HIRV-TB
Research type
Research Study
Full title
Human Immune Response Variation in Tuberculosis.
IRAS ID
242062
Contact name
Mahdad Noursadeghi
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/03/85 , Data Protection registration verification
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Tuberculosis (TB) remains a major threat to global health. Infection with the bacteria that causes this illness is widespread, but not everyone who is infected progresses to disease and we do not understand why. We think this is because the immune system is more effective against TB in some people, but because we don’t know how to identify people who are most likely to develop TB disease, we offer everyone preventative treatment with 3-6 months of antibiotics.
The aim of this study is to identify how and why immune responses to TB differ between people and identify the immune responses which are associated with an increased risk of TB disease. The results are expected to support future strategies for targeting treatment to people who need this most and to potentially design better vaccines against TB.
The study will recruit 1000 people with asymptomatic or latent TB infection (LTBI) to test the hypothesis that common variation in their genetic (DNA) code leads to different immune responses in biopsies from a TB skin test called the tuberculin skin test (TST). 400 hundred of these individuals who have been recently exposed to TB disease will be followed up regularly without receiving preventative LTBI treatment for up to two years in order to identify differences in immune responses within their TST that leads to increased risk of latent infection beginning to progress towards disease.
The study will take place within NHS TB clinics. In addition to the TST, participants will undergo chest xrays and blood tests to look for any evidence of progressive TB.
REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/0680
Date of REC Opinion
30 Apr 2018
REC opinion
Further Information Favourable Opinion