一项评估第三代天花疫苗候选药物 IMVAMUNE 免疫原性和安全性的随机、双盲、剂量探索性 II 期研究。
A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE.
机构信息
Bavarian Nordic GmbH, Fraunhoferstrasse 13, 82152 Martinsried, Germany.
出版信息
Vaccine. 2010 Feb 3;28(5):1209-16. doi: 10.1016/j.vaccine.2009.11.030. Epub 2009 Nov 25.
Abstract
IMVAMUNE is a Modified Vaccinia Ankara (MVA)-based virus that is being developed as a safer 3rd generation smallpox vaccine. In order to determine the optimal dose for further development, a double-blind, randomized Phase II trial was performed testing three different doses of IMVAMUNE in 164 healthy volunteers. All three IMVAMUNE doses displayed a favourable safety profile, with local reactions as the most frequent observation. The 1 x 10(8)TCID(50) IMVAMUNE dose induced a total antibody response in 94% of the subjects following the first vaccination and the highest peak seroconversion rates by ELISA (100%) and PRNT (71%). This IMVAMUNE dose was considered to be optimal for the further clinical development of this highly attenuated poxvirus as a safer smallpox vaccine.
摘要
IMVAMUNE 是一种基于改良安卡拉痘苗病毒（MVA）的病毒，被开发为更安全的第三代天花疫苗。为了确定进一步开发的最佳剂量，进行了一项双盲、随机的 II 期临床试验，在 164 名健康志愿者中测试了三种不同剂量的 IMVAMUNE。三种 IMVAMUNE 剂量均显示出良好的安全性，最常见的观察结果是局部反应。1×10(8)TCID(50)剂量的 IMVAMUNE 在第一次接种后诱导 94%的受试者产生总抗体反应，ELISA（100%）和 PRNT（71%）的峰值血清转化率最高。该剂量被认为是进一步临床开发这种高度减毒痘病毒作为更安全的天花疫苗的最佳选择。
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