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Human Ebola Vaccine Trials to Begin

  • Joe DeCapua

U.S. health officials announced Thursday the launch of the first human testing of a vaccine to prevent Ebola. The vaccine candidate was co-developed by the National Institute of Allergy and Infectious Diseases - and the pharmaceutical company GSK (GlaxoSmithKline).

Dr. Anthony Fauci says vaccine research has accelerated since the Ebola epidemic was first reported in West Africa last March.

"We are announcing the opening of a small human safety study of an investigational Ebola vaccine candidate that will be tested here at the NIH," he said. "This is the first of several Phase One clinical trials of Ebola vaccine candidates that we are set to launch."

Fauci is the head of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. He describes the West Africa Ebola outbreak as a “public health emergency that demands an all hands on deck response.”

"We have accelerated the time line for testing experimental Ebola vaccines that we have been developing for several years," he said. "And after an expedited review of the candidate product and clinical trial design by the United States Food and Drug Administration we have the green light to begin."

He says the trials will be based on three earlier versions of Ebola vaccine candidates. Those trials led to the vaccine that is now being studied. Next week, the first three volunteers will be enrolled in a study known as VRC207.

"The trial aims to enroll 20 healthy adults - ages 18 to 50 years - at the NIH Clinical Research Center here in Bethesda, Maryland," he said. "The study will evaluate the experimental vaccine’s safety and whether it generates an immune response in healthy adults that - based on our animal studies - could predict effectiveness in preventing the acquisition of Ebola infection."

Fauci says earlier studies of the experimental vaccine performed extremely well in protecting primates from Ebola infection. The current vaccine candidate uses a chimpanzee cold virus. The virus carries a gene related to the surface protein of the Zaire and Sudan strains of the Ebola virus. The Zaire strain is blamed for the West Africa epidemic.

"It is important to know that the Ebola gene contained in the investigational vaccine cannot cause a vaccinated individual to become infected with Ebola," he said. "The volunteers in the VRC207 trial will be divided into two groups to test first a lower and then a higher does of the vaccine.

The vaccine will be administered through an injection in the arm. The trial is scheduled to last 48 weeks, but initial findings could be available by the end of this year.

In October, a second trial will begin in the U.S., Britain, Mali and The Gambia to test a vaccine candidate that contains genetic material from only one of the Ebola strains.

Fauci says despite the vaccine research, precaution and prevention are the best defense right now against the disease.

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