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一项关于四价人乳头瘤病毒疫苗在阿拉斯加原住民儿童中的免疫原性的前瞻性队列研究,美国阿拉斯加。

A prospective cohort study of immunogenicity of quadrivalent human papillomavirus vaccination among Alaska Native Children, Alaska, United States.

机构信息

Arctic Investigations Program, Division of Preparedness and Emerging Infections, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Anchorage, AK, USA.

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.

出版信息

Vaccine. 2020 Sep 29;38(42):6585-6591. doi: 10.1016/j.vaccine.2020.08.005. Epub 2020 Aug 16.

Abstract

OBJECTIVE

In the United States, HPV vaccination is routinely recommended at age 11 or 12 years; the series can be started at age 9. We conducted a cohort study to assess long-term immunogenicity of quadrivalent HPV vaccine (4vHPV) in an American Indian/Alaska Native (AI/AN) Indigenous population.

METHODS

During 2011-2014, we enrolled AI/AN girls and boys aged 9-14 years, who were vaccinated with a 3-dose series of 4vHPV. Serum specimens were collected at five time points: immediately prior to doses 2 and 3, and at one month, one year, and two years after series completion. Antibody testing was performed using a multiplex virus-like-particle-IgG ELISA for 4vHPV types (HPV 6/11/16/18).

RESULTS

Among 477 children (405 girls/72 boys) completing the 3-dose series, median age at enrollment was 11.2 years. Of the 477, 72 (15%) were tested before dose 2 and 70 (15%) before dose 3. Following series completion, 435 (91%) were tested at one month, 382 (80%) at one year, and 351 (74%) at two years. All tested participants had detectable antibody to 4vHPV types at all time points measured. Geometric mean concentrations (GMCs) for 4vHPV types at one month and two years post-series completion were 269.9 and 32.7 AU/ml for HPV6, 349.3 and 42.9 AU/ml for HPV11, 1240.2 and 168.3 IU/ml HPV16, and 493.2 and 52.2 IU/ml for HPV18. Among children tested after each dose, GMCs after doses 1 and 2 were 3.9 and 32.2 AU/ml for HPV6, 5.3 and 45.6 AU/ml for HPV11, 20.8 and 187.9 IU/ml for HPV16; and 6.6 and 49.7 IU/ml for HPV18. No serious adverse events were reported.

CONCLUSION

All AI/AN children developed antibodies to all 4vHPV types after vaccination. GMCs rose after each dose, then decreased to a plateau over the subsequent two years. This cohort will continue to be followed to determine duration of antibody response.

摘要

目的

在美国,HPV 疫苗接种通常在 11 或 12 岁时推荐;该系列可以在 9 岁开始。我们进行了一项队列研究,以评估四价 HPV 疫苗(4vHPV)在美洲印第安人/阿拉斯加原住民(AI/AN)土著人群中的长期免疫原性。

方法

在 2011-2014 年期间,我们招募了年龄在 9-14 岁的 AI/AN 女孩和男孩,他们接受了三剂 4vHPV 系列疫苗接种。在五时间点采集血清标本:在接种第 2 剂和第 3 剂前,以及在接种系列完成后一个月、一年和两年。使用多聚酶联免疫吸附试验(ELISA)对 4vHPV 型(HPV 6/11/16/18)进行抗体检测。

结果

在完成三剂系列接种的 477 名儿童(405 名女孩/72 名男孩)中,中位入组年龄为 11.2 岁。在 477 名儿童中,72 名(15%)在接种第 2 剂前接受了检测,70 名(15%)在接种第 3 剂前接受了检测。在完成系列接种后,435 名(91%)在一个月时接受了检测,382 名(80%)在一年时接受了检测,351 名(74%)在两年时接受了检测。所有接受检测的参与者在所有测量时间点均检测到针对 4vHPV 型的抗体。在完成系列接种后一个月和两年时,HPV6 的几何平均浓度(GMC)分别为 269.9 和 32.7 AU/ml,HPV11 分别为 349.3 和 42.9 AU/ml,HPV16 分别为 1240.2 和 168.3 IU/ml,HPV18 分别为 493.2 和 52.2 IU/ml。在每次接种后接受检测的儿童中,HPV6 在接种第 1 剂和第 2 剂后的 GMC 分别为 3.9 和 32.2 AU/ml,HPV11 分别为 5.3 和 45.6 AU/ml,HPV16 分别为 20.8 和 187.9 IU/ml,HPV18 分别为 6.6 和 49.7 IU/ml。未报告严重不良事件。

结论

所有 AI/AN 儿童在接种疫苗后均产生了针对所有 4vHPV 型的抗体。每次接种后 GMC 均升高,然后在随后的两年内降至稳定水平。该队列将继续进行随访,以确定抗体反应的持续时间。

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