Affiliation:
1. Bandim Health Project, INDEPTH Network , Bissau , Guinea-Bissau
2. Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark and Odense University Hospital
3. Department of Public Health, GloHAU, Center for Global Health, Aarhus University
4. Danish Institute of Advanced Study, University of Southern Denmark , Odense
Abstract
Abstract
Background
Maternal priming with bacille Calmette-Guérin (BCG) has been associated with reduced mortality in male offspring. We investigated this association in a cohort of healthy BCG-vaccinated neonates.
Methods
This observational study within a randomized controlled trial comparing different BCG strains was conducted in Guinea-Bissau from 2017 to 2020. As part of trial inclusion procedures, on the day of discharge from the maternity ward, maternal BCG scar status was evaluated by visual inspection, followed by offspring BCG and polio vaccination. Through mortality data collected at telephone interviews at 6 weeks and 6 months of age, we assessed all-cause mortality risk in Cox proportional hazards models adjusted for maternal schooling and BCG strain, providing adjusted mortality rate ratios (aMRRs).
Results
In total, 64% (11 070/17 275) of mothers had a BCG scar, which was not associated with admission risk, admission severity, or all-cause mortality for females and the overall sample. By 6 months of age, the mortality rate (MR) was 4.1 (200 deaths/4919 person-years) for the maternal BCG scar cohort and 5.2 (139/2661) for no maternal scar (aMRR, 0.86; 95% Confidence Interval [CI], .69–1.06). In males, 6-month MRs were 4.3 (109 deaths/2531 person-years) for maternal BCG scar vs 6.3 (87/1376) for no scar (aMRR, 0.74; 95% CI, .56–.99). In females, 6-month MRs were 3.8 (91 deaths/2388 person-years) vs 4.0 (52/1286), respectively (aMRR, 1.04; 95% CI, .74–1.47; for interaction with sex, P = .16).
Conclusions
While we cannot rule out an association in females, being born to a mother with a BCG scar reduced the risk of death during early infancy for BCG-vaccinated males, reproducing findings from previous studies.
Funder
University of Southern Denmark
Augustinusfonden
MICA-Fonden
Research Center for Vitamins and Vaccines
Danish National Research Foundation
European and Developing Countries Clinical Trials Partnership
Publisher
Oxford University Press (OUP)