九价人乳头瘤病毒疫苗对相关疾病和确定性治疗的疗效：与历史安慰剂人群的比较。

Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population.

机构信息

Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, United States.

Department of Obstetrics and Gynecology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.

出版信息

Gynecol Oncol. 2019 Jul;154(1):110-117. doi: 10.1016/j.ygyno.2019.03.253. Epub 2019 Apr 11.

DOI:10.1016/j.ygyno.2019.03.253

PMID:30982556

Abstract

OBJECTIVE

Nine-valent human papillomavirus (9vHPV) vaccine efficacy against disease and cervical surgeries related to all nine vaccine components was assessed compared with a historic placebo population. This was not assessed in the 9vHPV vaccine efficacy trial since the trial was quadrivalent HPV (qHPV) vaccine-controlled, efficacy was measured for the five HPV types covered only by 9vHPV vaccine (HPV31/33/45/52/58), but not the four types covered by both vaccines (HPV6/11/16/18).

METHODS

Three international, randomized, double-blind studies were conducted using the same methodology. In the 9vHPV vaccine study (NCT00543543), 7106 and 7109 women received 9vHPV or qHPV vaccine, respectively. In the historic qHPV vaccine studies (FUTURE I [NCT00092521] and II [NCT00092534]), 8810 and 8812 women received qHPV vaccine or placebo, respectively, based on the same eligibility criteria. Cervical cytological testing was performed regularly. Biopsy or definitive therapy specimens were assessed for HPV DNA.

RESULTS

Among women negative for 14 HPV types prior to vaccination, incidence of high-grade cervical disease (9vHPV, n = 2 cases; placebo, n = 141 cases) and cervical surgery (9vHPV, n = 3 cases; placebo, n = 170 cases) related to the nine HPV types was reduced by 98.2% (95% confidence interval [CI], 93.6-99.7) and 97.8% (95% CI, 93.4-99.4), respectively. The 9vHPV vaccine did not prevent disease related to vaccine HPV types detected at baseline, but significantly reduced cervical, vulvar, and vaginal diseases related to other vaccine HPV types.

CONCLUSIONS

Effective implementation of the 9vHPV vaccine may substantially reduce the burden of HPV-related diseases and related medical procedures.

TRIAL REGISTRATIONS

clinicaltrials.gov: NCT00543543, NCT00092521, NCT00092534.

摘要

目的

评估九价人乳头瘤病毒（9vHPV）疫苗对所有九种疫苗成分相关疾病和宫颈手术的疗效，与历史安慰剂人群进行比较。由于该疫苗试验为四价 HPV（qHPV）疫苗对照试验，仅针对 9vHPV 疫苗覆盖的五种 HPV 类型（HPV31/33/45/52/58）测量了疗效，而不是两种疫苗都覆盖的四种类型（HPV6/11/16/18），因此未在 9vHPV 疫苗疗效试验中评估。

方法

使用相同的方法进行了三项国际、随机、双盲研究。在 9vHPV 疫苗研究（NCT00543543）中，7106 名和 7109 名女性分别接种了 9vHPV 或 qHPV 疫苗。在历史 qHPV 疫苗研究（FUTURE I[NCT00092521]和 II[NCT00092534]）中，8810 名和 8812 名女性分别根据相同的入选标准接种了 qHPV 疫苗或安慰剂。定期进行宫颈细胞学检测。对活检或明确治疗标本进行 HPV DNA 检测。

结果

在接种前 14 种 HPV 类型均为阴性的女性中，与九种 HPV 类型相关的高级别宫颈疾病（9vHPV，n=2 例；安慰剂，n=141 例）和宫颈手术（9vHPV，n=3 例；安慰剂，n=170 例）的发生率分别降低了 98.2%（95%置信区间[CI]，93.6-99.7）和 97.8%（95% CI，93.4-99.4）。9vHPV 疫苗不能预防基线时检测到的疫苗 HPV 类型相关疾病，但显著降低了与其他疫苗 HPV 类型相关的宫颈、外阴和阴道疾病。