BCG revaccination in children and adolescents

Phase 3

Suspended

• Registration Number: CTRI/2022/04/042311
• Lead Sponsor: ICMRNIRT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified