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| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI068614 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Medical Research Council, South Africa | OTHER |
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This substudy aims to identify cases of tuberculosis after the CoVPN 3008 clinical trial is completed.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| no TB (control) | Participants without TB will have a single follow-up visit to reassess TB symptoms and collect blood samples. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Evaluation at Day 4 | Diagnostic Test | Participants will undergo an abbreviated physical exam, assessment of concomitant medications, and reassessment for signs/symptoms of TB |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nigel Garrett | eThekwini CRS / Centre for the AIDS Programme of Research in South Africa (CAPRISA) | Study Chair |
| Philip Kotze | Qhakaza Mbokodo Research Clinic | Study Chair |
| Sufia Dadabhai | Blantyre CRS / Johns Hopkins Research Project | Study Chair |
| Nyaradzo Mgodi | University of Zimbabwe Clinical Trials Research Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaborone CRS | Gaborone | Botswana | ||||
| Eswatini Prevention Center CRS |
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| Laboratory Evaluation at Day 4 | Diagnostic Test | Peripheral blood samples, including serum, PBMC, and whole blood, are collected from participants. A tongue swab is also collected from each participant. |
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| Clinical Evaluation at week 26 | 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. |
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| Laboratory Evaluation at week 26 | 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. |
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| Mbabane |
| Eswatini |
| Moi University Clinical Research Centre | Eldoret | Kenya |
| Kisumu Crs | Kisumu | Kenya |
| Kombewa Clinical Research Center | Kisumu | Kenya |
| Blantyre CRS | Blantyre | Malawi |
| Malawi CRS | Lilongwe | Malawi |
| Synergy Biomed Research Institute | East London | Eastern Cape | South Africa |
| Nelson Mandela Academic Research Unit CRS | Mthatha | Eastern Cape | South Africa |
| PHOENIX Pharma (Pty) Ltd | Port Elizabeth | Eastern Cape | South Africa |
| Josha Resarch CRS | Bloemfontein | Free State | South Africa |
| MeCRU CRS | Ga-Rankuwa | Gauteng | South Africa |
| Clinical HIV Research Unit (CHRU)/ Helen Joseph CRS | Johannesburg | Gauteng | South Africa |
| Newtown Clinical Research | Johannesburg | Gauteng | South Africa |
| Soweto - Bara CRS | Johannesburg | Gauteng | South Africa |
| Wits RHI Ward 21 CRS | Johannesburg | Gauteng | South Africa |
| Tembisa Clinic 4 CoVPN CRS | Tembisa | Gauteng | South Africa |
| CAPRISA eThekwini CRS | Durban | KwaZulu-Natal | South Africa |
| Tongaat CRS | Durban | KwaZulu-Natal | South Africa |
| Vulindlela CRS | Durban | KwaZulu-Natal | South Africa |
| Isipingo CRS | Isipingo | KwaZulu-Natal | South Africa |
| Qhakaza Mbokodo Research Clinic CRS | Ladysmith | KwaZulu-Natal | South Africa |
| Aurum Institute Klerksdorp CRS | Klerksdorp | North West | South Africa |
| Rustenburg CRS | Rustenburg | North West | South Africa |
| Emavundleni CRS | Cape Town | Western Cape | South Africa |
| FAM-CRU (Family Clinical Research Unit) | Cape Town | Western Cape | South Africa |
| Groote Schuur HIV CRS | Cape Town | Western Cape | South Africa |
| Masiphumelele Clinical Research Site (MASI) CRS | Cape Town | Western Cape | South Africa |
| TASK Central | Cape Town | Western Cape | South Africa |
| Univeristy of Cape Town Lung CRS Institute | Cape Town | Western Cape | South Africa |
| TASK Eden | George | Western Cape | South Africa |
| Kliptown Soweto CRS | Johannesburg | South Africa |
| PHRU Matlosana CRS | Klerksdorp | South Africa |
| UVRI-IAVI HIV Vaccine Program LTD. CRS | Entebbe | Uganda |
| Baylor-Uganda CRS | Kampala | Uganda |
| Joint Clinical Research Centre | Kampala | Uganda |
| MU-JHU Research Collaboration CRS | Kampala | Uganda |
| Cfhrz Crs | Lusaka | Zambia |
| Matero Reference Clinic CRS | Lusaka | Zambia |
| UNC Global Projects / Kamwala District Health Centre | Lusaka | Zambia |
| Zambia Emory HIV Research Project - Ndola CoVPN CRS | Ndola | Zambia |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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