title: Safety analysis of a Vero-cell culture derived Japanese encephalitis vaccine, IXIARO (IC51), in 6 months of follow-up.
abstract: Japanese encephalitis (JE) is the most common viral encephalitis in Asia. IXIARO is a Vero cell-derived, inactivated JE virus vaccine which has recently been approved in the US, Europe, Canada and Australia (trade name JESPECT). This overview of the safety and tolerability of IXIARO, for 6 months after the first vaccination in 7 Phase III trials, includes: 3558 subjects with at least one IXIARO vaccination, 435 subjects with a JE-VAX (manufactured by BIKEN, distributed by Sanofi Pasteur) vaccination, and 657 with phosphate-buffered saline solution with 0.1% Al(OH)(3) (PBS+Alum) control vaccination. The percentage of subjects reporting solicited local adverse events (AEs) with IXIARO (54%) was similar to PBS+Alum vaccination (56%) as were solicited systemic adverse events (40% IXIARO; 40% PBS+Alum vaccination). JE-VAX showed a higher frequency of subjects with solicited local adverse events (61%) but a slightly lower frequency of subjects with solicited systemic adverse events (36%). The frequency of subjects with any solicited and unsolicited AE with IXIARO (64%) was also similar to PBS+Alum vaccination (61%) and JE-VAX (64%); as for subjects with serious AEs (1% IXIARO; 2% PBS+Alum vaccination, 1% JE-VAX). No serious allergic reactions were observed in any group. This safety analysis indicates that IXIARO has a favorable safety profile, comparable to PBS+Alum control vaccination and appears to have a better local tolerability profile than JE-VAX.
authors.affiliation: Intercell AG, Campus Vienna Biocenter 3, 1030 Wien, Austria.
authors.forename: Katrin
authors.initials: K
authors.lastname: Dubischar-Kastner
authors.forename: Astrid
authors.initials: A
authors.lastname: Kaltenboeck
authors.forename: Anton
authors.initials: A
authors.lastname: Klingler
authors.forename: Bernd
authors.initials: B
authors.lastname: Jilma
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Schuller
mesh_terms: D000328:Adult; D000818:Animals; D002522:Chlorocebus aethiops; D017326:Clinical Trials, Phase III as Topic; D004672:Encephalitis, Japanese / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D022321:Japanese Encephalitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D014709:Vero Cells; D055815:Young Adult
chemical_list: D022321:Japanese Encephalitis Vaccines