NIAID to test immunoglobulin for West Nile encephalitis

Sep 9, 2003 (CIDRAP News) – The National Institute of Allergy and Infectious Disease (NIAID) yesterday announced a clinical trial to assess whether a new immunoglobulin product can alleviate or prevent encephalitis in patients infected with West Nile virus (WNV).

Plans call for recruiting 100 WNV patients for treatment with a product that contains antibodies to WNV, the NIAID announced. The product was derived from the plasma of Israeli blood donors who have high levels of antibodies to WNV, which is endemic in Israel. Called Omr-IgG-am, the product is made by an Israeli company, Omrix.

"Currently, clinicians can provide only supportive care for patients infected with WNV," said NIAID Director Anthony S. Fauci, MD, PhD, in a news release. "We hope that the results from this study will ultimately give physicians and their patients a useful treatment option."

Severe neurologic disease—encephalitis or meningitis—occurs in about 1 of every 150 people infected with WNV, according to the Centers for Disease Control and Prevention. Advanced age is the leading risk factor. As of yesterday, 2,568 cases of WNV with 47 deaths had been reported so far this year, according to the CDC.

"This study will provide important information on the safety of intravenous immunoglobulin G–containing antibodies to WNV for treatment of encephalitis," said study chair Richard Whitley, MD, of the University of Alabama at Birmingham. The trial also aims to assess the efficacy of the product and yield information on the natural history of severe WNV infection.

The researchers seek to enroll 100 hospitalized adult patients who have WNV encephalitis or are determined to be at risk for it, the agency said. The patients will be randomly assigned to treatment with either a standard immunoglobulin, Omr-IgG-am, or a placebo.

Volunteers will be recruited through NIAID's Collaborative Antiviral Study Group, based at 35 sites around the country, and at the National Institutes of Health Clinical Center in Bethesda, Md. Participating institutions are in Alabama, California, Colorado, the District of Columbia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Texas, and Virginia.

See also:

NIAID news release
http://www.niaid.nih.gov/news/newsreleases/2003/Pages/wnv_trials.aspx

More details on the trial, including enrollment criteria and participating sites
http://www.clinicaltrials.gov/ct/show/NCT00068055?order=1

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