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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05190146

Enrollment

7203

Registered

2022-01-13

Start date

2021-12-20

Completion date

2024-08-16

Last updated

2024-12-13

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

Conditions

Tuberculosis, Pulmonary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to 34 Years

Healthy volunteers

Yes

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 \-

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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
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.

Countries

Bangladesh, Brazil, Democratic Republic of the Congo, India, Indonesia, Kenya, Mozambique, Peru, Philippines, South Africa, The Gambia, Uganda, Vietnam, Zambia

Outcome results