Phase 1 Study to Test Safety and Effects of Vaginal MucoCept-CVN, a Modified Lactobacillus to Prevent HIV, in Healthy Women Ages 18 to 45

What this Trial Is About

Researchers are evaluating MucoCept-CVN, a live biotherapeutic product containing a modified Lactobacillus strain native to the human vagina, designed to continuously express an anti-HIV drug. This first-in-human Phase 1 study aims to assess the safety, vaginal colonization, effects on vaginal microbiota, and antibiotic clearance of this investigational product in healthy women aged 18 to 45 years. The goal is to develop a self-renewing, female-initiated prevention product that promotes vaginal health and offers protection from HIV infection. Participants will be assigned to receive either one or three doses of MucoCept-CVN or a placebo in a randomized, double-blind fashion. The study involves four cohorts with different dosing regimens single or triple doses of the active product or placebo. After dosing, participants will undergo antibiotic treatment to clear the Lactobacillus strain. The study duration ranges from 23 to 67 days, including follow-up visits after antibiotic clearance. During the study, participants will attend frequent visits for evaluations including colposcopy, vaginal biopsy, and tests to monitor adverse events, vaginal inflammation, and bacterial colonization. Safety and tolerability will be closely monitored, and sexual partners will be informed and consented to ensure safety management. Researchers will measure safety outcomes and the ability to clear the product with antibiotics. Participants will be followed up for up to 8 weeks to assess these outcomes and acceptability of the product.

Safety Study of MucoCept-CVN