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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):493-9.JI

Abstract

BACKGROUND

Japanese encephalitis (JE) is the most important mosquito-borne viral encephalitis and has a high case fatality rate. It is caused by Japanese encephalitis virus. Improved vaccines are urgently needed for residents in countries of endemicity, travelers, and the military. The aim of the present trial was to evaluate the safety and tolerability of IC51, Intercell's Vero cell-derived, purified, inactivated JE vaccine.

METHODS

This was a randomized (3:1), double-blind, placebo-controlled, multicenter phase 3 trial. Healthy subjects were randomized to receive 2 doses of IC51 (n=2012) or placebo (n=663) at a 4-week interval. Adverse events following immunization (AEFI) were documented over a period of 2 months.

RESULTS

The rate of severe AEFI was similar in the IC51 group (0.5%) and the placebo group (0.9%). The rate of medically attended AEFI and all AEFI was also similar in the IC51 group and the placebo group. The same applied for all adverse events, including local and systemic tolerability. Importantly, there were no signs of acute allergic reactions.

CONCLUSION

The Intercell JE vaccine IC51 had a safety profile similar to that of placebo. These data, together with the immunogenicity data from a recent phase 3 trial, form the basis of application for licensure of this vaccine.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT00605058.

Authors+Show Affiliations

Intercell AG, Campus Vienna Biocenter 6, Medical University Vienna, Vienna, Austria.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18588481

Citation

Tauber, E, et al. "Randomized, Double-blind, Placebo-controlled Phase 3 Trial of the Safety and Tolerability of IC51, an Inactivated Japanese Encephalitis Vaccine." The Journal of Infectious Diseases, vol. 198, no. 4, 2008, pp. 493-9.
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;198(4):493-9.
Tauber, E., Kollaritsch, H., von Sonnenburg, F., Lademann, M., Jilma, B., Firbas, C., Jelinek, T., Beckett, C., Knobloch, J., McBride, W. J., Schuller, E., Kaltenböck, A., Sun, W., & Lyons, A. (2008). Randomized, double-blind, placebo-controlled phase 3 trial of the safety and tolerability of IC51, an inactivated Japanese encephalitis vaccine. The Journal of Infectious Diseases, 198(4), 493-9. https://doi.org/10.1086/590116
Tauber E, 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):493-9. PubMed PMID: 18588481.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind, placebo-controlled phase 3 trial of the safety and tolerability of IC51, an inactivated Japanese encephalitis vaccine. AU - Tauber,E, AU - Kollaritsch,H, AU - von Sonnenburg,F, AU - Lademann,M, AU - Jilma,B, AU - Firbas,C, AU - Jelinek,T, AU - Beckett,C, AU - Knobloch,J, AU - McBride,W J H, AU - Schuller,E, AU - Kaltenböck,A, AU - Sun,W, AU - Lyons,A, PY - 2008/7/1/pubmed PY - 2008/11/19/medline PY - 2008/7/1/entrez SP - 493 EP - 9 JF - The Journal of infectious diseases JO - J. Infect. Dis. VL - 198 IS - 4 N2 - BACKGROUND: Japanese encephalitis (JE) is the most important mosquito-borne viral encephalitis and has a high case fatality rate. It is caused by Japanese encephalitis virus. Improved vaccines are urgently needed for residents in countries of endemicity, travelers, and the military. The aim of the present trial was to evaluate the safety and tolerability of IC51, Intercell's Vero cell-derived, purified, inactivated JE vaccine. METHODS: This was a randomized (3:1), double-blind, placebo-controlled, multicenter phase 3 trial. Healthy subjects were randomized to receive 2 doses of IC51 (n=2012) or placebo (n=663) at a 4-week interval. Adverse events following immunization (AEFI) were documented over a period of 2 months. RESULTS: The rate of severe AEFI was similar in the IC51 group (0.5%) and the placebo group (0.9%). The rate of medically attended AEFI and all AEFI was also similar in the IC51 group and the placebo group. The same applied for all adverse events, including local and systemic tolerability. Importantly, there were no signs of acute allergic reactions. CONCLUSION: The Intercell JE vaccine IC51 had a safety profile similar to that of placebo. These data, together with the immunogenicity data from a recent phase 3 trial, form the basis of application for licensure of this vaccine. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00605058. SN - 0022-1899 UR - https://www.unboundmedicine.com/medline/citation/18588481/full_citation L2 - https://academic.oup.com/jid/article-lookup/doi/10.1086/590116 DB - PRIME DP - Unbound Medicine ER -