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.
N1 - Funding Information:
The work was supported by a contract from the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (N01A130025; Richard J. Whitley, MD, principal investigator). The study drug was provided by OMRIX Biopharmaceuticals, Ltd. (Tel Aviv, Israel).
Funding Information:
relevant financial relationships. Alison Freifeld, MD, has disclosed the following relevant financial relationships: served as an advisor or consultant for Merck & Co., Inc.; Siemens AG; received grants for clinical research from Merck & Co., Inc. Inmaculada B.Aban, PhD, has disclosed the following relevant financial relationships: received grants for clinical research from Alexion Pharmaceuticals, Inc.; Argenx US Inc.; Catalyst Pharmaceutical Partners, Inc.; Ra Pharmaceuticals, Inc. Richard Whitley, MD, has disclosed the following relevant financial relationships: served as an advisor or consultant for: GlaxoSmithKline; Merck & Co., Inc.; resTORbio, Inc.; Sanofi; owns stock, stock options, or bonds from: Gilead Sciences, Inc.
Funding Information:
The authors thank James Sejvar, Lyle Petersen, and Robert Lanciotti of the Centers for Disease Control and Prevention for invaluable discussions regarding the epidemiology and diagnosis of WNV infection. A list of investigators and coordinators who enrolled participants in this study is provided in the Appendix (http://wwwnc.cdc.gov/EID/article/25/11/19-0537-App1.pdf). The work was supported by a contract from the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (N01A130025; Richard J. Whitley, MD, principal investigator). The study drug was provided by OMRIX Biopharmaceuticals, Ltd. (Tel Aviv, Israel).
Publisher Copyright:
© 2019 Centers for Disease Control and Prevention (CDC). All rights reserved.
PY - 2019
Y1 - 2019
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.
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U2 - 10.3201/eid2511.190537
DO - 10.3201/eid2511.190537
M3 - Article
C2 - 31625835
AN - SCOPUS:85073509265
SN - 1080-6040
VL - 25
SP - 2064
EP - 2073
JO - Emerging Infectious Diseases
JF - Emerging Infectious Diseases
IS - 11
ER -