...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Vaccine >Phase I safety and antigencity of TA-GW: a recombinant HPV6 L2E7 vaccine for the treatment of genital warts
【24h】

Phase I safety and antigencity of TA-GW: a recombinant HPV6 L2E7 vaccine for the treatment of genital warts

机译：THE-GW的I期安全性和抗原性：重组HPV 6 L2E7疫苗，用于治疗尖锐湿疣

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

A phase I double-blind, randomized, placebo-controlled study was carried out in healthy subjects to assess the safety and immunogenicity of TA-GW. a recombinant HPV6 L2E7 fusion protein vaccine for the treatment of genital warts. Forty-two healthy male volunteers were randomised to receive three intramuscular injections of either 0. 3, 30 or 300 #mu#g of recombinant L2E7 adsorbed onto Alhydrogel. Two vaccination schedules were compared: weeks 0, 1 and 4 (accelerated schedule) and' weeks 0, 4 and 8 (classical schedule). Subjects were monitored for adverse events throughout. Immunogenicity was assessed by measuring L2E7 specific in vitro T cell proliferative responses, production of IFN#gamma# and IL-5 and serum antibodies. Dose-dependent and long-lived T and B cell immune responses were elicited by TA-GW with both vaccination schedules. In conclusion, TA-GW is both safe. well-tolerated and immunogenic. The results allow the selection of the 300-#mu#g vaccine formulation and accelerated vaccination schedule for phase II trials in patients with genital warts.
机译：在健康受试者中进行了I期双盲，随机，安慰剂对照研究，以评估TA-GW的安全性和免疫原性。一种重组HPV6 L2E7融合蛋白疫苗，用于治疗尖锐湿疣。 42名健康男性志愿者被随机分配接受3次肌内注射，分别吸附在Alhydrogel上的0、3、30或300＃μ＃g重组L2E7。比较了两种疫苗接种方案：第0、1和4周（加速方案）和第0、4和8周（经典方案）。整个过程中监测受试者的不良事件。通过测量L2E7特异性体外T细胞增殖反应，IFN＃γ＃和IL-5的产生以及血清抗体来评估免疫原性。两种疫苗接种方案均通过TA-GW引发了剂量依赖性和长寿命的T和B细胞免疫应答。总之，TA-GW都是安全的。良好的耐受性和免疫原性。结果可以为患有尖锐湿疣的II期临床试验选择300μg的疫苗制剂和加快接种进度。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号