BACKGROUND The Costa Rica HPV Vaccine Trial (CVT) has documented cross-protection of the bivalent HPV vaccine against HPV31/33/45 up to seven years after vaccination, even with one dose of the vaccine. However, the durability of such protection remains unknown. Here, we evaluate different schedules of the vaccine's efficacy against HPV31/33/45 out to 11 years post-vaccination, expanding to other non-targeted HPV types. METHODS We compared the rates of HPV infection in vaccinated women to the rates in a comparable cohort of unvaccinated women. We estimated the average vaccine efficacy (VEavg) against incident infections and tested for a change in VE over time. RESULTS Among 3-dose women, we observed statistically significant cross-protection against HPV31/33/45 (VEavg=64.4%, 95%CI: 57.7% to 70.0%). Additionally, we observed borderline, statistically significant cross-protection against HPV35 (VEavg=23.2%, 95%CI: 0.3% to 40.8%) and HPV58 (VEavg=21.2%, 95%CI: 4.2% to 35.3%). There was no decrease in VE over time (two-sided p-for-trend>0.05 for HPV31, 33, 35, 45, 58). As a benchmark, VEavg against HPV16/18 was 82.0% (95%CI: 77.3% to 85.7%). Among 1-dose women, we observed comparable efficacy against HPV31/33/45 (VEavg=54.4%, 95%CI: 21.0% to 73.7%). Acquisition of non-protected HPV types was similar between vaccinated and unvaccinated women, indicating that the difference in HPV infection rates was not attributable to differential genital HPV exposure. CONCLUSION Substantial cross-protection afforded by the bivalent vaccine against HPV31/33/45 and, to a lesser extent, HPV35 and HPV58, was sustained and remained stable after 11 years post-vaccination, reinforcing the notion that the vaccine is an effective option for protection against HPV-associated cancers.

中文翻译：

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二价 HPV 疫苗不同方案的交叉保护持久性：CVT 试验。


背景哥斯达黎加 HPV 疫苗试验 (CVT) 已证明二价 HPV 疫苗对 HPV31/33/45 的交叉保护作用长达七年，即使只接种一剂疫苗。然而，这种保护的持久性仍然未知。在这里，我们评估了疫苗接种后 11 年内针对 HPV31/33/45 的疫苗功效的不同时间表，并扩展到其他非靶向 HPV 类型。方法 我们将已接种疫苗的女性的 HPV 感染率与未接种疫苗的女性人群的 HPV 感染率进行了比较。我们估计了针对偶发感染的平均疫苗功效 (VEavg)，并测试了 VE 随着时间的推移的变化。结果 在 3 剂女性中，我们观察到针对 HPV31/33/45 的统计显着交叉保护（VEavg=64.4%，95%CI：57.7% 至 70.0%）。此外，我们观察到针对 HPV35（VEavg=23.2%，95%CI：0.3% 至 40.8%）和 HPV58（VEavg=21.2%，95%CI：4.2% 至 35.3%）的临界、统计显着交叉保护。随着时间的推移，VE 没有下降（HPV31、33、35、45、58 的两侧趋势 p>0.05）。作为基准，针对 HPV16/18 的 VEavg 为 82.0%（95%CI：77.3% 至 85.7%）。在 1 剂女性中，我们观察到针对 HPV31/33/45 的疗效相当（VEavg=54.4%，95%CI：21.0% 至 73.7%）。接种疫苗和未接种疫苗的女性获得非保护性 HPV 类型的情况相似，表明 HPV 感染率的差异并非归因于生殖器 HPV 暴露的差异。结论 二价疫苗针对 HPV31/33/45 以及较小程度的 HPV35 和 HPV58 提供的实质性交叉保护在疫苗接种后 11 年后持续并保持稳定，这强化了该疫苗是一种有效选择的观点。预防 HPV 相关癌症。