Tuberculosis, PulmonaryNCT05190146
Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden
An observational study of Tuberculosis, Pulmonary, run by Gates Medical Research Institute at 36 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 15 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Pulmonary
- How many people
- 7,203 participants
- Where
- 36 sitesin 14 countries
- Study dates
- 20 Dec 2021to 16 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 34 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A maximum of 7,203 participants who are at high risk of Mtb infection and TB (disease) will be enrolled.
Who may be able to join
None listed.
Who cannot join
- 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
- -
Trial locations and contacts
36 sites in 14 countries.
36 sites in 14 countries
South Africa8 sites
Investigational Site
Bloemfontein, 9301
Investigational Site
Durban, 4091
Investigational Site
Germiston, 1401
Investigational Site
Kimberley, 8301
Investigational Site
Mtubatuba, 3935
Investigational Site
Soshanguve, 0152
Investigational Site
Soweto, 1818
Investigational Site
Three Rivers, 1935
Philippines5 sites
Investigational Site
Dasmariñas, 4114
Investigational Site
Iloilo City, 5000
Investigational Site
Makati City, 1229
Investigational Site
Mandaluyong, 1552
Investigational Site
Quezon City, 1112
Indonesia3 sites
Investigational Site
Bakti, 13510
Investigational Site
Bandung, West Java, 45363
Investigational Site
Persabahan, 13230
Kenya3 sites
Investigational Site
Kisumu, 40100
Investigational Site
Mombasa, 0000
Investigational Site
Nairobi, 00100
Zambia3 sites
Investigational Site
Emmasdale, 10101
Investigational Site
Lusaka, 10101
Investigational Site
Ndola, 240262
Brazil2 sites
Investigational Site
Porto Alegre, 90035-903
Investigational Site
Rio de Janeiro, 21040-360
Mozambique2 sites
Investigational Site
Manica, 01929
Investigational Site
Maputo, 3943
Uganda2 sites
Investigational Site
Entebbe, 10005
Investigational Site
Mulago, 72052
Vietnam2 sites
Investigational Site
Hà Nội, 100000
Investigational Site
Ho Chi Minh City, 700000
Democratic Republic of the Congo1 site
Investigational Site
Kinshasa, 0000
About this study
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
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
- Medical subject headings
- Tuberculosis, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening
Secondary outcomes (3)
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.
Measured: Screening
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
Measured: Day 1 up to 30 months
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.
Measured: Day 1 up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start20 Dec 2021
- Primary completion11 Sep 2023
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gates Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gates MRI, Study director, Gates Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190146
- Sponsor's protocol ID
- Gates MRI TBV02-E01
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2021
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05190146
- Acronym / sponsor ID
- Gates MRI TBV02-E01
- Conditions
- Tuberculosis, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,203 participants (actual)
- Lead sponsor
- Gates Medical Research InstituteUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A maximum of 7,203 participants who are at high risk of Mtb infection and TB (disease) will be enrolled.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IGRA status per site
Time frame: Screening
Proportion of participants with a positive IGRA, per site, calculated using per protocol population. 95% CI will summarize the precision associated with the estimate.
3 secondary outcomes
IGRA status by age group per site
Time frame: Screening
Suspected pulmonary TB during follow-up period
Time frame: Day 1 up to 30 months
Laboratory-confirmed pulmonary TB during follow-up period
Time frame: Day 1 up to 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gates MRI study director
Gates Medical Research Institute
36 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by Gates Medical Research Institute at 36 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in South Africa, Philippines, Indonesia, Kenya, Zambia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGRA status per site (time frame: Screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.