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

Last updated: December 11, 2024
Sponsor: Bill & Melinda Gates Medical Research Institute
Overall Status: Completed

Phase

N/A

Condition

Hiv

Lung Disease

Treatment

N/A

Clinical Study ID

NCT05190146
Gates MRI TBV02-E01
  • Ages 15-34
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 7203
Study Start date:
December 20, 2021
Estimated Completion Date:
August 16, 2024

Connect with a study center

  • Investigational Site

    Dhaka, 1212
    Bangladesh

    Site Not Available

  • Investigational Site

    Porto Alegre, 90035-903
    Brazil

    Site Not Available

  • Investigational Site

    Rio De Janeiro, 21040-360
    Brazil

    Site Not Available

  • Investigational Site

    Kinshasa, 0000
    Congo, The Democratic Republic of the

    Site Not Available

  • Investigational Site

    Banjul, 00220
    Gambia

    Site Not Available

  • Investigational Site

    Pune, 411018
    India

    Site Not Available

  • Investigational Site

    Bandung, West Java 45363
    Indonesia

    Site Not Available

  • Investigational Site

    Bakti, 13510
    Indonesia

    Site Not Available

  • Investigational Site

    Persabahan, 13230
    Indonesia

    Site Not Available

  • Investigational Site

    Kisumu, 40100
    Kenya

    Site Not Available

  • Investigational Site

    Mombasa, 0000
    Kenya

    Site Not Available

  • Investigational Site

    Nairobi, 00100
    Kenya

    Site Not Available

  • Investigational Site

    Manica, 01929
    Mozambique

    Site Not Available

  • Investigational Site

    Maputo, 3943
    Mozambique

    Site Not Available

  • Investigational Site

    Comas, 15324
    Peru

    Site Not Available

  • Investigational Site

    Lima, 15313
    Peru

    Site Not Available

  • Investigational Site

    Dasmariñas, 4114
    Philippines

    Site Not Available

  • Investigational Site

    Iloilo City, 5000
    Philippines

    Site Not Available

  • Investigational Site

    Makati City, 1229
    Philippines

    Site Not Available

  • Investigational Site

    Mandaluyong City, 1552
    Philippines

    Site Not Available

  • Investigational Site

    Quezon City, 1112
    Philippines

    Site Not Available

  • Investigational Site

    Bloemfontein, 9301
    South Africa

    Site Not Available

  • Investigational Site

    Durban, 4091
    South Africa

    Site Not Available

  • Investigational Site

    Germiston, 1401
    South Africa

    Site Not Available

  • Investigational Site

    Kimberley, 8301
    South Africa

    Site Not Available

  • Investigational Site

    KwaZulu, 3935
    South Africa

    Site Not Available

  • Investigational Site

    Mtubatuba, 3935
    South Africa

    Site Not Available

  • Investigational Site

    Soshanguve, 0152
    South Africa

    Site Not Available

  • Investigational Site

    Soweto, 1818
    South Africa

    Site Not Available

  • Investigational Site

    Three Rivers, 1935
    South Africa

    Site Not Available

  • Investigational Site

    Entebbe, 10005
    Uganda

    Site Not Available

  • Investigational Site

    Mulago, 72052
    Uganda

    Site Not Available

  • Investigational Site

    Ho Chi Minh City, 700000
    Vietnam

    Site Not Available

  • Investigational Site

    Hà Nội, 100000
    Vietnam

    Site Not Available

  • Investigational Site

    Emmasdale, 10101
    Zambia

    Site Not Available

  • Investigational Site

    Lusaka, 10101
    Zambia

    Site Not Available

  • Investigational Site

    Ndola, 240262
    Zambia

    Site Not Available

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