Immediate Bacille Calmette-Guérin vaccination to neonates requiring perinatal treatment at the maternity ward in Guinea-Bissau: A randomized controlled trial

Frederik Schaltz-Buchholzer, Peter Aaby, Ivan Monteiro, Luis Camala, Simone Faurholt Simonsen, Hannah Nørtoft Frankel, Kristina Lindberg Larsen, Christian N Golding, Tobias R Kollmann, Nelly Amenyogbe, Christine Stabell Benn, Morten Bjerregaard-Andersen

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Abstract

Background: Randomized controlled trials (RCTs) indicate that bacille Calmette-Guérin (BCG) vaccination provides broad beneficial "nonspecific"protection against infections. We investigated the effect on in-hospital mortality of providing BCG immediately upon admission to a neonatal intensive care unit (NICU), rather than BCG-at-discharge. The pretrial NICU mortality was 13% and we hypothesized that BCG would reduce mortality by 40%. Methods: Parallel-group, open-label RCT was initiated in 2013 in Guinea-Bissau. Neonatal intensive care unit-admitted neonates were randomized 1:1 to BCG+oral polio vaccine (OPV) immediately (intervention) versus BCG+OPV at hospital discharge (control; usual practice). The trial was discontinued due to decreasing in-hospital mortality and major NICU restructuring. We assessed overall and disease-specific mortality by randomization allocation in cox proportional hazards models providing mortality rate ratios (MRRs). Results: We recruited 3353 neonates, and the overall mortality was 3.1% (52 of 1676) for BCG-vaccinated neonates versus 3.3% (55 of 1677) for controls (MRR=0.94; 0.64-1.36). For noninfectious causes of death, the MRR was 1.20 (0.70-2.07), and there tended to be fewer deaths from infections in the BCG group (N=14) than among controls (N=21) (MRR=0.65; 0.33-1.28). Conclusions: Providing BCG+OPV to frail neonates was safe and might protect against fatal infection in the immediate newborn period. Deaths due to prematurity and perinatal complications were unaffected by BCG.

OriginalsprogEngelsk
TidsskriftThe Journal of Infectious Diseases
Vol/bind224
Udgave nummer11
Sider (fra-til)1935-1944
ISSN0022-1899
DOI
StatusUdgivet - 1. dec. 2021

Bibliografisk note

© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

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