A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults

Phase 1 Active not recruiting 144 enrolled Sanofi

RandomizedSequentialDouble-blindPrevention

Summary

The main purposes of this study are to assess the safety, reactogenicity and immunogenicity of 4 dose levels of the bivalent combination Respiratory Syncytial Virus (RSV) / human Metapneumovirus (hMPV) vaccine candidate VXB-241 when administered as a single-dose regimen to healthy adults 60 to 83 years of age, and to assess the impact of revaccination approximately 1 year later.

Timeline

Start: 2024-08-13
Primary completion: 2025-02-14
Completion: 2027-05

Publications

Young A, Kolekar S, Mendoza CA, Jaberolansar N, Modhiran N, Webb T, McCuaig R, Kommajosyula V, Tardiota N, Dy Q, Amarilla AA, Dalrymple RL, Gillard M, Dutton JL, Magdalena J, Vandendriessche F, Smal J, Young PR, Watterson D, Hanon EJ, Chappell KJ. A second-generation molecular clamp stabilised bivalent candidate vaccine for protection against diseases caused by respiratory syncytial virus and human metapneumovirus. PLoS Pathog. 2025 Jul 17;21(7):e1013312. doi: 10.1371/journal.ppat.1013312. eCollection 2025 Jul.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Arexvy	Vaccine	120 ug	Intramuscular
Subject	VXB-241	Vaccine	60 ug	Intramuscular
Subject	VXB-241	Vaccine	120 ug	Intramuscular
Subject	VXB-241	Vaccine	240 ug	Intramuscular
Subject	VXB-241	Vaccine	480 ug	Intramuscular

Indications

No indication recorded.