This undated photo made available by the Antwerp Institute of Tropical Medicine in Antwerp, Belgium, shows the Ebola virus viewed through an electron microscope. The World Health Organization on Friday, Aug. 8, 2014 declared the Ebola outbreak in West Africa to be an international public health emergency that requires an extraordinary response to stop its spread. (AP Photo/Antwerp Institute of Tropical Medicine) ORG XMIT: VLM101 / AP
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, said NIH director Francis Collins, who said the agencies have taken "extraordinary measures" to launch the study as quickly as possible.
"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 using traditional methods, such as diagnosing cases, isolating those individuals to prevent them from infecting others, tracing their contacts and testing those people for the disease, as well.
Fauci has previously said that even an experimental vaccine would not be available until the middle of next year. The World Health Organization announced Thursday that it could take six to nine months to contain the current outbreak in Guinea, Sierra Leone, Liberia and Nigeria, and that the outbreak could grow to 20,000 cases.
In a significant announcement, Fauci said that drug giant GlaxoSmithKline (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 two very basic questions about the vaccine. 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 vaccine will use a monkey cold virus as a "vector" to deliver Ebola genes to the body. Cold viruses are notoriously good at infecting the body, so they make good delivery vehicles. The viruses act only like delivery trucks, and cannot cause harm. 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. Those antibodies would protect against a real infection, if the person were to be exposed to Ebola.
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.
Based on early results, scientists will be able to assess whether to go ahead with larger studies. The vaccine already has performed well in tests in animals, protecting them against Ebola infections.
Volunteers will be evaluated by NIH staff nine times over 48 weeks, Fauci says. To ensure safety of the volunteers - all healthy adults - scientists will give the vaccine to just three people at a time, pausing the trial to check for safety before vaccinating additional volunteers. Safety is "paramount" when testing an experimental drug against healthy people who are not sick or in danger.
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.
That vaccine also will be tested in the United Kingdom and the African countries of Mali and Gambia, 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.
In addition, the Centers for Disease Control and Prevention has begun talks with the Nigeria's ministry of health to conduct vaccine tests there, Fauci said. The CDC has not yet announced which vaccine it will test in Nigeria.
"We will share data from our studies as quickly as they become available," Fauci said.
The USA has been working on an Ebola vaccine partly to protect against a bioterrorist attack.
The experimental vaccine set to be tested next month was designed by scientist Nancy Sullivan, chief of the biodefense research section in the National Institute of Allergy and Infectious Disease's Vaccine Research Center. She worked with researchers at the U.S. Army Medical Research Institute of Infectious Diseases, and Okairos, a Swiss-Italian biotechnology company bought by GSK last year.
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