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Evaluation of durability of a single-dose of the bivalent HPV vaccine: the CVT Trial.
Journal of the National Cancer Institute ( IF 10.3 ) Pub Date : 2020-02-24 , DOI: 10.1093/jnci/djaa011
Aimée R Kreimer 1 , Joshua N Sampson 1 , Carolina Porras 2 , John T Schiller 1 , Troy Kemp 3 , Rolando Herrero 4 , Sarah Wagner 1, 5 , Joseph Boland 1, 5 , John Schussler 6 , Douglas R Lowy 1 , Stephen Chanock 1 , David Roberson 1, 5 , Mónica S Sierra 1 , Sabrina H Tsang 1 , Mark Schiffman 1 , Ana Cecilia Rodriguez 7 , Bernal Cortes 2 , Mitchell H Gail 1 , Allan Hildesheim 1 , Paula Gonzalez 2 , Ligia A Pinto 3 ,
Affiliation  

BACKGROUND Investigate the durability of vaccine efficacy (VE) against HPV16/18 infections and antibody response among non-randomized women who received a single-dose of the bivalent HPV vaccine compared to women who received multiple doses and unvaccinated women. METHODS HPV infections were compared between HPV16/18 vaccinated women aged 18 to 25 years who received one (N = 112), two (N = 62), or three (N = 1365) doses, and age- and geography-matched unvaccinated women (N = 1783) in the long-term followup of the Costa Rica HPV Vaccine Trial. Cervical HPV infections were measured at two study visits, approximately 9- and 11-years after initial HPV vaccination, using NCI next-generation sequencing TypeSeq1 assay. VE and 95% confidence intervals (CI) were estimated. HPV16/18-antibody levels were measured on all one- and two-dose women, and a subset of three-dose women, using a virus-like particle-based ELISA (n = 448). RESULTS Median follow-up for the HPV-vaccinated group was 11.3 years (interquartile range [IQR]: 10.9-11.7 years) and did not vary by dose group. VE against prevalent HPV16/18 infection was 80.2% (95%CI 70.7-87.0%) among three-dose, 83.8% (95%CI 19.5-99.2%) among two-dose, and 82.1% (95%CI 40.2-97.0%) among single-dose women. HPV16/18 antibody levels did not qualitatively decline between years four and 11, regardless of the number of doses given, although one-dose titers continue to be statistically significantly lower compared to two- and three-doses. CONCLUSION More than a decade after HPV vaccination, single-dose VE against HPV16/18 infection remained high and HPV16/18 antibodies remained stable. A single dose of bivalent HPV vaccine may induce sufficiently durable protection that obviates the need for more doses.

中文翻译:

单剂量二价HPV疫苗的耐久性评估:CVT试验。

背景技术与接受多次剂量和未接种疫苗的女性相比,研究了接受单剂量二价HPV疫苗的非随机分组妇女中针对HPV16 / 18感染的疫苗效力(VE)的持久性和抗体应答。方法比较18至25岁的HPV16 / 18接种疫苗的女性,分别接受一剂(N = 112),两剂(N = 62)或三剂(N = 1365)以及年龄和地理位置匹配的未接种疫苗的女性(N = 1783)在哥斯达黎加HPV疫苗试验的长期随访中。使用NCI下一代测序TypeSeq1分析法在首次HPV疫苗接种后约9年和11年的两次研究访问中测量宫颈HPV感染。估计VE和95%置信区间(CI)。测量了所有一剂和两剂妇女的HPV16 / 18抗体水平,和三剂剂量的女性子集,使用基于病毒的颗粒ELISA(n = 448)。结果HPV疫苗接种组的中位随访时间为11.3年(四分位间距[IQR]:10.9-11.7年),并且随剂量组而变化。对抗流行HPV16 / 18感染的VE在三剂中分别为80.2%(95%CI 70.7-87.0%),在两剂中为83.8%(95%CI 19.5-99.2%)和82.1%(95%CI 40.2-97.0) %)在单剂量女性中。HPV16 / 18抗体水平在第4年和第11年之间没有质的下降,尽管给予的剂量数量虽然在统计学上比两剂量和三剂量的滴度仍显着降低。结论接种HPV疫苗十多年后,针对HPV16 / 18感染的单剂量VE仍然很高,HPV16 / 18抗体保持稳定。
更新日期:2020-02-24
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