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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

15 year–34 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site, Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 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.
Suspected pulmonary TB during follow-up period

Time frame: Day 1 up to 30 months

Incidence rate of participants with suspected TB to be summarized by country. Exact 95% CI to be provided
Laboratory-confirmed pulmonary TB during follow-up period

Time frame: Day 1 up to 30 months

Incidence rate of participants with suspected TB to be summarized by country. Exact 95% CI to be provided.

Sponsors and collaborators

Lead sponsor

Gates Medical Research Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2024
First posted: Jan 13, 2022
Registry last updated: Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed