Efficacy of BCG Revaccination Compared With Oral Chemoprophylaxis in Household Contacts Aged 6-18 Years for Prevention of Tuberculosis Disease - A Phase III Open Labelled Randomised Controlled Trial (BRiC)

NCT05330884 Phase 3 SUSPENDED

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.

Details

Lead sponsor	Tuberculosis Research Centre, India
Phase	Phase 3
Status	SUSPENDED
Enrolment	9200
Start date	2024-07-15
Completion	2027-12

Conditions

• Tuberculosis Infection
• Tuberculosis

Interventions

• BCG vaccine
• Oral Chemoprophylaxis

Primary outcomes

• Incidence of TB (all forms - PTB / EPTB) as per NTEP guidelines — over 24 months
  Incidence of TB in BCG revaccinated and oral chemoprophylaxis groups (age and gender stratified)

Countries

India