Lack of efficacy of high-titered immunoglobulin in patients with West Nile virus central nervous system disease

the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group

Research output: Contribution to journalArticle

1 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2064-2073
Number of pages10
JournalEmerging infectious diseases
Volume25
Issue number11
DOIs
StatePublished - 2019

ASJC Scopus subject areas

  • Epidemiology
  • Microbiology (medical)
  • Infectious Diseases

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    the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group (2019). Lack of efficacy of high-titered immunoglobulin in patients with West Nile virus central nervous system disease. Emerging infectious diseases, 25(11), 2064-2073. https://doi.org/10.3201/eid2511.190537