12
Participants
Start Date
September 22, 2025
Primary Completion Date
February 28, 2027
Study Completion Date
October 31, 2027
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.
UCSF Zuckerberg San Francisco General Hospital, San Francisco
Collaborators (2)
Osel, Inc.
INDUSTRY
Duke University
OTHER
DFNet Research Inc.
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Craig Cohen, MD, MPH
OTHER