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

Completed

• Conditions: Tuberculosis, Pulmonary

• Registration Number: NCT05190146
• Lead Sponsor: Bill & Melinda Gates Medical Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-29
• Study Start: 2021-12-20
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-13
• Primary Completion: 2023-09-11
• Study Completion: 2024-08-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7203

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IGRA status per site	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 Outcome Measures

Name	Time	Method
IGRA status by age group per site	Screening	Proportion of participants with a positive IGRA, by age group (15 to 24 \[inclusive\], and 25 to 34 years of age \[inclusive\]) per site, calculated using per protocol population. 95% CI to summarize the precision associated with the estimates.
Laboratory-confirmed pulmonary TB during follow-up period	Day 1 up to 30 months	Incidence rate of participants with suspected TB to be summarized by country. Exact 95% CI to be provided.
Suspected pulmonary TB during follow-up period	Day 1 up to 30 months	Incidence rate of participants with suspected TB to be summarized by country. Exact 95% CI to be provided

Trial Locations

Locations (1)

Investigational Site; 🇿🇲 Ndola, Zambia