Center for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Maastricht University Medical Center, Amsterdam, The Netherlands.
Care and Public Health Research Institute, Maastricht University Medical Center, Amsterdam, The Netherlands.
J Infect Dis. 2018 Jan 4;217(2):213-222. doi: 10.1093/infdis/jix582.
Observational postmarketing studies are important to assess vaccine effectiveness (VE). We estimated VE from the bivalent human papillomavirus (HPV) vaccine against HPV positivity of vaccine and nonvaccine types in a high-risk population.
We included all vaccine-eligible women from the PASSYON study, a biennial cross-sectional survey in Dutch sexually transmitted infection clinics. Vaginal swabs were analyzed using a polymerase chain reaction-based assay (SPF10-LiPA25) able to detect the 12 high-risk HPV (hrHPV) types 16/18/31/33/35/39/45/51/52/56/58/59. We compared hrHPV positivity between self-reported vaccinated (≥1 dose) and unvaccinated women, and estimated VE by a logistic mixed model.
We included 1087 women of which 53% were hrHPV positive and 60% reported to be vaccinated. The adjusted pooled VE against HPV-16/18 was 89.9% (81.7%-94.4%). Moreover, we calculated significant VE against nonvaccine types HPV-45 (91%), HPV-35 (57%), HPV-31 (50%), and HPV-52 (37%). Among women who were offered vaccination 5/6 years ago, we estimated similar VE against HPV-16/18 (92%) and all hrHPV types (35%) compared to women who were offered vaccination <5 years ago (83% and 33%, respectively).
We demonstrated high VE of the bivalent vaccine against HPV-16/18 and cross-protection against HPV-45/35/31/52. Protection against HPV-16/18 was sustained up to 6 years postvaccination.
观察性上市后研究对于评估疫苗效力(VE)非常重要。我们在高危人群中,根据二价人乳头瘤病毒(HPV)疫苗对疫苗和非疫苗型 HPV 阳性的情况估计了 VE。
我们纳入了 PASSYON 研究中所有符合疫苗接种条件的女性,这是荷兰性传播感染诊所的一项两年一次的横断面调查。使用基于聚合酶链反应的检测方法(SPF10-LiPA25)对阴道拭子进行分析,该方法能够检测到 12 种高危 HPV(hrHPV)类型 16/18/31/33/35/39/45/51/52/56/58/59。我们比较了自我报告接种(≥1 剂)和未接种疫苗的女性之间的 hrHPV 阳性率,并通过逻辑混合模型估计 VE。
我们纳入了 1087 名女性,其中 53%为 hrHPV 阳性,60%报告接种了疫苗。针对 HPV-16/18 的调整后的 VE 为 89.9%(81.7%-94.4%)。此外,我们计算出针对非疫苗型 HPV-45(91%)、HPV-35(57%)、HPV-31(50%)和 HPV-52(37%)的显著 VE。在 5/6 年前被建议接种疫苗的女性中,我们估计针对 HPV-16/18 的 VE 与<5 年前被建议接种疫苗的女性相似(分别为 92%和 33%),同时对所有 hrHPV 类型的 VE 也相似(分别为 35%和 33%)。
我们证明了二价疫苗对 HPV-16/18 的高 VE 和对 HPV-45/35/31/52 的交叉保护作用。HPV-16/18 的保护作用在接种疫苗后持续了 6 年以上。