Immunobiological Markers in Prophylaxis Post-exposure with Single Dose of Rifampicin and BCG Vaccine in Contacts of Multibacillary Leprosy Cases: Study Protocol (Preprint)
BACKGROUND Leprosy contacts are 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, which reinforces the need for chemoprophylactic measures, such as the use single-dose rifampicin (SDR) combined with BCG vaccine. OBJECTIVE 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). RESULTS The study is still recruiting participants and is expected to be completed in September 2020. CONCLUSIONS Our study seeks to analyze the response of anti-NDO-LID, HO-1/HMOX tests 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) in home contacts of multibacillary leprosy cases. CLINICALTRIAL Brazilian Registry of Clinical Trials (ReBEC), RBR-6yg2z9. Retrospectively registered on 3 de Out. de 2019.