Safety Study of MucoCept-CVN

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 22, 2025

Primary Completion Date

February 28, 2027

Study Completion Date

October 31, 2027

Conditions
HIV -1 Infection
Interventions
DRUG

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."

DRUG

Placebo

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

Trial Locations (1)

94110

UCSF Zuckerberg San Francisco General Hospital, San Francisco

Sponsors
All Listed Sponsors
collaborator

Osel, Inc.

INDUSTRY

collaborator

Duke University

OTHER

collaborator

DFNet Research Inc.

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Craig Cohen, MD, MPH

OTHER