TY - JOUR AU - Gnann, John 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 AU - Whitley, Richard T1 - Lack of Efficacy of High-Titered Immunoglobulin in Patients with West Nile Virus Central Nervous System Disease T2 - Emerging Infectious Disease journal PY - 2019 VL - 25 IS - 11 SP - 2064 SN - 1080-6059 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. KW - West Nile virus KW - immunoglobulin KW - Omr-IgG-am KW - encephalitis KW - flavivirus KW - Polygam KW - viruses KW - WNV KW - central nervous system disease KW - neuroinvasive disease KW - United States KW - North America DO - 10.3201/eid2511.190537 UR - https://wwwnc.cdc.gov/eid/article/25/11/19-0537_article ER - End of Reference