Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants

IF 3.2 Papillomavirus Research Pub Date : 2020-12-01 DOI:10.1016/j.pvr.2020.100205

Shinya Murata, Masayoshi Shirakawa, Yoshie Sugawara, Michiko Shuto, Miyuki Sawata, Yoshiyuki Tanaka

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引用次数: 3

Abstract

Aim

The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants.

Methods

This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18–26 years (N = 1021; NCT00378560) and girls aged 9–17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity.

Results

Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset.

Conclusions

Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine.

Trial registration

Clinicaltrials. gov: NCT00378560 and NCT00411749.

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日本女性临床试验参与者接种四价人乳头瘤病毒疫苗后注射部位反应的事后分析

目的:在日本进行的临床试验中，四价人乳头瘤病毒(4vHPV)疫苗已显示出有效性和免疫原性，并且普遍耐受良好。我们报告了日本女性4vHPV临床试验参与者注射部位反应的详细安全性分析。方法:这项事后分析纳入了2项双盲、安慰剂对照的II期临床试验的数据，这些试验在18-26岁的日本年轻女性中进行，分别为3剂(第1天、第2个月、第6个月)4vHPV疫苗方案(N = 1021;NCT00378560)和9-17岁的女孩(N = 107;NCT00411749)。每次接种疫苗后15天，使用接种报告卡监测注射部位和全身不良事件(ae);在整个试验过程中都报告了严重的不良反应。对这些试验的数据进行事后分析，以检查注射部位ae的细节，包括发病日期、从发病到消退的时间和最大强度。结果85.6%的4vHPV疫苗接种者和72.4%的安慰剂接种者报告了注射部位不良反应，最常见的是红斑、疼痛、瘙痒和肿胀(各占4vHPV疫苗接种者的5%)。大多数注射部位ae在接种疫苗后3天内发病，强度为轻度至中度;很少有4vHPV疫苗接种者报告严重的注射部位不良反应(总体为2.0%)。所有注射部位的ae都得到了解决，大多数(4vHPV: 87.5%;安慰剂组:92.7%)在发病5天内消退。结论注射部位反应多为轻度或中度，持续时间短。基于这一事后分析，日本女性临床试验参与者对3剂4vHPV疫苗的耐受性良好。这些结果将进一步支持卫生保健提供者和疫苗接受者之间关于HPV疫苗的安全沟通。registrationClinicaltrials审判。网址:NCT00378560和NCT00411749。

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来源期刊

Papillomavirus Research VIROLOGY-

自引率

0.00%

发文量

审稿时长

14 weeks

期刊介绍： The official Journal of the International Papillomavirus Society Papillomavirus Research (PVR), the Journal of HPV and other Small DNA Tumor Viruses publishes innovative papers related to all aspects of papillomaviruses and other small DNA tumor viruses. The official journal of the International Papillomavirus Society, PVR is an open access publication that aims to bring together virologists, immunologists, epidemiologists and clinicians working in the booming field of HPV and animal papillomaviruses, polyomaviruses and other small DNA tumor viruses and their associated diseases, in order to foster and facilitate interdisciplinary communication. The journal welcomes original research articles, reviews, short communications, opinion articles and regional update reports on papillomaviruses and other tumor viruses in the following sections: a. Biology of papillomaviruses and related viruses from life cycle to cancer b. Epidemiology etiology and natural history studies c. Natural and induced immunity including vaccine research d. Intervention studies and strategies including i. Clinical studies and trials ii. HPV treatments iii. HPV vaccination programs iv. Diagnostics and screening e. Infection and disease prevention, modeling studies f. Guidelines and public health recommendations g. HPV Studies in special populations Regional and local studies on these viruses.