In response to the "devastating epidemic" in West Africa Ebola, US National Institutes of Health ( NIH) Director Francis Collins announced "extraordinary measures to accelerate vaccine clinical trials."
During a conference call this morning, Collins and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH, described several studies of different human Ebola vaccine that will begin in the coming months. None of these clinical trials will determine whether vaccines work. Instead, the goal will be to determine if they are safe and stimulating immune responses. Several Ebola vaccines have been tested in humans, but none has advanced large-scale efficacy studies.
The first trial will begin next week at the NIH Clinical Center in Bethesda, Maryland. The vaccine, a vaccine developed by GlaxoSmithKline, Research Center, NIAID contains genes for surface protein from two strains of the Ebola virus, including the Zaire now sewn West Africa in an adenovirus that infects chimpanzees. As explained Fauci, the chimpanzee adenovirus does not copy, but acts as a vehicle and provides Ebola genes to human cells, which must then make proteins that trigger an immune response. The vaccine has shown "very good protection" in monkey tests, Fauci noted.
This first study will involve 20 volunteers who will receive the vaccine at two different doses. Fauci said researchers hope to have initial data available by the end of the year, although the study will follow participants for 48 weeks. In October, NIAID will begin testing with a simpler version of the same monovalent vaccine containing only a surface protein gene of the Zaire strain of Ebola virus.
Fauci said testing monovalent vaccine soon begin in England, Mali and Gambia in collaboration with a consortium in the UK which includes the Wellcome Trust and the Medical Research Council of this country. These same tests that test the safety and immune responses. The three studies all involve 140 people.
Mali and Gambia currently has no cases of Ebola, and Fauci said they were chosen because they had the infrastructure to carry out the studies. The three West African countries most affected by the current outbreak, Liberia, Guinea and Sierra Leone- "would not allow the kind of careful Phase I want to do," said Fauci. Nigeria, which is also affected by the current epidemic is another possible site for the live vaccine studies I, he added.
a phase I study with a different vaccine, one that uses the vesicular stomatitis virus as a vector to deliver genes Ebola, also will begin this fall, Fauci said. human trials of this vaccine, developed by public health Agency of Canada, will be held at the Walter Reed Army Institute of research in Silver Spring, Maryland.
Fauci stressed that these first small studies are designed to ensure that these potential vaccines do not cause damage. "I fooled enough in my many years of experience in infectious diseases and vaccinology that you can not really predict what you might see, "said Fauci. "The worst thing ... is to leave something well before you've even tested a minimum of security. This would violate the scientific principles and, in many ways, even ethical principles "
* Ebola files :. Given the current Ebola epidemic, unprecedented in terms of number of people killed and the rapid geographic spread, science and science Translational Medicine made a collection of research articles and news on the viral disease available for researchers and the general public.
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