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Development of Third Ebola Vaccine Receives HHS Funding

Studies will prepare vaccine candidate for clinical trials

The Department of Health and Human Services (HHS) will provide approximately $5.8 million to Profectus BioSciences Inc. to accelerate the development of a vaccine to prevent Ebola virus disease.

The Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response is also providing expertise and technical assistance under a one-year contract with Profectus that can be extended to a total of 13 months and $8.6 million. The Baltimore company will manufacture vaccine for use in animal safety studies and future clinical trials and conduct animal studies to test safety.

Upon successful completion of this work, the company is expected to submit an investigational new drug application to the FDA that would allow the vaccine to begin the first clinical trials for safety in humans.

“We are pushing hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease,” said BARDA Director Robin Robinson, PhD. “Our goal is to close the global gap in vaccines and therapeutics needed to protect the public health from Ebola as highlighted by the epidemic in West Africa.”

The project builds on early research on this experimental vaccine supported by the National Institute of Allergy and Infectious Diseases (NIAID) and animal studies supported by the Department of Defense (DoD). In the DoD-supported studies, a single dose of the experimental Ebola vaccine provided 100% protection in nonhuman primates. BARDA will support further development of the vaccine against the Ebola virus strain responsible for the current epidemic.

Clinical trials are under way with other experimental vaccines. NIAID is supporting phase I clinical trials that examine an investigational Ebola vaccine developed by GlaxoSmithKline and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. Phase II clinical efficacy trials for these vaccine candidates are expected in 2015.

BARDA continues to explore measures to accelerate the manufacturing time for Ebola therapeutics and vaccines. The agency is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever.

Source: Department of Health and Human Services; October 16, 2014.

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