Skip to main content
Top
Published in: Drugs 1/2009

01-01-2009 | Adis Drug Profile

Japanese Encephalitis Vaccine (Inactivated, Adsorbed) [IXIARO®]

Authors: Sean T. Duggan, Greg L. Plosker

Published in: Drugs | Issue 1/2009

Login to get access

Abstract

  • ▴ The Japanese encephalitis vaccine IC-51 (IXIARO®) is an inactivated virus (strain SA14-14-2) that is manufactured in cultured Vero cells and is currently being developed for preventive vaccination against the Japanese encephalitis virus.
  • ▴ Administration of IXIARO® as a two-dose treatment in healthy adults provided high levels of seroprotection against Japanese encephalitis virus. Immune responses at 56 days post-vaccination, including seroconversion rates and geometric mean titres, were noninferior to those seen with a currently available licensed vaccine. Seroprotection was achieved 1 week after second vaccination.
  • ▴ Long-term seroprotection was also observed with the vaccine, with seroconversion rates and geometric mean titres maintained at both 6 and 12 months post-vaccination.
  • ▴ Coadministration with a hepatitis A vaccine had no effect on the immunogenicity of IXIARO®. Additionally, the vaccine immunogenicity was not compromised in subjects with pre-existing vaccine-induced antibodies for tick-borne encephalitis, a related flavivirus.
  • ▴ Vaccine immunogenicity was also observed in paediatric volunteers, with seroconversion rates not significantly different to an active comparator at 56 days post-vaccination.
  • ▴ The safety and tolerability profile of IXIARO® was generally similar to that of placebo with respect to systemic adverse events, and was associated with a numerically lower frequency of local injection site adverse events than the active comparator vaccine.
Literature
1.
go back to reference Centers for Disease Control and Prevention. Travelers’ health: yellow book. Chapter Centers for Disease Control and Prevention. Travelers’ health: yellow book. Chapter
2.
go back to reference Inactivated Japanese encephalitis virus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb Mortal Wkly Rep 1993; 42 (RR-01): 1–15 Inactivated Japanese encephalitis virus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb Mortal Wkly Rep 1993; 42 (RR-01): 1–15
4.
go back to reference Gould E, Solomon T. Pathogenic flaviviruses. Lancet 2008; 371(9611): 500–9CrossRef Gould E, Solomon T. Pathogenic flaviviruses. Lancet 2008; 371(9611): 500–9CrossRef
5.
go back to reference Solomon T. Control of Japanese encephalitis: within our grasp? N Engl J Med 2006; 355(9): 869–71CrossRef Solomon T. Control of Japanese encephalitis: within our grasp? N Engl J Med 2006; 355(9): 869–71CrossRef
6.
go back to reference Monath TP. Japanese encephalitis vaccines: current vaccines and future prospects. Curr Top Microbiol Immunol 2002; 267: 105–38PubMed Monath TP. Japanese encephalitis vaccines: current vaccines and future prospects. Curr Top Microbiol Immunol 2002; 267: 105–38PubMed
7.
go back to reference Sakaguchi M, Nakashima K, Takahashi H, et al. Anaphylaxis to Japanese encephalitis vaccine. Allergy 2001; 56(8): 804–5CrossRef Sakaguchi M, Nakashima K, Takahashi H, et al. Anaphylaxis to Japanese encephalitis vaccine. Allergy 2001; 56(8): 804–5CrossRef
8.
go back to reference Sugawara K, Nishiyama K, Ishikawa Y, et al. Development of vero cell-derived inactivated Japanese encephalitis vaccine. Biologicals 2002 Dec; 30(4): 303–14CrossRef Sugawara K, Nishiyama K, Ishikawa Y, et al. Development of vero cell-derived inactivated Japanese encephalitis vaccine. Biologicals 2002 Dec; 30(4): 303–14CrossRef
9.
go back to reference Lehner C, Eder G, Formica A, et al. Safety and immunogenicity of concomitant vaccination with IC51 and hepatitis A vaccine in healthy subjects: a single-blind randomized controlled phase 3 study [abstract no. 122]. 56th Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2007 Nov 4–8; New Orleans (LA), 36 Lehner C, Eder G, Formica A, et al. Safety and immunogenicity of concomitant vaccination with IC51 and hepatitis A vaccine in healthy subjects: a single-blind randomized controlled phase 3 study [abstract no. 122]. 56th Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2007 Nov 4–8; New Orleans (LA), 36
10.
go back to reference Schuller E, Klade CS, Wölfl G, et al. Comparison of a single, high-dose vaccination regimen to the standard regimen for the investigational Japanese encephalitis vaccine, IC51: a randomized, observer-blind, controlled phase 3 study. Vaccine. In press Schuller E, Klade CS, Wölfl G, et al. Comparison of a single, high-dose vaccination regimen to the standard regimen for the investigational Japanese encephalitis vaccine, IC51: a randomized, observer-blind, controlled phase 3 study. Vaccine. In press
