A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older

Summary

The purpose of this study for: Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3. Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen. Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.

Timeline

Start

2018-07-06

Primary completion

2022-05-16

Completion

2022-05-16

Publications

• Comeaux CA, Bart S, Bastian AR, Klyashtornyy V, De Paepe E, Omoruyi E, van der Fits L, van Heesbeen R, Heijnen E, Callendret B, Sadoff J. Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-Based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. J Infect Dis. 2024 Jan 12;229(1):19-29. doi: 10.1093/infdis/jiad220.

Drugs

Indications

No indication recorded.