BCG Revaccination in Children and Adolescents

NCT05330884 | Suspended Phase 3

• 1 other identifier: 2022 005
• Study Type: interventional
• Target: 9,200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BCG; Anti tuberculous Chemoprophylaxis; LTBI; TB; Vaccine

Outcome Measures

Primary Outcomes (1)

• Incidence of TB (all forms - PTB / EPTB) as per NTEP guidelines

  Incidence of TB in BCG revaccinated and oral chemoprophylaxis groups (age and gender stratified)

  over 24 months

Secondary Outcomes (2)

• Adverse events

  24 months

• MTB infection

  24 months

Study Arms (2)

vaccine - Bacille Calmette-Guérin vaccine (BCG )

EXPERIMENTAL

Bacille Calmette-Guérin vaccine (BCG ) dose 0.1ml intradermal

Biological: BCG vaccine

Chemoprophylaxis - as per NTEP guidelines

OTHER

Oral chemoprophylaxis: according to the existing standard of care (NTEP guidelines) Either six months of isoniazid (10mg/kg) or Rifapentine and isoniazid weekly for 3 months for DS TB Levofloxicillin or standard of care drug for DR TB: 15-20mg/kg/day

Drug: Oral Chemoprophylaxis

Interventions

BCG vaccine BIOLOGICAL

0.1ml BCg vaccine to be given intradermally

vaccine - Bacille Calmette-Guérin vaccine (BCG )

Oral Chemoprophylaxis DRUG

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

Chemoprophylaxis - as per NTEP guidelines

Eligibility Criteria

• Age: 6 Years - 18 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tuberculosis Research Centre, India: lead
• Institute of Child Health, Chennai: collaborator
• All India Institute of Medical Sciences: collaborator
• The Grant Medical College & Sir J.J. Group of Hospitals: collaborator
• All India Institute of Medical Sciences, Bhubaneswar: collaborator
• Rajendra Institute of Medical Sciences, Ranchi: collaborator
• National Institute of Tuberculosis and Respiratory Diseases, New Delhi: collaborator
• Rajiv Gandhi Hospital, Chennai: collaborator
• Madurai Medical College: collaborator
• Government Vellore Medical College, Vellore: collaborator

Study Sites (1)

Dr Aishwarya Venkataraman

Chennai, Tamil Nadu, 600031, India

Location

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Interventions

BCG Vaccine; Chemoprevention

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Drug Therapy; Therapeutics

Study Officials

• Aishwarya Venkataraman, MRCPCH

  ICMR-National Institute for Research in Tuberculosis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Non-inferiority randomised trial

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 15, 2022
• Study Start: July 15, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

IN (1)