Schöndorf I, Beran J, Cizkova D, Lesna V, Banzhoff A, Zent O
Novartis Vaccines and Diagnostics GmbH and Co. KG, Clinical Research and Medical Affairs, Emil-von-Behring-Str. 76, 35041 Marburg, Germany.
Vaccine. 2007 Feb 9;25(8):1470-5. doi: 10.1016/j.vaccine.2006.10.028. Epub 2006 Nov 10.
Tick-borne encephalitis (TBE) is caused by an arthropod-borne virus, belonging to the family of Flaviviridae. In case of disease, which can lead to neurological sequelae or even fatal outcomes, only symptomatic treatment is available. TBE can be prevented by vaccination. Various primary immunization schedules have been developed. To identify the most suitable schedule, the present randomised, controlled study was designed to provide data on the immune response elicited by four different immunization schedules obtained by ELISA and by neutralization test (NT). A total of 398 healthy subjects aged > or =12 years were randomised to vaccination according to either the rapid schedule (Group R, vaccination on days 0, 7 and 21), the conventional schedule (Group C, vaccination on days 0, 28 and 300), the modified conventional schedule (Group M, vaccination on days 0, 21 and 300) or the accelerated conventional schedule (Group A, vaccination on days 0, 14 and 300). Within 3 weeks (i.e. by day 21) antibody levels were higher in Group R and Group A than in Group M and Group C. Group R and Group C both had higher titres on days 42, 180 and 300, than Group A and Group M. The rapid schedule thus combines the advantages of fast protection and of high titres over the observation period of 300 days.
蜱传脑炎(TBE)由一种节肢动物传播病毒引起,属于黄病毒科。一旦发病,可能导致神经后遗症甚至致命后果,目前只有对症治疗方法。蜱传脑炎可通过接种疫苗预防。已制定了各种初次免疫方案。为确定最合适的方案,本随机对照研究旨在提供通过酶联免疫吸附测定(ELISA)和中和试验(NT)获得的四种不同免疫方案引发的免疫反应数据。总共398名年龄≥12岁的健康受试者被随机分组,分别按照快速方案(R组,在第0、7和21天接种疫苗)、传统方案(C组,在第0、28和300天接种疫苗)、改良传统方案(M组,在第0、21和300天接种疫苗)或加速传统方案(A组,在第0、14和300天接种疫苗)进行接种。在3周内(即到第21天),R组和A组的抗体水平高于M组和C组。在第42、180和300天,R组和C组的抗体滴度均高于A组和M组。因此,快速方案在300天的观察期内兼具快速产生保护作用和高抗体滴度的优点。