NIH to Start Human Testing of Ebola Vaccine Next Week

The initial testing will be conducted by the National Institute of Allergy and Infectious Diseases, part of NIH.

Human testing of an investigational vaccine to prevent Ebola virus disease will begin next week and will be conducted by the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. This early-stage trial is the initial human testing of an experimental vaccine co-developed by NIAID and GlaxoSmithKline; it will evaluate the vaccine's safety and its ability to generate an immune system response in healthy adults. The testing will take place at the NIH Clinical Center in Bethesda, Md.

It is the first of several Phase 1 clinical trials that will examine the vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada that is licensed to NewLink Genetics Corp. The other trials will begin this fall. NIH announced the trial Aug. 28, saying it has partnered with a British-based international consortium that includes the Wellcome Trust and Britain's Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali.

The U.S. Centers for Disease Control and Prevention is discussing the possibility of a Phase 1 study with Ministry of Health officials in Nigeria, as well.

"There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection," said NIAID Director Dr. Anthony S. Fauci, M.D. "The NIH is playing a key role in accelerating the development and testing of investigational Ebola vaccines. Today, we know the best way to prevent the spread of Ebola infection is through public health measures, including good infection control practices, isolation, contact tracing, quarantine, and provision of personal protective equipment. However, a vaccine will ultimately be an important tool in the prevention effort. The launch of Phase 1 Ebola vaccine studies is the first step in a long process."

According to NIH, the investigational vaccine now entering Phase 1 trials was designed by Nancy J. Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID's Vaccine Research Center, who collaborated with researchers there and at the U.S. Army Medical Research Institute of Infectious Diseases and Okairos, a Swiss-Italian biotechnology company acquired by GSK in 2013. The vaccine "is based on a type of chimpanzee cold virus, called chimp adenovirus type 3 (ChAd3). The adenovirus is used as a carrier, or vector, to deliver segments of genetic material derived from two Ebola virus species: Zaire Ebola and Sudan Ebola. Hence, this vaccine is referred to as a bivalent vaccine. The Zaire species of the virus is responsible for the current Ebola outbreak in West Africa," NIH said in its news release.

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