Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial

Thursday, 8th of October 2015

Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial

Biering-Sørensen S^1,2, Andersen A³, Ravn H^4,5, Monterio I⁶, Aaby P⁷, Benn CS^8,9.

¹Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. s.biering@bandim.org.
²Projécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. s.biering@bandim.org.
³Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. a.andersen@bandim.org.
⁴Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. hjn@ssi.dk.
⁵Odense Patient data Explorative Network, Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, DK-5000, Odense C, Denmark. hjn@ssi.dk.
⁶Projécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. ivan130978@gmail.com.
⁷Projécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. p.aaby@bandim.org.
⁸Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. cb@ssi.dk.
⁹Odense Patient data Explorative Network, Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, DK-5000, Odense C, Denmark. cb@ssi.dk.

BMC Pediatr. 2015 Sep 28;15(1):137. doi: 10.1186/s12887-015-0452-2.

Abstract below; full text, with figures, is at http://www.biomedcentral.com/1471-2431/15/137

BACKGROUND:

Randomised trials have shown that early Bacille Calmette-Guérin (BCG) vaccine reduces overall neonatal and infant mortality. However, no study has examined how BCG affects growth. We investigated the effect on infant growth of early BCG vaccine given to low-birth-weight (LBW) infants.

METHODS:

Two-thousand three hundred forty-three LBW infants were randomly allocated 1:1 to "early BCG" (intervention group) or "late BCG" (current practice). Furthermore, a subgroup (N = 1717) were included in a two-by-two randomised trial in which they were additionally randomised 1:1 to vitamin A supplementation (VAS) or placebo. Anthropometric measurements were obtained 2, 6, and 12 months after enrolment.

RESULTS:

Overall there was no effect of early BCG on growth in the first year of life. The effect of early BCG on weight and mid-upper-arm circumference at 2 months tended to be beneficial among girls but not among boys (interaction between "early BCG" and sex: weight p = 0.03 and MUAC p = 0.04). This beneficial effect among girls was particularly seen among the largest infants weighing 2.0 kg or more at inclusion.

CONCLUSION:

Though BCG vaccination is not recommended to be given to LBW infants at birth in Guinea-Bissau, early BCG had no negative effect on infant growth and may have had a beneficial effect for girls.

TRIAL REGISTRATION NUMBER:

ClinicalTrials.gov (NCT00146302) .