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

NCT05190146 | Completed

• 1 other identifier: Gates MRI TBV02-E01
• Study Type: observational
• Target: 7,203
• Locations: 13 countries
• Sites: 28

Brief 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.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• IGRA status by age group per site

  Screening

• Suspected pulmonary TB during follow-up period

  Day 1 up to 30 months

• Laboratory-confirmed pulmonary TB during follow-up period

  Day 1 up to 30 months

Eligibility Criteria

• Age: 15 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gates Medical Research Institute: lead

Study Sites (36)

Investigational Site

Dhaka, 1212, Bangladesh

Location

Investigational Site

Porto Alegre, 90035-903, Brazil

Location

Investigational Site

Rio de Janeiro, 21040-360, Brazil

Location

Investigational Site

Kinshasa, 0000, Democratic Republic of the Congo

Location

Investigational Site

Pune, 411018, India

Location

Investigational Site

Bandung, West Java, 45363, Indonesia

Location

Investigational Site

Bakti, 13510, Indonesia

Location

Investigational Site

Persabahan, 13230, Indonesia

Location

Investigational Site

Kisumu, 40100, Kenya

Location

Investigational Site

Mombasa, 0000, Kenya

Location

Investigational Site

Nairobi, 00100, Kenya

Location

Investigational Site

Manica, 01929, Mozambique

Location

Investigational Site

Maputo, 3943, Mozambique

Location

Investigational Site

Comas, 15324, Peru

Location

Investigational Site

Lima, 15313, Peru

Location

Investigational Site

Dasmariñas, 4114, Philippines

Location

Investigational Site

Iloilo City, 5000, Philippines

Location

Investigational Site

Makati City, 1229, Philippines

Location

Investigational Site

Mandaluyong, 1552, Philippines

Location

Investigational Site

Quezon City, 1112, Philippines

Location

Investigational Site

Bloemfontein, 9301, South Africa

Location

Investigational Site

Durban, 4091, South Africa

Location

Investigational Site

Germiston, 1401, South Africa

Location

Investigational Site

Kimberley, 8301, South Africa

Location

Investigational Site

Mtubatuba, 3935, South Africa

Location

Investigational Site

Soshanguve, 0152, South Africa

Location

Investigational Site

Soweto, 1818, South Africa

Location

Investigational Site

Three Rivers, 1935, South Africa

Location

Investigational Site

Banjul, 00220, The Gambia

Location

Investigational Site

Entebbe, 10005, Uganda

Location

Investigational Site

Mulago, 72052, Uganda

Location

Investigational Site

Hà Nội, 100000, Vietnam

Location

Investigational Site

Ho Chi Minh City, 700000, Vietnam

Location

Investigational Site

Emmasdale, 10101, Zambia

Location

Investigational Site

Lusaka, 10101, Zambia

Location

Investigational Site

Ndola, 240262, Zambia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for primary, secondary and exploratory endpoints; sputum samples for secondary and exploratory endpoints; and urine sample for exploratory endpoints

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gates MRI

  Gates Medical Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 13, 2022
• Study Start: December 20, 2021
• Primary Completion: September 11, 2023
• Study Completion: August 16, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

PE (2); PH (5); ZA (3); BR (2); VN (2); TH (1); KE (3); IN (1); UG (2); DE (1); ID (3); MO (2); BA (1)