Schwarz Tino F, Spaczynski Marek, Schneider Achim, Wysocki Jacek, Galaj Andrzej, Perona Pamela, Poncelet Sylviane, Zahaf Toufik, Hardt Karin, Descamps Dominique, Dubin Gary
Stiftung Juliusspital Würzburg, Zentrallabor, Juliuspromenade 19, D-97070 Würzburg, Germany.
Vaccine. 2009 Jan 22;27(4):581-7. doi: 10.1016/j.vaccine.2008.10.088. Epub 2008 Nov 18.
The immunogenicity and safety of an HPV-16/18 AS04-adjuvanted vaccine were assessed in women aged 26-55 years and compared with women aged 15-25 years in a Phase III, non-randomised, open-label, age-stratified study. Overall the vaccine was well tolerated and 100% seropositivity was achieved 1 month after the third dose in all age groups. There was a high correlation between HPV-16 and HPV-18 antibody levels (IgG) in cervicovaginal secretions and sera, regardless of age. The HPV-16/18 AS04-adjuvanted vaccine induces a robust and persistent immune response in women >26 years of age and generates antibodies that transudate through the cervix epithelium.
在一项III期、非随机、开放标签、年龄分层研究中，评估了HPV-16/18 AS04佐剂疫苗在26至55岁女性中的免疫原性和安全性，并与15至25岁女性进行了比较。总体而言，该疫苗耐受性良好，所有年龄组在第三剂接种后1个月均实现了100%血清阳性。无论年龄大小，宫颈阴道分泌物和血清中的HPV-16和HPV-18抗体水平（IgG）之间都存在高度相关性。HPV-16/18 AS04佐剂疫苗在26岁以上女性中诱导出强大而持久的免疫反应，并产生通过宫颈上皮渗出的抗体。
