On October 13th, researchers began testing a potential Ebola vaccine, called the VSV Ebola vaccine or BPSC1001, at the Walter Reed Army Institute of Research in Silver Spring, Maryland.
WRAIR’s Clinical Trials Center, part of the Translational Medicine Branch, is testing the Ebola vaccine candidate in healthy human volunteers. Although the trial’s focus is safety, researchers are evaluating how the immune system responds to the vaccine.
Researchers emphasize that the vaccine being tested cannot transmit the actual Ebola virus.
The vaccine is a combination of a part of the Ebola virus (only a gene for the protein covering, not the virus itself) and parts of another virus called vesicular stomatitis virus or VSV. VSV is not a human pathogen. However, VSV can help stimulate the human immune system to respond to the vaccine. The gene for the protein covering of Ebola may make VSV look enough like Ebola for the human immune system to be prepared for an actual exposure to Ebola and to stop infection.
“This is the first-in-human study for the VSV Ebola vaccine. We remain hopeful that the vaccine will progress quickly through the product development pipeline and are pleased to be a part of the development team,” said Colonel Shon Remich, director of Translational Medicine.
Scientists at the Public Health Agency of Canada’s National Microbiology Laboratory originally developed the VSV Ebola vaccine. The Canadian government owns the intellectual property associated with this vaccine and has licensed the rights to NewLink Genetics through its wholly owned subsidiary BioProtection Systems. The U.S. Defense Threat Reduction Agency is working with BioProtection Systems to further develop the product for use in humans.
“The Government of Canada is committed to supporting efforts to control the Ebola outbreak and hopes that advancing research on this experimental vaccine will be able to help address this global crisis,” said Canada’s Minister of Health Rona Ambrose. “These clinical trials are an important step in addressing some of the ethical considerations around providing an experimental vaccine to assist in controlling the outbreak.”
The Public Health Agency of Canada has a small supply of experimental vaccine, around 1,500 doses, and has made available the 20 vials required for the WRAIR clinical trials.
This vaccine has been tested preclinically, including studies at the US Army Medical Research Institute of Infectious Disease (USAMRIID), where studies showed the vaccine protected animals against Ebola disease. The vaccine has also been used as an emergency measure for two cases where a person was accidentally exposed to the Ebola virus, a treatment called post-exposure prophylaxis and also the indication currently under review by the US Food and Drug Administration. Since these emergency measures have been taken in very few individuals, there is little known about the effectiveness of the vaccine in humans. The FDA has reviewed and approved the vaccine for actual testing in humans based on outcomes from the animal studies.
WRAIR researchers say initial human testing of the VSV Ebola vaccine is only the first step in a process which may ultimately lead to larger studies in humans domestically and abroad, culminating in a licensed product.
In addition to this safety study of the VSV vaccine at WRAIR’s Clinical Trials Center, the National Institute of Allergy and Infectious Disease will soon begin a parallel human study of a similar Ebola vaccine to determine whether a special boost strategy for dosing will be safe and enhance the human immune responses when compared to single dosing. See the NIAID site for news release for more detail at http://www.niaid.nih.gov/news/newsreleases/2014.
About the Walter Reed Army Institute of Research
Headquartered in Silver Spring, Maryland and established in 1893, the Walter Reed Army Institute of Research (WRAIR) is the oldest, largest, and the most programmatically diverse military research institute of the US Army Medical Research and Materiel Command and Department of Defense. With four overseas research units in Thailand, Germany, Kenya and Georgia, WRAIR is comprised of two Centers of Excellence, the Center for Infectious Disease Research and the Center for Military Psychiatry and Neuroscience.