title: A Phase 2 study of a purified, inactivated virus vaccine to prevent Japanese encephalitis.
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.
authors.affiliation: Department of Virus Diseases, Division of Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA. arthur.lyons@na.amedd.army.mil
authors.forename: Arthur
authors.initials: A
authors.lastname: Lyons
authors.forename: Niranjan
authors.initials: N
authors.lastname: Kanesa-thasan
authors.forename: Robert A
authors.initials: RA
authors.lastname: Kuschner
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Eckels
authors.forename: Robert
authors.initials: R
authors.lastname: Putnak
authors.forename: Wellington
authors.initials: W
authors.lastname: Sun
authors.forename: Robert
authors.initials: R
authors.lastname: Burge
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Towle
authors.forename: Paul
authors.initials: P
authors.lastname: Wilson
authors.forename: Erich
authors.initials: E
authors.lastname: Tauber
authors.forename: David W
authors.initials: DW
authors.lastname: Vaughn
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D004672:Encephalitis, Japanese / Q000517:prevention & control; D005260:Female; D006801:Humans; D022321:Japanese Encephalitis Vaccines / Q000009:adverse effects / Q000276:immunology*; D008297:Male; D014611:Vaccination; D015164:Vaccines, Inactivated / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D022321:Japanese Encephalitis Vaccines; D015164:Vaccines, Inactivated