Actively Recruiting
Phase 1 Randomized Double-Blind Placebo-Controlled Safety Study of MucoCept-CVN Administered Vaginally to Healthy Women
Led by Craig Cohen, MD, MPH · Updated on 2026-02-03
12
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
Sponsors
C
Craig Cohen, MD, MPH
Lead Sponsor
O
Osel, Inc.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Safety Study of MucoCept-CVN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy pre-menopausal women aged 18 to 45 years with regular predictable menstrual cycles
- Ability to read and consent in English
- Previous experience of gynecological examinations
- Willingness to participate and comply with all study procedures for at least 53 days
- Agreement to STI testing and Pap smear
- Agreement to avoid using any other vaginal products during the study
- Commitment to sexual abstinence until clearance of the study product is confirmed and for 12 hours before the final visit
- For participants with male partners: agreement to use two forms of contraception (condoms plus hormonal or permanent method) during vaginal intercourse from clearance to final visit
- For participants with female partners: agreement to use female condoms during intercourse from clearance to final visit
- Agreement to inform sexual partner(s) about the study and sexual abstinence, with partners consenting separately before enrollment
You will not qualify if you...
- Presence of urogenital infections such as UTI, Trichomonas vaginalis, gonorrhea, chlamydia, syphilis, HIV-1/2, bacterial vaginosis, or vulvovaginal candidiasis
- Abnormal Pap smear result
- Pregnancy or within two months postpartum or lactating
- Antibiotic or antifungal use within 30 days before enrollment
- Use of investigational or immune-suppressive drugs within 30 days before enrollment or planned during the study
- Recent intrauterine device procedures, pelvic surgery, cervical treatments, abortion, or labioplasty within three months prior to enrollment
- Significant vaginal epithelial disruption found during pelvic exam
- Known allergy to MucoCept-CVN components or antibiotics used for clearance
- History of transplant surgery, cancer, HIV, diabetes, or conditions promoting microorganism growth
- Recent drug or alcohol abuse
- Unwillingness to abstain from sexual activity during the study by participant or partner
- Inability to present with sexual partner at enrollment or having multiple/anonymous partners
- Conditions limiting ability to participate as judged by study clinician
- History of Crohn's disease, ulcerative colitis, or antibiotic-associated colitis
- For sexual partners: known allergies, multiple sex partners, HIV infection, or participation in other clinical trials testing study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days depending on dosing schedule
Participants receive either one or three vaginal doses of MucoCept-CVN or placebo depending on cohort assignment.
1 to 3 dosing visits depending on cohort
Duration - 23 to 67 days
Participants are closely followed for 23 to 37 days until antibiotic clearance of L. jensenii 1153-1666 is achieved, with a final follow-up visit occurring 30 days after clearance.
Multiple visits over follow-up period including clearance assessment and final visit
Trial Site Locations
Total: 1 location
1
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
A
Anke Hemmerling, MD, PhD, MPH
C
Craig R Cohen, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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