August 29, 2014
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20 healthy people will participate in first human test
U.S. health officials announced that the first human trial of an experimental Ebola vaccine will start next week and that trials of other vaccines will follow close on its heels.
The vaccine trial will involve 20 healthy volunteers at the campus of the National Institutes of Health in Bethesda, Md., with results expected by the end of the year, said Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Disease.
Although NIH has been developing the vaccine for more than a decade, the public health emergency in West Africa has pushed both the NIH and the Food and Drug Administration to accelerate its development, NIH director Francis Collins said.
"This is a public health emergency that demands an all-hands-on-deck response," Fauci said.
Fauci called the Ebola epidemic, which has killed half of the 3,000 people infected, an "uncontrolled outbreak" that needs to be contained with traditional control methods as well.
Fauci has previously said that even an experimental vaccine would not be available until the middle of next year.
In a significant announcement, Fauci said that drug giant Glaxo-SmithKline (GSK) will co-develop the vaccine. That will make it much easier to "scale up" production of large quantities of the vaccine if it proves effective, Fauci said. He noted that it has been difficult to produce enough doses of an experimental medication, called ZMapp, which is being developed by a small San Diego biotech company. That company has said that it has given away all of its doses and has none left.
Fauci stressed that the phase 1 study—the earliest of all human tests—is aimed at answering: Is the vaccine safe? Does it provoke the immune system to respond to Ebola? Scientists will be able to gauge the vaccine's prospects for preventing infection by measuring whether a volunteer's immune system mounts a strong response to the Ebola genes in the vaccine.
The Ebola genes carried in those viruses can't cause someone to become sick with Ebola, Fauci said. But the genes would direct volunteers' bodies to create one Ebola protein. If the body recognizes that protein as foreign and dangerous, the immune system should create antibodies against it. The vaccine is designed to protect against two strains of Ebola virus, known as the Zaire and Sudan species. The current outbreak in West Africa is caused by the Zaire strain.
Another U.S.-based vaccine study, also using 20 volunteers, will test a vaccine that protects against just the Zaire strain of the virus. That trial also will be conducted at NIH and is set to begin in October, Fauci said.
NIH scientists also are working with the Department of Defense on an early-stage trial of a third Ebola vaccine, developed by the Public Health Agency of Canada and licensed to NewLink Genetics. That trial will begin this fall at Walter Reed National Military Medical Center.
"We will share data from our studies as quickly as they become available," Fauci said.
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