A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults

Phase 2 Completed 459 enrolled Janssen Vaccines & Prevention B.V.

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).

Timeline

Start: 2020-07-16
Primary completion: 2020-09-24
Completion: 2021-04-09

Publications

van Heesbeen R, Bastian AR, Omoruyi E, Rosen J, Comeaux CA, Callendret B, Heijnen E. Immunogenicity and safety of different dose levels of Ad26.RSV.preF/RSV preF protein vaccine in adults aged 60 years and older: A randomized, double-blind, placebo-controlled, phase 2a study. Vaccine. 2024 Dec 2;42(26):126273. doi: 10.1016/j.vaccine.2024.126273. Epub 2024 Sep 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad26.RSV.preF	Vaccine	3.7e+09 vg	Intramuscular
Subject	Ad26.RSV.preF	Vaccine	1e+11 vg	Intramuscular
Subject	Ad26.RSV.preF	Vaccine	1.6e+11 vg	Intramuscular
Subject	RSV preF protein	Protein / enzyme biologic	150 ug	Intramuscular

Indications

No indication recorded.