Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

5,694

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach

6 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

September 3, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed

8 days until next milestone

Study Start

First participant enrolled

September 13, 2024

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2025

Completed

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

September 3, 2024

Last Update Submit

January 23, 2026

Conditions

Tuberculosis

Keywords

Outcome Measures

Primary Outcomes (4)

Proportion of participants with TB
The 95% confidence interval on the proportion of participants with TB will be estimated using the "score" method
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 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 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 at Day 1, Day 4 and week 26

Study Arms (2)

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.

Diagnostic Test: Clinical Evaluation at Day 4Diagnostic Test: Laboratory Evaluation at Day 4Diagnostic Test: Clinical Evaluation at week 26Diagnostic 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.

Diagnostic Test: Clinical Evaluation at Day 4Diagnostic Test: Laboratory Evaluation at Day 4

Interventions

Clinical Evaluation at Day 4DIAGNOSTIC_TEST

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

Confirmed TBno TB (control)

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.

Confirmed TBno TB (control)

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.

Confirmed TB

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.

Confirmed TB

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

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.

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Medical Research Council, South Africacollaborator
COVID-19 Prevention Networklead
National Institute of Allergy and Infectious Diseases (NIAID)collaborator

Study Sites (41)

Gaborone CRS

Gaborone, Botswana

Location

Eswatini Prevention Center CRS

Mbabane, Eswatini

Location

Moi University Clinical Research Centre

Eldoret, Kenya

Location

Kisumu Crs

Kisumu, Kenya

Location

Kombewa Clinical Research Center

Kisumu, Kenya

Location

Blantyre CRS

Blantyre, Malawi

Location

Malawi CRS

Lilongwe, Malawi

Location

Synergy Biomed Research Institute

East London, Eastern Cape, South Africa

Location

Nelson Mandela Academic Research Unit CRS

Mthatha, Eastern Cape, South Africa

Location

PHOENIX Pharma (Pty) Ltd

Port Elizabeth, Eastern Cape, South Africa

Location

Josha Resarch CRS

Bloemfontein, Free State, South Africa

Location

MeCRU CRS

Ga-Rankuwa, Gauteng, South Africa

Location

Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS

Johannesburg, Gauteng, South Africa

Location

Newtown Clinical Research

Johannesburg, Gauteng, South Africa

Location

Soweto - Bara CRS

Johannesburg, Gauteng, South Africa

Location

Wits RHI Ward 21 CRS

Johannesburg, Gauteng, South Africa

Location

Tembisa Clinic 4 CoVPN CRS

Tembisa, Gauteng, South Africa

Location

CAPRISA eThekwini CRS

Durban, KwaZulu-Natal, South Africa

Location

Tongaat CRS

Durban, KwaZulu-Natal, South Africa

Location

Vulindlela CRS

Durban, KwaZulu-Natal, South Africa

Location

Isipingo CRS

Isipingo, KwaZulu-Natal, South Africa

Location

Qhakaza Mbokodo Research Clinic CRS

Ladysmith, KwaZulu-Natal, South Africa

Location

Aurum Institute Klerksdorp CRS

Klerksdorp, North West, South Africa

Location

Rustenburg CRS

Rustenburg, North West, South Africa

Location

Emavundleni CRS