TuberculosisCoVPN3008TBNCT06585683
Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008
An observational study of Tuberculosis, run by COVID-19 Prevention Network at 41 sites in 7 countries.
Trial summary
This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Clinical Evaluation at Day 4, Laboratory Evaluation at Day 4 and Clinical Evaluation at week 26
- How many people
- 5,694 participants
- Where
- 41 sitesin 7 countries
- Study dates
- 13 Sep 2024to 21 May 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: This study will involve approximately 6,000 volunteers who previously participated in the parent study, CoVPN 3008. Although volunteers may meet the inclusion/exclusion criteria, certain medical, psychiatric, occupational, or other conditions could complicate the evaluation of safety and/or immunogenicity, making some individuals unsuitable for enrollment or retention in the trial.
Who may be able to join
- Enrollment into the CoVPN 3008 clinical trial.
- Able and willing to complete the informed consent process: Volunteer demonstrates an understanding of this substudy.
- Willingness to discuss TB status, undergo related testing/monitoring labs, and receive referrals for TB care.
Who cannot join
- Investigator's concern for difficulty with venous access based on clinical history and physical examination.
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
South Africa26 sites
Josha Resarch CRS
Bloemfontein, Free State
Emavundleni CRS
Cape Town, Western Cape
FAM-CRU (Family Clinical Research Unit)
Cape Town, Western Cape
Groote Schuur HIV CRS
Cape Town, Western Cape
Masiphumelele Clinical Research Site (MASI) CRS
Cape Town, Western Cape
TASK Central
Cape Town, Western Cape
Univeristy of Cape Town Lung CRS Institute
Cape Town, Western Cape
CAPRISA eThekwini CRS
Durban, KwaZulu-Natal
Tongaat CRS
Durban, KwaZulu-Natal
Vulindlela CRS
Durban, KwaZulu-Natal
Synergy Biomed Research Institute
East London, Eastern Cape
MeCRU CRS
Ga-Rankuwa, Gauteng
TASK Eden
George, Western Cape
Isipingo CRS
Isipingo, KwaZulu-Natal
Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS
Johannesburg, Gauteng
Newtown Clinical Research
Johannesburg, Gauteng
Soweto - Bara CRS
Johannesburg, Gauteng
Wits RHI Ward 21 CRS
Johannesburg, Gauteng
Kliptown Soweto CRS
Johannesburg
Aurum Institute Klerksdorp CRS
Klerksdorp, North West
PHRU Matlosana CRS
Klerksdorp
Qhakaza Mbokodo Research Clinic CRS
Ladysmith, KwaZulu-Natal
Nelson Mandela Academic Research Unit CRS
Mthatha, Eastern Cape
PHOENIX Pharma (Pty) Ltd
Port Elizabeth, Eastern Cape
Rustenburg CRS
Rustenburg, North West
Tembisa Clinic 4 CoVPN CRS
Tembisa, Gauteng
Uganda4 sites
UVRI-IAVI HIV Vaccine Program LTD. CRS
Entebbe
Baylor-Uganda CRS
Kampala
Joint Clinical Research Centre
Kampala
MU-JHU Research Collaboration CRS
Kampala
Zambia4 sites
Cfhrz Crs
Lusaka
Matero Reference Clinic CRS
Lusaka
UNC Global Projects / Kamwala District Health Centre
Lusaka
Zambia Emory HIV Research Project - Ndola CoVPN CRS
Ndola
Kenya3 sites
Moi University Clinical Research Centre
Eldoret
Kisumu Crs
Kisumu
Kombewa Clinical Research Center
Kisumu
About this study
Official title: Tuberculosis Case Finding at the Completion of the CoVPN 3008 Clinical Trial: a Substudy to CoVPN 3008
This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.
Read the detailed description
This observational substudy will involve participants from the CoVPN 3008 trial, regardless of their HIV status, to study tuberculosis (TB). At the start, all participants will be screened for TB, even if they have no symptoms. They will receive chest x-rays and provide sputum samples for TB testing using Xpert Ultra, smear microscopy, and culture.
The study has two main groups. Group 1 includes participants with confirmed TB, and Group 2 includes participants without TB who will act as controls.
Participants with confirmed TB will start treatment and have a first follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. A second follow-up visit will take place at week 26 to evaluate their treatment progress, clinical outcomes, and TB status, ensuring they receive the necessary care.
