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

NCT ID: NCT05190146

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2024-08-16

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculosis, Pulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

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Minimum Eligible Age

15 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gates Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gates MRI

Role: STUDY_DIRECTOR

Gates Medical Research Institute

Locations

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Investigational Site

Dhaka, , Bangladesh

Site Status

Investigational Site

Porto Alegre, , Brazil

Site Status

Investigational Site

Rio de Janeiro, , Brazil

Site Status

Investigational Site

Kinshasa, , Democratic Republic of the Congo

Site Status

Investigational Site

Pune, , India

Site Status

Investigational Site

Bandung, West Java, Indonesia

Site Status

Investigational Site

Bakti, , Indonesia

Site Status

Investigational Site

Persabahan, , Indonesia

Site Status

Investigational Site

Kisumu, , Kenya

Site Status

Investigational Site

Mombasa, , Kenya

Site Status

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Nairobi, , Kenya

Site Status

Investigational Site

Manica, , Mozambique

Site Status

Investigational Site

Maputo, , Mozambique

Site Status

Investigational Site

Comas, , Peru

Site Status

Investigational Site

Lima, , Peru

Site Status

Investigational Site

Dasmariñas, , Philippines

Site Status

Investigational Site

Iloilo City, , Philippines

Site Status

Investigational Site

Makati City, , Philippines

Site Status

Investigational Site

Mandaluyong, , Philippines

Site Status

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Quezon City, , Philippines

Site Status

Investigational Site

Bloemfontein, , South Africa

Site Status

Investigational Site

Durban, , South Africa

Site Status

Investigational Site

Germiston, , South Africa

Site Status

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Kimberley, , South Africa

Site Status

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Mtubatuba, , South Africa

Site Status

Investigational Site

Soshanguve, , South Africa

Site Status

Investigational Site

Soweto, , South Africa

Site Status

Investigational Site

Three Rivers, , South Africa

Site Status

Investigational Site

Banjul, , The Gambia

Site Status

Investigational Site

Entebbe, , Uganda

Site Status

Investigational Site

Mulago, , Uganda

Site Status

Investigational Site

Hà Nội, , Vietnam

Site Status

Investigational Site

Ho Chi Minh City, , Vietnam

Site Status

Investigational Site

Emmasdale, , Zambia

Site Status

Investigational Site

Lusaka, , Zambia

Site Status

Investigational Site

Ndola, , Zambia

Site Status

Countries

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

Other Identifiers

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Gates MRI TBV02-E01

Identifier Type: -

Identifier Source: org_study_id