HIV -1 InfectionPhase 1NCT07181486
Safety Study of MucoCept-CVN
A Phase 1 study testing Live Biotherapeutic Product L. jensenii 1153-1666 in people with HIV -1 Infection, run by Craig Cohen, MD, MPH at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV -1 Infection
- What is being tested?
- Live Biotherapeutic Product L. jensenii 1153-1666
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 31 Oct 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Craig R Cohen, MD, MPH contact
United States1 site, 1 recruiting
- Recruiting
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Sara Newmann, MD MPH, 628-206-4220, sara.newmann@ucsf.edu
Emelly Argueta, BA, emelly.argueta@ucsf.edu
About this study
Official title: Phase 1 Randomized Double-Blind Placebo-Controlled Safety Study of MucoCept-CVN (Lactobacillus Jensenii 1153-1666) Administered Vaginally to Healthy Women
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.
Read more
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.
Read the detailed description
The goal of this first-in-human Phase 1 dose-ranging, randomized, placebo-controlled study is to collect critical data needed to advance the clinical development of MucoCept-CVN, specifically (1) understanding factors that influence vaginal colonization by L. jensenii 1153-1666, including dose and endogenous vaginal microbiota; and (2) pharmacokinetic, tissue and systemic effects of L. jensenii 1153-1666, such as adverse events (AE) and findings in colposcopy and vaginal biopsy, and (3) changes to the vaginal microbiota. We also need to show that (4) L. jensenii 1153-1666 can be sufficiently cleared with antibiotics should the need arise for rescue therapy.
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
- HIV -1 Infection
- Being tested
- Live Biotherapeutic Product L. jensenii 1153-1666, Placebo
- Keywords
- HIV prevention, live biotherapeutic product, MucoCept-CVN, Vaginal microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Biotherapeutic Product L. jensenii 1153-1666Drug
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.
PlaceboDrug
Each placebo applicator contains 200 mg of placebo powder comprising the same inactive ingredients of the preservation matrix as the study product.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MucoCept-CVN - Adverse Events
Proportion of participants with serious adverse events, any genital AEs and Grade 2 or above systemic AEs.
Measured: 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).
Measured: From enrollment to the end of follow up at 8 weeks
Secondary outcomes (4)
Safety of MucoCept-CVN - Vaginal Inflammation
Proportion of participants with colposcopic findings and inflammation in vaginal biopsy.
Measured: From enrollment to the end of follow up at 8 weeks
Vaginal Colonization with L. jensenii 1153-1666
Proportion of participants with achieved vaginal colonization and clearance of vaginal colonization with L. jensenii 1153-1666, using next generation sequencing (NGS).
Measured: From enrollment to the end of follow up at 8 weeks
Tolerability - Proportion of participants not stopping the study due to Adverse Events
Tolerability as proportion of participants not stopping the study due to AE.
Measured: From enrollment to the end of follow up at 8 weeks
Acceptability
Acceptability of MucoCept-CVN using a self-administered questionnaire at enrollment and final visit, including perceptions around method of delivery and dosing, and self-reported attitudes about positive and negative study product attributes.
Measured: From enrollment to the end of follow up at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start6 Oct 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV -1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig Cohen, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Osel, Inc., Duke University, DFNet Research Inc., National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor-investigator, Craig Cohen, MD, MPH, University of California, San Francisco
- Investigators
- Craig Cohen, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181486
- Sponsor's protocol ID
- U01AI186333
- Other IDs
- U01AI186333
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are committed to enhancing the value and further advancement of this research and we plan to make the data available as widely and freely as possible, while safeguarding the privacy of participants. Therefore, we will provide qualified researchers access to the data in a timely manner after main findings from the final dataset have been accepted for publication. The proposed research will include data from female subjects, including current medical history, concomitant medication information (including concurrent use of contraceptives), stage of menstrual cycle, and behavioral data (e.g. sexual behavior, douching and genital hygiene practices). In addition, there will be a comprehensive database of laboratory data, including results on strain colonization, measurement of CV-N in blood and vaginal fluid, and HIV infectivity assay results, etc.