'Aiea-based Hawaii Biotech is moving forward with human testing of a vaccine it is developing against the West Nile virus.

The study involves healthy subjects taking the vaccine as part of the study required by the U.S. Food and Drug Administration.

The first phase of a clinical development program is designed to assess safety, determine a dosage range and identify potential side effects.

The Hawaii Biotech West Nile vaccine candidate is designed to provide protective immunity, according to Hawaii Biotech.

"We did the first dose on the first patient right after Memorial Day," said Elliot Parks, company president and chief executive officer.

Parks said the next phases involve volunteers taking higher doses now that the first group of subjects has finished the first dose and a follow-up repeat of the same amount.

The second group in the trial — taking a larger dose — begins two weeks from today, Parks said.

West Nile virus is a disease carried by insects that can cause life-threatening illness in humans, horses and birds and has killed almost 800 people in the United States since it was first detected in this country in 1999.

Hawaii Biotech is a privately held biotechnology company focused on research and development of vaccines for emerging infectious diseases including West Nile virus and influenza.

According to the federal Centers for Disease Control and Prevention, cases of West Nile infections in humans have been reported in all states except Hawai'i, Alaska and Maine. The virus also has been reported in Europe, west and central Asia, Oceania, Africa and the Middle East.

Parks said it will take five to six months to get "from the beginning of the first patient to the last dose on the last patient."

What's it like for study volunteers? "It's akin to a flu shot," Parks said. "They have a diary that they fill out," where they record whether they had pain or a fever or any reactions.

This clinical study is using volunteers in four treatment groups in Honolulu.

Parks said the study is "an important milestone in Hawaii Biotech's maturation into a clinical stage company."

The results should be known within a year, he said.

He said the vaccine for the current trial was manufactured in two places, one in the United Kingdom and the other in Massachusetts.

The company also is developing vaccines for dengue virus and seasonal and pandemic influenza.

"This sets the stage for us to do our clinical trial on another vaccine, dengue," Parks said. "We expect to be doing that within the year."

For more information on the Web, visit Hawaii Biotech at www.hibiotech.com.