一项九价预防性 HPV 疫苗的前瞻性、单臂、开放标签、非随机、IIa 期临床试验，旨在评估 9-11 岁女童和男童中采用初免-加强免疫程序的免疫原性 - 临床方案。
A prospective, single-arm, open-label, non-randomized, phase IIa trial of a nonavalent prophylactic HPV vaccine to assess immunogenicity of a prime and deferred-booster dosing schedule among 9-11 year-old girls and boys - clinical protocol.
机构信息
The University of Arizona Cancer Center, 1515 N Campbell Ave, Tucson, AZ, 85724, USA.
Department of Pediatrics, University of California Los Angeles, Los Angeles, CA, USA.
出版信息
BMC Cancer. 2019 Apr 1;19(1):290. doi: 10.1186/s12885-019-5444-4.
BACKGROUND
Human papillomavirus (HPV) vaccines are indicated for the prevention of cancers and genital warts caused by vaccine-covered HPV types. Although the standard regimen requires a two or three-dose vaccine series, there is emerging data suggesting that a single dose of the bivalent or quadrivalent HPV vaccine generates persistently positive antibody titers. No similar data is yet available for the nonavalent HPV vaccine, currently the only HPV vaccine available in the United States. The overall objective of our study is to assess the stability and kinetics of antibody titers for 24 months following a single dose of the nonavalent HPV vaccine among preteen girls and boys.
METHODS
This is a prospective, single-arm, open-label, non-randomized, Phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose of the nonavalent HPV vaccine (GARDASIL® 9) over 24 months, with a deferred booster dose at 24 months and an optional booster at 30 months after the first dose. Participants provide blood specimens at 6, 12, 18, 24, and 30 months after the first dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) will be measured at each time point. The primary objective is to determine the stability of type-specific serologic GMT of HPV16 and HPV18 between the 6- vs. 12-month, 12- vs. 18-month, and 18- vs. 24-month visits. Secondary objectives are to determine the stability of type-specific serologic GMT of the other HPV types (HPV 6/11/31/33/45/52/58) between the visits and to assess safety and reactogenicity after each vaccine dose.
DISCUSSION
Single dose HPV vaccination could simplify the logistics and reduce costs of HPV vaccination in the US and across the world. This study will contribute important immunogenicity data on the stability and kinetics of type-specific antibody titers and inform feasibility of the single dose HPV vaccination paradigm.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02568566 . Registered on October 6, 2015.
背景
人乳头瘤病毒（HPV）疫苗用于预防由疫苗覆盖的 HPV 型引起的癌症和生殖器疣。尽管标准方案需要两剂或三剂疫苗系列，但有新的数据表明，双价或四价 HPV 疫苗的一剂可产生持续的阳性抗体滴度。目前在美国唯一可用的 HPV 疫苗九价 HPV 疫苗尚无类似数据。我们研究的总体目标是评估 9-11 岁女孩和男孩接种一剂九价 HPV 疫苗后 24 个月内抗体滴度的稳定性和动力学。
方法
这是一项针对 9-11 岁女孩和男孩的前瞻性、单臂、开放标签、非随机、IIa 期试验，旨在确定接种一剂九价 HPV 疫苗（加德西® 9）后 24 个月的免疫原性，在 24 个月时延迟加强剂，并在首次接种后 30 个月时选择加强剂。参与者在首次接种后 6、12、18、24 和 30 个月提供血液样本。在每个时间点测量九种疫苗类型（HPV 16/18/6/11/31/33/45/52/58）的血清几何平均滴度（GMT）。主要目标是确定 HPV16 和 HPV18 型在 6- vs. 12 个月、12- vs. 18 个月和 18- vs. 24 个月访视之间的血清学特异性 GMT 的稳定性。次要目标是确定其他 HPV 型（HPV 6/11/31/33/45/52/58）在访视之间的血清学特异性 GMT 的稳定性，并评估每次接种疫苗后的安全性和反应原性。
讨论
单剂 HPV 疫苗接种可以简化美国和全球 HPV 疫苗接种的后勤工作并降低成本。这项研究将提供关于特定类型抗体滴度的稳定性和动力学的重要免疫原性数据，并为单剂 HPV 疫苗接种模式的可行性提供信息。
试验注册
ClinicalTrials.gov 标识符：NCT02568566。于 2015 年 10 月 6 日注册。
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