical examinations, and vital signs) and reactogenicity will be performed in this study.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 1113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Adults Aged 18 to 59 Years, Including Those at High-risk for Severe RSV
Actual Study Start Date: September 29, 2021
Estimated Primary Completion Date: June 9, 2022
Estimated Study Completion Date: June 14, 2022
Arm:
- Experimental: Cohort (C)1 Group (G)1: Healthy Adults, 18-59 Years (Respiratory Syncytial Virus [RSV] vaccine)
- Placebo Comparator: C1 G2: Healthy Adults, 18-59 Years (Placebo)
- Experimental: C2 G3: High Risk Adult, 18-59 Years (RSV Vaccine)
- Placebo Comparator: C2 G4: High Risk Adult, 18-59 Years (Placebo)
- Experimental: C3 G5: Adults, 65 Years and Older (RSV Vaccine)
- Placebo Comparator: C3 G6: Adults, 65 Years and Older (Placebo)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 1113 |
| Actual Study start date | 29 September 2021 |
| Estimated Study Completion Date | 14 June 2022 |