ACUVAX says its US-based subsidiary, Hawaii Biotech, launched the Phase 1 study of its dengue fever vaccine candidate this week.

The double-blind, placebo-controlled, dose-escalation safety study in healthy subjects is being conducted at the St Louis University Center for Vaccine Development in the United States.

While the end points for the trial primarily surround the safety of the monovalent vaccine, which is based on Hawaii Biotech’s recombinant DNA technology platform, the patients enrolled in the study will also be monitored for their development of virus neutralising antibodies in response to the vaccine.

Hawaii Biotech has received funding for its dengue fever program from the US National Institutes for Health, the Pediatric Dengue Vaccine Initiative (which is funded by the Bill and Melinda Gates Foundation), and the company said last year that the US Army also contributed resources to the program.

In September 2008, Hawaii Biotech announced that researchers at the Walter Reed Army Institute of Research would help the company design the Phase 1 program and contribute to the “thought leadership” on the project.

Hawaii Biotech chief executive Dr Elliot Parks said in a statement yesterday that the trials confirmed the versatility of Hawaii’s subunit vaccine technology platform.

“This Phase 1 study will also prepare us for the initial clinical testing of Hawaii Biotech’s tetravalent dengue fever vaccine,” he said.

Hawaii Biotech’s dengue monovalent vaccine candidate is the first recombinant subunit vaccine for dengue to enter clinical studies, according to the company. It intends to test a dengue tetravalent vaccine candidate, developed with recombinant subunit vaccine technology, within a year.

According to the company, dengue fever is a significant disease in tropical and subtropical countries, with around 100 million people infected each year.

Acuvax owns around 40% of Hawaii Biotech, and last week announced that its Adelaide-based immunology subsidiary was about to in-licence a suite of recombinant DNA technologies for further development.

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