title: A purified inactivated Japanese encephalitis virus vaccine made in Vero cells.
abstract: A second generation, purified, inactivated vaccine (PIV) against Japanese encephalitis (JE) virus was produced and tested in mice where it was found to be highly immunogenic and protective. The JE-PIV was made from an attenuated strain of JE virus propagated in certified Vero cells, purified, and inactivated with formalin. Its manufacture followed current GMP guidelines for the production of biologicals. The manufacturing process was efficient in generating a high yield of virus, essentially free of contaminating host cell proteins and nucleic acids. The PIV was formulated with aluminum hydroxide and administered to mice by subcutaneous inoculation. Vaccinated animals developed high-titered JE virus neutralizing antibodies in a dose dependent fashion after two injections. The vaccine protected mice against morbidity and mortality after challenge with live, virulent, JE virus. Compared with the existing licensed mouse brain-derived vaccine, JE-Vax, the Vero cell-derived JE-PIV was more immunogenic and as effective as preventing encephalitis in mice. The JE-PIV is currently being tested for safety and immunogenicity in volunteers.
authors.affiliation: Walter Reed Army Institute of Research, Division of Communicable Diseases and Immunology, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA.
authors.forename: A K
authors.initials: AK
authors.lastname: Srivastava
authors.forename: J R
authors.initials: JR
authors.lastname: Putnak
authors.forename: S H
authors.initials: SH
authors.lastname: Lee
authors.forename: S P
authors.initials: SP
authors.lastname: Hong
authors.forename: S B
authors.initials: SB
authors.lastname: Moon
authors.forename: D A
authors.initials: DA
authors.lastname: Barvir
authors.forename: B
authors.initials: B
authors.lastname: Zhao
authors.forename: R A
authors.initials: RA
authors.lastname: Olson
authors.forename: S O
authors.initials: SO
authors.lastname: Kim
authors.forename: W D
authors.initials: WD
authors.lastname: Yoo
authors.forename: A C
authors.initials: AC
authors.lastname: Towle
authors.forename: D W
authors.initials: DW
authors.lastname: Vaughn
authors.forename: B L
authors.initials: BL
authors.lastname: Innis
authors.forename: K H
authors.initials: KH
authors.lastname: Eckels
mesh_terms: D000818:Animals; D002522:Chlorocebus aethiops; D006152:Cyclic GMP / Q000096:biosynthesis; D004353:Drug Evaluation, Preclinical; D004664:Encephalitis Virus, Japanese / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification; D004672:Encephalitis, Japanese / Q000517:prevention & control*; D005260:Female; D022321:Japanese Encephalitis Vaccines / Q000008:administration & dosage / Q000096:biosynthesis* / Q000302:isolation & purification; D051379:Mice; D008813:Mice, Inbred ICR; D012692:Serial Passage; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000096:biosynthesis / Q000302:isolation & purification; D014709:Vero Cells; D014779:Virus Replication
chemical_list: D022321:Japanese Encephalitis Vaccines; D015164:Vaccines, Inactivated; D006152:Cyclic GMP