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

Summary

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

Conditions

• Tuberculosis

Interventions

DIAGNOSTIC_TEST

Clinical Evaluation at Day 4

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

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.

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.

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Medical Research Council, South Africa

  collaborator OTHER

• COVID-19 Prevention Network

  lead NETWORK

Principal Investigators

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

• Philip Kotze · Qhakaza Mbokodo Research Clinic

• Sufia Dadabhai · Blantyre CRS / Johns Hopkins Research Project

• Nyaradzo Mgodi · University of Zimbabwe Clinical Trials Research Centre

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-13

Primary Completion

2025-03-28

Completion

2025-05-21

Countries

• Botswana
• Eswatini
• Kenya
• Malawi
• South Africa
• Uganda
• Zambia

Study Locations