A Multi-country, Epidemiologic Study to Assess the Interferon Gamma Release Assay (IGRA) Positivity, and to Build Capacity to Conduct a Tuberculosis (TB) Vaccine Efficacy Study, in Populations With a High TB Disease Burden

Bill & Melinda Gates Medical Research Institute1 site in 1 country7,203 target enrollmentDecember 20, 2021

ConditionsTuberculosis, Pulmonary

Overview

Phase: N/A
Intervention: Not specified
Conditions: Tuberculosis, Pulmonary
Sponsor: Bill & Melinda Gates Medical Research Institute
Enrollment: 7203
Locations: 1
Primary Endpoint: IGRA status per site
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 20, 2021

End Date

August 16, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Bill & Melinda Gates Medical Research Institute

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

IGRA status per site

Time Frame: Screening

Proportion of participants with a positive IGRA, per site, calculated using per protocol population. 95% CI will summarize the precision associated with the estimate.

Secondary Outcomes

IGRA status by age group per site(Screening)
Laboratory-confirmed pulmonary TB during follow-up period(Day 1 up to 30 months)
Suspected pulmonary TB during follow-up period(Day 1 up to 30 months)