Participants without TB will have a single follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. The study aims to identify potential biomarkers of TB by analyzing blood samples from both cases and controls, focusing on gene expression linked to TB, including hidden (subclinical) TB.
- Conditions
- Tuberculosis
- Being tested
- Clinical Evaluation at Day 4, Laboratory Evaluation at Day 4, Clinical Evaluation at week 26, Laboratory Evaluation at week 26
- Keywords
- TB
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Evaluation at Day 4Diagnostic test
Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB
Laboratory Evaluation at Day 4Diagnostic test
Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant.
Clinical Evaluation at week 26Diagnostic test
Participants will undergo another complete physical exam and have their medical (including TB) history, potential TB signs/symptoms, and concomitant medications reassessed. Chest radiography will be obtained for all participants. An assessment of TB outcomes will also be performed.
Laboratory Evaluation at week 26Diagnostic test
Peripheral blood samples, including serum, PBMC, and whole blood, will be collected. Participants not previously identified as living with HIV will undergo HIV diagnostic testing, while participants living with HIV will have their HIV viral load and CD4+ T-cell count measured.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed TB | Participants with confirmed TB will start treatment and have a follow-up visit soon after to check their TB symptoms again and collect blood samples. They will also have a second follow-up visit at week 26 to assess their treatment progress and TB status. Receives: Diagnostic Test: Clinical Evaluation at Day 4; Diagnostic Test: Laboratory Evaluation at Day 4; Diagnostic Test: Clinical Evaluation at week 26; Diagnostic Test: Laboratory Evaluation at week 26 | |
| no TB (control) | Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples. Receives: Diagnostic Test: Clinical Evaluation at Day 4; Diagnostic Test: Laboratory Evaluation at Day 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with TB
The 95% confidence interval on the proportion of participants with TB will be estimated using the "score" method
Measured: Measured at Day 1, Day 4 and week 26
Association parameters of each demographic variable with confirmed TB.
Proportions and 95% CIs will be estimated using the score method. A multivariate analysis will also be conducted using generalized linear regression models with TB as the outcome.
Measured: Measured at Day 1, Day 4 and week 26
Proportion of participants with confirmed TB at the six-month follow visit out of the total number of participants that are screened at the six-month visit and who had confirmed TB at their enrollment visit.
Proportion and 95% CI will be estimated using the score method.
Measured: Measured at Day 1, Day 4 and week 26
Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB.
TB risk scores will be computed from RNA sequencing data generated from each participant's baseline whole-blood sample (Tempus tube) provided upon enrollment into CoVPN 3008. Association of each score with confirmed TB will be assessed using cross-validated ROC curve analysis with area under curve (AUC) 95% CI estimated using the Delong method.
Measured: Measured at Day 1, Day 4 and week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start13 Sep 2024
- Primary completion28 Mar 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- COVID-19 Prevention Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa
- Responsible party
- Sponsor
- Investigators
- Nigel Garrett, Study chair, eThekwini CRS / Centre for the AIDS Programme of Research in South Africa (CAPRISA)Philip Kotze, Study chair, Qhakaza Mbokodo Research ClinicSufia Dadabhai, Study chair, Blantyre CRS / Johns Hopkins Research ProjectNyaradzo Mgodi, Study chair, University of Zimbabwe Clinical Trials Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585683
- Sponsor's protocol ID
- CoVPN 3008 TB substudy
- Other IDs
- UM1AI068614
- Acronym
- CoVPN3008TB
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuberculosis Case Finding at the Completion of the CoVPN 3008 Clinical Trial: a Substudy to CoVPN 3008
- ClinicalTrials.gov ID
- NCT06585683
- Acronym / sponsor ID
- CoVPN3008TB / CoVPN 3008 TB substudy
- Conditions
- Tuberculosis
- Keywords
- TB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,694 participants (actual)
- Lead sponsor
- COVID-19 Prevention NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 5 Sep 2024 (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.
This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.
Detailed description
This observational substudy will involve participants from the CoVPN 3008 trial, regardless of their HIV status, to study tuberculosis (TB). At the start, all participants will be screened for TB, even if they have no symptoms. They will receive chest x-rays and provide sputum samples for TB testing using Xpert Ultra, smear microscopy, and culture.