11.
go back to reference Schuller E, Jilma B, Voicu V, et al. Long-term immunogenicity of the new vero cell-derived, inactivated Japanese encephalitis virus vaccine IC51: six and 12month results of a multicenter follow-up phase 3 study. Vaccine 2008 Aug 12; 26(34): 4382–6CrossRef Schuller E, Jilma B, Voicu V, et al. Long-term immunogenicity of the new vero cell-derived, inactivated Japanese encephalitis virus vaccine IC51: six and 12month results of a multicenter follow-up phase 3 study. Vaccine 2008 Aug 12; 26(34): 4382–6CrossRef
12.
go back to reference Tauber E, Kollaritsch H, Korinek M, et al. Safety and immunogenicity of a vero-cell-derived, inactivated Japanese encephalitis vaccine: a non-inferiority, phase III, randomised controlled trial. Lancet 2007 Dec 1; 370(9602): 1847–53CrossRef Tauber E, Kollaritsch H, Korinek M, et al. Safety and immunogenicity of a vero-cell-derived, inactivated Japanese encephalitis vaccine: a non-inferiority, phase III, randomised controlled trial. Lancet 2007 Dec 1; 370(9602): 1847–53CrossRef
13.
go back to reference Schuller E, Klade CS, Heinz FX, et al. Effect of pre-existing anti-tick-borne encephalitis virus immunity on neutralising antibody response to the novel, vero cell-derived, inactivated Japanese encephalitis virus vaccine IC51. Vaccine 2008 Sep 17; 26(48): 6151–6CrossRef Schuller E, Klade CS, Heinz FX, et al. Effect of pre-existing anti-tick-borne encephalitis virus immunity on neutralising antibody response to the novel, vero cell-derived, inactivated Japanese encephalitis virus vaccine IC51. Vaccine 2008 Sep 17; 26(48): 6151–6CrossRef
14.
go back to reference Tauber E, Kollaritsch H, von Sonnenburg F, et al. Randomized, double-blind, placebo-controlled phase 3 trial of the safety and tolerability of IC51, an inactivated Japanese encephalitis vaccine. J Infect Dis 2008 Aug 15; 198(4): 493–9CrossRef Tauber E, Kollaritsch H, von Sonnenburg F, et al. Randomized, double-blind, placebo-controlled phase 3 trial of the safety and tolerability of IC51, an inactivated Japanese encephalitis vaccine. J Infect Dis 2008 Aug 15; 198(4): 493–9CrossRef
15.
go back to reference Schuller E, Kishore TSA, Klade C, et al. First clinical trial of a vero cell derived, inactivated Japanese encephalitis (JE) vaccine IC51 in pediatric population [abstract]. 57th Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2008 Dec 7–11; New Orleans (LA) Schuller E, Kishore TSA, Klade C, et al. First clinical trial of a vero cell derived, inactivated Japanese encephalitis (JE) vaccine IC51 in pediatric population [abstract]. 57th Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2008 Dec 7–11; New Orleans (LA)
18.
go back to reference Ferguson M, Kurane I, Wimalaratne O, et al. WHO informal consultation on the scientific basis of specifications for production and control of inactivated Japanese encephalitis vaccines for human use, Geneva, Switzerland, 1–2 June 2006. Vaccine 2007 Jul 20; 25(29): 5233–43CrossRef Ferguson M, Kurane I, Wimalaratne O, et al. WHO informal consultation on the scientific basis of specifications for production and control of inactivated Japanese encephalitis vaccines for human use, Geneva, Switzerland, 1–2 June 2006. Vaccine 2007 Jul 20; 25(29): 5233–43CrossRef
19.
go back to reference Hombach J, Solomon T, Kurane I, et al. Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2–3 September, 2004. Vaccine 2005; 23(45): 5205–11CrossRef Hombach J, Solomon T, Kurane I, et al. Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2–3 September, 2004. Vaccine 2005; 23(45): 5205–11CrossRef
20.
go back to reference Dubischar-Kastner K, Kaltenboeck A, Schuller E, et al. Six months safety of a vero-cell culture derived Japanese encephalitis vaccine, IXIARO®, IC51, across phase 3 trials and in a long-term follow-up cohort [abstract]. 57th Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2008 Dec 7–11; New Orleans (LA) Dubischar-Kastner K, Kaltenboeck A, Schuller E, et al. Six months safety of a vero-cell culture derived Japanese encephalitis vaccine, IXIARO®, IC51, across phase 3 trials and in a long-term follow-up cohort [abstract]. 57th Annual Meeting of the American Society of Tropical Medicine and Hygiene; 2008 Dec 7–11; New Orleans (LA)
Metadata
Title
Japanese Encephalitis Vaccine (Inactivated, Adsorbed) [IXIARO®]
Authors
Sean T. Duggan
Greg L. Plosker
Publication date
01-01-2009
Publisher
Springer International Publishing
Published in
Drugs / Issue 1/2009
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.2165/00003495-200969010-00008

Other articles of this Issue 1/2009

Drugs 1/2009 Go to the issue

Therapy In Practice

Chronic Prostatitis