Federal Project Grant Award Summary

Luna Bioscience, Inc., a woman-owned small business based in Westport, Connecticut, received a $300,239 Project Grant from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) awarded on July 14, 2026, with completion targeted for June 30, 2028. The project focuses on developing surrogate biomarkers to support clinical trials of human leptospirosis vaccines. Luna Bioscience will create in vitro assays that measure immunoglobulin G (IgG) antibody inhibition of virulence-modifying (VM) protein functions—specifically targeting DNase activity, target cell binding, and cytotoxicity—using purified IgG from vaccinated dogs and hamsters. These assays will establish predictive markers of vaccine efficacy based on the company's VM protein-based vaccine candidate.

The deliverables include validated in vitro test systems and benchmarking data comparing these surrogate markers against lethal challenge outcomes with various Leptospira interrogans serovars in hamster models following both vaccination and passive transfer of immune sera. Upon successful completion, the project will yield surrogate markers of efficacy capable of supporting human clinical trials for what would be the first pan-effective human leptospirosis vaccine, addressing a significant zoonotic bacterial disease affecting over one million people annually with fatality rates of 5-20%. The findings will have applications for domestic and military health protection, as well as expansion of Luna Bioscience's leptospirosis diagnostic and preventive products in low and middle-income countries.