Bacillus Calmette-Guérin vaccination at birth: Effects on infant growth. A randomized clinical trial. (September 2016)

• Record Type: Journal Article
• Authors: Kjærgaard, Jesper; Stensballe, Lone Graff; Birk, Nina Marie; Nissen, Thomas Nørrelykke; Thøstesen, Lisbeth Marianne; Pihl, Gitte Thybo; Nielsen, Agnethe Vale; Kofoed, Poul-Erik; Aaby, Peter; Pryds, Ole; Greisen, Gorm
• Is Part Of: Early human development. Volume 100(2016)
• Page Start: 49
• Page End: 54
• Publication Date: 2016-09
• Subjects: BCG -- Child growth -- Inflammation -- Body composition -- Non-specific effect -- Obesity; Fetus -- Periodicals; Neonatology -- Periodicals; Prenatal influences -- Periodicals; 612.65
• DOI: 10.1016/j.earlhumdev.2016.05.015
• Languages: English
• ISSNs: 0378-3782

Abstract

Abstract: Background: Bacillus Calmette-Guérin vaccine (BCG) induces a complex, pro-inflammatory immune response. Obesity is associated with low-grade inflammation. Aims: The purpose of the study was to test whether BCG at birth has effects on infant growth and body composition. Study design, subjects, and outcome measures: The Danish Calmette Study is a randomized, clinical trial. The study was conducted at three university hospitals and randomized 4262 children of gestational age ≥ 32 weeks to receive BCG within seven days of birth or to a no-intervention control group. Follow-up consisted of clinical examinations. Outcome measures were weight and length at 3 months, and weight, length, mid upper-arm circumference, and triceps and subscapular skinfold at 13 months. Data collectors were blinded to allocation. Anthropometric measurements were converted to z-scores using WHO reference population. Results: Follow-up was 94% complete at 3 and 13 months after birth. The children were bigger than the WHO reference population. There was no effect of BCG on weight z-score at 13 months (− 0.028 [95% confidence interval: − 0.085 to 0.029], p = 0.34). There was no effect on weight and length at 3 months, or length, mid-upper-arm circumference, or triceps and subscapular skinfold at 13 months. Conclusion: In this study, vaccination with BCG at birth did not have effects on child growth or body composition at 13 months. Trial registration: www.clinicaltrials.gov, registration numberNCT01694108 . Highlights: BCG vaccination may have non-specific effects on childhood morbidiy and mortality. This is the first study of BCGs' effect on child growth in a high income setting. BCG vaccination at birth does not affect child growth or body composition until 13 months of age.