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RecruitingAccepts healthy volunteersPhase 1

Safety Study of MucoCept-CVN

Craig Cohen, MD, MPH · with Osel, Inc., Duke University · NCT07181486

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
12
US sites recruiting
1
Study start
October 6, 2025
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Live Biotherapeutic Product L. jensenii 1153-1666; Placebo

Conditions: HIV -1 Infection

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Healthy pre-menopausal women 18-45 years of age, inclusive, with regular predictable menstrual cycles
  • Ability to read and consent in English
  • Previous experience of gynecological examinations
  • Consent to participate and adhere to all procedures, including frequent visits at the UCSF Clinical Research Center (CRC) facility for at least 53 days
  • Agree to get tested for STIs and a Pap Smear
  • Agree not to use any other vaginal product during the course of the study, including spermicides
  • Agree to sexual abstinence (no vaginal, anal, and receptive oral intercourse) until the elimination of L. jensenii 1153-1666 is confirmed and for 12 hours prior to the final study visit after clearance is confirmed
  • For participants with male sexual partners: Agree to use two forms of contraception, condoms plus hormonal or permanent method (intrauterine device [IUD] or tubal ligation) during vaginal intercourse from the time clearance is established to the Final Visit 30 days after clearance. Use of spermicides is not permitted.
  • For participants with female sexual partners: Agree to use female condoms during intercourse from the time clearance is established to the Final Visit 30 days after clearance. Use of hormonal or permanent method of contraception (IUD or tubal ligation) is not required.
  • Agree to inform their sexual partner about the goals of the study and importance of sexual abstinence (no vaginal, anal, and receptive oral intercourse) and present with their partner at enrollment visit for separate consent procedure for partners

Current sexual partners of participants must meet all the following criteria to be enrolled:

  • Ability to read and consent in English
  • Consent to participate and adhere to all procedures for sexual partners should exposure to L. jensenii 1153-1666 be suspected, including multiple visits at the UCSF Clinical Research Center (CRC)
  • Agree to sexual abstinence (no vaginal, anal, and receptive oral intercourse) until the elimination of L. jensenii 1153-1666 is confirmed, and for 12 hours prior to the final study visit after clearance is confirmed

Exclusion Criteria

  • Urogenital infection, including UTI, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum, HIV-1/2, BV, or vulvovaginal candidiasis
  • Abnormal Pap smear result
  • Pregnancy or within two months of last pregnancy or lactation
  • Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
  • Investigational or immune-suppressive drug use within 30 days of enrollment visit or 10 half-lives, or planned during the study
  • Intrauterine device insertion or removal, pelvic surgery, cervical cryotherapy, cervical laser or loop electrosurgical procedure, abortion, labioplasty within three months prior to enrollment
  • Findings during the pelvic exam at the enrollment visit involving significant deep disruption of the epithelium (e.g., Herpes genitalis lesions)
  • Known allergy to any component used in MucoCept-CVN or clindamycin and azithromycin in participant or sexual partner(s), including azithromycin-associated cholestatic jaundice.
  • History of transplant surgery, cancer, HIV, diabetes or condition that could facilitate the growth of microorganisms
  • Recent history of drug or alcohol abuse
  • Unwillingness to abstain from sexual activity during study by participant or sexual partner(s)
  • If in a sexual relationship, inability to present with their sexual partner before enrollment
  • If in a sexual relationship, having multiple concurrent partners or anonymous partners.
  • Any other condition which the study clinician feels would limit the participant's ability to be an appropriate study subject
  • History of regional enteritis (Crohn's disease), ulcerative colitis, or "antibiotic-associated" colitis

For sexual partners of study participants, the following exclusion criteria apply:

  • Known allergy to any component used in MucoCept-CVN or clindamycin and azithromycin, including azithromycin-associated cholestatic jaundice.
  • Having multiple concurrent sex partners or anonymous sex partners.
  • HIV-1/2 infection
  • Any other condition which the study clinician feels would limit the ability of sexual partner(s) to complete the study
  • Co-enrollment in clinical trials testing study drugs

Recruiting US locations

  • UCSF Zuckerberg San Francisco General Hospital

    San Francisco, CA 94110

    Site contact: Sara Newmann, MD MPH · 628-206-4220 · sara.newmann@ucsf.edu

Study contacts (from the official record)

  • Anke Hemmerling, MD, PhD, MPH · 415-322-0533 · anke.hemmerling@ucsf.edu
  • Craig R Cohen, MD, MPH · craig.cohen@ucsf.edu
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Safety Study of MucoCept-CVN (NCT07181486) | Bored Studies