Vaginal probiotic that releases an HIV-blocking protein for women
Phase 1 Randomized Double-Blind Placebo-Controlled Safety Study of MucoCept-CVN (Lactobacillus jensenii 1153-1666) Administered Vaginally to Healthy Women
This trial tests a vaginal probiotic made from Lactobacillus jensenii that continuously releases an HIV-blocking protein in healthy women to check safety and vaginal colonization.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of California, San Francisco NIH-funded |
| Lab location | 1 site (San Francisco, United States) |
| Project ID | NIH-11237099 on NIH RePORTER |
What this research studies
If you join, you will receive one or three vaginal doses of MucoCept-CVN, a live Lactobacillus jensenii engineered to release a modified cyanovirin-N protein that blocks HIV entry. The study will randomly assign 12 healthy women to get the probiotic or a placebo without knowing which one you receive, and staff will monitor safety, local colonization, tissue and systemic exposure, and any side effects. You will have vaginal samples taken and blood or tissue tests over follow-up visits so researchers can see if the bacteria establish themselves and whether the HIV-blocking protein is present. The information will help decide whether to move this approach into larger trials.
Who could benefit from this research
Good fit: Healthy adult women who meet screening criteria (for example not pregnant and without active vaginal infections) and can attend study visits at the San Francisco site.
Not a fit: People living with HIV or anyone seeking proven prevention or treatment options should not expect direct therapeutic benefit from this early safety trial.
Why it matters
Potential benefit: If successful, this could become a woman-controlled prevention option that lowers the risk of vaginal HIV acquisition by restoring protective lactobacilli that deliver an HIV-blocking protein.
How similar studies have performed: This is a first-in-human test of this engineered strain, though preclinical macaque studies showed a 63% reduction in SHIV transmission and other live biotherapeutic approaches have been explored.
Where this research is happening
San Francisco, United States
- University of California, San Francisco — San Francisco, United States (Active)
Researchers
- Principal investigator: Hemmerling, Anke — University of California, San Francisco
- Study coordinator: Hemmerling, Anke
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.