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研究发现女性生殖器疱疹的疫苗无效 [复制链接]

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二零一零年九月三十日

STATEMENT

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Study Finds Genital Herpes Vaccine Ineffective in Women

研究发现女性生殖器疱疹的疫苗无效



An experimental vaccine intended to prevent genital herpes disease in women, although generally safe and well-tolerated, proved ineffective when tested in the recently concluded clinical study known as the Herpevac Trial for Women.

一种试验性疫苗旨在预防生殖器疱疹的妇女疾病,虽然通常安全和耐受性良好,证明无效时,在最近结束的临床试验知名妇女Herpevac研究测试。

The Phase 3 trial, sponsored by GlaxoSmithKline (GSK) Biologicals, based in Belgium, with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, began in 2002.

第3期试验中,葛兰素史克(GSK)的生物赞助,总部设在比利时与美国过敏和传染病研究所(NIAID的),在美国国立卫生研究院的一部分,支持,于2002年。

A total of 8,323 women aged 18-30 years participated in the trial at 50 sites in the United States and Canada.

一岁的8,323名妇女参加了18-30年的审判在50美国和加拿大的网站。

At the time of their enrollment, the study participants were free of the two types of herpes simplex viruses (HSV), HSV-1 and HSV-2.

在他们入学时,参与研究的人的单纯疱疹病毒的两种类型(单纯疱疹病毒),HSV - 1和HSV - 2的自由。

Participants in the Herpevac trial were randomly divided into two groups.

在Herpevac试验受试者被随机分成两组。

One group received the candidate vaccine, containing HSV protein along with an adjuvant intended to boost immune responses.

其中一组收到的候选疫苗,含有单纯疱疹病毒蛋白以及旨在推动免疫反应的佐剂。

The second, control group received a version of Havrix, a licensed vaccine against hepatitis A. This study design gave all participants the potential opportunity to be protected against either genital herpes or hepatitis A. GSK developed the candidate vaccine and also manufactures Havrix.

第二,对照组收到了Havrix,对甲型肝炎疫苗的研究设计许可给了所有参与者的潜在机会,对任何生殖器疱疹或甲型肝炎葛兰素史克公司研制的候选疫苗保护的版本,同时也生产Havrix。

Each volunteer was vaccinated at the beginning of the study and again one and six months later.

每个志愿者接种在研究开始时,再一,六个月后。

The participants were followed for 20 months after the initial injection and evaluated at each visit for HSV infection and genital herpes disease.

与会者随访20个月后,每到一个初始注射单纯疱疹病毒生殖器疱疹病毒感染和疾病的访问评价。

In two earlier studies involving men and women who did not have genital herpes but whose sexual partners were known to be infected, the candidate vaccine prevented genital herpes disease in more than 70 percent of the female volunteers who were free of HSV-1 and HSV-2 but had no clear effect in men.

在涉及男性和女性谁没有生殖器疱疹,但其合作伙伴,被称为性感染两个早期的研究,候选疫苗防止了超过70的女性志愿者的百分之谁是HSV - 1和生殖器疱疹的单纯疱疹病毒免费疾病, 2,但没有男性明显的作用。

These studies formed the basis to conduct the larger Herpevac study in women only.

这些研究的基础上形成了开展妇女只有大Herpevac研究。

In the Herpevac study, however, the investigational vaccine was ineffective in protecting against genital herpes disease.

在Herpevac研究,但是,研究性疫苗在预防疾病生殖器疱疹保护不力。

The estimate of vaccine effectiveness was 20 percent, but all estimates have statistical uncertainty, and this effect was not substantially different from zero.

该疫苗效果的估计是百分之二十,但所有的估计,统计不确定性,而这一影响并不显着异于零。

It is not known at this time why the vaccine proved ineffective, but the study collaborators continue to evaluate the trial data and intend to provide a more detailed analysis at a later date.

我们不知道为什么在这个时候该疫苗被证明无效,但该项研究的合作者继续评价试验数据,并打算在日后提供更详细的分析。

All the study investigators have been informed of the results.

所有的研究调查人员被告知结果。

Study participants are being notified as to which vaccine they received, and those volunteers who received the candidate herpes vaccine are being offered Havrix.

研究参与者被通知到他们收到的疫苗,而那些志愿者疱疹谁收到候选疫苗正在提供Havrix。
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