Center for Vaccine Clinical Research, Fujian Provincial Center for Disease Control and Prevention, Fuzhou, China.
Department of Preventive Dentistry, Affiliated Stomatological Hospital, Fujian Medical University, Fuzhou, China.
J Med Virol. 2022 Feb;94(2):729-736. doi: 10.1002/jmv.27304. Epub 2021 Sep 4.
The safety of human papillomavirus (HPV) vaccines, one of the major challenges to public vaccination, has been controversial. This study assessed the adverse reactions of various HPV vaccines, including bivalent HPV (2vHPV), quadrivalent HPV (4vHPV), and 9-valent HPV (9vHPV) vaccines.
PubMed, Embase, and Central databases were searched for randomized controlled trials (RCTs) on the comparative safety of HPV vaccines. A network meta-analysis was performed based on the Bayesian framework random-effects model.
This study included 23 RCTs. Analysis across these reports indicated that the 2vHPV vaccine was associated with significantly more systemic adverse events than the 4vHPV vaccine (risk ratio [RR]: 1.28, 95% credible interval [CrI]: 1.14-1.44), 9vHPV vaccine (RR: 1.25, 95% CrI: 1.06-1.49), and placebo (RR: 1.31, 95% CrI: 1.18-1.46). However, there were no statistically significant differences in serious adverse events between the vaccinated and placebo groups. For injection-site adverse events, there were substantial inconsistencies between the direct and indirect effects; therefore, the analysis results of the safety were presented only for systemic and serious adverse events.
The 2vHPV vaccine resulted in more systemic adverse events than other vaccines and placebo. No significant differences in serious adverse events were observed. Further studies are needed to obtain more information regarding the safety of HPV vaccines.
人乳头瘤病毒（HPV）疫苗作为公众接种疫苗的主要挑战之一，其安全性一直存在争议。本研究评估了各种 HPV 疫苗（包括二价 HPV 疫苗[2vHPV]、四价 HPV 疫苗[4vHPV]和九价 HPV 疫苗[9vHPV]）的不良反应。
检索了 PubMed、Embase 和中央数据库中关于 HPV 疫苗比较安全性的随机对照试验（RCT）。基于贝叶斯框架随机效应模型进行网络荟萃分析。
本研究纳入了 23 项 RCT。对这些报告的分析表明，2vHPV 疫苗与更多的全身不良反应相关，与 4vHPV 疫苗（风险比 [RR]：1.28，95%可信区间 [CrI]：1.14-1.44）、9vHPV 疫苗（RR：1.25，95% CrI：1.06-1.49）和安慰剂（RR：1.31，95% CrI：1.18-1.46）相比。然而，接种组与安慰剂组之间的严重不良事件无统计学差异。对于注射部位不良反应，直接效应与间接效应之间存在很大不一致，因此仅呈现了全身和严重不良事件的安全性分析结果。
2vHPV 疫苗引起的全身不良反应多于其他疫苗和安慰剂。未观察到严重不良事件的显著差异。需要进一步研究以获取有关 HPV 疫苗安全性的更多信息。
