'Aiea-based Hawaii Biotech Inc. has received U.S. Food and Drug Administration approval to begin early-phase human trials of a vaccine against the West Nile virus.

The trial, which would be conducted on 24 volunteers, is contingent on the company receiving an unspecified added investment.

Hawaii Biotech is among a host of companies working on a vaccine for the West Nile virus, which last year resulted in 3,404 incidents of disease and 98 deaths in the United States, according to the U.S. Centers for Disease Control and Prevention.

Hawaii Biotech President and Chief Executive Carolyn Weeks-Levy said the trial could be conducted on O'ahu, but would not reveal further details.

"This is a substantial milestone for the company as it is a novel vaccine candidate with which the FDA has had little experience," she said in a news release. "Receiving this notification from the FDA that we may proceed to human clinical trials is the first step in proving our technology in a clinical setting and to the scientific community."

Weeks-Levy would not discuss how much money the company needs to raise to conduct the trial. Late last year, Hawaii Biotech received $2.1 million in investments to finance clinical trials of West Nile vaccine and development of the company's dengue and seasonal flu programs. Investors, who received a new series of preferred stock, include Hawai'i investors and Chopin Opus One. Chopin Opus is a major shareholder in Brisbane, Australia-based Avantogen Ltd., which owns 48 percent of Hawaii Biotech.

Results of the Phase I trial of Hawaii Biotech's recombinant, subunit West Nile vaccine could be available by year's end depending on the trial's start date. Currently there are no approved vaccines for West Nile, which is a mosquito-borne disease that can cause life-threatening illness in humans, horses and birds. No cases have been reported in Hawai'i so far.

In addition to Hawaii Biotech, various U.S. universities also are conducting human trials of West Nile vaccines.

The company's major corporate competitors include U.K.-based Acambis, which is conducting phase II trials of a West Nile vaccine. France's Sanofi Pasteur has exclusive rights to market the vaccine in the United States.

Another company, Netherlands-based Crucell, is in phase I clinical trials of its West Nile vaccine.

Hawaii Biotech stands to benefit from Acambis' work with the FDA, Weeks-Levy said.

"Acambis really has forged the regulatory pathway to get a vaccine approved," she said. "I think that helps us because the FDA has already thought about it."

Hawaii Biotech hopes its West Nile vaccine will have a competitive edge for treatment of those age 50 and older, who are at highest risk of contracting West Nile virus.

"I believe that will be true," Weeks-Levy said. "I hope this technology works really well."

Reach Sean Hao at shao@honoluluadvertiser.com.