The University of Connecticut received a $1,568,897 Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) to develop a universal vaccine against leptospirosis, an emerging infectious disease. The research aims to evaluate a multi-recombinant protein vaccine candidate for its ability to induce cross-protective immunity against diverse pathogenic Leptospira species and serovars in animal...
This Project Grant award for $300,000.00, provided by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), aims to develop rapid, point-of-care diagnostic tests for the early detection of leptospirosis, a potentially fatal zoonotic bacterial disease. The key objectives are to: Optimize and validate solid phase antigen-detection tests using leptospiral virulence-modifying proteins (VMP), lipoprotein LipL32, and...
The U.S. Department of Agriculture's (USDA) National Institute of Food and Agriculture (NIFA) awarded a $800,000 Project Grant under the Agriculture and Food Research Initiative (AFRI) program to Washington State University (WSU). The grant aims to develop a vaccine against anaplasmosis, a prevalent tick-borne infection in cattle that causes significant morbidity and an estimated $300 million in annual economic losses in the U.S. The project will test the protective capacity of outer membrane...
This Project Grant award of $300,000 from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) supports the development of a novel protein-based prophylactic drug, FC3/SCR(19-20), to prevent Lyme disease and relapsing fever. The primary awardee, Planet Biotechnology Inc., will use its plant-based expression system to produce and optimize variants of this fusion protein to enhance bioavailability, safety, and...
The National Institute of Allergy and Infectious Diseases (NIAID) awarded a $137,229 Project Grant (CFDA 93.855 - Allergy and Infectious Diseases Research) to Chulalongkorn University in Thailand. The funding will support a 5-year research study to identify predictive biomarkers for severe acute leptospirosis and its long-term complications, such as chronic kidney disease. The key objectives of the study are to: 1) Characterize the host response and identify novel biomarkers that can predict the...
This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), part of the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $298,938 to develop an orally available immunotherapy product, HPX-612, for the treatment of visceral leishmaniasis, a parasitic disease caused by Leishmania and transmitted by sandflies. The project aims to evaluate the preclinical pharmacokinetic profile of HPX-612, determine optimal dosing, and confirm efficacy in...
The University of Missouri System, under a $650,000 project grant from the USDA National Institute of Food and Agriculture (NIFA) Agriculture and Food Research Initiative (AFRI) program, is developing safe and effective live attenuated swine influenza vaccines using Newcastle disease virus (NDV) as the vector. The project aims to address the challenges with current swine influenza vaccines, which often fail to provide cross-protection against diverse virus strains. The key products and...
The USDA National Institute of Food and Agriculture (NIFA) awarded a $800,000 Project Grant under the Agriculture and Food Research Initiative (AFRI) program to Louisiana State University (LSU) to engineer a novel vaccine vector platform. The key objectives are to: Incorporate PRRSV envelope proteins into a pseudorabies virus vector and evaluate its protective efficacy against virulent PRRSV challenge strains. PRRSV is a devastating swine virus that causes significant economic losses in the...
Long Island University received a three-year, $627,000 Project Grant award from the United States Department of Agriculture National Institute of Food and Agriculture under the Agriculture and Food Research Initiative competitive grants program. The grant will fund research to develop an improved vaccine for bovine respiratory disease (BRD) in cattle. BRD costs the U.S. beef industry over $3 billion annually. Current commercial vaccines have limited effectiveness. The university will generate...
This Project Grant award from the National Center for Advancing Translational Sciences (NCATS), an institute under the National Institutes of Health, is focused on the development of a thermostable microneedle patch formulation for the AgTrioVX malaria vaccine candidate. The total funding amount is $1,199,511 over a 2-year period from June 1, 2024 to May 31, 2026. The key objective of this project is to produce a novel AgTrioVX microneedle patch that can protect against malaria in a mouse model,...
