BCG Revaccination in Children and Adolescents

Summary

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.

Conditions

• Tuberculosis Infection
• Tuberculosis

Interventions

BIOLOGICAL

BCG vaccine

0.1ml BCg vaccine to be given intradermally

DRUG

Oral Chemoprophylaxis

Oral chemoprophylaxis will be standard of care - either 6 months of Isoniazid or 3 months of weekly Isoniazid and Rifapentine

Sponsors & Collaborators

• Institute of Child Health, Chennai

  collaborator UNKNOWN

• All India Institute of Medical Sciences

  collaborator OTHER

• The Grant Medical College & Sir J.J. Group of Hospitals

  collaborator OTHER_GOV

• All India Institute of Medical Sciences, Bhubaneswar

  collaborator OTHER

• Rajendra Institute of Medical Sciences, Ranchi

  collaborator UNKNOWN

• National Institute of Tuberculosis and Respiratory Diseases, New Delhi

  collaborator UNKNOWN

• Rajiv Gandhi Hospital, Chennai

  collaborator UNKNOWN

• Madurai Medical College

  collaborator OTHER

• Government Vellore Medical College, Vellore

  collaborator UNKNOWN

• Tuberculosis Research Centre, India

  lead OTHER_GOV

Principal Investigators

• Aishwarya Venkataraman, MRCPCH · ICMR-National Institute for Research in Tuberculosis

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-15

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• India

Study Locations