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Neonatal BCG vaccination and atopic dermatitis before 13 months of age: A randomized clinical trial
L M Thøstesen1, J Kjaergaard2, G T Pihl1
1Paediatric Department, Kolding Hospital, Kolding, Denmark.
Insights
Neonatal Bacillus Calmette-Guérin (BCG) vaccination reduced atopic dermatitis risk in infants with an atopic predisposition. The study highlights BCG
Area of Science:
- Immunology
- Pediatrics
- Allergy Research
Background:
- Emerging evidence suggests Bacillus Calmette-Guérin (BCG) vaccination may offer protection against allergic diseases.
- Atopic dermatitis is a common allergic condition in infants and children.
Purpose of the Study:
- To investigate the efficacy of neonatal BCG vaccination in preventing clinical atopic dermatitis.
- To explore whether the effect of BCG vaccination on atopic dermatitis differs based on atopic predisposition.
Main Methods:
- A randomized controlled trial (Danish Calmette Study, 2012-2015) involving newborns randomized to receive BCG or no BCG within 7 days of birth.
- Exclusion criteria included prematurity (<32 weeks gestation), low birth weight (<1000 g), known immunodeficiency, or non-Danish speaking parents.
- Data collection involved telephone interviews and clinical examinations up to 13 months of age.
Main Results:
- Clinical atopic dermatitis occurred in 22.7% of the BCG group versus 25.4% of the control group (Relative Risk [RR] = 0.90).
- BCG vaccination significantly reduced atopic dermatitis risk in infants with an atopic predisposition (RR = 0.84) but not in those without (RR = 1.09).
- The interaction between BCG vaccination and atopic predisposition was statistically significant (P = .04).
Conclusions:
- Neonatal BCG vaccination is effective in preventing atopic dermatitis, particularly in infants with a genetic predisposition.
- The number needed to treat with BCG to prevent one case of atopic dermatitis in predisposed infants was 21.
Background:
Studies have suggested that Bacillus Calmette-Guérin (BCG) vaccination may reduce the risk of allergic diseases, including atopic dermatitis.
Methods:
The Danish Calmette Study was conducted 2012-2015. Within 7 days of birth new-borns were randomised 1:1 to BCG or no BCG. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency or no Danish-speaking parent. Data were collected through telephone interviews and clinical examinations until 13 months.
Results:
Clinical atopic dermatitis was diagnosed in 466/2,052 (22.7%) children in the BCG group and 495/1,952 (25.4%) children in the control group (RR = 0.90 [95% confidence intervals 0.80-1.00]). The effect of neonatal BCG vaccination differed significantly between children with atopic predisposition (RR 0.84 (0.74-0.95)) and children without atopic predisposition (RR 1.09 [0.88-1.37]) (test of no interaction, P = .04).
Conclusion:
Among children with atopic predisposition, the number-needed-to-treat with BCG to prevent one case of atopic dermatitis was 21 (12-76).
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