BCG revaccination in children and adolescents

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 control trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042311

Enrollment

9600

Registered

2022-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: vaccine - Bacille Calmette-Guérin vaccine (BCG ): 0.1ml of BCG vaccine to be given intradermal Control Intervention1: Oral chemoprophylaxis: according to the existing standard of care:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy household contacts aged > 5 to 18 years 2. Previously vaccinated with BCG at birth or least 5 years ago - evidence of scar or documented immunisation record. 3. General good health – through history and baseline screening 4. Agrees to continue in the study for 2 years post enrollment 5. 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

Exclusion criteria: 1.Any acute illness on recruitment day (Evaluate the child again at a later stage) 2.Fever =38 degree Celsius on recruitment day (Evaluate the child again at a later) 3.History / presence of autoimmune disease 4.Pregnancy – female participants > 15 years of age will have pregnancy test done after caretakers and participants informed consent 5.Evidence of active TB disease 6.On treatment for active TB disease or LTBI 7.HIV positive 8.Any history or present possible immunodeficiency condition 9.History of administration of immunoglobulins/immunotherapy/immune-suppressants/blood products in the preceding 3 months or planned administration during the study period 10.History of allergic reactions to vaccines in past 11.History of severe adverse reactions to primary BCG 12.Pre-existing liver dysfunction 13.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. 14.History of previous administration of newer/trial TB vaccines 15. Participation in other clinical trials in preceding 3 months or planned / concurrent participation 16.History of chronic renal failure, malignancy, transplants (cardiac/renal/liver), inflammatory or metabolic conditions, neurological/seizure/psychiatric disorders – issues that make participant unlikely to volunteer

Design outcomes

Primary

Measure	Time frame
Incidence of TB (all forms - PTB / EPTB) as per NTEP guidelines in BCG revaccinated and oral chemoprophylaxis groupsTimepoint: Assessment at one year (12 months after recruitment) and two years (24 months after recruitment)	—

Secondary

Measure	Time frame
• Incidence of adverse events in children in each arm • Efficacy of BCG revaccination in preventing TB incidence among C-Tb skin test positive and negative participants at baseline • Incidence of MTB infection (conversion of C-Tb test negative to positive at 6, 12 and 24 months) • Immunogenicity between groups Timepoint: over 24 months	—

Countries

India

Contacts

Public ContactAishwarya Venkataraman

ICMR-NIRT

aishwarya.v@nirt.res.in914428369533

Outcome results