The Effect on Hospital Admissions of Providing BCG Vaccine at Birth to Low-Birth-Weight Infants: Randomised Trial in Guinea-Bissau

Start date: 30 January, 2012 End date: 11 February, 2013 Project type: Master's Thesis (prior to 2018) Project code: A15876 Countries: Guinea-Bissau Institutions: Statens Serum Institut (SSI), Denmark Grant recipient: Frederik Schaltz-Buchholzer Total grant: 15,000 DKK



To examine the effect of early BCG vaccination to low-birth-weight (LBW) infants on the risk and causes of neonatal and infant hospital admissions.

Study of a secondary outcome within a randomised controlled trial (RCT) of BCG-atbirth (intervention) versus delayed BCG (current practice).
Methods, materials
The RCT was conducted at the Bandim health Project in Guinea-Bissau. From 2004-2008 we recruited 2320 LBW children. The children randomized to early BCG were vaccinated by our team at the maternity ward at the national hospital Simão Mendes (NHSM) and at three health centres. Those randomized to the intervention group received BCG during the normal routine service. Data on hospital admissions including length, cause and outcome were collected at the paediatric ward, NHSM and at home follow-up visits during the first year of life. We assessed the effect of early versus late BCG on neonatal (28d) and infant (1yr) hospitalisation incidence in Cox models providing incidence rate ratios (IRR). We also calculated IRRs for major disease groups, including malaria, pneumonia, diarrheal diseases and septicaemia. All analyses were stratified by sex and neonatal vitamin A supplementation (NVAS) status.

In the neonatal period, we found a non-significant reduction in the risk of hospital admission in the early BCG group compared with BCG-unvaccinated children, the
neonatal IRR being 0.78 (CI: 0.48-1.26, p = 0.31). This was due to a borderline significant 43% reduction in the risk of sepsis, IRR 0.57 (0.30-1.08, p=0.08).
By 1 year of age, the IRR was 0.97 (CI: 0.78-1.22).In the infant period, we found a tendency towards fewer cases of sepsis (IRR 0.66 (0.37-1.16) and gastroenteritis (IRR 0.59 (0.30-1.15) but not pneumonia (1.34 (0.89-2.01) in the early BCG group. We found no sex-differential effects of BCG and no interaction with NVAS.
BCG-at-birth to LBW infants is safe and may reduce neonatal mortality by protecting against neonatal sepsis.