Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model

Phase 2 Completed 145 enrolled Barinthus Biotherapeutics

RandomizedParallel-groupQuadruple-blindPrevention

Summary

A Phase 2, single center, randomized, double blind study evaluating the safety, efficacy, and immunogenicity of MVA NP+M1 in the H3N2 human influenza challenge model; on healthy adult volunteers.

Timeline

Start: 2019-06-03
Primary completion: 2019-12-16
Completion: 2020-04-17

Outcome

Missed primary endpoint

registry analysis (other test); MVA-NP+M1 (ITT) vs Placebo (ITT); p = 0.1711; Wilcoxon (Mann-Whitney) NCT03883113 ↗

paper The primary outcome, overall viral load as determined by quantitative PCR, did not show a statistically significant difference PMID 38729196 ↗

Publications

Evans TG, Castellino F, Kowalik Dobczyk M, Tucker G, Walley AM, Van Leuven K, Klein J, Rutkowski K, Ellis C, Eagling-Vose E, Treanor J, van Baalen C, Filkov E, Laurent C, Thacker J, Asher J, Donabedian A. Assessment of CD8+ T-cell mediated immunity in an influenza A(H3N2) human challenge model in Belgium: a single centre, randomised, double-blind phase 2 study. Lancet Microbe. 2024 Jul;5(7):645-654. doi: 10.1016/S2666-5247(24)00024-7. Epub 2024 May 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MVA-NP+M1	Vaccine	0.5 ml	Intramuscular
Subject	MVA-NP+M1	Vaccine	1.5e+08 unknown	Intramuscular