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

被引：33

作者：

Schuller, Elisabeth ^{[1
]}

Made, Christoph S. ^{[1
]}

Woelfl, Gabriele ^{[1
]}

Kaltenboeck, Astrid ^{[1
]}

Dewasthaly, Shailesh ^{[1
]}

Tauber, Erich ^{[1
]}

机构：

[1] Intercell AG, A-1030 Vienna, Austria

来源：

VACCINE | 2009年 / 27卷 / 15期

关键词：

IC51; Japanese encephalitis; Vaccination regimen; RAPID IMMUNIZATION SCHEDULE; TBE VACCINATION; VIRUS-VACCINE; SAFETY; IMMUNOGENICITY; TRIAL; HOLIDAY; BALI; LIVE;

D O I：

10.1016/j.vaccine.2008.12.062

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

The standard administration of the investigational Japanese encephalitis vaccine IC51 is 2 doses of 6 mu g with a 28-day interval. This study investigated the immunogenicity of a single-immunization, high-dose regimen (1 x 12 mu g) compared to the 2-injection, standard regimen to determine the immune response that one, high-close 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. (C) 2009 Elsevier Ltd. All rights reserved.

引用

收藏

页码：2188 / 2193

页数：6

相关论文

共 19 条

[1] Fatal Japanese encephalitis in a Danish tourist visiting Bali for 12 days [J].

Buhl, MR ;

Black, FT ;

Andersen, PL ;

Laursen, A .

SCANDINAVIAN JOURNAL OF INFECTIOUS DISEASES, 1996, 28 (02) :189-189

[2]

Burke D. S., 1988, The arboviruses: epidemiology and ecology. Volume III., P63

[3]

Igarashi Akira, 1992, World Health Statistics Quarterly, V45, P299

[4] Japanese encephalitis in a Finnish traveler on a two-week holiday in Thailand [J].

Lehtinen, Ville A. ;

Huhtamo, Eili ;

Siikamaki, Heli ;

Vapalahti, Olli .

JOURNAL OF CLINICAL VIROLOGY, 2008, 43 (01) :93-95

[5] Short-term safety of live attenuated Japanese encephalitis vaccine (SA14-14-2): Results of a randomized trial with 26,239 subjects [J].

Liu, ZL ;

Hennessy, S ;

Strom, BL ;

Tsai, TF ;

Wan, CM ;

Tang, SC ;

Xiang, CF ;

Bilker, WB ;

Pan, XP ;

Yao, YJ ;

Xu, ZW ;

Halstead, SB .

JOURNAL OF INFECTIOUS DISEASES, 1997, 176 (05) :1366-1369

[6] A Phase 2 study of a purified, inactivated virus vaccine to prevent Japanese encephalitis [J].

Lyons, Arthur ;

Kanesa-thasan, Niranjan ;

Kuschner, Robert A. ;

Eckels, Kenneth H. ;

Putnak, Robert ;

Sun, Wellington ;

Burge, Robert ;

Towle, Andrew C. ;

Wilson, Paul ;

Tauber, Erich ;

Vaughn, David W. .

VACCINE, 2007, 25 (17) :3445-3453

[7] Chimeric live, attenuated vaccine against Japanese encephalitis (ChimeriVax-JE): Phase 2 clinical trials for safety and immunogenicity, effect of vaccine dose and schedule, and memory response to challenge with inactivated Japanese encephalitis antigen [J].

Monath, TP ;

Guirakhoo, F ;

Nichols, R ;

Yoksan, S ;

Schrader, R ;

Murphy, C ;

Blum, P ;

Woodward, S ;

McCarthy, K ;

Mathis, D ;

Johnson, C ;

Bedford, P .

JOURNAL OF INFECTIOUS DISEASES, 2003, 188 (08) :1213-1230

[8] Tick-borne encephalitis (TBE) vaccination:: Applying the most suitable vaccination schedule [J].

Schoendorf, I. ;

Beran, J. ;

Cizkova, D. ;

Lesna, V. ;

Banzhoff, A. ;

Zent, O. .

VACCINE, 2007, 25 (08) :1470-1475

[9] Tick-borne encephalitis (TBE) vaccination in children -: Advantage of the rapid immunization schedule (i.e., days 0, 7, 21) [J].

Schoendorf, Ines ;

Ternak, Gabor ;

Oroszlan, Gyorgy ;

Nicolay, Uwe ;

Banzhoff, Angelika ;

Zent, Olaf .

HUMAN VACCINES, 2007, 3 (02) :42-47

[10] Long-term immunogenicity of the new Vero cell-derived, inactivated Japanese encephalitis virus vaccine IC51 Six and 12 month results of a multicenter follow-up phase 3 study [J].

Schuller, E. ;

Jilma, B. ;

Voicu, V. ;

Golor, G. ;

Kollaritsch, H. ;

Kaltenboeck, A. ;

Klade, C. ;

Tauber, E. .

VACCINE, 2008, 26 (34) :4382-4386