在一项为期 90 个月随访的中国女性中进行的 3 期、随机、双盲、安慰剂对照临床试验中评估四价人乳头瘤病毒疫苗的安全性。
Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up.
机构信息
Department of Cancer 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, Beijing, 100021, China.
Department of Obstetrics and Gynecology, Peking University People's Hospital, 11 Xizhimen South Street, Beijing 100044, China.
出版信息
Vaccine. 2019 Feb 4;37(6):889-897. doi: 10.1016/j.vaccine.2018.12.030. Epub 2019 Jan 9.
BACKGROUND
A quadrivalent human papillomavirus (qHPV) vaccine (HPV6/11/16/18) has demonstrated efficacy and acceptable safety in international studies. However, these studies did not include participants from mainland China, which has a substantial burden of HPV-related disease. This is the first safety report with a follow-up period of up to 90 months from a randomized, double-blind, placebo-controlled trial of qHPV vaccine in Chinese women 20-45 years of age.
METHODS
Participants were randomized 1:1 to receive three doses of qHPV vaccine or placebo (Day1, Month 2, and Month 6). Efficacy outcomes are reported elsewhere. Injection-site and systemic adverse events (AEs) were collected using vaccination report cards (VRCs) for 15 days following each vaccination. Serious AEs (SAEs), pregnancy outcomes, new medical conditions, and fetal/infant SAEs were collected during the entire study.
RESULTS
Of 3006 participants randomized, AEs were reported by 926 (61.8%) qHPV vaccine recipients and 856 (57.1%) placebo recipients over the entire study. Four participants (two in each group) discontinued the study vaccination due to AEs that were considered vaccination-related. Within 15 days following any vaccination, injection-site AEs prompted for on the VRC were more frequent among qHPV vaccine recipients (37.6% vs 27.8%), and systemic AEs prompted for on the VRC were similar in frequency between qHPV vaccine and placebo groups (46.8% vs 45.1%). Thirty-eight and 43 participants reported SAEs in qHPV vaccine and placebo groups, respectively. No SAE was considered qHPV vaccine-related. Pregnancy outcomes, fetal/infant SAEs, and new medical conditions were generally similar in frequency between the qHPV vaccine and placebo groups, and within normal ranges.
CONCLUSION
The qHPV vaccine was well tolerated and demonstrated a favorable safety profile in Chinese women 20-45 years of age, consistent with findings from global trials and safety surveillance studies.
TRIAL REGISTRATION
clinicaltrials.gov; NCT00834106.
背景
四价人乳头瘤病毒（HPV）疫苗（HPV6/11/16/18）在国际研究中已证明具有疗效和可接受的安全性。然而，这些研究并未包括来自中国大陆的参与者，中国大陆 HPV 相关疾病负担沉重。这是一项在 20-45 岁中国女性中进行的四价 HPV 疫苗随机、双盲、安慰剂对照试验的首个安全性报告，随访时间长达 90 个月。
方法
参与者按 1:1 随机分配接受三剂四价 HPV 疫苗或安慰剂（第 1 天、第 2 个月和第 6 个月）。疗效结果在其他地方报告。接种报告卡（VRC）在每次接种后 15 天内收集注射部位和全身不良事件（AE）。严重不良事件（SAE）、妊娠结局、新的医疗状况和胎儿/婴儿 SAE 在整个研究期间收集。
结果
在 3006 名随机分配的参与者中，整个研究期间，926 名（61.8%）四价 HPV 疫苗接种者和 856 名（57.1%）安慰剂接种者报告了 AE。4 名参与者（每组 2 名）因 AE 而停止研究接种，AE 被认为与接种有关。在任何接种后 15 天内，VRC 提示的注射部位 AE 在四价 HPV 疫苗接种者中更为频繁（37.6%比 27.8%），VRC 提示的全身 AE 在四价 HPV 疫苗和安慰剂组之间的频率相似（46.8%比 45.1%）。四价 HPV 疫苗组和安慰剂组分别有 38 名和 43 名参与者报告 SAE。没有 SAE 被认为与四价 HPV 疫苗有关。妊娠结局、胎儿/婴儿 SAE 和新的医疗状况在四价 HPV 疫苗组和安慰剂组之间的频率大致相似，且处于正常范围内。
结论
四价 HPV 疫苗在 20-45 岁中国女性中具有良好的耐受性和有利的安全性，与全球试验和安全性监测研究结果一致。
试验注册
clinicaltrials.gov；NCT00834106。
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