Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden

Bill & Melinda Gates Medical Research Institute

Status: Completed

Conditions: Tuberculosis, Pulmonary

Study type: Observational

Funder types: Other

Identifiers

NCT05190146

Gates MRI TBV02-E01

Details and patient eligibility

About

The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study.

Enrollment: 7,203 patients

Sex: All

Ages: 15 to 34 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Capable of giving signed informed consent and informed assent (as appropriate), which includes compliance with the requirements listed in the informed consent form (ICF) and informed assent form (IAF)

Between 15 and 34 years of age (inclusive)

Participants who agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to relocate from the study area for the duration of the study.

Exclusion Criteria:

History of active TB within the last 24 months (i.e., 24 months from end of treatment to day of screening, based on history [no documentation required])

History of previous administration of an experimental Mtb vaccine

Unstable / uncontrolled chronic condition according to the judgment of the investigator