BCG Revaccination in Children and Adolescents

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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
• Treatments: BCG Vaccine

Criteria

Inclusion Criteria:

• Healthy household contacts aged 6 to 18 yr

• Previously vaccinated with BCG at birth or least 5 years ago - evidence of scar or documented immunisation record.

• General good health - through history and baseline screening

• Agrees to continue in the study for 2 years post enrollment

• Children previously treated for LTBI and completed treatment at least 6 months ago - can also be included. However, they should be current HHC

Exclusion Criteria:

• Any acute illness on recruitment day (Evaluate the child again at a later stage)

• Fever ≥38 degree Celsius on recruitment day (Evaluate the child again at a later)

• History of autoimmune disease

• Pregnancy - female participants > 15 years of age will have pregnancy test done after caretakers and participants informed consent

• Evidence of active TB disease

• On treatment for active TB disease or LTBI

• HIV positive or any history or present possible immunodeficiency condition

• History of allergic reactions to vaccines in past

• Pre-existing liver dysfunction

• ALT/AST is ≥ 3 times upper limit of normal (ULN) in the presence of symptoms or ≥ 5 times the ULN in the absence of symptoms and/or total bilirubin greater than ULN along with raised ALT/AST.