Arbyn Marc, Bryant Andrew, Beutels Philippe, Martin-Hirsch Pierre Pl, Paraskevaidis Evangelos, Van Hoof Elke, Steben Marc, Qiao Youlin, Zhao Fang-Hui, Schneider Achim, Kaufmann Andreas, Dillner Joakim, Markowitz Lauri, Hildesheim Allan
Unit of Cancer Epidemiology, Scientific Institute of Public Health, Brussels, Belgium.
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Cochrane Database Syst Rev. 2011;2011(4). doi: 10.1002/14651858.CD009069.
This is the protocol for a review and there is no abstract. The objectives are as follows: To evaluate the immunogenicity, clinical efficacy, and safety of prophylactic HPV vaccines in females. The assessment of clinical efficacy will address protection against HPV infection (for homologous and heterologous HPV types), against re-infection, against cervical cancer and its precursors (high-grade CIN (grade 2 or grade 3), adenocarcinoma in situ) in women previously not exposed to HPV infection (negative at enrolment for both HPV DNA and antibodies against the vaccine HPV types). We will assess clinical effectiveness by evaluating outcomes in all women, irrespective of the HPV DNA or serology status at enrolment. Evaluation by fine age and time since sexual debut categories is also planned.
这是一项综述的方案,没有摘要。目标如下:评估预防性人乳头瘤病毒(HPV)疫苗在女性中的免疫原性、临床疗效和安全性。临床疗效评估将涉及对HPV感染(针对同源和异源HPV类型)、再感染、宫颈癌及其癌前病变(高级别宫颈上皮内瘤变(2级或3级)、原位腺癌)的预防,这些评估针对既往未感染HPV的女性(入组时HPV DNA和针对疫苗HPV类型的抗体均为阴性)。我们将通过评估所有女性的结局来评估临床有效性,无论其入组时的HPV DNA或血清学状态如何。还计划按精确年龄和首次性行为后的时间类别进行评估。