Actively Recruiting
Safety Study of MucoCept-CVN
Led by Craig Cohen, MD, MPH · Updated on 2026-02-03
12
Participants Needed
1
Research Sites
107 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
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.
CONDITIONS
Official 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 menstrual cycles
- Ability to read and consent in English
- Previous experience with gynecological exams
- Willingness to participate and attend frequent study visits for at least 53 days
- Agree to STI testing and Pap smear
- Agree not to use other vaginal products including spermicides during the study
- Agree to sexual abstinence until elimination of L. jensenii 1153-1666 is confirmed and for 12 hours before final visit
- Female participants with male partners must use two forms of contraception from clearance to final visit (condoms plus hormonal or permanent method); no spermicides allowed
- Female participants with female partners must use female condoms during intercourse from clearance to final visit
- Agree to inform sexual partners about the study and sexual abstinence requirements and have partners consent separately before enrollment
You will not qualify if you...
- Current urogenital infections including UTI, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, syphilis, HIV-1/2, bacterial vaginosis, or vulvovaginal candidiasis
- Abnormal Pap smear results
- Pregnancy, lactation, or within two months postpartum
- Use of antibiotics or antifungals within 30 days prior to enrollment
- Use of investigational or immune-suppressive drugs within 30 days or planned during the study
- Recent pelvic procedures or surgeries within three months prior to enrollment
- Significant epithelial disruption found during pelvic exam at enrollment
- Known allergy to MucoCept-CVN components or related antibiotics for participant or partner
- History of transplant surgery, cancer, HIV, diabetes, or conditions promoting microorganism growth
- Recent drug or alcohol abuse
- Unwillingness by participant or partner to abstain from sexual activity during study
- Inability to attend enrollment with sexual partner if applicable
- Having multiple or anonymous sexual partners
- Conditions limiting ability to complete study as determined by clinician
- History of Crohn's disease, ulcerative colitis, or antibiotic-associated colitis
- For partners: allergy to study components, multiple or anonymous partners, HIV infection, co-enrollment in other drug trials, or conditions limiting study completion
AI-Screening
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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
CONTACT
C
Craig R Cohen, MD, MPH
CONTACT
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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