RecruitingPhase 1NCT07181486

Safety Study of MucoCept-CVN

Phase 1 Randomized Double-Blind Placebo-Controlled Safety Study of MucoCept-CVN (Lactobacillus Jensenii 1153-1666) Administered Vaginally to Healthy Women

Sponsor

Craig Cohen, MD, MPH

Enrollment

12 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety of a vaginal gel called MucoCept-CVN in healthy premenopausal women. MucoCept-CVN is being developed as a potential way to protect against vaginal infections, and this trial is an early safety study. **You may be eligible if...** - You are a healthy woman between 18 and 45 years old - You have regular, predictable menstrual cycles (premenopausal) - You are able to read and consent in English - You have experience with gynecological examinations - You are able to visit the research clinic regularly for at least 53 days - You are willing to abstain from vaginal, anal, and oral sex during certain parts of the study **You may NOT be eligible if...** - You are pregnant, trying to become pregnant, or breastfeeding - You have a history of certain vaginal infections, STIs, or abnormal Pap smears - You use other vaginal products (like spermicides) that you are unwilling to stop - You have certain health conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLive Biotherapeutic Product L. jensenii 1153-1666

The vaginally administered MucoCept-CVN contains Lactobacillus jensenii 1153-1666, a natural component of the human vaginal microbiota that has been modified to continuously express the potent HIV entry inhibitor modified-cyanovirin-N (mCV-N) right at the site of infection. MucoCept-CVN is supplied as a prefilled vaginal applicator containing Lactobacillus jensenii 1153-1666, a modified strain of L. jensenii 1153 by integrating a modified cyanovirin-N gene into its chromosome to enhance the strain's ability to inhibit HIV. Each applicator contains 200 mg of MucoCept-CVN powder (1 x 109 CFU), and an inactive preservation matrix.

DRUGPlacebo

Each placebo applicator contains 200 mg of placebo powder comprising the same inactive ingredients of the preservation matrix as the study product.

Locations(1)

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, United States

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NCT07181486

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