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

Academic Article

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.
  • Published In

    Digital Object Identifier (doi)

    Author List

  • Gnann JW; Agrawal A; Hart J; Buitrago M; Carson P; Hanfelt-Goade D; Tyler K; Spotkov J; Freifeld A; Moore T
  • Start Page

  • 2064
  • End Page

  • 2073
  • Volume

  • 25
  • Issue

  • 11