Abstract | BACKGROUND: 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.
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Authors | Ajit Rayamajhi, Sam Nightingale, Nisha Keshary Bhatta, Rupa Singh, Rachel Kneen, Elizabeth Ledger, Krishna Prasad Bista, Penny Lewthwaite, Chandeshwar Mahaseth, Lance Turtle, Jaimie Sue Robinson, Sareen Elizabeth Galbraith, Malgorzata Wnek, Barbara Wilmot Johnson, Brian Faragher, Michael John Griffiths, Tom Solomon |
Journal | PloS one
(PLoS One)
Vol. 10
Issue 4
Pg. e0122608
( 2015)
ISSN: 1932-6203 [Electronic] United States |
PMID | 25886645
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents
- Antibodies, Neutralizing
- Immunoglobulins, Intravenous
- Interleukin-6
- Interleukin-4
- Dexamethasone
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Topics |
- Anti-Inflammatory Agents
(therapeutic use)
- Antibodies, Neutralizing
(blood, therapeutic use)
- Child
- Child, Preschool
- Dexamethasone
(therapeutic use)
- Double-Blind Method
- Encephalitis Virus, Japanese
(immunology)
- Encephalitis, Japanese
(drug therapy, pathology)
- Enzyme-Linked Immunosorbent Assay
- Female
- Follow-Up Studies
- Humans
- Immunoglobulins, Intravenous
(therapeutic use)
- Infant
- Interleukin-4
(blood)
- Interleukin-6
(blood)
- Male
- Nepal
- Placebo Effect
- Treatment Outcome
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