Hawaii Biotech, Inc. President and CEO Elliot Parks, Ph.D., announced today that the company has initiated a Phase 1 clinical study with their monovalent dengue vaccine candidate.
The double-blind, placebo controlled, dose escalation safety study in healthy subjects is being conducted at the Saint Louis University Center for Vaccine Development.
Vaccine recipients in this study will also be monitored for virus neutralizing antibodies. “This dengue clinical study is an important milestone in Hawaii Biotech’s maturation as a clinical stage company. In addition it confirms the versatility of our subunit vaccine technology platform,” Parks notes. “This Phase 1 study will also prepare us for the initial clinical testing of Hawaii Biotech’s tetravalent dengue vaccine.”
Hawaii Biotech’s dengue monovalent vaccine candidate is the first recombinant subunit vaccine for dengue to enter clinical studies. Previous dengue vaccine candidates tested in the clinic have been either live-attenuated or DNA-based vaccines.
Hawaii Biotech intends to test a dengue tetravalent vaccine candidate, developed using the company’s recombinant subunit vaccine technology, within a year.
The first phase of clinical development program is designed to assess safety, determine a dose range and identify potential side effects. Results from this clinical study are expected within a year.
Hawaii Biotech’s dengue subunit vaccine candidate has been developed with financial assistance from the National Institutes of Health, the Department of Defense, and the Pediatric Dengue Vaccine Initiative.
About Dengue: 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.
Dengue is caused by one of four closely related, but distinct, virus serotypes (DEN1, DEN2, DEN3, and DEN4), of the family Flaviviridae, which also includes yellow fever, West Nile, Japanese encephalitis, and tick-borne encephalitis viruses. Dengue is transmitted by the bite of a mosquito infected with any one of the four dengue viruses.
Infection with dengue virus results in severe flu-like symptoms that can lead to a life-threatening hemorrhagic fever. During the last quarter century, many tropical regions of the world have seen 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.
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