Aerosol BCG Challenge Study in Historically BCG-vaccinated Volunteers

Summary

The purpose of this study is to evaluate the human clinical response to BCG challenge in historically BCG-vaccinated healthy adult volunteers. It will involve 12 participants in a controlled dose escalation. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity.

Timeline

Start

2022-05-17

Primary completion

2023-06-20

Completion

2023-06-20

Publications

• Fredsgaard-Jones T, Harris SA, Morrison H, Ateere A, Nassanga B, Ramon RL, Mitton C, Fletcher E, Decker J, Preston-Jones H, Jackson S, Mawer A, Satti I, Barer M, Hinks T, Bettinson H, McShane H. A dose escalation study to evaluate the safety of an aerosol BCG infection in previously BCG-vaccinated healthy human UK adults. Front Immunol. 2024 Nov 14;15:1427371. doi: 10.3389/fimmu.2024.1427371. eCollection 2024.

Drugs

Indications