Immune therapy to prevent and treat genital gonorrhea in women
Official title: Therapy and Prophylaxis for Genital Tract Infection
Funded at Therapyx, INC. · NIH-11142976 · Data updated 2026-11-12
A new intravaginal immune treatment designed for women with gonorrhea that helps antibiotics clear infection and aims to create lasting protection against future infections.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Therapyx, INC. NIH-funded |
| Lab location | 1 site (Buffalo, United States) |
| Project start | February 1, 2013 |
| Project end | July 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $1,000,000 |
| NIH project number | 5SB1AI104067-09 |
| Project ID | NIH-11142976 on NIH RePORTER |
Who could benefit from this research
✓Could help
Women diagnosed with active Neisseria gonorrhoeae infection who are willing to receive intravaginal immune therapy alongside standard antibiotic treatment would be ideal candidates.
✕Less likely to help
People without gonorrhea, men, or anyone with contraindications to IL-12 or to intravaginal treatments (for example certain pregnant individuals) may not benefit from this therapy.
What this research studies
You would receive GneX12, a therapy that delivers a small dose of human interleukin-12 in biodegradable microparticles into the vagina together with standard antibiotics to turn an active infection into a source of protective immunity. In mice this approach sped bacterial clearance, triggered T-cell and antibody responses, and protected against re-infection for at least six months across different strains. The developers optimized dose and dosing schedule, measured initial pharmacokinetics after intravaginal delivery, and scaled up manufacturing with consistent product batches. The next step would be clinical testing in women to confirm safety, immune responses, and protection against reinfection.
Why it matters
Potential benefit: If successful, this approach could lower the risk of repeat gonorrhea infections and offer a treatment option for antibiotic-resistant strains.
How similar studies have gone: Preclinical mouse studies showed strong protection and accelerated clearance, but this immune-therapy approach has not yet been proven in human clinical trials.
Where this research is happening
-
Therapyx, INC.
Buffalo, United States Active
Researchers
- Principal investigator: Auci, Dominick — Therapyx, INC.
- Study coordinator: Auci, Dominick
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.