[Source: US Centers for Disease Control and Prevention (CDC), Emerging Infectious Diseases Journal, full page: (LINK). Abstract, edited.]
Volume 25, Number 11—November 2019 / CME ACTIVITY – Research
Lack of Efficacy of High-Titered Immunoglobulin in Patients with West Nile Virus Central Nervous System Disease
John W. Gnann , Amy Agrawal, John Hart, Martha Buitrago, Paul Carson, Diane Hanfelt-Goade, Ken Tyler, Jared Spotkov, Alison Freifeld, Thomas Moore, Jorge Reyno, Henry Masur, Penelope Jester, Ilet Dale, Yufeng Li, Inmaculada Aban, Fred D. Lakeman, Richard J. Whitley , and for the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group
Author affiliations: University of Alabama at Birmingham, Birmingham, Alabama, USA (J.W. Gnann, Jr., P. Jester, I. Dale, Y. Li, I. Aban, F.D. Lakeman, R.J. Whitley); National Institutes of Health Clinical Center, Bethesda, Maryland, USA (A. Agrawal, H. Masur); University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA (J. Hart); Idaho Falls Infectious Diseases PLLC, Idaho Falls, Idaho, USA (M. Buitrago); North Dakota State University, Fargo, North Dakota, USA (P. Carson); University of New Mexico, Albuquerque, New Mexico, USA (D. Hanfelt-Goade); University of Colorado at Denver Anschutz Medical Campus, Aurora, Colorado, USA (K. Tyler); Kaiser Permanente South Bay Medical Center, Harbor City, California, USA (J. Spotkov); University of Nebraska Medical Center, Omaha, Nebraska, USA (D. Freifeld); Via Christi Hospital St. Francis, Wichita, Kansas, USA (T. Moore); Infectious Diseases Consultations, Rapid City, South Dakota, USA (J. Reyno)aurie Barclay, MD, freelance writer and reviewer, Medscape, LLC. Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.
West Nile Virus (WNV) can result in clinically severe neurologic disease. There is no treatment for WNV infection, but administration of anti-WNV polyclonal human antibody has demonstrated efficacy in animal models. We compared Omr-IgG-am, an immunoglobulin product with high titers of anti-WNV antibody, with intravenous immunoglobulin (IVIG) and normal saline to assess safety and efficacy in patients with WNV neuroinvasive disease as part of a phase I/II, randomized, double-blind, multicenter study in North America. During 2003–2006, a total of 62 hospitalized patients were randomized to receive Omr-IgG-am, standard IVIG, or normal saline (3:1:1). The primary endpoint was medication safety. Secondary endpoints were morbidity and mortality, measured using 4 standardized assessments of cognitive and functional status. The death rate in the study population was 12.9%. No significant differences were found between groups receiving Omr-IgG-am compared with IVIG or saline for either the safety or efficacy endpoints.
Keywords: West Nile Virus; WNND; Immunoglobulins.