Durability of Cross-Protection by Different Schedules of the Bivalent HPV Vaccine: The CVT Trial

Durability of Cross-Protection by Different Schedules of the Bivalent HPV Vaccine: The CVT Trial
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不同接种方案的双价HPV疫苗交叉保护的持久性:CVT试验

DOI:
10.1093/jnci/djaa010
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发表时间:
2020-10-01
影响因子:
10.3
通讯作者:
Herrero, Rolando
Herrero, Rolando
中科院分区:
医学1区
文献类型:
--
作者:
Tsang, Sabrina H.;Sampson, Joshua N.;Herrero, Rolando

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背景:哥斯达黎加 HPV 疫苗试验记录了二价 HPV 疫苗在接种疫苗后长达 7 年内针对 HPV31/33/45 的交叉保护作用,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 的不同疫苗接种方案的功效,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,我们观察到对 HPV31/33/45 具有统计学显着的交叉保护作用(VEavg = 64.4%,95% 置信区间 [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、统计学显着交叉保护。随着时间的推移,VE 没有下降(HPV31、-33、-35、-45 和 -58 的两侧 P 趋势 > .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,这强化了二价疫苗是预防 HPV 相关癌症的有效选择的观点。
Background: The Costa Rica HPV Vaccine Trial has documented cross-protection of the bivalent HPV vaccine against HPV31/33/45 up to 7 years after vaccination, even with one dose of the vaccine. However, the durability of such protection remains unknown. Here, we evaluate the efficacy of different schedules of the vaccine against HPV31/33/45 out to 11 years postvaccination, expanding to other nontargeted HPV types. Methods: We compared the rates of HPV infection in vaccinated women with 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% confidence interval [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-trend > .05 for HPV31, -33, -35, -45, and -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 nonprotected 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. Conclusions: 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 postvaccination, reinforcing the notion that the bivalent vaccine is an effective option for protection against HPV-associated cancers.