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Immunoprophylaxis with BCG vaccine combined with the use of rifampicin in a single dose in contacts less than 15 years old at home of patients with Leprosy

Immunochemioprophylaxis in the prevention of Leprosy contacts in children under 15 years of age - WHO - World Health Organization

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6yg2z9
Enrollment
Unknown
Registered
2019-10-03
Start date
2019-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leprosy [Hansen's disease]

Interventions

Contacts of patients with leprosy under the age of fifteen will be included in the study. The contacts will receive a single supervised dose of rifampicin. In this type of study, all patients receive
Drug
D03.633.400.811.700

Sponsors

Universidade de Cuiabá
Collaborator
Universidade Federal de Mato Grosso
Lead Sponsor
Universidade do Estado de Mato Grosso
Collaborator
Universidade Federal de Juiz de Fora
Collaborator
Instituto Oswaldo Cruz
Collaborator

Eligibility

Age
5 Years to 15 Years

Inclusion criteria

Inclusion criteria: Individuals younger than 15 years (5 years to 14 years, 11 months and 29 days); household contacts of new leprosy cases diagnosed and registered in the National Notification of Injury Information System (SINAN/MT) in 2018 (treatment or treatment virgin) up to 4 weeks of MDT use) of both sexes; who resided or resided within five years before/during the diagnosis of the index case.

Exclusion criteria

Exclusion criteria: It is those who refuse to undergo the clinical examination; who are diagnosed with leprosy during the examination; those who have a history of hypersensitivity after the previous dose of the vaccine or any component of the vaccine; pregnant women, patients receiving high dose corticosteroids ( 2 mg/kg/day for children up to 10 kg or 20 mg/kg/day for individuals over 10 kg) for a period of more than two weeks; patients taking other immunosuppressive therapies (antineoplastic chemotherapy, radiotherapy, among others).

Design outcomes

Primary

MeasureTime frame
Analyze the SDR strategy and BCG vaccine immunoprophylaxis using the Enzyme-Linked Immunosorbent Assay Immunosorbent Assay (ELISA) for detection of anti-NDO-LID antibodies and serum concentration - IFN-gamma in contacts under the age of fifteen, of multibacillary cases. The findings are expected to indicate a seroconversion of serological titers and increased immune response after intervention as a protective factor against the disease.

Secondary

MeasureTime frame
To evaluate the clinical manifestations of the disease, adverse events and the level of acceptability of the strategy; ;To analyze the variables regarding sociodemographic, cohabitational, clinical / epidemiological characteristics, consanguineous condition, characteristic of the index case, time of breastfeeding and serological test response.

Countries

Brazil

Contacts

Public ContactCamila;Omar Sato;Espinosa Domínguez

Universidade Federal de Mato Grosso;Universidade do Estado de Mato Grosso

camila_sato@hotmail.com;oaetmpan@gmail.com+55 (65) 999615892;+55 (65) 99995940

Outcome results

None listed

Source: REBEC (via WHO ICTRP)