The study has two main groups. Group 1 includes participants with confirmed TB, and Group 2 includes participants without TB who will act as controls.
Participants with confirmed TB will start treatment and have a first follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. A second follow-up visit will take place at week 26 to evaluate their treatment progress, clinical outcomes, and TB status, ensuring they receive the necessary care.
Participants without TB will have a single follow-up visit on Day 4 to reassess TB symptoms and collect blood samples. The study aims to identify potential biomarkers of TB by analyzing blood samples from both cases and controls, focusing on gene expression linked to TB, including hidden (subclinical) TB.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confirmed TB | – | Diagnostic Test: Clinical Evaluation at Day 4, Diagnostic Test: Laboratory Evaluation at Day 4, Diagnostic Test: Clinical Evaluation at week 26, Diagnostic Test: Laboratory Evaluation at week 26Participants with confirmed TB will start treatment and have a follow-up visit soon after to check their TB symptoms again and collect blood samples. They will also have a second follow-up visit at week 26 to assess their treatment progress and TB status. |
| no TB (control) | – | Diagnostic Test: Clinical Evaluation at Day 4, Diagnostic Test: Laboratory Evaluation at Day 4Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will involve approximately 6,000 volunteers who previously participated in the parent study, CoVPN 3008. Although volunteers may meet the inclusion/exclusion criteria, certain medical, psychiatric, occupational, or other conditions could complicate the evaluation of safety and/or immunogenicity, making some individuals unsuitable for enrollment or retention in the trial.
Key inclusion criteria (3 listed)
- Enrollment into the CoVPN 3008 clinical trial.
- Able and willing to complete the informed consent process: Volunteer demonstrates an understanding of this substudy.
- Willingness to discuss TB status, undergo related testing/monitoring labs, and receive referrals for TB care.
Key exclusion criteria (1 listed)
- Investigator's concern for difficulty with venous access based on clinical history and physical examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Evaluation at Day 4Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB | Diagnostic test | Confirmed TB, no TB (control) |
| Laboratory Evaluation at Day 4Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant. | Diagnostic test | Confirmed TB, no TB (control) |
| Clinical Evaluation at week 26Participants will undergo another complete physical exam and have their medical (including TB) history, potential TB signs/symptoms, and concomitant medications reassessed. Chest radiography will be obtained for all participants. An assessment of TB outcomes will also be performed. | Diagnostic test | Confirmed TB |
| Laboratory Evaluation at week 26Peripheral blood samples, including serum, PBMC, and whole blood, will be collected. Participants not previously identified as living with HIV will undergo HIV diagnostic testing, while participants living with HIV will have their HIV viral load and CD4+ T-cell count measured. | Diagnostic test | Confirmed TB |
Primary outcome
Proportion of participants with TB
Time frame: Measured at Day 1, Day 4 and week 26
The 95% confidence interval on the proportion of participants with TB will be estimated using the "score" method
Association parameters of each demographic variable with confirmed TB.
Time frame: Measured at Day 1, Day 4 and week 26
Proportions and 95% CIs will be estimated using the score method. A multivariate analysis will also be conducted using generalized linear regression models with TB as the outcome.
Proportion of participants with confirmed TB at the six-month follow visit out of the total number of participants that are screened at the six-month visit and who had confirmed TB at their enrollment visit.
Time frame: Measured at Day 1, Day 4 and week 26
Proportion and 95% CI will be estimated using the score method.
Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB.
Time frame: Measured at Day 1, Day 4 and week 26
TB risk scores will be computed from RNA sequencing data generated from each participant's baseline whole-blood sample (Tempus tube) provided upon enrollment into CoVPN 3008. Association of each score with confirmed TB will be assessed using cross-validated ROC curve analysis with area under curve (AUC) 95% CI estimated using the Delong method.
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 26 Jan 2026.
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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.
Nigel Garrett study chair
eThekwini CRS / Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Philip Kotze study chair
Qhakaza Mbokodo Research Clinic
Sufia Dadabhai study chair
Blantyre CRS / Johns Hopkins Research Project
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by COVID-19 Prevention Network at 41 sites in 7 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 3 inclusion and 1 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in South Africa, Uganda, Zambia, Kenya, Malawi and 2 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?
Proportion of participants with TB (time frame: Measured at Day 1, Day 4 and week 26). The study lists 4 primary outcomes in all. 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 26 Jan 2026.