Clinical trial NCT05190146: Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis, Pulmonary
Lead sponsor: Bill & Melinda Gates Medical Research Institute
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 7203
Sex: ALL
Minimum age (years): 15
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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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Primary outcomes:
measure: IGRA status per site
timeFrame: Screening
Secondary outcomes:
measure: IGRA status by age group per site
timeFrame: Screening
measure: Suspected pulmonary TB during follow-up period
timeFrame: Day 1 up to 30 months
measure: Laboratory-confirmed pulmonary TB during follow-up period
timeFrame: Day 1 up to 30 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Investigational Site
city: Porto Alegre
country: Brazil
facility: Investigational Site
city: Rio De Janeiro
country: Brazil
facility: Investigational Site
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Investigational Site
city: Banjul
country: Gambia
facility: Investigational Site
city: Pune
country: India
facility: Investigational Site
city: Bandung
country: Indonesia
facility: Investigational Site
state: West Java
city: Bakti
country: Indonesia
facility: Investigational Site
city: Persabahan
country: Indonesia
facility: Investigational Site
city: Kisumu
country: Kenya
facility: Investigational Site
city: Mombasa
country: Kenya
facility: Investigational Site
city: Nairobi
country: Kenya
facility: Investigational Site
city: Manica
country: Mozambique
facility: Investigational Site
city: Maputo
country: Mozambique
facility: Investigational Site
city: Comas
country: Peru
facility: Investigational Site
city: Lima
country: Peru
facility: Investigational Site
city: Dasmariñas
country: Philippines
facility: Investigational Site
city: Iloilo City
country: Philippines
facility: Investigational Site
city: Makati City
country: Philippines
facility: Investigational Site
city: Mandaluyong City
country: Philippines
facility: Investigational Site
city: Quezon City
country: Philippines
facility: Investigational Site
city: Bloemfontein
country: South Africa
facility: Investigational Site
city: Durban
country: South Africa
facility: Investigational Site
city: Germiston
country: South Africa
facility: Investigational Site
city: Kimberley
country: South Africa
facility: Investigational Site
city: Mtubatuba
country: South Africa
facility: Investigational Site
city: Soshanguve
country: South Africa
facility: Investigational Site
city: Soweto
country: South Africa
facility: Investigational Site
city: Three Rivers
country: South Africa
facility: Investigational Site
city: Entebbe
country: Uganda
facility: Investigational Site
city: Mulago
country: Uganda
facility: Investigational Site
city: Ho Chi Minh City
country: Vietnam
facility: Investigational Site
city: Hà Nội
country: Vietnam
facility: Investigational Site
city: Emmasdale
country: Zambia
facility: Investigational Site
city: Lusaka
country: Zambia
facility: Investigational Site
city: Ndola
country: Zambia
facility: Investigational Site
Study officials:
affiliation: Bill & Melinda Gates Medical Research Institute
name: Gates MRI
role: STUDY_DIRECTOR
References: