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

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.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Estimated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Dhaka, Bangladesh, 1212
        • Investigational Site
      • Porto Alegre, Brazil, 90035-903
        • Investigational Site
      • Rio De Janeiro, Brazil, 21040-360
        • Investigational Site
      • Kinshasa, Congo, The Democratic Republic of the, 0000
        • Investigational Site
      • Banjul, Gambia, 00220
        • Investigational Site
      • Pune, India, 411018
        • Investigational Site
      • Bakti, Indonesia, 13510
        • Investigational Site
      • Persabahan, Indonesia, 13230
        • Investigational Site
    • West Java
      • Bandung, West Java, Indonesia, 45363
        • Investigational Site
      • Kisumu, Kenya, 40100
        • Investigational Site
      • Mombasa, Kenya, 0000
        • Investigational Site
      • Nairobi, Kenya, 00100
        • Investigational Site
      • Manica, Mozambique, 01929
        • Investigational Site
      • Maputo, Mozambique, 3943
        • Investigational Site
      • Comas, Peru, 15324
        • Investigational Site
      • Lima, Peru, 15313
        • Investigational Site
      • Dasmariñas, Philippines, 4114
        • Investigational Site
      • Iloilo City, Philippines, 5000
        • Investigational Site
      • Makati City, Philippines, 1229
        • Investigational Site
      • Mandaluyong City, Philippines, 1552
        • Investigational Site
      • Quezon City, Philippines, 1112
        • Investigational Site
      • Bloemfontein, South Africa, 9301
        • Investigational Site
      • Durban, South Africa, 4091
        • Investigational Site
      • Germiston, South Africa, 1401
        • Investigational Site
      • Kimberley, South Africa, 8301
        • Investigational Site
      • Mtubatuba, South Africa, 3935
        • Investigational Site
      • Soshanguve, South Africa, 0152
        • Investigational Site
      • Soweto, South Africa, 1818
        • Investigational Site
      • Three Rivers, South Africa, 1935
        • Investigational Site
      • Entebbe, Uganda, 10005
        • Investigational Site
      • Mulago, Uganda, 72052
        • Investigational Site
      • Ho Chi Minh City, Vietnam, 700000
        • Investigational Site
      • Hà Nội, Vietnam, 100000
        • Investigational Site
      • Emmasdale, Zambia, 10101
        • Investigational Site
      • Lusaka, Zambia, 10101
        • Investigational Site
      • Ndola, Zambia, 240262
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 34 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A maximum of 8000 participants who are at high risk of Mtb infection and TB (disease) will be enrolled.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening
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
Day 1 up to 30 months
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.
Day 1 up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gates MRI, Bill & Melinda Gates Medical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Actual)

September 11, 2023

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tuberculosis, Pulmonary

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