LEPTOSPIROSIS VACCINE DEVELOPMENT - SUMMARY/ABSTRACT. LEPTOSPIROSIS IS A GLOBALLY IMPORTANT NEGLECTED DISEASE CAUSED BY PATHOGENIC LEPTOSPIRA. IT IS ESTIMATED TO CAUSE MORE THAN 1 MILLION GLOBAL CASES ANNUALLY WITH A 5-20% CASE-FATALITY RATE, SIGNIFICANT MORBIDITY, AND IMPORTANT PUBLIC HEALTH CONSEQUENCES. CURRENTLY THERE IS NO SAFE AND EFFECTIVE VACCINE TO PREVENT HUMAN LEPTOSPIROSIS. LEPTOX, INC. PROPOSES TO DEVELOP THE FIRST HUMAN LEPTOSPIROSIS VACCINE. PATHOGENIC LEPTOSPIRA ARE EXTRACELLULAR ORGANISMS, BUT MECHANISMS BY WHICH THEY EXERT THEIR PATHOGENETIC EFFECTS WERE UNCLEAR UNTIL OUR DISCOVERY OF THE LEPTOSPIRAL VIRULENCE MODIFYING (VM) PROTEINS' CYTOTOXIN FUNCTION, FOLLOWED BY OUR DEMONSTRATION OF THE POTENTIAL FOR VM PROTEINS TO BE THE ANTIGEN COMPONENTS OF A PAN- LEPTOSPIROSIS VACCINE. SEVERE HUMAN LEPTOSPIROSIS HAS ALMOST EXCLUSIVELY BEEN REPORTED TO BE DUE TO STRAINS OF L. INTERROGANS. THIS PROPOSAL FOCUSES ON A L. INTERROGANS VM PROTEIN-BASED LEPTOSPIROSIS VACCINE, ALTHOUGH CROSS SPECIES PROTECTION MAY BE POSSIBLE. RECENTLY PUBLISHED ANIMAL MODEL DATA DEMONSTRATED THAT AS FEW AS TWO RECOMBINANT VM PROTEINS PROVIDE ROBUST CROSS-SEROVAR PROTECTION FROM DISEASE/DEATH AFTER LETHAL L. INTERROGANS CHALLENGE IN MICE. THESE DATA INDICATE STRONG POTENTIAL FOR VM PROTEINS AS PAN-L. INTERROGANS PROTECTIVE ANTIGENS. IN THIS PHASE I, WE WILL OPTIMIZE DOSE, DELIVERY AND COMPOSITION OF RECOMBINANT E. COLI- PRODUCED VM PROTEINS IN COMBINATION WITH HUMAN-COMPATIBLE ADJUVANT TO DETERMINE PROTECTIVE EFFICACY IN THE LETHAL HAMSTER CHALLENGE MODEL OF LEPTOSPIROSIS. IN AIM 1, WE WILL PRODUCE RECOMBINANT TAGLESS VM PROTEIN IMMUNOGENS, ANALYZE THEIR IMMUNOGENICITY AND, IN THE STANDARD HAMSTER MODEL, COMPARE THEIR PROTECTIVE EFFICACY TO STANDARD, COMMERCIALLY AVAILABLE BACTERIN VACCINES; CONTINGENCY EXPERIMENTS WILL ALSO ASSESS CHEMICALLY INACTIVATED WILD TYPE PROTEINS AND PROTEINS PURIFIED FROM INCLUSION BODIES AS ALTERNATIVE FORMS OF THE VM PROTEIN IMMUNOGEN; STRUCTURAL MODELING SUGGESTS THAT VM PROTEIN DISULFIDE BOND-DEPENDENT CONFORMATION MAY NOT BE CRITICAL FOR ANTIGENICITY. IN AIM 2, WE WILL COMPARE WILD TYPE AND GENETICALLY MUTATED TOXOID-FORMS OF TAGLESS, RECOMBINANT E. COLI-PRODUCED VM PROTEINS IN THE LETHAL HAMSTER MODEL. PROTECTIVE IMMUNE RESPONSES FOR BOTH AIMS WILL BE ASSESSED BY PROTECTION FROM CLINICAL DISEASE AND DEATH AND BY DETERMINATION OF BACTERIAL LOAD AND VIABILITY IN LIVER AND KIDNEY AT VARIOUS TIME POINTS. BIOMARKERS OF PROTECTIVE IMMUNITY (I.E., ANTIBODY TITERS AGAINST THE PROTOTYPE VACCINE ANTIGENS AND CROSS-REACTIVITY AMONG SEROVARS AND BETWEEN DIFFERENT LEPTOSPIRA SPECIES' VM PROTEINS) WILL BE MEASURED; THE PUTATIVE ANTIBODY-MEDIATED PROTECTIVE MECHANISM OF IMMUNITY WILL BE TESTED BY PASSIVE TRANSFER EXPERIMENTS. AT THE END OF THIS PHASE I PROJECT, WE WILL HAVE DEVELOPED FINAL PAN-L. INTERROGANS VM-PROTEIN-BASED VACCINE PROTOTYPES FOR FURTHER ANIMAL TESTING. FOLLOWING PHASE I, THIS PROTOTYPE WILL BE TESTED IN DOG CLINICAL TRIALS, WHICH WILL LEAD TO A FIRST COMMERCIAL PRODUCT FOR THESE COMPANION ANIMALS. ANIMAL VACCINE DEVELOPMENT WILL LEAD TOWARDS FDA IND SUBMISSION FOR A HUMAN LEPTOSPIROSIS VACCINE, UPON WHICH STRATEGIC PARTNERSHIPS FOR LEPTOSPIROSIS VACCINE DEVELOPMENT WILL BE FORMED.