Soshanguve

Researchers are evaluating the safety, tolerability, pharmacokinetics, and neutralization of three broadly neutralizing monoclonal antibodies—VRC07-523LS, PGT121.414.LS, and PGDM1400LS—administered intravenously in adults without HIV. This is a randomized, double-blind, controlled phase 2 clinical trial involving approximately 200 adult participants aged 18 to 65 years. The study aims to understand how these antibody combinations behave in the body and their safety profile over an 18-month participation period. Participants will receive intravenous infusions of the antibodies at different dosages: VRC07-523LS at 400 mg or 3200 mg, PGT121.414.LS at 400 mg or 1600 mg, and PGDM1400LS at 400 mg or 1600 mg. The study includes controlled administration of these biological treatments to assess their effects at varying dose levels. During the study, participants will undergo multiple assessments including monitoring for local and systemic adverse events at specific days (1, 4, 7, 169, and 173), and monitoring for unsolicited and serious adverse events throughout 48 weeks. Laboratory tests will evaluate changes in liver enzymes (ALT, AST, alkaline phosphatase), kidney function (creatinine), and complete blood count at baseline and several points up to day 337. Researchers will also track any early discontinuations and overall tolerability throughout the study duration.

Researchers are evaluating the safety, immune response, and clinical efficacy of a candidate urinary tract infection (UTI) vaccine in adults aged 18 to 64 years. This study includes two parts: Part 1 focuses on escalating doses of the vaccine in healthy participants to assess safety, while Part 2 evaluates the vaccine's effectiveness in females with a recent history of E. coli-confirmed UTI. The study is designed as a Phase 1/2, observer-blind, randomized, placebo-controlled trial conducted across multiple centers. Participants receive different formulations of the candidate UTI vaccine or placebo given by intramuscular injection on a schedule of two doses, separated by two months. Part 1 involves a safety lead-in with increasing antigen doses, and Part 2 begins after reviewing safety data from Part 1, focusing on effectiveness in women who have had at least one confirmed UTI episode in the previous year. Both parts follow the same dosing schedule and include placebo groups for comparison. Participants will be monitored for adverse events, including local and systemic reactions within 7 days after each dose and any unsolicited events within 30 days. Serious adverse events and immune-related conditions leading to withdrawal will be tracked throughout the study, which lasts up to 426 days from the first dose. Blood tests will assess laboratory changes, and urinary tract infection rates will be recorded in Part 2. Safety and immune response data will be collected to evaluate the vaccine's profile over the study period.

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 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.

Researchers are evaluating the safety, tolerability, and how the body processes bictegravir/lenacapavir (BIC/LEN) in children and adolescents aged 2 to 17 years with virologically suppressed HIV-1 who are on stable and complex antiretroviral regimens. This Phase 2/3 open-label study aims to confirm the appropriate dose of the lenacapavir loading dose and the BIC/LEN fixed-dose combination while assessing safety through 24 weeks. Participants will receive oral tablets of lenacapavir and the BIC/LEN fixed-dose combination without regard to food. The study includes different age and weight cohorts to evaluate steady-state pharmacokinetics and to confirm dosing in children and adolescents. The treatment period lasts up to 24 weeks, during which dosing and effects will be monitored. During the study, participants will undergo assessments including measurements of drug concentration levels (Cmax, AUCtau, Ctrough) from Day 1 through Week 24. Researchers will monitor treatment-emergent adverse events and laboratory abnormalities throughout this period. The study involves regular safety evaluations and pharmacokinetic analyses to understand how BIC/LEN behaves and is tolerated in the pediatric population.