NCT05070546

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 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,124 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus Infection Prevention

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.RSV.preF-based Vaccine	Participants will receive a single IM injection of an RSV vaccine.
OTHER	Placebo	Participants will receive a single IM injection of matching placebo.

Timeline

• Start date: 2021-09-29
• Primary completion: 2022-08-12
• Completion: 2022-08-12
• First posted: 2021-10-07
• Last updated: 2025-05-25
• Results posted: 2023-10-04

Locations

23 sites across 5 countries: United States, Belgium, Germany, Spain, Sweden

Regulatory

• FDA-regulated drug study