SBIR-STTR Award

A Randomized Phase I Clinical Trial of Hydrovax-Chikv, a Novel Inactivated Chikungunya Virus Vaccine
Profile last edited on: 2/9/2021

Program
SBIR
Agency
NIH | NIAID
Total Award Amount
$290,420
Award Phase
1
Principal Investigator
Ian J Amanna
Activity Indicator

Company Information

Najit Technologies Inc

15232 NW Greenbrier Parkway
Beaverton, OR 97006
   (971) 727-3571
   info@najittech.com
   www.najittech.com
Multiple Locations:   
Congressional District:   01
County:   Washington

Phase I

Phase I year
2020
Phase I Amount
$290,420
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. To address this critical unmet need, we have discovered a safe and immunogenic peroxide-inactivated chikungunya virus vaccine, HydroVax-CHIKV. Importantly, this advanced vaccine is safe and provides complete protection against infection and CHIKV-associated pathology in a robust mouse model. Here, we propose a double-blind, randomized, placebo-controlled Phase 1 dose escalation trial to evaluate the preliminary safety and immunogenicity of HydroVax-CHIKV. Our goal is to eventually provide vaccine coverage to vulnerable populations and the successful completion of this study will represent a key milestone in the advancement of a clinically relevant vaccine against chikungunya virus and provide a much- needed approach to protect the most susceptible members of society including infants, elderly, and those with potentially compromised immune functions.

Public Health Relevance Statement:
In this proposal, we provide preclinical data demonstrating the safety, immunogenicity, and protective efficacy of an advanced HydroVax vaccine platform and propose to evaluate the safety and immunogenicity of a novel peroxide-inactivated whole-virus chikungunya virus vaccine in a double-blind placebo-controlled Phase 1 clinical trial.

Project Terms:
Address; Adult; Adverse event; Alphavirus; Americas; Attention; Attenuated; Award; base; Caribbean region; Case Fatality Rates; cGMP production; chikungunya; chikungunya infection; Chikungunya virus; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; clinically relevant; Country; Culicidae; Data; Data Analyses; Department of Defense; Development; Disease; Disease Outbreaks; Dose; Double-Blind Method; Ebola; Elderly; Enrollment; Epidemic; FDA approved; Female; Fever; Flavivirus; General Population; Goals; Grant; hemorrhagic fever virus; Hydrogen Peroxide; immune function; Immunize; immunogenic; immunogenicity; India; Individual; Infant; Infection; Infrastructure; International; Investigational Drugs; Investigational New Drug Application; Island; Laboratories; Life; male; member; mouse model; Nature; novel; Outcome Measure; Pathology; Peroxides; Phase; Phase I Clinical Trials; phase I trial; Phase I/II Trial; Placebos; Polyarthralgias; Population; pre-clinical; primary endpoint; Production; protective efficacy; Protocols documentation; Randomized; Reporting; Research Personnel; Safety; safety assessment; secondary endpoint; Serious Adverse Event; seroconversion; Signs and Symptoms; Societies; stability testing; Technology; Test Result; Testing; Time; Toxic effect; Toxicology; United States National Institutes of Health; Vaccination; vaccine candidate; vaccine development; vaccine trial; Vaccines; Venezuelan Equine Encephalitis Virus; Veterans; Virus; Vulnerable Populations; West Nile virus; Western Equine Encephalitis Virus

Phase II

Phase II year
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Phase II Amount
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