ill provide important information on the safety of intravenous immunoglobulin G-containing antibodies to WNV for treatment of encephalitis," says study chair Richard Whitley, M.D., of the University of Alabama at Birmingham. In addition to determining if Omr-IgG-am is safe and well-tolerated, the study will collect information on the efficacy of this treatment in preventing death or neurologic disability. The study also will help researchers characterize the natural history of severe WNV infection.

The study seeks to enroll 100 hospitalized patients 18 years of age or older who have WNV-related encephalitis or are determined to be at risk of developing encephalitis based on clinical symptoms and the presence of antibodies to the virus. Patients will be assigned at random to one of three groups: those given standard intravenous immunoglobulin from U.S. sources (which has no detectable antibodies to WNV); those given Omr-IgG-am; or those given a placebo. Each participant will receive a single-dose infusion of drug or placebo and will be observed for the first week and then at days 7 and 14, and at 1 and 3 months.

Volunteers are being recruited through NIAID's Collaborative Antiviral Study Group (CASG), based at 35 sites around the country (for more information, see the CASG Web site at www.casg.uab.edu) and through the NIH Clinical Center in Bethesda, MD. More information on the trial and participating sites also can be found at www.clinicaltrials.gov. NIAID's Walla Dempsey, Ph.D., is project officer on the contract that funds the study.

Information about NIAID's research on WNV can be found at http://www.niaid.nih.gov/publications/wnile/default.htm.

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Contact: NIAID Office of Communications and Public Liaison
niaidnews@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
8-Sep-2003

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