MucoCept-CVN for HIV Prevention

Overseen By Craig R Cohen, MD, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Craig Cohen, MD, MPH

Must not be taking: Antibiotics, Antifungals, Immunosuppressants

Disqualifiers: Urogenital infection, Abnormal Pap, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3-5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MucoCept-CVN, which uses a special type of bacteria to help prevent HIV in women while promoting vaginal health. The researchers aim to determine the treatment's safety and how well it remains in the body. Participants will be healthy women with regular menstrual cycles who can commit to regular clinic visits and specific study requirements. If successful, this treatment could offer a self-renewing, female-initiated method to prevent HIV. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken antibiotics or antifungal medications within 30 days before joining. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that MucoCept-CVN is likely to be safe for humans?

Research shows that MucoCept-CVN, a new treatment being tested for preventing HIV, might be safe. MucoCept-CVN uses a type of bacteria called Lactobacillus, commonly found in the human body, and has been modified to help fight HIV.

Since this is the first time MucoCept-CVN is being tested in humans, researchers are still collecting detailed safety information. However, reaching this stage of testing indicates it has shown promise in earlier research regarding its safety. In past studies, treatments that reach this point are usually well-tolerated in controlled environments.

In this study, participants will receive either one or three doses of the treatment, and researchers will closely monitor any side effects. The aim is to ensure MucoCept-CVN does not cause significant harm while potentially offering a new way to prevent HIV. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MucoCept-CVN for HIV prevention because it offers a potentially groundbreaking approach compared to existing options like PrEP (pre-exposure prophylaxis) pills. Unlike these oral medications, MucoCept-CVN is being explored as a topical microbicide, which could provide a more direct line of defense against HIV transmission. This delivery method might offer benefits such as localized action, potentially fewer systemic side effects, and ease of use, particularly for women. Additionally, the ability to administer it in single or triple doses could provide flexibility in prevention strategies, enhancing adherence and effectiveness.

What evidence suggests that MucoCept-CVN might be an effective treatment for HIV prevention?

Research has shown that MucoCept-CVN uses a special type of Lactobacillus bacteria, which naturally resides in the human vagina. This bacteria is modified to release a drug that combats HIV. This method could offer women a long-lasting way to prevent HIV. Early studies suggest that MucoCept-CVN may significantly lower the risk of HIV in women by settling in the vaginal area and continuously producing the anti-HIV drug. In this trial, participants will receive either a single dose, a triple dose of MucoCept-CVN, or a placebo. Although this treatment is new, its mechanism shows promise in protecting against HIV. ^{1 2 3 5 6}

Who Is on the Research Team?

Craig Cohen, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for healthy women who may be at risk of HIV. Participants will receive either the MucoCept-CVN, which is a modified Lactobacillus strain designed to protect against HIV, or a placebo. The study requires taking one or three doses followed by antibiotics to clear the introduced strain.

Inclusion Criteria

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

Exclusion Criteria

Pregnancy or within two months of last pregnancy or lactation

Known allergy to specific components

Recent history of drug or alcohol abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or three doses of MucoCept-CVN or placebo, followed by antibiotics to clear the Lactobacillus strain

3-5 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final follow-up visit occurring 30 days after antibiotic clearance

4 weeks

Final follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• MucoCept-CVN

Trial Overview The study tests MucoCept-CVN, an innovative biotherapeutic that produces anti-HIV drugs within the vagina. It's compared with a placebo in this first-in-human Phase 1 trial focused on safety and effects on vaginal health.

How Is the Trial Designed?

Group I: Single Dose MucoCept-CVN Active Control 1 Intervention

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.

Group II: Triple Dose MucoCept-CVN Active Control 1 Intervention

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.

Group III: Placebo (Single Dose and Triple Dose) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Craig Cohen, MD, MPH

Lead Sponsor

DFNet Research Inc.

Collaborator

Trials

2

Recruited

680+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Osel, Inc.

Industry Sponsor

Trials

7

Recruited

250+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07181486

NCT07181486 | Safety Study of MucoCept-CVN If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, long-acting, female-initiated prevention product ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07181486

UCSF HIV/AIDS Trial → Study of MucoCept-CVN If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention product for women that ...

3. reporter.nih.gov reporter.nih.gov/search/0nw-tI68RkONFCDIJUk2AQ/project-details/10999145

Project Details Research to date is proof- of-concept that MucoCept-CVN may be safe and lead to a significant reduction in female HIV acquisition.

4. withpower.com withpower.com/trial/phase-1-human-immunodeficiency-virus-type-1-hiv-1-infection-8-2025-aafbf

MucoCept-CVN for HIV Prevention · Info for Participants 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 ...

5. reporter.nih.gov reporter.nih.gov/search/cKoXtRxn2U2IgmOgqFNymg/project-details/10223989

Project Details Colonization of the vaginal mucosa by this strain along with the continuous secretion of mCV-N is expected to reduce HIV acquisition in the female genital tract ...

6. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=U01AI186333&arg_ProgOfficeCode=104

Award Information | HHS TAGGS Phase 1 Randomized Double-Blind Placebo-Controlled Safety Study of MucoCept-CVN (Lactobacillus jensenii 1153-1666) Administered Vaginally to Healthy Women ...