Phase II year
2017
(last award dollars: 2019)
Phase II Amount
$2,983,602
Chikungunya virus (CHIKV) is an alphavirus that has gained significant attention due to its ability to cause large epidemics among susceptible populations and to be spread beyond endemic countries by international travelers. Among a population of approximately 750,000 on the French island of La Reunion, 266,000 people were infected and over 200 CHIKV-related fatalities occurred during the 2006 outbreak. Likewise, an estimated 1.4 million people were infected with CHIKV in India during outbreaks that occurred from 2006 to 2007 and recently there have been more than 1.7 million people infected with CHIKV in the Caribbean and the Americas. At present, there is no commercial vaccine available for CHIKV. The development of an inactivated CHIKV vaccine suitable for immunizing the general population as well as vulnerable groups including infants and the elderly represents an important unmet clinical need. We have developed a versatile vaccine platform based on inactivating viruses with hydrogen peroxide (H2O2) and here, we present preclinical efficacy data demonstrating that our optimized prototype H2O2-CHIKV vaccine can provide complete protection against infection and CHIKV-associated pathology in a robust mouse model. Based on this innovative new approach to vaccine development and promising preclinical data with CHIKV, we propose a detailed research plan to perform all necessary IND-enabling studies and to manufacture clinical-grade H2O2-inactivated CHIKV vaccine suitable for Phase I trials.
Public Health Relevance Statement: PUBLIC HEALTH RELEVANCE There is currently no vaccine available to combat chikungunya virus, a pathogen that causes debilitating and sometimes lethal infection. Our advanced technology for developing a safe and effective H2O2-inactivated chikungunya virus vaccine represents a new approach to this unmet clinical need.
Project Terms: Alphavirus; Americas; Antibody Response; Arthritis; Attention; Attenuated; Attenuated Vaccines; Awareness; base; Caribbean region; Case Fatality Rates; Cessation of life; Chikungunya virus; Clinical; Clinical Immunology; Clinical Virology; combat; Consultations; Country; Culicidae; Cyclic GMP; Data; design; Detection; Development; Disease; Disease Outbreaks; Ebola Vaccines; Ebola virus; Elderly; Epidemic; Europe; Fever; Formulation; Foundations; General Population; Goals; Growth; Health; Hepatitis A Virus; Hydrogen Peroxide; Immunity; immunogenic; immunogenicity; Immunology; In Vitro; in vivo; Inactivated Vaccines; India; Industry; Infant; Infection; innovation; International; Island; Japanese encephalitis virus; Knowledge; Laboratories; Life; Macaca mulatta; manufacturing process development; Measles; meetings; Modeling; mouse model; Mumps; Mus; neutralizing antibody; novel; novel strategies; novel vaccines; Outcome; Pan American Health Organization; pathogen; Pathology; Peroxides; Phase I Clinical Trials; phase I trial; Poliomyelitis; Polyarthralgias; Population; potency testing; pre-clinical; preclinical efficacy; Preclinical Testing; prevent; protective efficacy; prototype; Publishing; Recommendation; Regulatory Affairs; Reporting; Research; Research Infrastructure; Research Personnel; Resources; Rubella; Safety; safety testing; Satellite Viruses; Schedule; Small Business Innovation Research Grant; Techniques; Technology; Testing; Toxic effect; Toxicity Tests; vaccine candidate; vaccine development; Vaccine Production; Vaccines; Viral; Viremia; virology; Virus; Virus Diseases; Vulnerable Populations; Work; Yellow Fever; Yellow fever virus
