Safety Study of MucoCept-CVN

MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV. The goal of this first-in-human Phase 1 dose-ranging, randomized, placebo-controlled study of MucoCept-CVN is to collect data on safety, colonization, changes to the vaginal microbiota and clearance of the strain with antibiotics. Twelve healthy women will be enrolled and take either one or three doses of MucoCept-CVN or placebo, and a week later will receive antibiotics to clear the Lactobacillus strain. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, long-acting, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV.

The goal of this first-in-human Phase 1 dose-ranging, randomized, placebo-controlled study is to collect critical data needed to advance the clinical development of MucoCept-CVN, specifically (1) understanding factors that influence vaginal colonization by L. jensenii 1153-1666, including dose and endogenous vaginal microbiota; and (2) pharmacokinetic, tissue and systemic effects of L. jensenii 1153-1666, such as adverse events (AE) and findings in colposcopy and vaginal biopsy, and (3) changes to the vaginal microbiota. We also need to show that (4) L. jensenii 1153-1666 can be sufficiently cleared with antibiotics should the need arise for rescue therapy. Twelve healthy women will be enrolled. Two women in Cohort 1 will receive one dose of active investigational product. Four women in Cohort 2 will be randomized 1:1 to either receive one dose of active investigational product or placebo. Two women in Cohort 3 will receive three doses of active investigational product. Four women in Cohort 4 will be randomized 1:1 to either receive three doses of active investigational product or placebo. Participants will be closely followed over the course of 23-37 days until antibiotic clearance of L. jensenii 1153-1666 is achieved, with a final follow-up visit occurring 30 days after clearance (Day 53-67). Any sexual partners of study participants will be informed and consented before enrollment of study participants, and need to agree to sexual abstinence during the study. Should exposure to L. jensenii 1153-1666 occur in sexual partners, they will receive testing for L. jensenii 1153-1666 and antibiotic clearance as safety management.