Lack of Efficacy of High-Titered Immunoglobulin in Patients with West Nile Virus Central Nervous System Disease

Details

• Alternative Title:
  Emerg Infect Dis
• Personal Author:
  Gnann, John W. ; Agrawal, Amy ; Hart, John ; Buitrago, Martha ; Carson, Paul ; Hanfelt-Goade, Diane ; Tyler, Ken ; Spotkov, Jared ; Freifeld, Alison ; Moore, Thomas ; Reyno, Jorge ; Masur, Henry ; Jester, Penelope ; Dale, Ilet ; Li, Yufeng ; Aban, Inmaculada ; Lakeman, Fred D. ; Whitley, Richard J.
• Corporate Authors:
  for the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group
• Description:
  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.
• Subjects:
  Central Nervous System Disease Encephalitis Flavivirus Immunoglobulin Lack Of Efficacy Of High-Titered Immunoglobulin In Patients With West Nile Virus Central Nervous System Disease Neuroinvasive Disease Omr-IgG-am Polygam Research Viruses West Nile Virus WNV

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• Source:
  Emerg Infect Dis. 25(11):2064-2073
• Pubmed ID:
  31625835
• Pubmed Central ID:
  PMC6810207
• Document Type:
  Journal Article
• Place as Subject:
  North America
• Location:
  North America
• Volume:
  25
• Issue:
  11
• Collection(s):
  Emerging Infectious Diseases
• Main Document Checksum:
  urn:sha256:7258a240302fc06e7c760a53d342cfa1b71549bcf85de30a01b1dee746902c4b
• Download URL:
  https://stacks.cdc.gov/view/cdc/83001/cdc_83001_DS1.pdf
• File Type:
  [PDF - 1004.41 KB ]