Project Grant R44AI167605
- This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research Federal Grant Program (CFDA 93.855), provides $281,786 to L2 Diagnostics LLC for the development of a safe and effective viral vector-based vaccine to induce both humoral and cellular immune protection against Powassan virus. The goal is to leverage the Modified Vaccinia Ankara vector platform to stimulate robust antibody and T cell responses that...
- This $199,984 Project Grant awarded by the National Science Foundation (NSF) Engineering program (CFDA 47.041) aims to increase the fundamental understanding of the immune response to various Lyme disease antigens using bacterial outer membrane vesicles (OMVs) as a novel carrier system. The research objectives are to: 1) explore fusion proteins as a proof of concept to present full Borrelia burgdorferi (BB) antigens on OMVs, 2) determine the potential to express multiple BB antigen epitopes on...
- This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research Federal Grant Program (CFDA 93.855), provides $461,375 to Yale University to systematically identify interactions between Lyme disease bacteria (Borrelia burgdorferi) and the extracellular, secreted, and transmembrane proteins of the tick vector Ixodes scapularis. The goal is to develop a better understanding of the critical pathogen-vector...
- The National Institute of Allergy and Infectious Diseases (NIAID) awarded a $165,000 Project Grant under the Allergy and Infectious Diseases Research program (CFDA 93.855) to Tufts University School of Medicine for the development of an improved transposon mutagenesis system to enable comprehensive genetic analysis of Borrelia burgdorferi, the bacterium that causes Lyme disease. The project aims to create a high-efficiency transposon insertional mutagenesis system for B. burgdorferi to...
- This $436,236 Project Grant award from the National Institute of Allergy and Infectious Diseases (CFDA 93.855 - Allergy and Infectious Diseases Research) aims to develop a sensitive solid-state biosensor that targets the Borrelia burgdorferi (BB) protease as a biomarker to accurately diagnose both early- and late-stage active Lyme disease infections. The award to The Leland Stanford Junior University will fund research to create an epitaxial graphene-based biosensor that provides high...
- This Project Grant award of $192,500.00 from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research Federal Grant Program (CFDA 93.855) supports research to identify key mechanisms of how the Lyme disease-causing bacteria Borrelia burgdorferi invades the central nervous system. The research aims to develop a reproducible small animal model of Lyme neuroborreliosis, which has been a critical gap in understanding the pathology of Lyme...
- This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $3,315,179 to Tufts University School of Medicine to conduct research on the microbial determinants of excessive inflammation and severe Lyme disease. The researchers will leverage a unique collection of clinical samples and isogenic Borrelia burgdorferi strains to systematically delineate the immunogenic...
- The National Institute of Allergy and Infectious Diseases (NIAID) awarded a $417,845 Project Grant under the Allergy and Infectious Diseases Research program (CFDA 93.855) to the University of Nebraska Medical Center (UNMC) to adapt an in vitro human skin model for studying Borrelia burgdorferi transmission and colonization by the blacklegged deer tick (Ixodes scpaularis). The project aims to modify the skin model to increase tick feeding efficiency, demonstrate B. burgdorferi transmission and...
- This $2,494,866 Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) supports research to characterize innate immune signaling pathways in the tick Ixodes scapularis. The project aims to improve understanding of immune signaling in ticks, which are vectors of Lyme disease and other emerging infectious diseases. The research will combine cell culture-based methods with in vivo assays...
- This federal Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $191,250 to Washington State University (WSU) to conduct research on the immune evasion mechanism of the Lyme disease spirochete, Borrelia burgdorferi. The award supports mechanistic studies on the role of genetic factors in the antigenic variation of the VlsE surface protein, a key mechanism for persistent...
