Wittermann Christoph, Schöndorf I, Gniel D
Am Bachlanger 3, D-82362, Weilheim, Germany.
Vaccine. 2009 Mar 4;27(10):1661-6. doi: 10.1016/j.vaccine.2008.10.003. Epub 2008 Oct 20.
Two paediatric tick-borne encephalitis vaccines, Encepur Children and FSME-IMMUN Junior, are used widely in Europe. This study compared the immunogenicity and safety of both vaccines, administered using the conventional (Days 0, 28, and 300) or accelerated (Days 0, 14, and 300) schedule and evaluated whether a third dose of Encepur Children can complete a primary vaccination course initiated with FSME-IMMUN Junior. A total of 334 children 1 to < 11 years of age were enrolled in this Phase IV randomized, controlled, single-blind, multi-centre trial. All subjects, irrespective of study arm, received Encepur Children as the third dose on Day 300. The percentage of subjects with antibody titres > or = 10, as determined by neutralization test (NT), was assessed and local and systemic reactions were monitored and solicited. Within both the conventional and accelerated schedules, the proportion of subjects achieving an NT > or = 10 was higher in the group that received Encepur Children, compared with the group that received FSME-IMMUN Junior, at Days 42 and 300 (conventional schedule Day 300, P < 0.001 Encepur Children versus FSME-IMMUN Junior; accelerated schedule Days 42 and 300, P<0.001 Encepur Children versus FSME-IMMUN Junior). The third dose of Encepur Children led to a substantial increase in the proportion of subjects in the FSME-IMMUN Junior groups achieving NT > or = 10. Overall, >95% of all children achieved NT > or = 10, on completion of the primary vaccination course. Encepur Children provides an immune response, measured by neutralizing TBE antibodies, that is superior to FSME-IMMUN Junior and can successfully be used to complete a primary vaccination course initiated with FSME-IMMUN Junior. Both vaccines were well tolerated, with comparable safety profiles; no vaccine-related serious adverse events were reported.
两种儿科蜱传脑炎疫苗，即Encepur儿童疫苗和FSME - IMMUN Junior疫苗，在欧洲广泛使用。本研究比较了这两种疫苗在采用常规接种程序（第0、28和300天）或加速接种程序（第0、14和300天）时的免疫原性和安全性，并评估了Encepur儿童疫苗的第三剂能否完成以FSME - IMMUN Junior疫苗开始的基础免疫疗程。共有334名1至<11岁的儿童参加了这项IV期随机、对照、单盲、多中心试验。所有受试者，无论所属研究组如何，均在第300天接受Encepur儿童疫苗作为第三剂。通过中和试验（NT）测定抗体滴度≥10的受试者百分比，并监测和收集局部及全身反应。在常规和加速接种程序中，在第42天和第300天，接受Encepur儿童疫苗的组中达到NT≥10的受试者比例高于接受FSME - IMMUN Junior疫苗的组（常规接种程序第300天，Encepur儿童疫苗组与FSME - IMMUN Junior疫苗组相比，P<0.001；加速接种程序第42天和第300天，Encepur儿童疫苗组与FSME - IMMUN Junior疫苗组相比，P<0.001）。Encepur儿童疫苗的第三剂使FSME - IMMUN Junior疫苗组中达到NT≥10的受试者比例大幅增加。总体而言，在完成基础免疫疗程后，所有儿童中>95%的儿童达到NT≥10。Encepur儿童疫苗通过中和性蜱传脑炎抗体测量，提供了优于FSME - IMMUN Junior疫苗的免疫反应，并且可以成功用于完成以FSME - IMMUN Junior疫苗开始的基础免疫疗程。两种疫苗耐受性良好，安全性相当；未报告与疫苗相关的严重不良事件。
