Randomized Trial Evaluating the Non-specific Effects of BCG-Bulgaria and BCG-Denmark in Guinea-Bissau: Effects on Mortality, Morbidity, and BCG Skin Reactions

BCGSTRAIN IV

The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of Hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare vaccination with Bacillus Calmette-Guérin (BCG) Danish strain (AJ Vaccines, Copenhagen 1331 strain) versus BCG-Bulgaria (BB-NCIPD, BCG-SL 222 Sofia strain) 1:1 in 15,000 infants with respect to mortality, morbidity and case-fatality rate during hospital admission. The trial will also examine the association between BCG strains and BCG skin reaction kinetics and characteristics. As a secondary aim, this large study will be used to further evaluate the role of maternal BCG immune priming for overall health, since there are indications that the maternal BCG scar status influences offspring health outcomes.

2022-10-21

2024-07-01

2024-10-01

Recruiting

Early phase I

15000

Inclusion criteria: - Healthy infants under one year of age who are vaccinated at the HNSM maternity ward. Exclusion criteria: * Infants who have already received either BCG or oral polio vaccine (OPV) * Infants who are moribund due to gross malformation or acute illness (about to die or be transferred to the pediatric ward according to the local health physician assessment); the latter children can be recruited when they are discharged from the pediatric ward or the neonatal intensive care unit.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Outcome assessor-blinded RCT', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "Following informed consent, the child's mother/guardian selects, from a stack of envelopes, a closed envelope that contains a sealed randomization lot indicating allocation to either BCG-Denmark or BCG-Bulgaria. The mother, inclusion assistant and vaccinator will thus not be blinded to the intervention allocation. All assistants assessing outcomes during follow-up procedures and providers of care will be blinded to the randomization allocation.", 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 15000, 'type': 'ESTIMATED'}}

2024-01-22