TB041: Aerosol BCG challenge trial in healthy UK adults
Research type
Research Study
Full title
A clinical challenge trial to evaluate controlled human infection with BCG administered by the aerosol inhaled route compared with the intradermal route in healthy, BCG-naïve, UK adult volunteers
IRAS ID
192512
Contact name
Helen McShane
Contact email
Sponsor organisation
University of Oxford
Eudract number
2015-004981-27
Clinicaltrials.gov Identifier
15/SC/0716, South Central Oxford A
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
Tuberculosis (TB) is one of the leading causes of death due to an infectious disease. It is estimated that a third of the world’s population is latently infected with M.tb, and these people carry a 10% lifetime risk of developing active life-threatening disease. In 2013, there were 9 million new cases worldwide and 1.5 million people died of TB, so the development of an effective vaccine is a global health priority. Currently, there is no reliable alternative to large, randomized controlled trials to assess vaccine efficacy against TB and these trials are challenging, time consuming and costly. The development of a safe controlled human challenge model would greatly facilitate TB vaccine development as it could be used both to guide vaccine selection and to facilitate identification and validation of potential immunological correlates of protection.
Three studies to date have evaluated BCG as a challenge agent via intradermal injection into the upper arm. The natural route of infection for M.tb is by inhalation of infectious droplets, leading to infection in the lung. The lung has its own distinct mucosal immune system and therefore administering BCG challenge directly to the lungs should more closely represent TB infection than an injection of BCG in the arm.
This trial will involve giving BCG to BCG naïve, healthy UK adult volunteers, 18 volunteers will be given BCG challenge via aerosol and 12 via the intradermal route. We will perform a bronchoscopy 14 days later on all volunteers and take bronchoalveolar lavage washings (BAL) to measure the amount of BCG recovered from the lungs. The group who receives intradermal BCG challenge will also have a skin biopsy at day 14 to measure the amount of BCG recovered from this route, so that comparisons can be made between the two routes. Blood tests to look at immunological markers will be taken.
This trial will take place at three sites, the CCVTM and the OUH NHS Foundation Trust, Oxford and the NIHR-WTCRF, Birmingham.REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0716
Date of REC Opinion
16 Dec 2015
REC opinion
Favourable Opinion