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.

ICMRNIRT0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年9月18日

试验速览

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•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

•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

发起方

ICMRNIRT