Loew-Baselli A, Konior R, Pavlova B G, Fritsch S, Poellabauer E, Maritsch F, Harmacek P, Krammer M, Barrett P N, Ehrlich H J
Baxter BioScience, Global Clinical R&D, Industriestr. 67, A-1221Vienna, Austria.
Vaccine. 2006 Jun 12;24(24):5256-63. doi: 10.1016/j.vaccine.2006.03.061. Epub 2006 Apr 3.
A prospective, randomised, multicentre, single-blind phase 3 study was performed to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN "adults" (five consecutive lots) in comparison to another licensed TBE vaccine (Encepur), with polygeline) (two lots) in healthy volunteers (n=3966) aged 16-65 years. The safety of the third vaccination with FSME-IMMUN "adults" (6 months after the first vaccination) was investigated in a follow-up study on the same population (n=3705) and TBE antibody titres were analysed pre- and post-vaccination in a subgroup of volunteers (n=564). Following the first vaccination, the overall incidence of fever (> or =38.0 degrees C) was 0.8% in the FSME-IMMUN "adults" study group and 5.6% in the comparator study group; fever was mainly mild. The fever rate after the second vaccination was 0.6% and 0.5% in the two study groups, respectively. Local and systemic reactions after the first vaccination occurred with a lower frequency in the FSME-IMMUN "adults" study group than in the comparator group. Upon analysing the tolerability of the third vaccination with FSME-IMMUN "adults", similar results were determined in both study groups of volunteers previously vaccinated with FSME-IMMUN "adults" or with the comparator vaccine. The immunogenicity results demonstrated similar seroconversion rates (as determined by ELISA or neutralization test) before and after the third vaccination in the FSME-IMMUN "adults" group and in the comparator group respectively. The results of both studies demonstrate that: (1) FSME-IMMUN "adults" is safe and highly immunogenic, (2) all five production lots of FSME-IMMUN "adults" were consistent with respect to a low rate of adverse events, (3) FSME-IMMUN "adults" induces considerably lower adverse reaction rates than the comparator vaccine after the first vaccination, and (4) two vaccinations with the comparator vaccine can be successfully followed by a third vaccination with FSME-IMMUN "adults".
开展了一项前瞻性、随机、多中心、单盲3期研究，以评估在16至65岁健康志愿者（n = 3966）中，由两剂（间隔21 - 35天）接种蜱传脑炎（TBE）疫苗FSME-IMMUN“成人型”（连续五批）组成的疫苗接种方案与另一种已获许可的TBE疫苗（Encepur，含聚明胶肽）（两批）相比的安全性。在同一人群（n = 3705）的随访研究中，调查了FSME-IMMUN“成人型”第三剂接种（首次接种后6个月）的安全性，并在一组志愿者（n = 564）中分析了接种前后的TBE抗体滴度。首次接种后，FSME-IMMUN“成人型”研究组发热（≥38.0℃）的总体发生率为0.8%，对照研究组为5.6%；发热主要为轻度。第二次接种后，两个研究组的发热率分别为0.6%和0.5%。FSME-IMMUN“成人型”研究组首次接种后的局部和全身反应发生率低于对照组。在分析FSME-IMMUN“成人型”第三剂接种的耐受性时，先前接种FSME-IMMUN“成人型”或对照疫苗的两组志愿者得出了相似的结果。免疫原性结果表明，FSME-IMMUN“成人型”组和对照组在第三次接种前后的血清转化率相似（通过ELISA或中和试验测定）。两项研究结果均表明：（1）FSME-IMMUN“成人型”安全且免疫原性高；（2）FSME-IMMUN“成人型”的所有五批生产批次在不良事件发生率低方面是一致的；（3）FSME-IMMUN“成人型”首次接种后引起的不良反应率明显低于对照疫苗；（4）在两剂对照疫苗接种后，用FSME-IMMUN“成人型”进行第三次接种可以成功进行。
