Randomized Trial Evaluating the Non-specific Effects of Different BCG Strains in Guinea-Bissau: Effects on Early-life Mortality and Morbidity
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bandim Health Project
- Enrollment
- 16,390
- Locations
- 1
- Primary Endpoint
- Rate of all-cause mortality overall and stratified by maternal BCG scar status and sex
Study Overview
Brief Summary
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 BCG-Japan versus BCG-Russia 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 characteristics by six weeks (data collected by telephone) and at two and six months (data collected at home-visits to a subgroup of the cohort).
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 maternal BCG scarring enhances the non-specific effects of BCG.
Detailed Description
This two-year outcome assessor-blinded RCT will be conducted at the maternity ward of hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare BCG-Japan versus BCG-Russia 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 characteristics by six weeks (data collected by telephone) and at two and six months (data collected at home-visits to a subgroup of the cohort).
HYPOTHESES
The aim is to investigate the following hypotheses:
- Compared with BCG-Russia, receiving BCG-Japan is associated with
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
Following informed consent, the mother selects, from a stack of envelopes, a closed envelope that contains a sealed randomization lot indicating allocation to either BCG-Japan or BCG-Russia. The mother, inclusion assistant and vaccinator will thus not be blinded to the intervention allocation. All assistants assessing outcomes during the follow-up procedures outlined and providers of care will be blinded to the randomization allocation.
Eligibility Criteria
- Ages
- 0 Days to 42 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy infants present at the HNSM maternity ward on the day of discharge or procuring vaccination at the ward.
Exclusion Criteria
- •Infants older than 6 weeks (>42 days) of age
- •Infants that have already received either BCG or oral polio vaccine (OPV)
- •Infants that 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 may be recruited when they are discharged from the pediatric ward or the neonatal intensive care unit).
Outcomes
Primary Outcomes
Rate of all-cause mortality overall and stratified by maternal BCG scar status and sex
Time Frame: Six weeks of age
Data on mortality is collected from all available information sources (admission at HNSM, telephone follow-up, HDSS data)
Secondary Outcomes
- Rate of adverse events(6 months)
- In-hospital case-fatality risk ratio overall and stratified by maternal BCG scar status and sex(Six weeks and six months of age)
- Rate of hospital admissions overall and stratified by maternal BCG scar status and sex(Six weeks and six months of age)
- Prevalence of different BCG skin reaction types(Two and six months of age)
- Size of BCG skin reactions(Two and six months of age)
- Prevalence of BCG skin reactions(Six weeks and six months of age)