Recruiting
Phase 1

MucoCept-CVN

Sponsor:

Craig Cohen, MD, MPH

Code:

NCT07181486

Conditions

HIV -1 Infection

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Live Biotherapeutic Product L. jensenii 1153-1666

Placebo

Study Details

Brief 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.

Conditions

HIV -1 Infection

Study ID

NCT07181486

Start date

Oct 6, 2025

Status verified date

Sep, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Healthy pre-menopausal women 18-45 years of age, inclusive, with regular predictable menstrual cycles
2. Ability to read and consent in English
3. Previous experience of gynecological examinations
4. Consent to participate and adhere to all procedures, including frequent visits at the UCSF Clinical Research Center (CRC) facility for at least 53 days
5. Agree to get tested for STIs and a Pap Smear
6. Agree not to use any other vaginal product during the course of the study, including spermicides
7. 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
8. 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.
9. 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.
10. 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:

1. Ability to read and consent in English
2. 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)
3. 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:

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

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

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Single Dose MucoCept-CVN

Two women in Cohort 1 will receive a single dose of active investigational product. Two of four women in Cohort 2 (1:1 randomization) will receive a single doses of active investigational product.

active comparator: Triple Dose MucoCept-CVN

Two women in Cohort 3 will receive three doses of active investigational product. Two of four women in Cohort 4 (1:1 randomization) will receive three doses of active investigational product.

placebo comparator: Placebo (Single Dose and Triple Dose)

Two of four women in Cohort 2 (1:1 randomization) will receive one dose of placebo.

Two of four women in Cohort 4 (1:1 randomization) will receive three dose of placebo.

Interventions

Live 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.

Placebo

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

Primary outcome measure

  • Safety of MucoCept-CVN - Adverse Events [ Time Frame: From enrollment to the end of follow up at 8 weeks ]
  • Antibiotic Clearance of L.jensenii 1153-1666 [ Time Frame: From enrollment to the end of follow up at 8 weeks ]

Central Contacts and Locations

Central contacts

Anke Hemmerling, MD, PhD, MPH

415-322-0533anke.hemmerling@ucsf.edu

Craig R Cohen, MD, MPH

craig.cohen@ucsf.edu

Locations

UCSF Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Sara Newmann, MD MPH

628-206-4220sara.newmann@ucsf.edu

Emelly Argueta, BA

emelly.argueta@ucsf.edu

Principal Investigator:

Sara Newmann, MD MPH

More Information

Sponsor

Craig Cohen, MD, MPH

Last update posted

Feb 3, 2026

Last verified

Sep, 2025

Keywords

  • HIV prevention
  • live biotherapeutic product
  • MucoCept-CVN
  • Vaginal microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Craig Cohen, MD, MPH on 2026-02-03.