Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine
Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine
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DOI：
10.1086/521679
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发表时间：
2007-10-15
影响因子：
6.4
通讯作者：
Barr, Eliav
中科院分区：
文献类型：
--
作者：
Giuliano, Anna R.;Lazcano-Ponce, Eduardo;Barr, Eliav
背景四价（6、11、16和18型）人乳头瘤病毒（HPV）L1病毒样颗粒疫苗在预防HPV-6、-11、-16和-18相关的宫颈和生殖器疾病方面的有效性为95%-100%。疫苗效力被认为是由体液免疫介导的。在这里，我们分析了受试者的基线特征对疫苗诱导的免疫应答的影响。分析了2/3期研究中随机接受四价HPV疫苗或安慰剂的12，343名9-26岁受试者的免疫原性数据。检查的协变量为第1天HPV血清状态、年龄、人种/种族、居住地区、哺乳状态、激素避孕药使用、吸烟状况、巴氏试验诊断、免疫抑制剂或抗炎剂使用以及性伴侣数量。抗HPV应答总结为第3次给药后1个月血清抗HPV- 6、- 11、- 16或- 18几何平均滴度。接种开始时的年龄与疫苗诱导的抗HPV应答成反比。与基线时血清阴性的受试者相比，在第1天对疫苗HPV类型血清阳性的受试者亚群的疫苗接种导致对该类型的抗HPV应答更稳健。抗HPV应答在其余人口统计学亚组中具有可比性。在具有不同基线特征的受试者中，四价HPV疫苗的免疫原性相当。这些数据支持在广泛的基线受试者特征范围内接种四价HPV疫苗。
Background. The quadrivalent ( types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle vaccine was 95%-100% effective in preventing cervical and genital disease related to HPV-6, - 11, - 16, and - 18. Vaccine efficacy is thought to be mediated by humoral immunity. Here, we analyze the effect of the baseline characteristics of subjects on vaccine-induced immune responses.Methods. Immunogenicity data from 12,343 subjects 9-26 years old randomized to quadrivalent HPV vaccine or placebo in phase 2/3 studies were analyzed. Covariates examined were day 1 HPV serostatus, age, race/ethnicity, region of residence, lactation status, hormonal contraceptive usage, smoking status, Pap test diagnosis, immunosuppressant or anti-inflammatory agent use, and number of sex partners. Anti-HPV responses were summarized as serum anti-HPV- 6, - 11, - 16, or - 18 geometric mean titers 1 month after dose 3.Results. Age at vaccination initiation was inversely proportional to the vaccine-induced anti-HPV response. Vaccination of subpopulations of subjects who were seropositive at day 1 to a vaccine HPV type resulted in more robust anti-HPV responses to that type, compared with those in subjects who were seronegative at baseline. Anti-HPV responses were comparable among the remaining demographic subgroups.Conclusions. The immunogenicity of quadrivalent HPV vaccine was comparable among subjects with differing baseline characteristics. These data support vaccination with quadrivalent HPV vaccine across a broad range of baseline subject characteristics.