HONOLULU — Hawaii Biotech Inc. announced Jan. 7 that it has completed recruitment and dosing in a multiple dose Phase 1 clinical study of its dengue virus monovalent vaccine.
The double-blind, placebo-controlled, dose escalation safety study in healthy subjects is being conducted at the St. Louis University Center for Vaccine Development. Vaccine recipients in this study are being monitored for safety as well as for development of virus neutralizing antibodies.
President and CEO Elliot Parks indicated that preliminary safety results and immunologic data from the healthy volunteers treated with three doses of the vaccine would be available later this quarter. Complete results are expected to be announced by fourth quarter 2010.
Hawaii Biotech is developing a dengue virus sub-unit vaccine designed with high fidelity to the native viral antigens in order to provide protective immunity to the recipients. The vaccine is nonreplicating and designed to be safer than live-attenuated vaccines, the company says.
Dengue, also known as "break-bone fever," is a prevalent infectious disease in tropical and subtropical countries throughout the world. Approximately 3.5 billion people live in endemic countries and about 100 million people are infected with dengue every year. Dengue infections result in an estimated 20,000 deaths.
During the past 25 years, many tropical regions have experienced an increase in dengue cases. The southern United States is potentially susceptible to dengue epidemics as the types of mosquitoes that transmit dengue virus are prevalent there. Dengue cases were reported in southern Florida in late 2009.
Hawaii Biotech recently successfully completed a Phase 1 clinical trial of its West Nile vaccine in healthy human subjects. The company is in pre-clinical development with a vaccine for tick-borne encephalitis. HBI's product pipeline also includes vaccine candidates for malaria and influenza.