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. 2021 Jan 4;7(1):e05757.
doi: 10.1016/j.heliyon.2020.e05757. eCollection 2021 Jan.

Determinants of Bacille Calmette-Guérin scarification in Danish children

Trine Mølbæk Jensen  1 , Signe Kjeldgaard Jensen  1 , Nina Marie Birk  1 , Andreas Rieckmann  2   3 , Thomas Hoffmann  1 , Christine Stabell Benn  2   4   5 , Dorthe Lisbeth Jeppesen  1 , Ole Pryds  1 , Thomas Nørrelykke Nissen  1
Affiliations

Determinants of Bacille Calmette-Guérin scarification in Danish children

Trine Mølbæk Jensen et al. Heliyon. .

Abstract

Background: Studies in low-income countries have shown that among Bacille Calmette-Guérin (BCG) vaccinated children, those who develop a BCG-scar have significantly better survival than those who do not develop a scar. In a Danish multicenter randomized clinical trial we assessed determinants for developing a BCG-scar and for BCG scar size following neonatal BCG vaccination.

Methods: At three Danish hospitals, newborns were randomized 1:1 to BCG vaccination or no BCG vaccination. The infants were invited for a clinical examination at the ages of 3 and 13 months. At 13 months, the scar site was inspected and scar size measured. We investigated three groups of determinants; external, parental, and individual-level determinants on relative scar prevalence and differences in median scar sizes.

Results: Among 2118 BCG vaccinated infants, 2039 (96 %) were examined at 13 months; 1857 of these (91 %) had developed a BCG-scar. Compared with Copenhagen University Hospital, Hvidovre (85 %), Copenhagen University Hospital, Rigshospitalet had a scar prevalence of 95 % (adjusted Prevalence ratio (aPR) = 1.24 [CI 95 %: 1.18 to 1.30]); it was 93 % at Kolding Hospital (aPR 1.27 [CI 95 %: 1.19 to 1.35]). Increasing vaccine experience was positively associated with developing a scar and with scar size.

Conclusion: Across multiple potential determinants of BCG scaring and size, logistical factors dominated. The results support that injection technique is an important determinant of developing a scar. Given the strong link between having a BCG scar and subsequent health, improved BCG vaccination technique could play a major role for child health.

Keywords: BCG scar; BCG vaccine; Heterologous immunity; Non-specific effects.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
The skin reaction after BCG vaccination. Upper: Following a correctly applied intradermal BCG vaccination a visible white wheal appears at the injection site. Lower: Measuring of a BCG scar (mm) at the end of the 13-month clinical examination.
Figure 2
Figure 2
Trial profile of infants included into the study.
Figure 3
Figure 3
Difference in BCG vaccination scars by vaccinator and study site in the 1857 BCG-vaccinated children in the Danish Calmette Study who developed a scar.
See this image and copyright information in PMC

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