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.
The 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.
Schuller
Elisabeth
E
Intercell AG, Campus Vienna Biocenter 2, 1030 Wien, Austria.
Klade
Christoph S
CS
Wölfl
Gabriele
G
Kaltenböck
Astrid
A
Dewasthaly
Shailesh
S
Tauber
Erich
E
D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D004664:Encephalitis Virus, Japanese / Q000276:immunology; D004672:Encephalitis, Japanese / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D022321:Japanese Encephalitis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D014611:Vaccination / Q000379:methods*; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D022321:Japanese Encephalitis Vaccines; D015164:Vaccines, Inactivated