Isipingo

Researchers are evaluating the safety and immune response of the MTBVAC vaccine in adolescents and adults aged 12 to 55 years living with or without HIV in South Africa. The study focuses on comparing MTBVAC to the BCG vaccine and is conducted as a Phase 2a clinical trial. Participants are grouped based on HIV status, CD4+ T cell counts, and IGRA status to better understand the vaccine's effects in different subpopulations. The study is divided into two parts, with Part A including two cohorts and Part B having one cohort, each with four groups. Participants are randomized to receive either a single 0.1 mL injection of MTBVAC or BCG vaccine intradermally. Enrollment in the third cohort will begin only if safety criteria are met for the first two cohorts. All participants receive one dose and are followed for 48 weeks to monitor outcomes. Participants will undergo various assessments throughout the study, including monitoring for adverse events up to 48 weeks and evaluating immune cell responses at baseline and weeks 4 and 10. Researchers will track solicited and unsolicited adverse events, serious adverse events, and Grade 3 or higher adverse events. Safety, immune responses, and overall health will be carefully observed through clinical exams, laboratory tests, and questionnaires during the study period.

Researchers are evaluating the long-term use of a long-acting injectable drug called cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in people at risk of acquiring HIV. This study focuses on participants who have completed or are currently enrolled in previous related studies HPTN 083 and HPTN 084 and their sub-studies. The goal is to monitor new HIV infections, serious adverse events, injection site reactions, and other adverse events that might cause withdrawal over an extended period. Participants will receive CAB LA by gluteal intramuscular injection at a dose of 600 mg every 8 weeks. This treatment continues from the parent studies, and participants will be followed for up to approximately 3 years. The study includes ongoing treatment with CAB LA and regular assessments to evaluate safety and effectiveness as part of this long-term follow-up. During the study, participants will undergo regular HIV testing, safety monitoring, and evaluation of injection site reactions and adverse events. Researchers will track the number of new HIV infections and detailed characteristics of these infections from the start of the study through the follow-up period. This includes monitoring serious and grade 3 or 4 injection site reactions, as well as other adverse events that may lead to withdrawal from the study. Participants will be observed closely to ensure continued safety throughout the study duration.

Researchers are evaluating the safety and immune response of three experimental HIV vaccines made from mRNAs encoding HIV immunogens in adults without HIV who are in good health in South Africa. This Phase 1 study aims to assess vaccines named mRNA-1645-eODGT8, mRNA-1645-CoreG28v2, and mRNA-1645-N332GT5 to understand how well they stimulate the immune system and their safety profile. The study is divided into two parts, each with two cohorts and groups receiving different vaccine regimens or placebos. In Part A, participants receive either 10 mcg doses of mRNA-1645-eODGT8 followed by mRNA-1645-CoreG28v2, or two doses of mRNA-1645-N332GT5, or placebo, given by muscle injection at Week 0 and Week 8. In Part B, participants receive higher doses (30 mcg) of the same vaccines or placebo on the same schedule. Random assignment determines who receives vaccines or placebo within each group. Participants will attend multiple visits over 24 weeks including screening and follow-up at Weeks 2, 7.5, 10, 15.5, and 24. During visits, they will undergo physical exams, medical history review, vaccine injections, blood and urine tests, heart monitoring, cell collections, pregnancy and HIV tests, counseling, and questionnaires. The study will track safety by monitoring side effects and measure immune responses at several time points after vaccination.