Safety Study of MucoCept-CVN
ConditionHIV -1 Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorCraig Cohen, MD, MPH
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Live Biotherapeutic Product L. jensenii 1153-1666
DrugThe 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
DrugEach placebo applicator contains 200 mg of placebo powder comprising the same inactive ingredients of the preservation matrix as the study product.
Treatment groups
12 Participants
are divided into 3 treatment groupsGroup A: Single Dose MucoCept-CVNActive comparator 1 intervention
Group B: Triple Dose MucoCept-CVNActive comparator 1 intervention
Group C: Placebo (Single Dose and Triple Dose)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety of MucoCept-CVN - Adverse Events
Proportion of participants with serious adverse events, any genital AEs and Grade 2 or above systemic AEs.
Time frame
From enrollment to the end of follow up at 8 weeks2
Antibiotic Clearance of L.jensenii 1153-1666
Inability to clear L. jensenii 1153-1666 after administration of antibiotics, using next generation sequencing (NGS).
Time frame
From enrollment to the end of follow up at 8 weeksSecondary outcomes
1
Safety of MucoCept-CVN - Vaginal Inflammation
Proportion of participants with colposcopic findings and inflammation in vaginal biopsy.
Time frame
From enrollment to the end of follow up at 8 weeks2
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).
Time frame
From enrollment to the end of follow up at 8 weeks3
Tolerability - Proportion of participants not stopping the study due to Adverse Events
Tolerability as proportion of participants not stopping the study due to AE.
Time frame
From enrollment to the end of follow up at 8 weeks4
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.
Time frame
From enrollment to the end of follow up at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Craig Cohen, MD, MPH
Lead sponsor
University of California, San Francisco
Sponsor institution
Osel, Inc.
Collaborator
Duke University
Collaborator
DFNet Research Inc.
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov