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The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial

Najaaraq Lund1, Andreas Andersen2, Anna Sofie K Hansen3

  • 1Research Center for Vitamins and Vaccines, Statens Serum Institut, Copenhagen Department of Pediatrics, Kolding Hospital/University of Southern Denmark, Kolding.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|July 30, 2015
PubMed

Insights

Oral polio vaccine at birth (OPV0) may offer nonspecific protection against infant mortality, particularly when administered early. This randomized trial found no increased mortality, suggesting a potential protective effect against infectious diseases.

Area of Science:

  • Immunology
  • Pediatrics
  • Public Health

Background:

  • Observational studies suggested routine vaccines, including oral polio vaccine at birth (OPV0), might have nonspecific effects on mortality, with some indicating increased male infant mortality.
  • The potential for non-specific effects of vaccines on mortality necessitates rigorous investigation through randomized controlled trials.

Purpose of the Study:

  • To investigate the effect of oral polio vaccine given at birth (OPV0) on infant mortality in a randomized trial setting.
  • To determine if OPV0 is associated with increased or decreased mortality in infants, contradicting previous observational findings.

Main Methods:

  • A randomized trial involving 7012 healthy neonates assigned to BCG vaccination only or BCG with OPV0.
  • All infants received subsequent oral polio vaccine (OPV) doses and pentavalent vaccines at 6, 10, and 14 weeks.
  • Mortality was tracked to 12 months of age using Cox regression to calculate hazard ratios (HRs).

Main Results:

  • The trial contradicted the hypothesis of increased mortality with OPV0; the overall HR for BCG + OPV0 vs. BCG only was 0.83 (95% CI, 0.61-1.13).
  • A significant protective effect was observed for infants receiving BCG + OPV0 within the first 2 days of life (HR 0.58, 95% CI, 0.38-0.90).
  • Beneficial effects were noted particularly in males when OPV0 was administered early, with an HR of 0.55 (95% CI, 0.32-0.95) from enrollment until OPV campaigns.

Conclusions:

  • This randomized trial suggests OPV0 may be associated with nonspecific protection against infectious disease mortality, especially when given early.
  • The findings highlight the need for continued mortality monitoring during vaccine transitions, such as the phasing out of OPV.
  • This study provides crucial evidence from the only randomized trial on the mortality effects of OPV0.
Abstract

Keywords:
heterologous immunityinfant mortalityneonatesnonspecific effectsoral polio vaccine

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