Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
9200 participants
INTERVENTIONAL
2024-07-15
2027-12-31
Brief Summary
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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.
Detailed Description
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Primary:
To demonstrate the effect of BCG revaccination in comparison to oral chemoprophylaxis on the incidence of Mycobacterium tuberculosis disease in healthy household contacts aged 6-18 years.
Secondary:
* To compare the safety of BCG revaccination with oral chemoprophylaxis
* To study the efficacy of BCG revaccination in comparison to oral chemoprophylaxis in preventing Mycobacterium tuberculosis infection
* To study the immunogenicity of BCG revaccination
Methodology The 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. A total of 9200 children will be recruited across 7 sites in India. Children will be randomised into 2 study arms: 1) BCG; 2) Oral chemoprophylaxis.
All children will be household contacts of microbiologically confirmed pulmonary TB patients. Contacts of MDR TB adults will also be included in the study. Both C-Tb skin test positive and negative children will be included. Similarly, both well-nourished and malnourished children will be included. All children will be followed up for 24 months post recruitment and the incidence of TB (all forms - PTB / EPTB) will be compared between the groups. TB will be diagnosed as per the NTEP guidelines and LTBI will be based on the C-TB skin test results.
Immunology bloods will be done in 10% of the participants - 920 children at baseline, 3, 6 12 and 24 months. The immunology component of this trial is designed so as to decipher clearly the effects of BCG revaccination on adaptive and innate cell responses. Full Blood Count for Monocyte/Lymphocyte ratio, Whole Blood culture for Intracellular Staining, Innate assays, Mycobacterial Growth Inhibition Assay and acute phase proteins will be performed between groups
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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vaccine - Bacille Calmette-Guérin vaccine (BCG )
Bacille Calmette-Guérin vaccine (BCG ) dose 0.1ml intradermal
BCG vaccine
0.1ml BCg vaccine to be given intradermally
Chemoprophylaxis - as per NTEP guidelines
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
Oral Chemoprophylaxis
Oral chemoprophylaxis will be standard of care - either 6 months of Isoniazid or 3 months of weekly Isoniazid and Rifapentine
Interventions
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BCG vaccine
0.1ml BCg vaccine to be given intradermally
Oral Chemoprophylaxis
Oral chemoprophylaxis will be standard of care - either 6 months of Isoniazid or 3 months of weekly Isoniazid and Rifapentine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
18 Years
ALL
Yes
Sponsors
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Institute of Child Health, Chennai
UNKNOWN
All India Institute of Medical Sciences
OTHER
The Grant Medical College & Sir J.J. Group of Hospitals
OTHER_GOV
All India Institute of Medical Sciences, Bhubaneswar
OTHER
Rajendra Institute of Medical Sciences, Ranchi
UNKNOWN
National Institute of Tuberculosis and Respiratory Diseases, New Delhi
UNKNOWN
Rajiv Gandhi Hospital, Chennai
UNKNOWN
Madurai Medical College
OTHER
Government Vellore Medical College, Vellore
UNKNOWN
Tuberculosis Research Centre, India
OTHER_GOV
Responsible Party
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Principal Investigators
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Aishwarya Venkataraman, MRCPCH
Role: PRINCIPAL_INVESTIGATOR
ICMR-National Institute for Research in Tuberculosis
Locations
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Dr Aishwarya Venkataraman
Chennai, Tamil Nadu, India
Countries
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Other Identifiers
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2022 005
Identifier Type: -
Identifier Source: org_study_id