HPV-16/18 AS04 佐剂疫苗对切除治疗后预防后续感染和疾病的影响：一项随机对照试验的事后分析。
Impact of HPV-16/18 AS04-adjuvanted vaccine on preventing subsequent infection and disease after excision treatment: post-hoc analysis from a randomized controlled trial.
机构信息
Department of Epidemiology, National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, PO Box 2258, Beijing, 100021, China.
Department of Cytology and Pathology, National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
出版信息
BMC Infect Dis. 2020 Nov 16;20(1):846. doi: 10.1186/s12879-020-05560-z.
BACKGROUND
It is widely acknowledged that HPV prophylactic vaccine could prevent new infections and their associated lesions among women who are predominantly HPV-naive at vaccination. Yet there still remains uncertainty about whether HPV vaccination could benefit to individuals who have undergone surgery for cervical disease.
METHODS
This post-hoc analysis intends to focus on intent-to-treat participants who underwent excision treatment at baseline and the follow-up period in a phase II/III, double-blind, randomized trial ( ClinicalTrials.gov , number NCT00779766 ) conducted in Jiangsu province, China. We evaluate the impact of HPV vaccination on preventing women from subsequent infection and cervical lesions (LSIL+ and CIN2+) after excision treatment.
RESULTS
One hundred sixty-eight (vaccine, n = 87; placebo, n = 81) performed excisional treatment in this clinical trial. We observed a significant effect of vaccination on acquiring 14 high-risk HPV (HR-HPV) infection after treatment (vaccine efficacy: 27.0%; 95% CI 4.9, 44.0%). The vaccine efficacy against new infections after treatment for 14 HR-HPV infection was estimated as 32.0% (95%CI 1.8, 52.8%), and was 41.2% (95%CI -162.7, 86.8%) for HPV16/18 infection. The accumulative clearance rates of the vaccine group and placebo group were 88.9 and 81.6% for HPV16/18 infection (P = 0.345), 63.4, 48.7% for 14 HR-HPV infection (P = 0.062), respectively. No significant difference was observed on the persistent rate of HPV16/18, 14 HR-HPV infection and occurrence rate of LSIL+ between the two groups.
CONCLUSIONS
No significant evidence from this study showed that HPV-16/18 AS04-adjuvanted vaccine could lead to viral faster clearance or have any effect on the rates of persistent infection among women who had excision treatment. However, the vaccine may still benefit post-treatment women with "primary prophylactic" effect. Further research is required in clarifying the effect of using the prophylactic HPV vaccine as therapeutic agents.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT00779766 . Date and status of trial registration: October 24, 2008. Completed; Has Results.
背景
广泛认为 HPV 预防性疫苗可预防疫苗接种时 HPV 初筛阴性的女性中 HPV 新感染及其相关病变。然而，对于已接受宫颈疾病手术的个体，HPV 疫苗是否有益仍存在不确定性。
方法
本事后分析专注于在江苏省开展的一项 II/III 期、双盲、随机临床试验（ClinicalTrials.gov 编号 NCT00779766）中，在基线和随访期间接受切除术治疗的意向治疗参与者。我们评估 HPV 疫苗接种对预防女性在切除术后发生新的 HPV 感染和宫颈病变（LSIL+和 CIN2+）的影响。
结果
本临床试验中 168 名（疫苗组 n=87；安慰剂组 n=81）接受了切除术治疗。我们观察到疫苗接种对治疗后 14 种高危型 HPV（HR-HPV）感染的显著效果（疫苗效力：27.0%；95%CI 4.9，44.0%）。对于治疗后 14 种 HR-HPV 感染的新感染，疫苗效力估计为 32.0%（95%CI 1.8，52.8%），对于 HPV16/18 感染为 41.2%（95%CI -162.7，86.8%）。疫苗组和安慰剂组 HPV16/18 感染的累积清除率分别为 88.9%和 81.6%（P=0.345），14 种 HR-HPV 感染分别为 63.4%和 48.7%（P=0.062）。两组间 HPV16/18、14 种 HR-HPV 感染的持续性率和 LSIL+的发生率无显著差异。
结论
本研究未提供 HPV-16/18 AS04 佐剂疫苗可导致病毒更快清除或对切除术后女性持续感染率产生任何影响的明确证据。然而，疫苗可能仍对接受“初级预防”的术后女性有益。需要进一步研究来阐明预防性 HPV 疫苗作为治疗剂的效果。
试验注册
ClinicalTrials.gov 标识符：NCT00779766。试验注册日期和状态：2008 年 10 月 24 日。已完成；有结果。
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