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Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?

Författare

  • Peter Aaby
  • Adam Roth
  • Henrik Ravn
  • Bitiguida Mutna Napirna
  • Amabelia Rodrigues
  • Ida Maria Lisse
  • Lone Stensballe
  • Birgitte Rode Diness
  • Karen Rokkedal Lausch
  • Najaaraq Lund
  • Sofie Biering-Sorensen
  • Hilton Whittle
  • Christine Stabell Benn

Summary, in English

Background. Observational studies have suggested that BCG may have nonspecific beneficial effects on survival. Low-birth-weight (LBW) children are not given BCG at birth in Guinea-Bissau; we conducted a randomized trial of BCG at birth (early BCG) vs delayed BCG. Methods. In the period 2004-2008 we recruited 2320 LBW children in Bissau. The children were visited at home at 2, 6, and 12 months of age. With a pretrial infant mortality of 250 per 1000, we hypothesized a 25% reduction in infant mortality for LBW children. Results. Infant mortality was only 101 per 1000 during the trial. In the primary analysis, infant mortality was reduced insignificantly by 17% (mortality rate ratio [MRR] = .83 [.63-1.08]). In secondary analyses, early BCG vaccine was safe with an MRR of .49 (.21-1.15) after 3 days and .55 (.34-.89) after 4 weeks. The reduction in neonatal mortality was mainly due to fewer cases of neonatal sepsis, respiratory infection, and fever. The impact of early BCG on infant mortality was marked for children weighing <1.5 kg (MRR = .43 [.21-.85]) who had lower coverage for diphtheria-tetanus-pertussis vaccinations. Conclusions. Though early BCG did not reduce infant mortality significantly, it may have a beneficial effect in the neonatal period. This could be important for public health because BCG is often delayed in low-income countries.

Publiceringsår

2011

Språk

Engelska

Sidor

245-252

Publikation/Tidskrift/Serie

Journal of Infectious Diseases

Volym

204

Issue

2

Dokumenttyp

Artikel i tidskrift

Förlag

Oxford University Press

Ämne

  • Infectious Medicine

Status

Published

Forskningsgrupp

  • Clinical Microbiology, Malmö

ISBN/ISSN/Övrigt

  • ISSN: 1537-6613