Oxxon公司的治疗性乙肝疫苗Hi-8的IIa期临床结果

sanguogame

尝试翻译要点如下，不对之处请指正：

疫苗构成：
两颗"primes"DNA质粒，两颗修改过的牛痘病毒Ankala(MVA)"boosts"，嫁接两个ＨＢＶ表面抗原

试验方案：
分四针，三个礼拜一针
对照组为使用拉米夫定或联用HI-8和拉米夫定
共有54名志愿者参加试验

试验结果：
单独使用Hi-8组，9周后发现5例(5/21)HbeAg消失，4例(4/21)HbeAg血清学转换（阳转阴），发生HbeAg血清学转换的志愿者身上，HBV DNA下降3个log以上。同时使用Hi-8和拉米夫定的试验者身上示发现更优效果。检测到HBV特异性T细胞数量增加，应答率提高。

结论：

疗效相当于拉米夫定其至更好，且未发现毒副作用。只要四针，保障期最少一年。

Hi-8™ HBV



Oxxon is developing Hi-8™ HBV, an immunotherapeutic encoding the HBV surface antigen delivered by a DNA prime and a MVA boost. A phase II study in 54 patients with chronic HBV has been completed. The patients were randomized to receive either Hi-8™ HBV alone, Hi-8™ HBV plus standard antiviral therapy (lamivudine) or lamivudine alone.

A 9-week course of Hi-8™ HBV was safe and well tolerated and led to HBeAg seroconversion in 19% (4/21) of patients at 52 weeks. A viral load decrease of up to 3 logs and liver function normalisation was seen in patients that seroconverted. No synergy with lamivudine was observed.

Hi-8™ therefore shows promise as an agent with similar efficacy to standard treatments but with the benefit of being given in a short, well tolerated regimen rather than by daily/weekly dosing for at least one year. In addition, there are further opportunities to improve the efficacy of Hi-8™ HBV by altering the dosing and the dose scheduling.

Oxxon is seeking a development and marketing partner to take the hepatitis B programme forward towards commercialisation.

会飞的猪

多一种药总是好的，顶一下

sdhbq

真的吗？不敢相信啊。但愿是真的，9/54，合30%转阴率。

ybdn

以下是引用sdhbq在2007-9-28 16:24:00的发言：
真的吗？不敢相信啊。但愿是真的，9/54，合30%转阴率。

呵呵，你的30％是咋算的？

坚持到胜利

好药

特深沉

效果很一般嘛

jangle

不错。

luofreemed

出处在哪呢？

medline

现在评论太早了

观望。

zttz

都两年了，好像也没有新进展啊