Fraga, Spain

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

    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.

    Phase

    N/A

    Span

    50 weeks

    Sponsor

    COVID-19 Prevention Network

    Ladysmith, KwaZulu-Natal

    Recruiting

  • Evaluating the Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living With and Without HIV in South Africa

    This study will evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa. The study will be conducted in two parts (Part A and B). Part A will include two Cohorts (Cohort 1 and 2) and each Cohort will have four groups. Part B will have one Cohort which will also have four groups. Participants will be recruited into three cohorts (Cohorts 1-3) based on their HIV status and, for People Living With HIV, their CD4+ T cell count and WHO clinical stage prior to ART initiation/re-initiation. Within each cohort, they will be stratified into subgroups based on their IGRA status. For Cohorts 1 and 2 which will enroll simultaneously, participants will be randomized to receive MTBVAC or BCG according to the ratio of the planned sample sizes within the cohort; there is no placebo group in this trial. Enrollment of Cohort 3 will proceed if safety criteria are met for Cohorts 1 and 2, with randomization to MTBVAC and BCG. Participants in all groups will receive a single ID study product injection of 0.1 mL in volume and will be followed for 48 weeks.

    Phase

    2

    Span

    105 weeks

    Sponsor

    HIV Vaccine Trials Network

    Ladysmith

    Recruiting

    Healthy Volunteers

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