Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2025-09-22
2027-10-31
Brief Summary
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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.
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Detailed Description
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Twelve healthy women will be enrolled. Two women in Cohort 1 will receive one dose of active investigational product. Four women in Cohort 2 will be randomized 1:1 to either receive one dose of active investigational product or placebo. Two women in Cohort 3 will receive three doses of active investigational product. Four women in Cohort 4 will be randomized 1:1 to either receive three doses of active investigational product or placebo. Participants will be closely followed over the course of 23-37 days until antibiotic clearance of L. jensenii 1153-1666 is achieved, with a final follow-up visit occurring 30 days after clearance (Day 53-67).
Any sexual partners of study participants will be informed and consented before enrollment of study participants, and need to agree to sexual abstinence during the study. Should exposure to L. jensenii 1153-1666 occur in sexual partners, they will receive testing for L. jensenii 1153-1666 and antibiotic clearance as safety management.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Cohort 2 (single dose randomized) and Cohort 4 (triple dose randomized) are double-blinded.
Study Groups
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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.
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.
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.
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 (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.
Placebo
Each placebo applicator contains 200 mg of placebo powder comprising the same inactive ingredients of the preservation matrix as the study product.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Osel, Inc.
INDUSTRY
Duke University
OTHER
DFNet Research Inc.
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Craig Cohen, MD, MPH
OTHER
Responsible Party
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Craig Cohen, MD, MPH
Professor, Obstetrics, Gynecology, and Reproductive Sciences
Principal Investigators
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Craig Cohen, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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study recruitment website
Other Identifiers
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