Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia - A Randomized controlled trial
Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia - A Randomized controlled trial
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DOI：
10.1097/01.aog.0000192397.41191.fb
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发表时间：
2006-01-01
影响因子：
7.2
通讯作者：
Barr, E
中科院分区：
文献类型：
--
作者：
Mao, C;Koutsky, LA;Barr, E
目的：人乳头瘤病毒（HPV）病毒样颗粒（VLP）疫苗在预防持续性HPV感染方面已被证明有效。保护是否持续超过18个月，因此，宫颈上皮内瘤变（CIN）的影响率2-3尚未确定。我们报告了一项为期48个月的HPV16 L1 VLP疫苗试验的结果。方法：共有2391名女性，年龄16-23岁，参加了一项随机、双盲、安慰剂对照试验。在第1天、第2个月和第6个月肌肉注射40 μ g HPV16 L1 VLP疫苗或安慰剂。在第1天、第7个月、第6个月至第48个月采集生殖器样本进行HPV16 DNA和巴氏试验。如果有临床指征，在研究结束时进行阴道镜检查和宫颈活检。用放射免疫法测定血清HPV16抗体滴度。结果：在每个方案人群中的750名安慰剂接受者中，12名妇女发生了hpv16相关的CIN2-3（6名CIN2和6名CIN3）。在755名疫苗接种者中，无病例（疫苗效力100%，95%可信区间[CI] 65-100%）。安慰剂接受者中有111例持续HPV16感染，疫苗接受者中有7例（疫苗有效性94%，95% CI 88-98%）。免疫后，HPV16血清抗体几何平均滴度在第7个月达到峰值（1,519毫默克单位[mMU]/mL），在第18个月下降（202 mMU/mL），并在第30个月至第48个月保持相对稳定（128-150 mMU/mL）。结论：疫苗HPV16 L1 VLP在免疫后至少3.5年对持续的HPV16感染和HPV16相关的CIN2-3提供了高水平的保护。针对HPV16的L1 VLP疫苗的管理可能会降低宫颈癌的风险。
OBJECTIVE: Human papillomavirus (HPV) virus-like particle (VLP) vaccines have demonstrated effectiveness in preventing persistent HPV infections. Whether protection lasts longer than 18 months and, thus, impacts rates of cervical intraepithelial neoplasia (CIN) 2-3 has not yet been established. We present results from an HPV16 L1 VLP vaccine trial through 48 months.METHODS: A total of 2,391 women, aged 16-23 years, participated in a randomized, double-blind, placebo-controlled trial. Either 40 mu g HPV16 L1 VLP vaccine or placebo was given intramuscularly at day 1, month 2, and month 6. Genital samples for HPV16 DNA and Pap tests were obtained at day 1, month 7, and then 6-monthly through month 48. Colposcopy and cervical biopsies were performed if clinically indicated and at study exit. Serum HPV16 antibody titer was measured by radioimmunoassay.RESULTS: Among 750 placebo recipients in the per protocol population, 12 women developed HPV16-related CIN2-3 (6 CIN2 and 6 CIN3). Among 755 vaccine recipients, there were no cases (vaccine efficacy 100%, 95% confidence interval [CI] 65-100%). There were 111 cases of persistent HPV16 infection in placebo recipients and 7 cases in vaccine recipients (vaccine efficacy 94%, 95% CI 88-98%). After immunization, HPV16 serum antibody geometric mean titers peaked at month 7 (1,519 milli-Merck units [mMU]/mL), declined through month 18 (202 mMU/mL), and remained relatively stable between month 30 and month 48 (128-150 mMU/mL).CONCLUSION: The vaccine HPV16 L1 VLP provides high-level protection against persistent HPV16 infection and HPV16-related CIN2-3 for at least 3.5 years after immunization. Administration of L1 VLP vaccines targeting HPV16 is likely to reduce risk for cervical cancer.