Axel Lehrer was the expert Hawaiʻi media turned to when ebola struck last year.

The John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa and Hawaiʻi Biotech, Inc. (HBI) have agreed to partner in the clinical development of a filovirus vaccine. The first generation recombinant subunit vaccine is aimed at providing protection against infection by the Ebola virus. There are currently no vaccines licensed for use against Ebola Virus Disease and other diseases caused by closely related viruses. Ebola vaccine candidates currently in clinical development have yet to demonstrate safety and efficacy in humans to gain regulatory approval.

Bringing vaccine into clinical studies

The filovirus vaccine was originally developed by Axel Lehrer and others at HBI while Lehrer was an employee with the company. Last year, Lehrer assumed a position with UH Mānoa, which allowed him to continue his important work on the development of the vaccine candidate within the JABSOM Department of Tropical Medicine, Medical Microbiology and Pharmacology. Based upon promising results from testing the recombinant Ebola vaccine candidate in animal models (this testing occurred on the U.S. mainland via collaborations with several biosafety laboratories) and the renewed interest in a safe and effective Ebola vaccine triggered by the current Ebola outbreak in West Africa, JABSOM, UH Mānoa and HBI have agreed to join forces to bring this vaccine into clinical studies. While the initial vaccine to be tested in humans is designed to protect against the Ebola virus alone, research at JABSOM and HBI is underway to formulate a trivalent vaccine that will also protect against two other closely related filoviruses, the Sudan virus and the Marburg virus.

“This partnership will leverage the research capability and the expertise in tropical medicine here at JABSOM with HBI’s experience in developing commercially viable vaccines against viruses that infect humans,” said Vivek R. Nerurkar, professor and chair of the Department of Tropical Medicine, Medical Microbiology and Pharmacology and director of the JABSOM Biocontainment Facility at UH Mānoa.

“We are delighted to be working closely with the Department of Tropical Medicine at UH Mānoa and contributing our long-standing experience in developing subunit vaccines to protect against hemorrhagic and neuro-invasive viruses,” said Elliot Parks, CEO of HBI. “Ours is a productive partnership with UH Mānoa which mutually strengthens our respective contributions to this joint vaccine development program. This joint collaboration furthers our goal to continue development of vaccines for emerging infectious diseases.”

Goal is a safe and effective Ebola vaccine

Under this partnership, HBI will contribute commercial expertise in the manufacture of this vaccine and its components, quality assurance and control, clinical conduct, and regulatory affairs. The ultimate goal is a safe and effective Ebola vaccine to protect humans from this dangerous, and too often lethal, virus causing hemorrhagic fevers.

Lehrer, the principal investigator, added, “I am pleased to have the opportunity to continue research on this vaccine candidate within the Department of Tropical Medicine, Medical Microbiology and Pharmacology at UH Mānoa. Retaining a relationship with HBI and its talented team whom I know well will help to assure continuity with the advanced development activities. HBI’s commercial sensibilities will complement the academic research environment at UH Mānoa”.

—By Tina Shelton