Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults

Phase 2 Terminated 2364 enrolled Barinthus Biotherapeutics Clinical Network Services (CNS) Pty Ltd · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults aged 18 years and over. To assess the effect of MVA-NP+M1 on the reduction of laboratory confirmed influenza when given as an adjunct to licensed quadrivalent influenza vaccine (QIV) in adults

Timeline

Start: 2019-03-18
Primary completion: 2019-10-15
Completion: 2020-01-21

Outcome

Missed primary endpoint

Stopped: “The trial is being stopped for futility. Season 2 cancelled.”

registry MVA-NP+M1 Group vs Saline Placebo Group; p = 0.1146; Relative Risk 1.52 (95% CI 0.90 to 2.55) NCT03880474 ↗

paper the incidence of laboratory-confirmed influenza did not differ between the MVA-NP+M1 group PMID 35305317 ↗

Publications

Evans TG, Bussey L, Eagling-Vose E, Rutkowski K, Ellis C, Argent C, Griffin P, Kim J, Thackwray S, Shakib S, Doughty J, Gillies J, Wu J, Druce J, Pryor M, Gilbert S. Efficacy and safety of a universal influenza A vaccine (MVA-NP+M1) in adults when given after seasonal quadrivalent influenza vaccine immunisation (FLU009): a phase 2b, randomised, double-blind trial. Lancet Infect Dis. 2022 Jun;22(6):857-866. doi: 10.1016/S1473-3099(21)00702-7. Epub 2022 Mar 16.

Drugs

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