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Early BCG Vaccination, Hospitalizations, and Hospital Deaths: Analysis of a Secondary Outcome in 3 Randomized Trials

Frederik Schaltz-Buchholzer1,2,3, S Biering-Sørensen1,2, N Lund1

  • 1Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.

The Journal of Infectious Diseases
|September 22, 2018
PubMed

Insights

Early BCG vaccination did not alter infant hospitalization rates but significantly reduced in-hospital mortality, mainly by preventing fatal sepsis cases. These beneficial effects were nonspecific.

Area of Science:

  • Neonatal immunology
  • Infectious disease epidemiology
  • Vaccine efficacy studies

Background:

  • Investigating the impact of early Bacillus Calmette-Guérin (BCG) vaccination on infant hospitalizations.
  • Analyzing data from three randomized trials involving low-weight neonates.

Purpose of the Study:

  • To determine the effects of early BCG vaccination on the risk, cause, and severity of infant hospitalizations.
  • To assess BCG vaccination's influence on hospitalization incidence rates and in-hospital mortality.

Main Methods:

  • Utilized Cox models to evaluate hospitalization risk and incidence rate ratios (IRRs).
  • Assessed severity using in-hospital case-fatality rates and cohort study risk ratios (RRs).
  • Collected hospitalization data from the pediatric ward of the National Hospital.

Main Results:

  • BCG vaccination did not significantly change overall infant hospitalization rates (IRR: 0.96; 95% CI, 0.84-1.10).
  • BCG vaccination significantly reduced in-hospital mortality rates (RR: 0.72; 95% CI, 0.53-0.99).
  • BCG vaccination showed a trend towards reducing sepsis hospitalizations and significantly reduced neonatal sepsis mortality (RR: 0.46; 95% CI, 0.22-0.98).

Conclusions:

  • Early BCG vaccination effectively reduces infant in-hospital mortality, primarily through prevention of fatal sepsis.
  • The protective effects of BCG vaccination on mortality are nonspecific, suggesting a broader immune modulation.
  • No confirmed tuberculosis hospitalizations were observed in the BCG or control groups.
Abstract

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