Weatherford

Researchers are evaluating the safety, tolerability, and immune response duration of a second dose of the RSVpreF vaccine given during later pregnancies. The study also examines how long immunity lasts from a single dose given during a previous pregnancy by analyzing blood samples from nonpregnant participants who had the vaccine before. This is a Phase 3 trial focused on pregnant women and their babies as well as nonpregnant women previously vaccinated. Pregnant participants are grouped into Cohort 1, who previously received RSVpreF in a Pfizer trial and will get a second dose, and Cohort 2, who received RSVpreF previously via commercial or trial means and will be randomly given either RSVpreF or placebo. Both groups will be monitored for safety and immune response. Cohort 3 includes nonpregnant women who had RSVpreF before and will provide blood samples to check how long protection lasts, without receiving further vaccination. Participants will undergo safety monitoring during pregnancy and after birth. Infants will be followed for six months to assess safety and antibody levels. Blood tests will measure immune response, including neutralizing antibodies at birth. The study tracks local and systemic reactions, adverse events, serious adverse events, and new medical conditions in both pregnant participants and their infants over various timeframes throughout the study.

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.