Enrolment of 22,000 adolescent women to cancer registry follow-up for long-term human papillomavirus vaccine efficacy: guarding against guessing
Enrolment of 22,000 adolescent women to cancer registry follow-up for long-term human papillomavirus vaccine efficacy: guarding against guessing
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DOI：
10.1258/095646206778145550
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发表时间：
2006-08-01
影响因子：
1.4
通讯作者：
Paavonen, Jorma
中科院分区：
文献类型：
--
作者：
Lehtinen, Matti;Apter, Dan;Paavonen, Jorma
癌症是女性中第二常见的癌症。为青少年接种HPV16/18疫苗可能会预防很大比例的宫颈癌和其他肛门癌。然而，由于伦理原因，临床研究无法证实这一点。为了确定HPV16/18病毒样颗粒(VLP)疫苗对宫颈原位癌(CIS+)和浸润性宫颈癌的长期疫苗效果，对以下三组青春期妇女进行了研究：(1)接种HPV疫苗；(2)接种甲型肝炎对照疫苗；(3)未接种疫苗的对照妇女。通过基于人群的癌症登记，这些队列将被动地跟踪CIS+终点的累积发生率。2004年5月至2005年6月期间，来自芬兰18个城市的24,046名16至17岁的青春期妇女被邀请参加HPV16/18VLP双价疫苗的第三阶段试验。2005年5月，共有58,996名18至19岁的妇女被邀请参加，作为未接种疫苗的对照。报告说如果她们年轻1-2岁就愿意参加HPV疫苗试验的妇女有资格参加。在我们的队列中，15年来CIS+的累积发病率(CI)约为0.45%。70%-80%效价的VE需要3357-3189名HPV16/18疫苗接种者、3357-3189名其他疫苗接种者和6714-9567名未接种疫苗的对照组。我们现在招募了2404名HPV16/18疫苗接受者、2404名甲型肝炎疫苗接受者和5130名未接种疫苗的对照组。这项登记加上我们先前参加的另一项第三阶段试验，保证了足够的力量，以便到2020年，我们最终能够提供关于针对CIS+的HPV16/18疫苗效力的数据。
carcinoma, the second most common cancer among women. Vaccination of adolescents against HPV16/18 might prevent large proportion of cervical and other anogenital cancers. However, because of ethical reasons this cannot be proven by clinical studies. To determine the long-term vaccine efficacy (VE) of HPV16/18 virus-like-particle (VLP) vaccine against cervical carcinoma in situ (CIS +) and invasive cervical carcinoma, the following three population-based cohorts of adolescent women have been enrolled: (1) women vaccinated with the HPV vaccine; (2) women vaccinated with hepatitis A control vaccine; and (3) unvaccinated control women. These cohorts will be passively followed for cumulative incidence of CIS + endpoints by population-based cancer registry. Overall 24,046 16- to 17-year-old adolescent women from 18 cities in Finland were invited between May 2004 and June 2005 to participate in a phase III trial with bivalent HPV16/18 VLP vaccine. A total of 58,996 18- to 19-year-old women were invited in May 2005 to participate as unvaccinated controls. Women who reported their willingness to participate in an HPV vaccination trial had they been 1-2 years younger were eligible. Cumulative incidence (CI) of CIS + in our cohorts over 15 years is approximately 0.45%. VE of 70% against CIS+ with 80% power requires 3357-3189 HPV16/18 vaccine recipients, 3357-3189 other vaccine recipients, and 6714-9567 unvaccinated controls. We have now enrolled 2404 HPV16/18 vaccine recipients, 2404 hepatitis A-vaccine recipients, and 5130 unvaccinated controls. This enrolment in addition to our earlier enrolment in another phase III trial guarantees enough power so that by 2020 we can ultimately provide data on the efficacy of HPV16/18 vaccination against CIS+.