Safety Study of MucoCept-CVN

NCT07181486 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: U01AI186333
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Safety of MucoCept-CVN - Adverse Events

  Proportion of participants with serious adverse events, any genital AEs and Grade 2 or above systemic AEs.

  From enrollment to the end of follow up at 8 weeks

• Antibiotic Clearance of L.jensenii 1153-1666

  Inability to clear L. jensenii 1153-1666 after administration of antibiotics, using next generation sequencing (NGS).

  From enrollment to the end of follow up at 8 weeks

Secondary Outcomes (4)

• Safety of MucoCept-CVN - Vaginal Inflammation

  From enrollment to the end of follow up at 8 weeks

• Vaginal Colonization with L. jensenii 1153-1666

  From enrollment to the end of follow up at 8 weeks

• Tolerability - Proportion of participants not stopping the study due to Adverse Events

  From enrollment to the end of follow up at 8 weeks

• Acceptability

  From enrollment to the end of follow up at 8 weeks

Study Arms (3)

Single Dose MucoCept-CVN

ACTIVE COMPARATOR

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.

Drug: Live Biotherapeutic Product L. jensenii 1153-1666

Triple Dose MucoCept-CVN

ACTIVE COMPARATOR

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.

Drug: Live Biotherapeutic Product L. jensenii 1153-1666

Placebo (Single Dose and Triple Dose)

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Live Biotherapeutic Product L. jensenii 1153-1666 DRUG

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.

Single Dose MucoCept-CVN; Triple Dose MucoCept-CVN

Placebo DRUG

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

Placebo (Single Dose and Triple Dose)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osel, Inc.: collaborator
• Duke University: collaborator
• DFNet Research Inc.: collaborator
• Craig Cohen, MD, MPH: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

Related Links

• study recruitment website

Study Officials

• Craig Cohen, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anke Hemmerling, MD, PhD, MPH

CONTACT

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

Craig R Cohen, MD, MPH

CONTACT

craig.cohen@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For this first-in-human study, the first two participants for single dose (Cohort 1) and triple dose (Cohort 3) are unblinded and will receive the investigational product MucoCept-CVN. Cohort 2 (single dose randomized) and Cohort 4 (triple dose randomized) are double-blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Obstetrics, Gynecology, and Reproductive Sciences

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: February 3, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 01 May 2028 - 30 April 2033
• Access Criteria: We will provide qualified researchers access to the data after main findings from the final dataset have been accepted for publication. We will remove identifiers from the datasets prior to release and will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed and (4) ethical committee approval from the UCSF IRB.

Locations

US (1)