Effects of Neonatal BCG-Japan Versus BCG-Russia Vaccination on Overall Mortality and Morbidity: Randomized Controlled Trial From Guinea-Bissau (BCGSTRAIN II)

Frederik Schaltz-Buchholzer*, Sebastian Nielsen, Marcus Kjær Sørensen, Elise Brenno Stjernholm, Rebecca Alison Fabricius, Paulo Umbasse, Ivan Monteiro, Elsi Jose Carlos Cá, Peter Aaby, Christine Stabell Benn*

*Corresponding author for this work

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Abstract

Background. Vaccination with the Danish strain of bacille Calmette-Guérin (BCG) has been associated with pronounced reductions in all-cause neonatal mortality and morbidity. Developing a skin reaction postvaccination is associated with markedly reduced mortality risk. It is unknown whether the beneficial nonspecific effects are maintained across different BCG strains.
Methods. This was an open-label randomized controlled trial in Guinea-Bissau, comparing BCG-Japan (n = 8754) versus BCGRussia (n = 8752) for all-cause hospital admission risk by 6 weeks of age (primary outcome) and 6 months of age. Additional secondary outcomes were in-hospital case-fatality risk (CFR), all-cause mortality, and BCG skin reaction prevalence. Participants were followed through telephone calls at 6 weeks and 6 months, with a subgroup also visited at home. We assessed admission and mortality risk in Cox models providing incidence rate ratios (IRRs) and mortality rate ratios. CFR and skin reactions were assessed by binomial regression providing risk ratios. Analyses were done overall and stratified by sex.
Results. BCG strain was not associated with admission risk, the BCG-Japan/BCG-Russia IRR being 0.92 (95% confidence interval [CI], .81–1.05) by 6 weeks and 0.92 (95% CI, .82–1.02) by 6 months. By 6 months of age, there were significantly fewer BCG-Japan infants with no skin reaction (1%) than for BCG-Russia (2%), the risk ratio being 0.36 (95% CI, .16–.81). BCG-Japan skin reactions were also larger.
Conclusions. Both vaccines induced a skin reaction in almost all participants. The BCG strains had comparable effects on morbidity and mortality, but BCG-Japan was associated with more and larger skin reactions that are indicators of lower mortality risk.
Original languageEnglish
Article numberofae057
JournalOpen Forum Infectious Diseases
Volume11
Issue number3
Number of pages11
ISSN2328-8957
DOIs
Publication statusPublished - Mar 2024

Keywords

  • bacille Calmette-Guerin vaccine
  • BCG strains
  • early-life morbidity and mortality
  • nonspecific effects of vaccines

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