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

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.

Timeline

Start

2021-09-29

Primary completion

2022-08-12

Completion

2022-08-12

Publications

• LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.
• Jastorff A, Gymnopoulou E, Salas J, Merrall E, Buntinx E, Martin C, Askling HH, Schenkenberger I, Yuste AC, Smith W, Sotolongo R, Von Engelhardt C, Bastian AR, Comeaux C, Ligtenberg N, Callendret B, Heijnen E. Safety and immunogenicity of the Ad26/protein preF RSV vaccine in adults aged 18 to 59 years with and without at-risk comorbidities for severe respiratory syncytial virus disease: A phase 3, randomized, controlled, immunobridging trial. Vaccine. 2025 Jan 1;43(Pt 1):126514. doi: 10.1016/j.vaccine.2024.126514. Epub 2024 Nov 12.

Drugs

Indications