Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine.
Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine.
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DOI：
10.1093/jnci/djr319
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发表时间：
2011-10-05
期刊：
影响因子：
--
通讯作者：
CVT Vaccine Group
中科院分区：
文献类型：
--
作者：
Kreimer AR;Rodriguez AC;Hildesheim A;Herrero R;Porras C;Schiffman M;González P;Solomon D;Jiménez S;Schiller JT;Lowy DR;Quint W;Sherman ME;Schussler J;Wacholder S;CVT Vaccine Group
人乳头瘤病毒（HPV）疫苗的三剂方案昂贵且难以完成，特别是在最需要预防宫颈癌的环境中。我们在我们的哥斯达黎加疫苗试验中评价了少于三剂HPV 16/18疫苗Cervarix的疫苗效力。女性被随机分配接受三剂HPV 16/18疫苗或对照疫苗，并在间隔10个月或更长时间的访视中对持续存在的HPV 16或HPV 18感染事件进行随访（中位随访时间为4.2年）。在排除没有随访或在入组时HPV 16和HPV 18 DNA阳性的妇女后，5967名妇女接受了三剂疫苗（2957 HPV疫苗vs 3010对照疫苗），802名接受了两剂疫苗（422 HPV vs 380对照疫苗），384名接受了一剂疫苗（196 HPV vs 188对照疫苗）。接受HPV疫苗和对照疫苗的女性之间，每个剂量组接受较少剂量的原因和其他随机化前后的特征是平衡的。持续1年的HPV 16或HPV 18感染事件与对照疫苗的剂量无关。三剂HPV疫苗的疫苗有效率为80.9%（95%置信区间[CI] = 71.1%至87.7%; HPV组和对照组分别发生25起和133起事件），两种剂量组为84.1%（95% CI = 50.2%至96.3%; 3和17起事件），以及100%（95% CI = 66.5%至100%; 0和10起事件）。在未感染的妇女接种疫苗四年后，这项非随机分析表明，两剂HPV 16/18疫苗，甚至一剂疫苗，与三剂疫苗一样具有保护作用。
Three-dose regimens for human papillomavirus (HPV) vaccines are expensive and difficult to complete, especially in settings where the need for cervical cancer prevention is greatest. We evaluated the vaccine efficacy of fewer than three doses of the HPV16/18 vaccine Cervarix in our Costa Rica Vaccine Trial. Women were randomly assigned to receive three doses of the HPV16/18 vaccine or to a control vaccine and were followed for incident HPV16 or HPV18 infection that persisted in visits that were 10 or more months apart (median follow-up 4.2 years). After excluding women who had no follow-up or who were HPV16 and HPV18 DNA positive at enrollment, 5967 women received three vaccine doses (2957 HPV vaccine vs 3010 control vaccine), 802 received two doses (422 HPV vs 380 control), and 384 received one dose (196 HPV vs 188 control). Reasons for receiving fewer doses and other pre- and post-randomization characteristics were balanced within each dosage group between women receiving the HPV and control vaccines. Incident HPV16 or HPV18 infections that persisted for 1 year were unrelated to dosage of the control vaccine. Vaccine efficacy was 80.9% for three doses of the HPV vaccine (95% confidence interval [CI] = 71.1% to 87.7%; 25 and 133 events in the HPV and control arms, respectively), 84.1% for two doses (95% CI = 50.2% to 96.3%; 3 and 17 events), and 100% for one dose (95% CI = 66.5% to 100%; 0 and 10 events). Four years after vaccination of women who appeared to be uninfected, this nonrandomized analysis suggests that two doses of the HPV16/18 vaccine, and maybe even one dose, are as protective as three doses.
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