Efficacy of single-dose HPV vaccination among young African women.
Efficacy of single-dose HPV vaccination among young African women.
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DOI：
10.1056/evidoa2100056
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发表时间：
2022-06
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单剂 HPV 疫苗如果有效，将具有巨大的优势；简化实施并降低成本。我们在肯尼亚 15-20 岁女性中进行了一项随机、多中心、双盲、对照试验，比较单剂量九价 (HPV 16/18/31/33/45/52/58/6/11) 或二价 (HPV 16/18) HPV 疫苗接种与脑膜炎球菌疫苗接种。入组后，每月 6 次宫颈拭子和每月 3 次阴道拭子进行 HPV DNA 检测。对登记血清进行了 HPV 抗体检测。修改后的意向治疗 (mITT) 队列由入组时 HPV 抗体检测呈阴性、入组时和第三个月检测 HPV DNA 呈阴性的参与者组成。主要结局是第 18 个月时持续发生疫苗型 HPV 感染。2018 年 12 月至 2021 年 6 月期间，2,275 名女性被随机分配和随访； 758 人接种了非价 HPV 疫苗，760 人接种了二价 HPV 疫苗，757 人接种了脑膜炎球菌疫苗；保留率为 98%。在 HPV 16/18 mITT 队列中检测到 38 例持续性感染：分配到二价组和非价组的参与者各 1 例，分配到脑膜炎球菌组的参与者各 1 例；一价疫苗功效 (VE) 为 97.5% (95% CI 81.7-99.7%, p=<0.0001)，二价疫苗功效为 97.5% (95% CI 81.6-99.7%, p=<0.0001)。在 HPV 16/18/31/33/45/52/58 mITT 队列中检测到 33 例持续感染：4 例在非无价组，29 例在脑膜炎球菌组； HPV 16/18/31/33/45/52/58 的非价 VE 为 88.9% (95%CI 68.5-96.1%, p<0.0001)。各组的 SAE 发生率为 4.5-5.2%。在我们研究的 18 个月时间范围内，单剂量二价和非价 HPV 疫苗在预防持续致癌 HPV 感染方面均非常有效，与多剂量方案类似。
Single-dose HPV vaccination, if efficacious, would be tremendously advantageous; simplifying implementation and decreasing costs. We performed a randomized, multi-center, double-blind, controlled trial of single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11) or bivalent (HPV 16/18) HPV vaccination compared to meningococcal vaccination among Kenyan women aged 15-20 years. Enrollment and six monthly cervical swabs and a month three vaginal swab were tested for HPV DNA. Enrollment sera were tested for HPV antibodies. The modified intent-to-treat (mITT) cohort comprised participants who tested HPV antibody negative at enrollment and HPV DNA negative at enrollment and month three. The primary outcome was incident persistent vaccine-type HPV infection by month 18. Between December 2018 and June 2021, 2,275 women were randomly assigned and followed; 758 received the nonavalent HPV vaccine, 760 the bivalent HPV vaccine, and 757 the meningococcal vaccine; retention was 98%. Thirty-eight incident persistent infections were detected in the HPV 16/18 mITT cohort: one each among participants assigned to the bivalent and nonavalent groups and 36 among those assigned to the meningococcal group; nonavalent Vaccine Efficacy (VE) was 97.5% (95%CI 81.7-99.7%, p=<0.0001), and bivalent VE was 97.5% (95%CI 81.6-99.7%, p=<0.0001). Thirty-three incident persistent infections were detected in the HPV 16/18/31/33/45/52/58 mITT cohort: four in the nonavalent group and 29 in the meningococcal group; nonavalent VE for HPV 16/18/31/33/45/52/58 was 88.9% (95%CI 68.5-96.1%, p<0.0001). The rate of SAEs was 4.5-5.2% by group. Over the 18 month time-frame we studied, single-dose bivalent and nonavalent HPV vaccines were each highly effective in preventing incident persistent oncogenic HPV infection, similar to multidose regimens.