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. 2019 Oct 8;37(43):6510-6517.
doi: 10.1016/j.vaccine.2019.08.067. Epub 2019 Sep 6.

BCG vaccine and leprosy household contacts: Protective effect and probability to becoming sick during follow-up

Rafaela Resende Gomes  1 , Douglas Eulálio Antunes  2 , Diogo Fernandes Dos Santos  3 , Elaine Fávaro Pípi Sabino  3 , Dulcinéia Bernardes Oliveira  1 , Isabela Maria Bernardes Goulart  3
Affiliations

BCG vaccine and leprosy household contacts: Protective effect and probability to becoming sick during follow-up

Rafaela Resende Gomes et al. Vaccine. .

Abstract

Background: Immunoprophylaxis with Bacillus Calmette-Guérin (BCG) vaccine is still the most effective intervention in the prevention of leprosy among household contacts (HHCs) of leprosy patients.

Methods: A retrospective cohort study using data of 5.061 HHCs for a period of 16 years (follow-up of 7 years per leprosy HHCs), evaluating the occurrence of disease as the main outcome and the presence or absence of BCG scars verified at the first evaluation. Statistical analyzes were performed using the relative risk, hazard ratio and survival curves by Kaplan-Meier test.

Results: A total of 92 contacts sickened, of which 41.3% (38/92) in the first year and 58.7% (54/92) in the course of the other years of follow-up. Of those who became sick, 62% (57/92) developed borderline tuberculoid (BT). The additional protective effect occurred for those who had 2 BCG scars at the first follow-up assessment (Relative Risk: 0.41; p = 0.007) when compared to those not previously exposed to the vaccine. The number of BCG scars examined at the first assessment (t0 = time zero) affected the occurrence of the outcome evidenced by the difference in survival curves throughout the follow-up (Log Rank, p = 0.041; Breslow, p = 0.012; Tarone-Ware, p = 0.020). Leprosy HHCs with 0 BCG scar at time zero (t0) have a shorter survival time (average time of 22 months between t0 and outcome) when compared to those with 2 BCG scars (average time of 36 months between t0 and outcome).

Conclusions: Vaccination of healthy individuals without signs and symptoms of leprosy is extremely important because BCG vaccine has an additional protective effect in those cases with 2 BCG scars throughout follow-up. Reducing the risk of leprosy HHCs becoming sick depends on preventive actions such as immunoprophylaxis and index cases treatment.

Keywords: Bacillus Calmette-Guérin vaccine; Household contacts; Leprosy; Relative risk; Survival curve.

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