A Phase 2 study of a purified, inactivated virus vaccine to prevent Japanese encephalitis

Arthur Lyons*, Niranjan Kanesa-thasan, Robert A. Kuschner, Kenneth H. Eckels, Robert Putnak, Wellington Sun, Robert Burge, Andrew C. Towle, Paul Wilson, Erich Tauber, David W. Vaughn

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

58 Scopus citations

Abstract

Japanese encephalitis (JE) is a serious disease caused by the JE virus. New generation JE vaccines are needed to prevent this disease. We conducted this Phase 2 randomized, open label, unblinded, single center study of a new, cell-culture derived, purified inactivated virus (JE-PIV) vaccine. The JE-PIV vaccine was administered in either two or three intramuscular (IM) doses (6.0 or 12.0 mcg each) with observation over 8 weeks. All volunteers completed the protocol without serious adverse reactions. Headache and transient tenderness at the injection site were the most common complaints. There were no laboratory abnormalities believed to be related to vaccine during the study. JE-PIV was well tolerated, resulted in high seroconversion rates [Day 56 (primary endpoint); 95-100%] and induced enduring immune responses up to 2 years after vaccination. Expanded Phase 3 trials are planned.

Original languageEnglish
Pages (from-to)3445-3453
Number of pages9
JournalVaccine
Volume25
Issue number17
DOIs
StatePublished - 30 Apr 2007
Externally publishedYes

Keywords

  • Inactivated
  • Japanese encephalitis
  • Vaccine
  • Virus

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