INTRANASAL VACCINE AGAINST LYME DISEASE - ABSTRACT WE PROPOSE TO DEVELOP INTRANASAL, PARAINFLUENZA 5 (PIV5) VIRAL-VECTOR DELIVERED VACCINES AGAINST HUMAN LYME DISEASE (LD) TO BE ADMINISTERED USING A PRIME-BOOST SCHEDULE, FOR THE US MARKET. A RECENT NEW ESTIMATE OF LD BY THE CDC PLACES THE NEW NUMBER AT 476,000 ANNUAL CASES, UP FROM 329,000 IN 2015 WHICH STRONGLY SUGGESTS THAT THE NUMBER OF AMERICANS AFFECTED BY THIS VECTOR-BORNE DISEASE IS INCREASING. CURRENTLY, THERE IS NO HUMAN LYME DISEASE VACCINE AVAILABLE IN THE MARKET. A PRIME-BOOST VACCINATION WITH AN INTRANASAL IMMUNOGEN IS A SCIENTIFIC AND TECHNOLOGIC ADVANCE OVER BEST VACCINATION PROTOCOLS IN DEVELOPMENT FOR LD THAT CURRENTLY RELY ON PARENTERAL INOCULATION OF A MINIMUM OF 3 DOSES OVER 1 YEAR. OUR PRELIMINARY STUDIES SHOW THAT INTRANASAL ADMINISTRATION OF A MODIFIED OSPA VACCINE DELIVERED BY THE LABORATORY STRAIN WR-PIV5 VIRAL VECTOR (WR-PIV5-OSPABPBPK) VIA PRIME-BOOST (2 DOSES), PRODUCES AN IMMUNE RESPONSE THAT IS 100% PROTECTIVE AGAINST TICK TRANSMITTED B. BURGDORFERI INFECTION IN MICE CHALLENGED 4 MONTHS AFTER THE 1ST DOSE. PIV5 IS A SAFE DELIVERY VECTOR USED TO DEVELOP MANY VACCINES, ONE OF WHICH IS UNDERGOING A HUMAN CLINICAL TRIAL. THE COMMERCIALIZATION POTENTIAL AND SOCIETAL IMPACT OF DEVELOPING A NOVEL, SAFE AND EFFICACIOUS LD VACCINE THAT CAN BE DELIVERED BY A NON-INVASIVE METHOD IS HIGHLY SIGNIFICANT GIVEN THAT IT MAY INDUCE MORE DURABLE IMMUNE RESPONSES, IT COULD DIMINISH VACCINE HESITANCY AND INCREASE VACCINE COMPLIANCE, AND IT COULD ENABLE SELF-ADMINISTRATION OF ONE OR BOTH DOSES. THE NOVELTY OF THE VACCINE PROPOSED IN THIS DIRECT TO PHASE II SBIR APPLICATION RELATES TO: 1) THE USE OF A MODIFIED FULL LENGTH OSPA PROTEIN IN WHICH THE PUTATIVE AUTOANTIGENIC EPITOPE HAS BEEN REPLACED; 2) A NEEDLE-FREE INTRANASAL DELIVERY METHOD IN A SAFE, HIGHLY IMMUNOGENIC VIRAL VECTOR; 3) THE REDUCED NUMBER OF IMMUNIZATIONS; 4) EASE OF ADMINISTRATION; AND 5) THE POTENTIAL TO INCREASE IMMUNITY LONGEVITY. WE PROPOSE TO DEVELOP A NEW VIRAL VECTOR EXPRESSING OSPABPBPK BASED ON THE PIV5 VACCINE STRAIN (CPI) AND EVALUATE INTRANASAL VACCINE EFFICACY IN MICE AS COMPARED TO THE WR-PIV5- ABPBPK SHOWN IN PRELIMINARY RESULTS; WE WILL ALSO ASSESS IMMUNOGENICITY, SAFETY AND EFFICACY OF THE BEST VACCINE CANDIDATE IN THE NON-HUMAN PRIMATE (NHP) MODEL OF LYME DISEASE; LAST, WE WILL PERFORM STUDIES REQUIRED FOR INVESTIGATIONAL NEW DRUG (IND) REGULATORY APPROVAL BY FDA. ONCE THE NOVEL VACCINE IS SHOWN TO MEET PRE-SET PERFORMANCE CRITERIA SPECIFIED IN OUR MILESTONES (>80% EFFICACY IN MICE AND NON-HUMAN PRIMATE MODELS), IT WILL BE TRADEMARKED AS LYMEMIST AND THE COMPANY WILL IMPLEMENT A PLAN TO COMMERCIALIZE IT.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | $0 | 6/20/25 | ||
| Not listed | $999.9k | 6/25/24 | ||
| Not listed | $1.0m | 6/13/23 | ||
| Not listed | $1.0m | 6/13/23 | ||
| Not listed | $988.5k | 7/12/22 |