By InvitationPhase 4

BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine and Infant Mortality in Africa

Guinea-Bissau6,000 participantsStarted 2025-05-09

Plain-language summary

Studies in low-income countries show that vaccines can have important non-specific effects on other infections. Live BCG vaccine can train the immune system and reduce susceptibility to unrelated infections. In contrast, non-live diphtheria-tetanus-pertussis-containing (DTP) vaccine enhances susceptibility in females: DTP vs no DTP is associated with 2-fold higher mortality, and in DTP-vaccinated children, females have higher mortality than males. These effects are seen as long as a vaccine is the most recent vaccine. WHO recommends BCG at birth followed by three DTP vaccines. A metaanalysis based on observational studies has shown that co-administration of BCG+DTP is associated with lower mortality than BCG followed by DTP. The investigators will implement a randomised trial in urban Guinea-Bissau, including 6000 children, to test the hypothesis that an extra dose of BCG given with DTP3 (BCG2+DTP3 vs. DTP3) can: * reduce death and hospital admissions by 25% * reduce the F/M severe morbidity hazard ratio

Who can participate

Age range

14 Weeks – 24 Weeks

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: * Children, who are between 14 weeks and 24 weeks of age, * Received DTP2 at least 4 weeks earlier and who are due to receive DTP3. Exclusion Criteria: * Children, who are ill and require hospitalization. * Children with severe malformations * Children, who had suppurative lymphadenitis after BCG1 (extremely rare)

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

Non-accidental servere morbidity

Timeframe: Baseline to the age of measles vaccine (scheduled at 9 months, to be received by latest by 12 months. Children will be censored upon migration or death.

Trial details

NCT IDNCT07005726

SponsorBandim Health Project

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-05

View on ClinicalTrials.gov More Infant Morbidity trials