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West Nile vaccine to enter clinical trial

The trial will determine the safety of the vaccine, as well as measure the response of participant's immune systems to the inactivated virus.

By Stephen Feller

BETHESDA, Md., July 6 (UPI) -- The National Institutes of Health announced a clinical trial to test the safety of a West Nile vaccine in humans after it successfully protected mice from lethal doses of the virus in lab tests.

Researchers at Oregon Health and Science University had been working on the vaccine for the mosquito-borne disease since 2009.

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"Since first appearing in the United States in 1999, West Nile Virus has emerged as an important health threat in this country," said Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, in a press release. "NIAID is committed to research efforts to advance a preventive vaccine that could protect people against West Nile Virus infection."

In 2014, 2,205 cases of West Nile were reported and 97 deaths were attributed to the virus in the U.S., bringing the total number of cases since 1999 to 41,762 and the total number of deaths in that time to 1,765. The majority of people infected show no symptoms, however 1 in 5 experience symptoms that include fever, headache, body aches, nausea, and vomiting. The elderly and other immunocompromised people are most at risk for illness or death from the virus.

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The Phase 1 trial, which will determine the safety of the vaccine in humans, as well as its ability to produce an immune response, will be conducted at Duke University with 50 healthy men and women between the ages of 18 and 50.

Volunteers will be split into three groups: one receiving a low dose, one being given a high dose, and the rest taking a placebo. In total, 40 of the 50 participants will receive the actual vaccine. Researchers will then track the participants for 14 months.

The vaccine, called HydroVax-001, contains inactivated virus cells incapable of infecting a host but still able to trigger immune system responses expected to protect the body from West Nile. Because the vaccine contains inactivated cells, it will be usable in a wide array of people, including those with compromised immune systems.

Enrollment in the trial is expected to be completed by December 2015.

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