This Small Business Technology Transfer (STTR) Phase I proposal is in response to âNIH/NIAID Research Topics in Division of Microbiology and Infectious Diseases and Bacteriology and Mycology Branch: Vaccine for prevention of human Q fever.â Q fever is a worldwide zoonotic disease that is caused by the obligate intracellular Gram-negative bacterium, Coxiella burnetii. The highly infectious nature of C. burnetii and its unique resistance to heat, ultraviolet light, and other environmental factors make this organism an important zoonotic pathogen, and potentially useful in bioterrorism and biological warfare. Human Q fever can develop into a severe chronic, potentially fatal disease, and there is no vaccine commercially available for prevention of human Q fever in the US. Therefore, ZenVax LLC intends to develop a safe and effective licensed vaccine against Q fever. ZenVax is a new startup biotech company, focused on the development of safe, effective, and novel vaccines against microbial pathogens. The long-term goal of this STTR project is to develop a safe and effective licensed vaccine against Q fever. ZenVax will also use the development of a Q fever mimotope vaccine as the model system to demonstrate the concept that mimotope vaccine technology can be utilized as a broad platform against other bacterial pathogens. Our premise is that a peptide mimic of a C. burnetii phase I lipopolysaccharides (PI-LPS) protective epitope (m1E41920) conjugated to keyhole limpet haemocyanin (m1E41920-KLH) conferred significant protection against C. burnetii infection. The overall objective of this STTR Phase I application is to define, optimize and validate a multivalent mimotope vaccine against Q fever. This project is significant, because it will establish the âproof of principleâ not only for Q fever vaccine but also for a broad vaccine platform/approach against other microbial pathogens in general. Upon completion of the Phase I project, we expect to define a multivalent mimotope vaccine that will be optimized and manufactured as a vaccine under GMP/GLP conditions for further safety and immunogenicity testing in the Phase II project.
Public Health Relevance Statement: Project narrative: This STTR project aims to use the development of a Q fever mimotope vaccine as the model system to prove the concept that the mimotope vaccine technology can be utilized as a broad platform against other microbial pathogens.
Project Terms: Acute; Adjuvant; Aerosols; Antigens; Australia; Autoantibodies; Bacteriology; base; Biological Models; Biological Warfare; biosecurity; Biotechnology; bioterrorism/chemical warfare; Businesses; Cells; Chronic; Chronic Disease; Clinical; Communicable Diseases; Coxiella burnetii; Development; Diagnosis; Disease; Disease Outbreaks; Dose; Environmental Risk Factor; Epitopes; Erythema; experience; Exposure to; flu; Formalin; Goals; Gram-Negative Bacteria; Headache; Health; high risk; Home environment; Human; Hypersensitivity skin testing; Immunity; Immunization; immunogenicity; Immunoglobulin G; Immunologic Memory; Inactivated Vaccines; Individual; Infection; Infectious Diseases Research; Keyhole Limpet Hemocyanin; Laboratory Animals; Laboratory Research; Lipopolysaccharides; Membrane; Microbiology; Middle East; Missouri; Monitor; National Institute of Allergy and Infectious Disease; Nature; Netherlands; novel vaccines; Organism; pathogen; pathogenic bacteria; pathogenic microbe; Pathogenicity; peptidomimetics; Phase; Prevention; protective efficacy; Public Health; Publishing; Q Fever; Reporting; Research; Research Peer Review; Resistance; response; Route; Safety; Serological; seropositive; side effect; Soldier; Structure; Surface; Swelling; Symptoms; T-Lymphocyte; Technology; Technology Transfer; Testing; The science of Mycology; Translating; Ultraviolet Rays; United States National Institutes of Health; Universities; Vaccination; vaccine candidate; Vaccines; Whole Cell Vaccine; Work; Z