Pertussis Challenge Study in Adults Vaccinated With BPZE1

Summary

This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.

Timeline

Start

2022-06-20

Primary completion

2023-07-25

Completion

2023-10-26

Outcome

Missed primary endpoint

paper 14 [58%; 95% CI 39-76] of 24 vs seven [33%; 17-55] of 21 in the placebo group; p=0·091). PMID 41344352 ↗

Publications

• Gbesemete D, Ramasamy MN, Ibrahim M, Hill AR, Raud L, Ferreira DM, Guy J, Dale AP, Laver JR, Coutinho T, Faust SN, Reed TAN, Babbage G, Weissfeld L, Lang W, Locht C, Samal V, Goldstein P, Solovay K, Rubin K, Noviello S, Read RC. Efficacy, immunogenicity, and safety of the live attenuated nasal pertussis vaccine, BPZE1, in the UK: a randomised, placebo-controlled, phase 2b trial using a controlled human infection model with virulent Bordetella pertussis. Lancet Microbe. 2025 Dec;6(12):101211. doi: 10.1016/j.lanmic.2025.101211. Epub 2025 Dec 1.

Drugs

Indications