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

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 - Jan 1 2019

Fingerprint

West Nile virus
Central Nervous System Diseases
Immunoglobulins
Intravenous Immunoglobulins
Immunoglobulin G
Virus Diseases
Safety
Mortality
Antibodies
North America
Nervous System Diseases
Double-Blind Method
Multicenter Studies
Animal Models
Morbidity
Population

ASJC Scopus subject areas

  • Epidemiology
  • Microbiology (medical)
  • Infectious Diseases

Cite this

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

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.

In: Emerging infectious diseases, Vol. 25, No. 11, 01.01.2019, p. 2064-2073.

Research output: Contribution to journalArticle

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, vol. 25, no. 11, pp. 2064-2073. https://doi.org/10.3201/eid2511.190537
the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Lack of efficacy of high-titered immunoglobulin in patients with West Nile virus central nervous system disease. Emerging infectious diseases. 2019 Jan 1;25(11):2064-2073. https://doi.org/10.3201/eid2511.190537
the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. / Lack of efficacy of high-titered immunoglobulin in patients with West Nile virus central nervous system disease. In: Emerging infectious diseases. 2019 ; Vol. 25, No. 11. pp. 2064-2073.
@article{d365acbd5f174a12a43b276a158949eb,
title = "Lack of efficacy of high-titered immunoglobulin in patients with West Nile virus central nervous system disease",
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.",
author = "{the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group} and Gnann, {John W.} and Amy Agrawal and John Hart and Martha Buitrago and Paul Carson and Diane Hanfelt-Goade and Ken Tyler and Jared Spotkov and Alison Freifeld and Thomas Moore and Jorge Reyno and Henry Masur and Penelope Jester and Ilet Dale and Yufeng Li and Inmaculada Aban and Lakeman, {Fred D.} and Whitley, {Richard J.}",
year = "2019",
month = "1",
day = "1",
doi = "10.3201/eid2511.190537",
language = "English (US)",
volume = "25",
pages = "2064--2073",
journal = "Emerging Infectious Diseases",
issn = "1080-6040",
publisher = "Centers for Disease Control and Prevention (CDC)",
number = "11",

}

TY - JOUR

T1 - Lack of efficacy of high-titered immunoglobulin in patients with West Nile virus central nervous system disease

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

AU - Gnann, John W.

AU - Agrawal, Amy

AU - Hart, John

AU - Buitrago, Martha

AU - Carson, Paul

AU - Hanfelt-Goade, Diane

AU - Tyler, Ken

AU - Spotkov, Jared

AU - Freifeld, Alison

AU - Moore, Thomas

AU - Reyno, Jorge

AU - Masur, Henry

AU - Jester, Penelope

AU - Dale, Ilet

AU - Li, Yufeng

AU - Aban, Inmaculada

AU - Lakeman, Fred D.

AU - Whitley, Richard J.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85073509265&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85073509265&partnerID=8YFLogxK

U2 - 10.3201/eid2511.190537

DO - 10.3201/eid2511.190537

M3 - Article

C2 - 31625835

AN - SCOPUS:85073509265

VL - 25

SP - 2064

EP - 2073

JO - Emerging Infectious Diseases

JF - Emerging Infectious Diseases

SN - 1080-6040

IS - 11

ER -