Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women
Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women
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DOI：
10.1542/peds.2006-0461
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发表时间：
2006-11-01
期刊：
影响因子：
8
通讯作者：
Reisinger, Keith S.
中科院分区：
文献类型：
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作者：
Block, Stan L.;Nolan, Terry;Reisinger, Keith S.
OBJECTIVE.研究表明，对16- 23岁女性预防性接种四价人乳头瘤病毒（6、11、16、18型）L1病毒样颗粒疫苗可预防型特异性人乳头瘤病毒感染和相关临床疾病。我们进行了一项非劣效性免疫原性研究，以将年轻女性的有效性结果与青春期前和青春期的女孩和男孩联系起来，后者是人乳头瘤病毒疫苗接种的主要目标。我们招募了506名女孩和510名男孩（10-15岁）和513名女性（16-23岁）。参与者在第1天、第2个月和第6个月接种疫苗，并在第1天、第3个月和第7个月对盲态样本进行血清学检测。使用类型特异性免疫测定法测定中和抗体浓度，并总结为几何平均滴度和血清转换率。还评估了疫苗耐受性。到第7个月，各组中所有4种人乳头瘤病毒类型的血清转换率均>= 99%。到第7个月，与女性相比，女孩或男孩的抗人乳头瘤病毒几何平均滴度不劣于女性，高出1.7至2.7倍。大多数（> 97%）注射部位不良事件的强度为轻度至中度。在接种疫苗后5天内，报告发烧≥ 37.8摄氏度的男孩（13.8%）和女孩（12.8%）明显多于妇女（7.3%）。大多数（96.4%）发热为轻度（< 39 ℃）。四价疫苗中对所有4种人乳头瘤病毒类型的非劣效免疫原性应答允许将在年轻女性中产生的有效性数据桥接到女孩中。男孩的结果支持实施性别中立的人乳头瘤病毒疫苗接种计划。这种疫苗通常耐受性良好。
OBJECTIVE. Prophylactic vaccination of 16- to 23-year-old females with a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine has been shown to prevent type-specific human papillomavirus infection and associated clinical disease. We conducted a noninferiority immunogenicity study to bridge the efficacy findings in young women to preadolescent and adolescent girls and boys, who represent a primary target for human papillomavirus vaccination.METHODS. We enrolled 506 girls and 510 boys (10-15 years of age) and 513 females (16-23 years of age). Participants were vaccinated on day 1, at month 2, and at month 6, and serology testing was performed on day 1 and at months 3 and 7 on blinded samples. Neutralizing antibody concentrations were determined using type-specific immunoassays and summarized as geometric mean titers and seroconversion rates. Vaccine tolerability also was assessed.RESULTS. By month 7, seroconversion rates were >= 99% for all 4 human papillomavirus types in each group. By month 7, compared with women, anti-human papilloma virus geometric mean titers in girls or boys were noninferior and were 1.7- to 2.7-fold higher. Most (> 97%) injection-site adverse events were mild to moderate in intensity. Significantly more boys (13.8%) and girls (12.8%) than women (7.3%) reported fevers >= 37.8 degrees C within 5 days of vaccination. Most (96.4%) fevers were mild (< 39 degrees C).CONCLUSIONS. Noninferior immunogenic responses to all 4 human papillomavirus types in the quadrivalent vaccine permit the bridging of efficacy data that were generated in young women to girls. The results in boys lend support for the implementation of gender-neutral human papillomavirus vaccination programs. This vaccine generally was well tolerated.