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Bacillus Calmette-Guérin vaccination at birth: Effects on infant growth. A randomized clinical trial
Jesper Kjærgaard1, Lone Graff Stensballe2, Nina Marie Birk3
1Research Unit Womens' and Childrens' Health, The Department of Paediatrics and Adolescent Medicine, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark; The Neonatal Department, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark.
Insights
Bacillus Calmette-Guérin (BCG) vaccination at birth did not impact infant growth or body composition by 13 months. This randomized trial found no significant effects on weight, length, or other key anthropometric measures.
Area of Science:
- Immunology
- Pediatrics
- Public Health
Background:
- Bacillus Calmette-Guérin (BCG) vaccine triggers a pro-inflammatory immune response.
- Obesity is linked to chronic low-grade inflammation.
- Understanding BCG's systemic effects beyond tuberculosis prevention is crucial.
Purpose of the Study:
- To investigate the impact of early-life BCG vaccination on infant growth.
- To assess BCG's effect on infant body composition.
- To evaluate BCG's influence on anthropometric measurements in the first year of life.
Main Methods:
- Randomized clinical trial (Danish Calmette Study) involving 4262 infants.
- Infants received BCG vaccine within seven days of birth or were in a control group.
- Follow-up included anthropometric measurements at 3 and 13 months, with data collectors blinded to allocation.
Main Results:
- Follow-up completion rate was 94% at both 3 and 13 months.
- No significant effect of BCG vaccination on weight z-score at 13 months (p=0.34).
- BCG vaccination did not influence weight, length, mid-upper-arm circumference, or skinfold thickness at 3 or 13 months.
Conclusions:
- BCG vaccination at birth does not appear to affect child growth or body composition up to 13 months.
- Findings suggest BCG's primary role is in infectious disease prevention, with limited impact on early development.
- Further research may explore long-term effects or BCG's influence on different populations.
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 ≥32weeks 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 3months, and weight, length, mid upper-arm circumference, and triceps and subscapular skinfold at 13months. 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 13months after birth. The children were bigger than the WHO reference population. There was no effect of BCG on weight z-score at 13months (-0.028 [95% confidence interval: -0.085 to 0.029], p=0.34). There was no effect on weight and length at 3months, or length, mid-upper-arm circumference, or triceps and subscapular skinfold at 13months.
Conclusion:
In this study, vaccination with BCG at birth did not have effects on child growth or body composition at 13months.
Trial Registration:
www.clinicaltrials.gov, registration number NCT01694108.
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