Partnership with Hawaii Biotech Pursues Vaccine Against Ebola

The University of Hawaii John A. Burns School of Medicine is ready to move forward with human clinical trials for a vaccine to combat the deadly Ebola virus.

“Based on animal trials in mice, guinea pigs and monkeys, we have selected now a formulation we believe is worth testing in humans,” said Axel Lehrer, UH’s principal investigator. “We’re defining what will be most likely protective in humans.”

The medical school and Hawaii Biotech Inc. have formalized a partnership for the clinical development of a so-called trivalent vaccine that ultimately will protect against two other closely related filoviruses: the Sudan and Marburg viruses.

“Being able to protect against all three of these related viruses would be a major breakthrough,” said Elliot Parks, president and chief executive officer of Hawaii Biotech.

There are no vaccines to protect against Ebola licensed for use in humans, and clinical trials for several candidates are in various phases, according to the World Health Organization. Health officials are hoping for a safe and effective vaccine by the end of 2015, WHO said.

But reaching the clinical trials phase - a key milestone in vaccine development - is contingent upon obtaining $3 million to $5 million in government grants and contracts, Lehrer said, adding that “the time frame is entirely dependent on funding.” Once funding is obtained, human clinical trials are expected to start within 12 to 18 months.

The entire project, including clinical trials, is estimated at roughly $12 million.

UH researchers are focused on producing the protein that is a component of the virus that causes hemorrhagic fevers to induce immunity in animals and humans. It is the only vaccine that is “non-replicating,” meaning that it is not going to live in a patient.

“The unique benefit over the other vaccines out there is that this can be safely used in the entire spectrum of the population,” Lehrer said. “The other vaccines have viruses inoculated into the people (similar to influenza or flu vaccines). This is not a live vaccine.”

Additional vaccine efficacy studies would be conducted on the mainland at high-security bio-safety laboratories in Maryland, Texas and Montana.

“We’re not going to test it locally,” he said. “We cannot do these experiments here, and actually, we don’t want to. You will never be able to expose humans to a virus as deadly as Ebola. It’s not ethically feasible.”

Liberia has been declared free of the recent Ebola epidemic. The outbreak is ongoing in Guinea and Sierra Leone.

WHO rapidly moved several vaccines into clinical trials in West Africa in response to the Ebola outbreak last year. The vaccine candidates are being produced by GlaxoSmithKline, Johnson & Johnson and Merck.

In April the Centers for Disease Control and Prevention announced it was vaccinating about 6,000 health and other front-line workers as part of an Ebola vaccine trial in Sierra Leone.

Under the partnership, UH would work on research and development while Hawaii Biotech will use its commercial expertise in the manufacturing of the vaccine. The final patented product would be co-owned by both parties.

“The first generation of vaccines which have been developed to protect against one virus only is not on the market,” Lehrer said. “However, we are working on the next generation. We are behind but we have a unique advantage. This is why this vaccine is still in the running. Our ultimate goal is protecting against three viruses because we don’t know which one will cause the next major outbreak.”