Clinical trial NCT06585683: Post-Trial Tuberculosis Case Finding: A Substudy of CoVPN 3008
Official title: Tuberculosis Case Finding at the Completion of the CoVPN 3008 Clinical Trial: a Substudy to CoVPN 3008
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis
Keywords: TB
Lead sponsor: COVID-19 Prevention Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Medical Research Council, South Africa
First posted: 2024-09-05
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with TB
timeFrame: Measured at Day 1, Day 4 and week 26
measure: Association parameters of each demographic variable with confirmed TB.
timeFrame: Measured at Day 1, Day 4 and week 26
measure: 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.
timeFrame: Measured at Day 1, Day 4 and week 26
measure: Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB.
timeFrame: Measured at Day 1, Day 4 and week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Gaborone CRS
city: Mbabane
country: Eswatini
facility: Eswatini Prevention Center CRS
city: Eldoret
country: Kenya
facility: Moi University Clinical Research Centre
city: Kisumu
country: Kenya
facility: Kisumu Crs
city: Kisumu
country: Kenya
facility: Kombewa Clinical Research Center
city: Blantyre
country: Malawi
facility: Blantyre CRS
city: Lilongwe
country: Malawi
facility: Malawi CRS
city: East London
country: South Africa
facility: Synergy Biomed Research Institute
state: Eastern Cape
city: Mthatha
country: South Africa
facility: Nelson Mandela Academic Research Unit CRS
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: PHOENIX Pharma (Pty) Ltd
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Josha Resarch CRS
state: Free State
city: Ga-Rankuwa
country: South Africa
facility: MeCRU CRS
state: Gauteng
city: Johannesburg
country: South Africa
facility: Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS
state: Gauteng
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research
state: Gauteng
city: Johannesburg
country: South Africa
facility: Soweto - Bara CRS
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits RHI Ward 21 CRS
state: Gauteng
city: Tembisa
country: South Africa
facility: Tembisa Clinic 4 CoVPN CRS
state: Gauteng
city: Durban
country: South Africa
facility: CAPRISA eThekwini CRS
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Tongaat CRS
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Vulindlela CRS
state: KwaZulu-Natal
city: Isipingo
country: South Africa
facility: Isipingo CRS
state: KwaZulu-Natal
city: Ladysmith
country: South Africa
facility: Qhakaza Mbokodo Research Clinic CRS
state: KwaZulu-Natal
city: Klerksdorp
country: South Africa
facility: Aurum Institute Klerksdorp CRS
state: North West
city: Rustenburg
country: South Africa
facility: Rustenburg CRS
state: North West
city: Cape Town
country: South Africa
facility: Emavundleni CRS
state: Western Cape
city: Cape Town
country: South Africa
facility: FAM-CRU (Family Clinical Research Unit)
state: Western Cape
city: Cape Town
country: South Africa
facility: Groote Schuur HIV CRS
state: Western Cape
city: Cape Town
country: South Africa
facility: Masiphumelele Clinical Research Site (MASI) CRS
state: Western Cape
city: Cape Town
country: South Africa
facility: TASK Central
state: Western Cape
city: Cape Town
country: South Africa
facility: Univeristy of Cape Town Lung CRS Institute
state: Western Cape
city: George
country: South Africa
facility: TASK Eden
state: Western Cape
city: Johannesburg
country: South Africa
facility: Kliptown Soweto CRS
city: Klerksdorp
country: South Africa
facility: PHRU Matlosana CRS
city: Entebbe
country: Uganda
facility: UVRI-IAVI HIV Vaccine Program LTD. CRS
city: Kampala
country: Uganda
facility: Baylor-Uganda CRS
city: Kampala
country: Uganda
facility: Joint Clinical Research Centre
city: Kampala
country: Uganda
facility: MU-JHU Research Collaboration CRS
city: Lusaka
country: Zambia
facility: Cfhrz Crs
city: Lusaka
country: Zambia
facility: Matero Reference Clinic CRS
city: Lusaka
country: Zambia
facility: UNC Global Projects / Kamwala District Health Centre
city: Ndola
country: Zambia
facility: Zambia Emory HIV Research Project - Ndola CoVPN CRS
Study officials:
affiliation: eThekwini CRS / Centre for the AIDS Programme of Research in South Africa (CAPRISA)
name: Nigel Garrett
role: STUDY_CHAIR
affiliation: Qhakaza Mbokodo Research Clinic
name: Philip Kotze
role: STUDY_CHAIR
affiliation: Blantyre CRS / Johns Hopkins Research Project
name: Sufia Dadabhai
role: STUDY_CHAIR
affiliation: University of Zimbabwe Clinical Trials Research Centre
name: Nyaradzo Mgodi
role: STUDY_CHAIR
References: