A small number of Ebola vaccines will be rushed to clinical trials so that they can become available to curb the spread of Ebola virus disease soon. NewLink Genetics Corp has a licensed Ebola vaccine already and they will launch a human safety clinical trial this summer using the stock of the vaccine they already have on hand. This Canadian company has already contracted two manufacturing companies so that tens of thousands of doses of the vaccine can be produced within the next two months to make sure they can complete the clinical trials.
Another company, BioProtection Systems Corp, was given $1 million from the United States Defense Threat Reduction Agency to carry our pre-clinical toxicology tests on the vaccine. They will also speed up manufacturing to assist with getting clinical trials started soon.
GlaxoSmithKline, a British pharmaceutical company, is working on getting approval from the U.S. Food and Drug Administration (FDA) to start a clinical trial on a vaccine it has developed. It hopes to begin the clinical trial by next month. They are working in collaboration with the Vaccine Research Center at the National Institutes of Health to get a Phase 1 clinical trial initiated.
Another vaccine called ZMapp, developed by the biotechnology company Mapp Biopharmaceutical, is available and has already been used on three people who contracted Ebola virus disease. Two cases have been reported to have shown improvement and the third person has died.
The rush to get the Ebola vaccine into clinical trials comes from the Ebola virus disease outbreak that is occurring in West Africa. Over 1,000 cases of Ebola virus disease have been confirmed so far. Ebola virus disease has a 90 percent fatality rate and the symptoms of the disease are bleeding, diarrhea, high fever and vomiting.
There has been consideration of who would participate in these early clinical trials of the Ebola virus vaccines. The U.S. Centers for Disease Control and Prevention (CDC), Walter Reed Army Medical Center and the National Institutes of Health are in discussions about recruiting volunteers for the clinical trials. Medical workers who would likely work with Ebola virus disease patients and military personnel are considered to be likely participants in the studies. The FDA is said to be highly supportive of these efforts. Both the United States and West Africa may be sites for the clinical trials of the Ebola vaccines.
The NewLink Ebola vaccine employs a “weakened” version of a pathogen called vesicular stomatitius virus that has a gene replaced by a gene from the Ebola virus as the active agent in the vaccine. After this modified virus is injected into the body, the immune system recognizes the actual Ebola protein as foreign and makes antibodies to destroy it.
The World Health Organization (WHO) has already convened an ethics panel to discuss the ethical implications of offering an Ebola vaccine early; that is, without full, long-term testing, and the panel gave a statement of approval. If these rushed clinical trials for an Ebola virus vaccine are successful, the hope is they will become available for general use by 2015.
By Margaret Lutze