Ferris Daron G, Samakoses Rudiwilai, Block Stanley L, Lazcano-Ponce Eduardo, Restrepo Jaime Alberto, Mehlsen Jesper, Chatterjee Archana, Iversen Ole-Erik, Joshi Amita, Chu Jian-Li, Krick Andrea Likos, Saah Alfred, Das Rituparna
Department of Obstetrics and Gynecology, Augusta University, Augusta, Georgia.
Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand.
Pediatrics. 2017 Dec;140(6). doi: 10.1542/peds.2016-3947.
We describe the final 10-year data for the long-term follow-up study of the 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents.
In the base study (V501-018), 1661 sexually inactive boys and girls received the 4vHPV vaccine (early vaccination group [EVG], managed for 9.9 years) or a placebo at day 1, month 2, and month 6. Thereafter, at month 30, the placebo group (catch-up vaccination group [CVG], managed for 7.4 years) received the 4vHPV vaccine by using the same dosing schedule. Long-term anti-HPV type 6, 11, 16, and 18 immune responses were assessed. Effectiveness was estimated by calculating the incidence rate of the primary endpoints (HPV types 6, 11, 16, and 18-related disease or persistent infection).
For HPV types 6, 11, and 16, 89% to 96% of subjects remained seropositive through 10-years postvaccination. The preadolescents had 38% to 65% higher geometric mean titers at month 7, which remained 16% to 42% higher at 10 years compared with adolescents. No cases of HPV type 6, 11, 16, and 18-related diseases were observed. Ten subjects had a persistent infection of ≥6 months duration with vaccine-type HPV and 2 subjects had persistent infection for ≥12 months. No new serious adverse events were reported through 10 years.
A 3-dose regimen of the 4vHPV vaccine was immunogenic, clinically effective, and generally well tolerated in preadolescents and adolescents during 10 years of follow-up. These long-term findings support efforts to vaccinate this population against HPV before exposure.
我们描述了四价人乳头瘤病毒（4vHPV）疫苗针对青春期前和青春期青少年长期随访研究的最终10年数据。
在基础研究（V501 - 018）中，1661名性活跃期前的男孩和女孩在第1天、第2个月和第6个月接受了4vHPV疫苗（早期疫苗接种组[EVG]，管理9.9年）或安慰剂。此后，在第30个月时，安慰剂组（补种疫苗组[CVG]，管理7.4年）按照相同的给药方案接受了4vHPV疫苗。评估了针对HPV 6、11、16和18型的长期免疫反应。通过计算主要终点（HPV 6、11、16和18型相关疾病或持续感染）的发病率来估计有效性。
对于HPV 6、11和16型，89%至96%的受试者在接种疫苗后10年内保持血清阳性。青春期前儿童在第7个月时的几何平均滴度比青少年高38%至65%，在10年时仍比青少年高16%至42%。未观察到HPV 6、11、16和18型相关疾病的病例。10名受试者发生了持续时间≥6个月的疫苗型HPV持续感染，2名受试者发生了持续时间≥12个月的持续感染。在10年期间未报告新的严重不良事件。
4vHPV疫苗的3剂接种方案具有免疫原性、临床有效性，并且在10年随访期间青春期前和青春期青少年中总体耐受性良好。这些长期研究结果支持在该人群暴露前接种HPV疫苗的努力。
