Aerosol BCG Challenge Trial in Healthy UK Adults

Summary

TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will also look to evaluate and compare the amount of BCG recovered from the lungs and from the skin, following challenge by either the aerosol or the intradermal route.

Timeline

Start

2016-03-07

Primary completion

2019-05-09

Completion

2019-05-09

Publications

• Satti I, Marshall JL, Harris SA, Wittenberg R, Tanner R, Lopez Ramon R, Wilkie M, Ramos Lopez F, Riste M, Wright D, Peralta Alvarez MP, Williams N, Morrison H, Stylianou E, Folegatti P, Jenkin D, Vermaak S, Rask L, Cabrera Puig I, Powell Doherty R, Lawrie A, Moss P, Hinks T, Bettinson H, McShane H. Safety of a controlled human infection model of tuberculosis with aerosolised, live-attenuated Mycobacterium bovis BCG versus intradermal BCG in BCG-naive adults in the UK: a dose-escalation, randomised, controlled, phase 1 trial. Lancet Infect Dis. 2024 Aug;24(8):909-921. doi: 10.1016/S1473-3099(24)00143-9. Epub 2024 Apr 12.

Drugs

Indications