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Randomized Controlled Trial Comparative Study
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.
- Elisabeth Schuller, Christoph S Klade, Gabriele Wölfl, Astrid Kaltenböck, Shailesh Dewasthaly, and Erich Tauber.
- Intercell AG, Campus Vienna Biocenter 2, 1030 Wien, Austria.
- Vaccine. 2009 Mar 26; 27 (15): 2188-93.
AbstractThe standard administration of the investigational Japanese encephalitis vaccine IC51 is 2 doses of 6 microg with a 28-day interval. This study investigated the immunogenicity of a single-immunization, high-dose regimen (1 x 12 microg) compared to the 2-injection, standard regimen to determine the immune response that one, high-dose injection can confer. The single, high-dose regimen resulted in about 60% seroconversion rate (SCR) at 10 days after administration, but it did not reach the almost 100% SCR achieved by the 2-dose standard administration at Day 35. The standard regimen conferred essentially 100% seroconversion already 7 days after the second immunization.
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