Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008

NCT ID: NCT06585683

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5694 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-13

Study Completion Date

2025-05-21

Brief Summary

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This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.

Detailed Description

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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

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Tuberculosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Clinical Evaluation at Day 4

Intervention Type DIAGNOSTIC_TEST

Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB

Laboratory Evaluation at Day 4

Intervention Type DIAGNOSTIC_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 26

Intervention Type DIAGNOSTIC_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 26

Intervention Type DIAGNOSTIC_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.

no TB (control)

Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples.

Clinical Evaluation at Day 4

Intervention Type DIAGNOSTIC_TEST

Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB

Laboratory Evaluation at Day 4

Intervention Type DIAGNOSTIC_TEST

Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant.

Interventions

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Clinical Evaluation at Day 4

Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB

Intervention Type DIAGNOSTIC_TEST

Laboratory Evaluation at Day 4

Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant.

Intervention Type DIAGNOSTIC_TEST

Clinical Evaluation at week 26

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.

Intervention Type DIAGNOSTIC_TEST

Laboratory Evaluation at week 26

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Investigator's concern for difficulty with venous access based on clinical history and physical examination.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Medical Research Council, South Africa

OTHER

Sponsor Role collaborator

COVID-19 Prevention Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nigel Garrett

Role: STUDY_CHAIR

eThekwini CRS / Centre for the AIDS Programme of Research in South Africa (CAPRISA)

Philip Kotze

Role: STUDY_CHAIR

Qhakaza Mbokodo Research Clinic

Sufia Dadabhai

Role: STUDY_CHAIR

Blantyre CRS / Johns Hopkins Research Project

Nyaradzo Mgodi

Role: STUDY_CHAIR

University of Zimbabwe Clinical Trials Research Centre

Locations

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Gaborone CRS

Gaborone, , Botswana

Site Status

Eswatini Prevention Center CRS

Mbabane, , Eswatini

Site Status

Moi University Clinical Research Centre

Eldoret, , Kenya

Site Status

Kisumu Crs

Kisumu, , Kenya

Site Status

Kombewa Clinical Research Center

Kisumu, , Kenya

Site Status

Blantyre CRS

Blantyre, , Malawi

Site Status

Malawi CRS

Lilongwe, , Malawi

Site Status

Synergy Biomed Research Institute

East London, Eastern Cape, South Africa

Site Status

Nelson Mandela Academic Research Unit CRS

Mthatha, Eastern Cape, South Africa

Site Status

PHOENIX Pharma (Pty) Ltd

Port Elizabeth, Eastern Cape, South Africa

Site Status

Josha Resarch CRS

Bloemfontein, Free State, South Africa

Site Status

MeCRU CRS

Ga-Rankuwa, Gauteng, South Africa

Site Status

Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS

Johannesburg, Gauteng, South Africa

Site Status

Newtown Clinical Research

Johannesburg, Gauteng, South Africa

Site Status

Soweto - Bara CRS

Johannesburg, Gauteng, South Africa

Site Status

Wits RHI Ward 21 CRS

Johannesburg, Gauteng, South Africa

Site Status

Tembisa Clinic 4 CoVPN CRS

Tembisa, Gauteng, South Africa

Site Status

CAPRISA eThekwini CRS

Durban, KwaZulu-Natal, South Africa

Site Status

Tongaat CRS

Durban, KwaZulu-Natal, South Africa

Site Status

Vulindlela CRS

Durban, KwaZulu-Natal, South Africa

Site Status

Isipingo CRS

Isipingo, KwaZulu-Natal, South Africa

Site Status

Qhakaza Mbokodo Research Clinic CRS

Ladysmith, KwaZulu-Natal, South Africa

Site Status

Aurum Institute Klerksdorp CRS

Klerksdorp, North West, South Africa

Site Status

Rustenburg CRS

Rustenburg, North West, South Africa

Site Status

Emavundleni CRS

Cape Town, Western Cape, South Africa

Site Status

FAM-CRU (Family Clinical Research Unit)

Cape Town, Western Cape, South Africa

Site Status

Groote Schuur HIV CRS

Cape Town, Western Cape, South Africa

Site Status

Masiphumelele Clinical Research Site (MASI) CRS

Cape Town, Western Cape, South Africa

Site Status

TASK Central

Cape Town, Western Cape, South Africa

Site Status

Univeristy of Cape Town Lung CRS Institute

Cape Town, Western Cape, South Africa

Site Status

TASK Eden

George, Western Cape, South Africa

Site Status

Kliptown Soweto CRS

Johannesburg, , South Africa

Site Status

PHRU Matlosana CRS

Klerksdorp, , South Africa

Site Status

UVRI-IAVI HIV Vaccine Program LTD. CRS

Entebbe, , Uganda

Site Status

Baylor-Uganda CRS

Kampala, , Uganda

Site Status

Joint Clinical Research Centre

Kampala, , Uganda

Site Status

MU-JHU Research Collaboration CRS

Kampala, , Uganda

Site Status

Cfhrz Crs

Lusaka, , Zambia

Site Status

Matero Reference Clinic CRS

Lusaka, , Zambia

Site Status

UNC Global Projects / Kamwala District Health Centre

Lusaka, , Zambia

Site Status

Zambia Emory HIV Research Project - Ndola CoVPN CRS

Ndola, , Zambia

Site Status

Countries

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Botswana Eswatini Kenya Malawi South Africa Uganda Zambia

Other Identifiers

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UM1AI068614

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CoVPN 3008 TB substudy

Identifier Type: -

Identifier Source: org_study_id

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