MVA-BN-RSV Vaccine Trial

Phase 3 Terminated 20419 enrolled Bavarian Nordic

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Phase 3 randomized, double blind study comparing recombinant MVA-BN-RSV vaccine vs placebo for efficacy and safety in adults \>=60 years of age

Timeline

Start: 2022-04-19
Primary completion: 2023-06-29
Completion: 2023-09-01

Outcome

Mixed primary results

Stopped: “The trial was terminated after the first RSV season because of the failure to meet the primary outcome measures of vaccine efficacy”

paper The primary objective was not met for LRTD with ≥3 symptoms since the lower bound of the 95% CI was below 20 %, the prespecified success criterion. PMID 39461302 ↗

registry analysis (other test); MVA-BN-RSV vs Placebo; Vaccine Efficacy 59.0 (95% CI 34.7 to 74.3) NCT05238025 ↗

Publications

Jordan E, Jenkins V, Silbernagl G, Chavez MPV, Schmidt D, Schnorfeil F, Schultz S, Chen L, Salgado F, Jacquet JM, Welte T, De Moerlooze L. A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study. Vaccine. 2024 Dec 2;42(26):126427. doi: 10.1016/j.vaccine.2024.126427. Epub 2024 Oct 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MVA-BN-RSV	Vaccine	0.5 ml	Intramuscular
Subject	MVA-BN-RSV	Vaccine	3e+08 unknown	Intramuscular