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

December 11, 2024 updated by: Bill & Melinda Gates Medical Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7203

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1212
        • Investigational Site
  • Brazil
      • Porto Alegre, Brazil, 90035-903
        • Investigational Site
      • Rio De Janeiro, Brazil, 21040-360
        • Investigational Site
  • Congo, The Democratic Republic of the
      • Kinshasa, Congo, The Democratic Republic of the, 0000
        • Investigational Site
  • Gambia
      • Banjul, Gambia, 00220
        • Investigational Site
  • India
      • Pune, India, 411018
        • Investigational Site
  • Indonesia
      • Bakti, Indonesia, 13510
        • Investigational Site
      • Persabahan, Indonesia, 13230
        • Investigational Site
    • West Java
      • Bandung, West Java, Indonesia, 45363
        • Investigational Site
  • Kenya
      • Kisumu, Kenya, 40100
        • Investigational Site
      • Mombasa, Kenya, 0000
        • Investigational Site
      • Nairobi, Kenya, 00100
        • Investigational Site
  • Mozambique
      • Manica, Mozambique, 01929
        • Investigational Site
      • Maputo, Mozambique, 3943
        • Investigational Site
  • Peru
      • Comas, Peru, 15324
        • Investigational Site
      • Lima, Peru, 15313
        • Investigational Site
  • Philippines
      • 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
  • South Africa
      • 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
  • Uganda
      • Entebbe, Uganda, 10005
        • Investigational Site
      • Mulago, Uganda, 72052
        • Investigational Site
  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Investigational Site
      • Hà Nội, Vietnam, 100000
        • Investigational Site
  • Zambia
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 7,203 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bill & Melinda Gates Medical Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gates MRI TBV02-E01

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

product manufactured in and exported from the U.S.

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.

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