- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05190146
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
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gates MRI
- Phone Number: 18577022108
- Email: clinical.trials@gatesmri.org
Study Contact Backup
- Name: Gates MRI
- Phone Number: 18667895767
- Email: clinical.trials@gatesmri.org
Study Locations
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Dhaka, Bangladesh, 1212
- Investigational Site
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Porto Alegre, Brazil, 90035-903
- Investigational Site
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Rio De Janeiro, Brazil, 21040-360
- Investigational Site
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Kinshasa, Congo, The Democratic Republic of the, 0000
- Investigational Site
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Banjul, Gambia, 00220
- Investigational Site
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Pune, India, 411018
- Investigational Site
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Bakti, Indonesia, 13510
- Investigational Site
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Persabahan, Indonesia, 13230
- Investigational Site
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West Java
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Bandung, West Java, Indonesia, 45363
- Investigational Site
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Kisumu, Kenya, 40100
- Investigational Site
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Mombasa, Kenya, 0000
- Investigational Site
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Nairobi, Kenya, 00100
- Investigational Site
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Manica, Mozambique, 01929
- Investigational Site
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Maputo, Mozambique, 3943
- Investigational Site
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Comas, Peru, 15324
- Investigational Site
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Lima, Peru, 15313
- Investigational Site
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Dasmariñas, Philippines, 4114
- Investigational Site
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Iloilo City, Philippines, 5000
- Investigational Site
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Makati City, Philippines, 1229
- Investigational Site
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Mandaluyong City, Philippines, 1552
- Investigational Site
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Quezon City, Philippines, 1112
- Investigational Site
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Bloemfontein, South Africa, 9301
- Investigational Site
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Durban, South Africa, 4091
- Investigational Site
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Germiston, South Africa, 1401
- Investigational Site
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Kimberley, South Africa, 8301
- Investigational Site
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Mtubatuba, South Africa, 3935
- Investigational Site
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Soshanguve, South Africa, 0152
- Investigational Site
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Soweto, South Africa, 1818
- Investigational Site
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Three Rivers, South Africa, 1935
- Investigational Site
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Entebbe, Uganda, 10005
- Investigational Site
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Mulago, Uganda, 72052
- Investigational Site
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Ho Chi Minh City, Vietnam, 700000
- Investigational Site
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Hà Nội, Vietnam, 100000
- Investigational Site
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Emmasdale, Zambia, 10101
- Investigational Site
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Lusaka, Zambia, 10101
- Investigational Site
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Ndola, Zambia, 240262
- Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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Study Plan
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 |
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IGRA status per site
Time Frame: Screening
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Proportion of participants with a positive IGRA, per site, calculated using per protocol population.
95% CI will summarize the precision associated with the estimate.
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Screening
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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IGRA status by age group per site
Time Frame: Screening
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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.
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Screening
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Suspected pulmonary TB during follow-up period
Time Frame: Day 1 up to 30 months
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Incidence rate of participants with suspected TB to be summarized by country.
Exact 95% CI to be provided
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Day 1 up to 30 months
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Laboratory-confirmed pulmonary TB during follow-up period
Time Frame: Day 1 up to 30 months
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Incidence rate of participants with suspected TB to be summarized by country.
Exact 95% CI to be provided.
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Day 1 up to 30 months
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Collaborators and Investigators
Investigators
- Study Director: Gates MRI, Bill & Melinda Gates Medical Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gates MRI TBV02-E01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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