A preliminary randomized double blind placebo-controlled trial of intravenous immunoglobulin for Japanese encephalitis in Nepal.

Autor: Rayamajhi A; Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom; National Academy of Medical Sciences, Kathmandu, Nepal; Kanti Children's Hospital, Kathmandu, Nepal., Nightingale S; Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom., Bhatta NK; BP Koirala Institute of Health Sciences, Dharan, Nepal., Singh R; BP Koirala Institute of Health Sciences, Dharan, Nepal., Kneen R; Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom, and 8: Alder Hey Children’s National Health Service Foundation Trust, Liverpool, United Kingdom., Ledger E; Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom., Bista KP; Kanti Children's Hospital, Kathmandu, Nepal., Lewthwaite P; Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom., Mahaseth C; National Academy of Medical Sciences, Kathmandu, Nepal; Kanti Children's Hospital, Kathmandu, Nepal., Turtle L; Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom., Robinson JS; Centers for Disease Control and Prevention, Division of Vector-Borne Diseases, Arbovirus Diseases Branch Diagnostic & Reference Laboratory, Fort Collins, Colorado, United States of America., Galbraith SE; Institute for Health and Wellbeing, Leeds Metropolitan University, Leeds, United Kingdom., Wnek M; Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom., Johnson BW; Centers for Disease Control and Prevention, Division of Vector-Borne Diseases, Arbovirus Diseases Branch Diagnostic & Reference Laboratory, Fort Collins, Colorado, United States of America., Faragher B; Liverpool School of Tropical Medicine, Liverpool, United Kingdom., Griffiths MJ; Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom; Alder Hey Children's National Health Service Foundation Trust, Liverpool, United Kingdom., Solomon T; Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom; The Walton Centre National Health Service Foundation Trust, Liverpool, United Kingdom; National Consortium for Zoonosis Research, Liverpool, United Kingdom; National Institute for Health Research-Health Protection Research Unit in Emerging and Zoonotic Infections, Liverpool, United Kingdom.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2015 Apr 17; Vol. 10 (4), pp. e0122608. Date of Electronic Publication: 2015 Apr 17 (Print Publication: 2015).
DOI: 10.1371/journal.pone.0122608
Abstrakt: Background: Japanese encephalitis (JE) virus (JEV) is a mosquito-borne flavivirus found across Asia that is closely related to West Nile virus. There is no known antiviral treatment for any flavivirus. Results from in vitro studies and animal models suggest intravenous immunoglobulin (IVIG) containing virus-specific neutralizing antibody may be effective in improving outcome in viral encephalitis. IVIG's anti-inflammatory properties may also be beneficial.
Methodology/principal Findings: We performed a pilot feasibility randomized double-blind placebo-controlled trial of IVIG containing anti-JEV neutralizing antibody (ImmunoRel, 400mg/kg/day for 5 days) in children with suspected JE at two sites in Nepal; we also examined the effect on serum neutralizing antibody titre and cytokine profiles. 22 children were recruited, 13 of whom had confirmed JE; 11 received IVIG and 11 placebo, with no protocol violations. One child (IVIG group) died during treatment and two (placebo) subsequently following hospital discharge. Overall, there was no difference in outcome between treatment groups at discharge or follow up. Passive transfer of anti-JEV antibody was seen in JEV negative children. JEV positive children treated with IVIG had JEV-specific neutralizing antibody titres approximately 16 times higher than those treated with placebo (p=0.2), which was more than could be explained by passive transfer alone. IL-4 and IL-6 were higher in the IVIG group.
Conclusions/significance: A trial of IVIG for JE in Nepal is feasible. IVIG may augment the development of neutralizing antibodies in JEV positive patients. IVIG appears an appealing option for JE treatment that warrants further study.
Trial Registration: ClinicalTrials.gov NCT01856205.
Databáze: MEDLINE
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