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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05190146
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
Bill & Melinda Gates Medical Research Institute

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.

Condition or disease
Tuberculosis, Pulmonary

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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 20, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis




Primary Outcome Measures :
  1. IGRA status [ Time Frame: Screening ]
    Proportion of participants with a positive IGRA, per site, calculated using protocol population. 95% CI will summarize the precision associated with the estimate


Secondary Outcome Measures :
  1. IGRA status [ Time Frame: Screening ]
    Proportion of participants with a positive IGRA, per site using per protocol population. 95% CI to summarize the precision associated with estimates. A logistic regression model will estimate the association age with probability of positive IGRA

  2. Suspected pulmonary TB during follow-up period [ Time Frame: Day 1 up to 30 months ]
    Incidence rate of participants with suspected TB to be summarized overall. Exact 95% CI to be provided

  3. Laboratory-confirmed pulmonary TB during follow-up period [ Time Frame: Day 1 up to 30 months ]
    Incidence rate of participants with suspected TB to be summarized overall. Exact 95% CI


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 34 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A maximum of 8000 participants who are at high risk of Mtb infection and TB (disease) will be enrolled.
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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05190146


Contacts
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Contact: Gates MRI 18577022108 clinical.trials@gatesmri.org
Contact: Gates MRI 18667895767 clinical.trials@gatesmri.org

Locations
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Gambia
Investigational Site Recruiting
Banjul, Gambia
Kenya
Investigational Site Recruiting
Kisumu, Kenya
Investigational Site Not yet recruiting
Mombasa, Kenya
Investigational Site Recruiting
Nairobi, Kenya
South Africa
Investigational Site Active, not recruiting
Bloemfontein, South Africa, 9301
Investigational Site Active, not recruiting
Durban, South Africa, 4091
Investigational Site Active, not recruiting
Germiston, South Africa, 1401
Investigational Site Active, not recruiting
Kimberley, South Africa, 8301
Investigational Site Active, not recruiting
Mtubatuba, South Africa, 3935
Investigational Site Active, not recruiting
Soshanguve, South Africa, 152
Investigational Site Active, not recruiting
Soweto, South Africa, 1818
Investigational Site Active, not recruiting
Three Rivers, South Africa, 1935
Sponsors and Collaborators
Bill & Melinda Gates Medical Research Institute
Investigators
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Study Director: Gates MRI Bill & Melinda Gates Medical Research Institute
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Responsible Party: Bill & Melinda Gates Medical Research Institute
ClinicalTrials.gov Identifier: NCT05190146    
Other Study ID Numbers: Gates MRI TBV02-E01
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases