Central Kentucky Research Associates is one of eight American test sites for an Ebola vaccine that developers hope will help combat the outbreaks of the virus in West Africa by March.
Additional vaccine studies are underway, or planned to begin soon, at clinical research centers in Switzerland, Germany, Kenya and Gabon in an effort coordinated by the World Health Organization, and in Canada by the Canadian Immunization Research Network, according to a news release from pharmaceutical giant Merck, which became involved in the effort last week.
The vaccine that Central Kentucky Research Associates, or CKRA, will be testing was licensed by the Public Health Agency of Canada. CKRA was contracted through NewLink Genetics, an Iowa-based company. Merck and NewLink announced a partnership Nov. 24.
"There is a real race on to come up with a vaccine," said Dr. James Borders, a principal investigator at CKRA.
The Lexington company declined to disclose the cost of the trial in Kentucky. According to The Associated Press, NewLink announced in August that it received a $1 million contract from the U.S. Defense Threat Reduction Agency to help fund research leading up to human testing.
Borders also declined to say how much participants will be paid. A call for volunteers on the CKRA Facebook page did not disclose payment.
Other studies advertised on the CKRA website have a pay range of $40 to $50 a visit. While researchers pay for participation, they generally try to avoid money being the primary factor for volunteer involvement, Borders said.
There is a global interest in the vaccine, one of five being supported by several American federal health agencies, including the National Institutes of Health. The World Health Organization also is actively involved in the creation of the vaccine being tested in Kentucky. Talks are ongoing to test the vaccine in West Africa if the clinical trials prove successful, according to a new release from the National Institute of Allergy and Infectious Diseases.
The Ebola vaccine will work like all vaccines, Borders said. It will introduce a small amount of the attenuated virus into the body to trigger a response to help the immune system prepare for and protect against further exposure, Borders said. An attenuated virus is technically viable but has been weakened to the point it is harmless.
In vaccine being tested in Kentucky, an Ebola protein is inserted into the vesicular stomatitis virus, which primarily is found in cattle. The vaccine is officially known as VSV-ZEBOV
It already has been tested in primates.
The National Institutes of Health announced Nov. 28 that an initial trial of 20 people found all 20 developed anti-Ebola antibodies. The NIH reported no adverse effects from the vaccine.
Though there is a lot of misinformation and concern about the Ebola virus in the community, the research study is safe, Borders said.
The only health threat to study subjects should be minor flulike symptoms, he said, adding that participants would not be able to transmit the Ebola virus to others. Still, the study participants will receive the vaccine under strict restrictions to minimize any adverse effects, he said, adding that they can't work in health care, work around children or animals, or a have a person within their household with a suppressed immune system.
The protocol also dictates participants must take actions to prevent blood or body fluid exposure by using latex condoms during sexual activity and avoiding open mouth kissing for seven days after receiving the vaccine.
The first vaccines could be given next week, he said. The company has a database of participants in previous vaccine studies that will be contacted. Traditionally, many CKRA volunteers are University of Kentucky students, he said.
Early testing of the vaccine is promising, he said.
"It looks like it is going to be quite effective," he said. It's possible it can be effective not only as a preventative vaccine but also as a treatment once someone is infected.
Another Ebola treatment — Zmapp — also is being worked on in Kentucky. Kentucky BioProcessing, an Owensboro company, grew the ZMapp compound given to two American Ebola survivors. It has gone into full-scale production of the drug, which is derived from tobacco plants. Reynolds American owns the contract production facility where Zmapp is made.
Reynolds American spokesman David Howard said this week that the company was focusing on producing more ZMapp in the hopes of starting clinical trials for its use as an Ebola treatment.