Previously submitted to: JMIR Research Protocols (no longer under consideration since Sep 09, 2021)
Date Submitted: Jun 2, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Immunobiological Markers in Prophylaxis Post-exposure with Single Dose of Rifampicin and BCG Vaccine in Contacts of Multibacillary Leprosy Cases: Study Protocol
ABSTRACT
Leprosy contacts are a sensitive indicator of the magnitude of severity, and a high risk for infection and disease, especially if the individuals are exposed to the bacillus with multibacillary cases. Our study will analyze the serological response of anti-NDO-LID, HO-1/HMOX and serum IFN-γ concentration as a prophylactic measure after the use of single-dose rifampicin (SDR) combined with the Bacillus Calmette-Guérin vaccine (BCG) among multibacillary leprosy household contacts.
Methods:
Intervention study based on a prospective cohort of household contacts of new cases of multibacillary leprosy diagnosed and registered in the Information System on Diseases of Compulsory Declaration (SINAN – Sistema de Informação de Agravos de Notificação) and residents in the municipalities of Cuiabá and Cáceres, Mato Grosso, in the years 2019 and 2020. Contacts with no signs and symptoms compatible with the disease of the intervention group will receive single-dose rifampicin (SDR) combined with BCG vaccine and will be compared to the control group. The follow-up of the cohort will last 12 months. The analyses of the anti-NDO-LID, HO-1/HMOX and serum concentration of IFN-γ tests as immunological markers before, 6 and 12 months after the intervention will be conducted in a reference laboratory (FIOCRUZ). Variations in markers will be compared in individuals in the intervention and control group, with a 5% significance level. The identification of serum parameters associated with greater predisposition to illness can contribute to a cost-effective strategy.
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