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

Tuberculosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05190146
• Other study ID #: Gates MRI TBV02-E01
• Status: Active, not recruiting
• Start date: December 20, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Bill & Melinda Gates Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8000
• Est. completion date: September 30, 2024
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 34 Years

Eligibility

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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Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Locations

Country	Name	City	State
Bangladesh	Investigational Site	Dhaka
Brazil	Investigational Site	Porto Alegre
Brazil	Investigational Site	Rio De Janeiro
Congo, The Democratic Republic of the	Investigational Site	Kinshasa
Gambia	Investigational Site	Banjul
India	Investigational Site	Pune
Indonesia	Investigational Site	Bakti
Indonesia	Investigational Site	Bandung	West Java
Indonesia	Investigational Site	Persabahan
Kenya	Investigational Site	Kisumu
Kenya	Investigational Site	Mombasa
Kenya	Investigational Site	Nairobi
Mozambique	Investigational Site	Manica
Mozambique	Investigational Site	Maputo
Peru	Investigational Site	Comas
Peru	Investigational Site	Lima
Philippines	Investigational Site	Dasmariñas
Philippines	Investigational Site	Iloilo City
Philippines	Investigational Site	Makati City
Philippines	Investigational Site	Mandaluyong City
Philippines	Investigational Site	Quezon City
South Africa	Investigational Site	Bloemfontein
South Africa	Investigational Site	Durban
South Africa	Investigational Site	Germiston
South Africa	Investigational Site	Kimberley
South Africa	Investigational Site	Mtubatuba
South Africa	Investigational Site	Soshanguve
South Africa	Investigational Site	Soweto
South Africa	Investigational Site	Three Rivers
Uganda	Investigational Site	Entebbe
Uganda	Investigational Site	Mulago
Vietnam	Investigational Site	Hà N?i
Vietnam	Investigational Site	Ho Chi Minh City
Zambia	Investigational Site	Emmasdale
Zambia	Investigational Site	Lusaka
Zambia	Investigational Site	Ndola

Sponsors (1)

Lead Sponsor	Collaborator
Bill & Melinda Gates Medical Research Institute

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGRA status per site	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	IGRA status by age group per site	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
Secondary	Suspected pulmonary TB during follow-up period	Incidence rate of participants with suspected TB to be summarized by country. Exact 95% CI to be provided	Day 1 up to 30 months
Secondary	Laboratory-confirmed pulmonary TB during follow-up period	Incidence rate of participants with suspected TB to be summarized by country. Exact 95% CI to be provided.	Day 1 up to 30 months