Bacille Calmette Guerin (BCG) vaccine is one of the most used vaccines of the world, to
reduce the risks of natural tuberculous infection. The efficacy of BCG vaccination in
newborns is well known and has a documented protective effect against meningitis and
disseminated TB in children. However, there is considerable uncertainty on BCG revaccination.
It is known that BCG revaccination enhances immune responses, but it is yet to be established
if BCG revaccination can help prevent TB disease in household contacts.
The primary aim of this study is to assess the efficacy of BCG revaccination compared to oral
chemoprophylaxis in preventing TB disease in house hold contacts aged 6-18 years.
The study is designed as a multicentre randomised controlled trial with two groups of healthy
household contacts aged 6-18 years receiving either the BCG vaccine or oral chemoprophylaxis.
They will be followed up for 24 months to compare the incidence of TB disease in each arm.
Phase:
Phase 3
Details
Lead Sponsor:
Tuberculosis Research Centre, India
Collaborators:
All India Institute of Medical Sciences, Bhubaneswar All India Institute of Medical Sciences, Guwahati All India Institute of Medical Sciences, Patna Government Vellore Medical College, Vellore Institute of Child Health, Chennai Madurai Medical College National Institute of Tuberculosis and Respiratory Diseases, New Delhi Rajendra Institute of Medical Sciences, Ranchi Rajiv Gandhi Hospital, Chennai The Grant Medical College & Sir J.J. Group of Hospitals