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BMC pediatrics
Sep 28, 2015;15 137.

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

Sofie Biering-Sørensen, Andreas Andersen, Henrik Ravn, Ivan Monterio, Peter Aaby, Christine Stabell Benn
Author Information
  1. Sofie Biering-Sørensen: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. s.biering@bandim.org.
  2. Andreas Andersen: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. a.andersen@bandim.org.
  3. Henrik Ravn: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. hjn@ssi.dk.
  4. Ivan Monterio: Projécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. ivan130978@gmail.com.
  5. Peter Aaby: Projécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. p.aaby@bandim.org.
  6. Christine Stabell Benn: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. cb@ssi.dk.
PMID: 26416147 DOI: 10.1186/s12887-015-0452-2

Abstract

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).

Associated Data

ClinicalTrials.gov | NCT00146302

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Grants

  1. 243149/European Research Council

MeSH Term

Adjuvants, Immunologic
Anthropometry
BCG Vaccine
Body Weight
Dietary Supplements
Female
Humans
Infant
Infant, Low Birth Weight
Infant, Newborn
Male
Sex Factors
Vitamin A
Vitamins

Chemicals

Adjuvants, Immunologic
BCG Vaccine
Vitamins
Vitamin A
Journal Article Randomized Controlled Trial
Article has an altmetric score of 4

Word Cloud

Created with Highcharts 10.0.0BCGeffectearlygrowthinfantsamongvaccineinfantLBWBCG"randomised2beneficialgirls0givenlow-birth-weight1:1"early=trialmonthsfirstyearweightBACKGROUND:RandomisedtrialsshownBacilleCalmette-GuérinreducesoverallneonatalmortalityHoweverstudyexaminedaffectsinvestigatedMETHODS:Two-thousandthreehundredforty-threerandomlyallocatedinterventiongroup"latecurrentpracticeFurthermoresubgroupN1717includedtwo-by-twoadditionallyvitaminsupplementationVASplaceboAnthropometricmeasurementsobtained612enrolmentRESULTS:Overalllifemid-upper-armcircumferencetendedboysinteractionsex:p03MUACp =04particularlyseenlargestweighingkginclusionCONCLUSION:ThoughvaccinationrecommendedbirthGuinea-BissaunegativemayTRIALREGISTRATIONNUMBER:ClinicalTrialsgovNCT00146302Earlyeffectslife:controlled

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