Safety Study of MucoCept-CVN

Part of paid clinical trials in San Francisco, California.

Sponsor
Craig Cohen, MD, MPH
Study ID
NCT07181486
Phase
PHASE1
Status
Recruiting
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Conditions

  • HIV -1 Infection

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

Start date
Oct 6, 2025
Status verified
Sep 2025
Primary completion
Feb 28, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Safety of MucoCept-CVN - Adverse Events [ Time Frame: From enrollment to the end of follow up at 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110
Sara Newmann, MD MPH
[email protected]
628-206-4220
Emelly Argueta, BA
[email protected]
Sara Newmann, MD MPH (PRINCIPAL_INVESTIGATOR)

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UCSF Zuckerberg San Francisco General Hospital· San Francisco, CA

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