BCG Revaccination in Children and Adolescents (NCT05330884) | Clinical Trial Compass
SuspendedPhase 3
BCG Revaccination in Children and Adolescents
Stopped: changes in protocol
India9,200 participantsStarted 2024-07-15
Plain-language 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.
Who can participate
Age range
6 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of TB (all forms - PTB / EPTB) as per NTEP guidelines