九价人乳头瘤病毒疫苗在中国 9 至 26 岁女性中的免疫原性和安全性：一项 3 期、开放性、免疫桥接研究。
Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in Chinese females aged 9 to 26 years: A phase 3, open-label, immunobridging study.
机构信息
Guangdong Provincial Institute of Biological Products and Materia Medica, 200 Xipengling Road, Guangzhou, Guangdong Province 510440, PR China.
Guangdong Provincial Center for Disease Control and Prevention, 160 Qunxian Road, Guangzhou, Guangdong Province 511430, PR China.
出版信息
Vaccine. 2021 Jan 22;39(4):760-766. doi: 10.1016/j.vaccine.2020.11.008. Epub 2020 Nov 22.
BACKGROUND
The quadrivalent human papillomavirus (qHPV; HPV6/11/16/18) vaccine was approved for use in Chinese women aged 20-45 years in 2017. This Phase 3, open-label study (NCT03493542) aimed to assess immunogenicity and safety of the qHPV vaccine in Chinese girls aged 9-19 years versus Chinese young women aged 20-26 years; we report results from Day 1 through Month 7. The study will continue through Month 60 to assess antibody persistence in Chinese girls aged 9-19 years.
METHODS
Participants aged 9-26 years received three doses of the qHPV vaccine (Day 1, Month 2, Month 6). Geometric mean titers (GMTs) and seroconversion percentages for anti-HPV6/11/16/18 antibodies were determined by competitive Luminex immunoassay (cLIA) in serum samples obtained on Day 1 and at Month 7. Injection-site adverse events (AEs) and systemic AEs within 30 days post-vaccination, and serious AEs (SAEs) occurring at any time during the study, were recorded.
RESULTS
In total, 766 participants (383 aged 9-19 years; 383 aged 20-26 years) were enrolled and received ≥1 vaccine dose. All participants in the per-protocol immunogenicity population of both age groups seroconverted to each of the vaccine HPV types at Month 7. Anti-HPV6/11/16/18 antibody GMTs at Month 7 in participants aged 9-19 years were non-inferior to those in participants aged 20-26 years. Injection-site AEs and systemic AEs were reported by 36.6% and 49.3% of 9-19-year-olds, and 40.7% and 54.8% of 20-26-year-olds, respectively. There were no vaccine-related SAEs. No participants discontinued the vaccine due to an AE and no deaths were reported.
CONCLUSION
Antibody responses induced by the 3-dose qHPV vaccination regimen in Chinese girls aged 9-19 years were non-inferior to those in Chinese young women aged 20-26 years. The vaccine was generally well tolerated in the study population. ClinicalTrials.gov Identifier: NCT03493542.
背景
四价人乳头瘤病毒（qHPV；HPV6/11/16/18）疫苗于 2017 年获准在中国 20-45 岁女性中使用。这项 3 期、开放性标签研究（NCT03493542）旨在评估 qHPV 疫苗在中国 9-19 岁女孩与中国 20-26 岁年轻女性中的免疫原性和安全性；我们报告了从第 1 天到第 7 个月的结果。该研究将继续进行到第 60 个月，以评估中国 9-19 岁女孩的抗体持久性。
方法
年龄在 9-26 岁的参与者接受三次 qHPV 疫苗（第 1 天、第 2 个月、第 6 个月）接种。通过竞争 Luminex 免疫分析（cLIA）在第 1 天和第 7 个月时采集的血清样本中确定抗 HPV6/11/16/18 抗体的几何平均滴度（GMT）和血清转化率。记录接种后 30 天内的注射部位不良事件（AE）和全身 AE，以及研究期间任何时间发生的严重不良事件（SAE）。
结果
共有 766 名参与者（383 名 9-19 岁；383 名 20-26 岁）入组并接受了至少一剂疫苗。两个年龄组的方案免疫人群中，所有参与者在第 7 个月时均对每种疫苗 HPV 类型产生了血清转化率。9-19 岁参与者在第 7 个月时的抗 HPV6/11/16/18 抗体 GMT 与 20-26 岁参与者相当。9-19 岁组的注射部位 AE 和全身 AE 分别报告了 36.6%和 49.3%，20-26 岁组分别报告了 40.7%和 54.8%。没有与疫苗相关的 SAE。没有参与者因 AE 而停止接种疫苗，也没有死亡报告。
结论
在中国 9-19 岁女孩中，3 剂 qHPV 疫苗接种方案诱导的抗体反应与中国 20-26 岁年轻女性相当。在研究人群中，该疫苗总体耐受性良好。临床试验.gov 标识符：NCT03493542。
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