Abstract

Objective of the study: to assess the effect of the frequency of administration of the BCG vaccine on the nature and structure of clinical forms of tuberculosis (TB) in children. Materials and methods of research: a cohort observational retrospective continuous comparative multicenter crosssectional study was carried out. The data (registration form № 089/u-tube) of 3253 children of 7–14 years old with newly revealed changes in the lungs of a specific genesis, registered in 2019–2020 in the institutions of the anti-tuberculosis service of the Russian Federation were analyzed. Two comparison groups were identified: group 1 (observation group) – children who received a double injection of BCG vaccine (vaccination and revaccination) (n=184), group 2 (comparison group) – children who received a single BCG vaccination (n=3358). To achieve this goal, 5 null hypotheses were identified for testing which groups are formed from the received data array with the necessary parameters. The data were analyzed using univariate and multivariate analyzes (including confounding factors). Results: it was found that BCG revaccination does not reduce the risk of TB compared with residual changes after, it does not reduce the proportion of generalized forms of TB compared with localized forms (OR=2,4, p=0,08). The frequency of vaccination has not a statistically significant effect on the frequency of bacterial excretion (aOR=1,6, p=0,15) and destruction of lung tissue (OR=1,1, p=1). Revaccination has a statistically significant effect on the ratio of primary and secondary forms of TB, reducing the likelihood of its primary forms (aOR=0,4, p<0,001). In the course of multivariate analysis, it was found that the formation of primary or secondary TB, as well as the frequency of bacterial excretion in the comparison groups, was significantly influenced by confounding factors. Conclusion: this work has demonstrated the absence of a pronounced protective effect of repeated administration of the BCG vaccine on the clinical course of a specific process.

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