九价人乳头瘤病毒疫苗在9至15岁女孩和男孩中的长期免疫原性、有效性和安全性:8年随访后的中期分析

Sven-Eric Olsson , Jaime Alberto Restrepo , Julio Cesar Reina , Punnee Pitisuttithum , Angels Ulied , Meera Varman , Pierre Van Damme , Edson Duarte Moreira Jr. , Daron Ferris , Stanley Block , Oliver Bautista , Nancy Gallagher , Jennifer McCauley , Alain Luxembourg
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引用次数: 29

摘要

背景:九价人乳头瘤病毒(9vHPV)疫苗可预防与HPV 6、11、16、18、31、33、45、52和58型相关的感染和疾病。在9- 15岁的女孩和男孩中进行的为期36个月的9vHPV疫苗的三期免疫原性研究被扩展到评估接种后大约10年的长期免疫原性和有效性。我们描述了一项基于疫苗接种后约8年随访的中期分析结果。在基础研究中接受三剂9vHPV疫苗(分别在第1天、第2个月和第6个月)并同意随访的9-15岁参与者被纳入长期随访研究扩展(N = 1272[女性,N = 971;男性,n = 301])。在第66个月和第90个月采集血清以评估抗体反应。为了进行有效性分析,从参与者年满16岁开始,每6个月收集生殖器拭子(通过聚合酶链反应[PCR]评估HPV DNA)并进行外生殖器检查(检测外生殖器病变)。当女性参与者达到21岁时,每年进行宫颈细胞学检查;细胞学异常的参与者根据协议指定的算法进行阴道镜检查。外部生殖器和宫颈活检异常病变进行,组织学诊断裁定病理小组。采用PCR检测标本的HPV DNA。结果每种9vHPV疫苗的几何平均滴度在第7个月左右达到峰值,并在第90个月逐渐下降。通过人乳头瘤病毒免疫球蛋白Luminex免疫测定,到第90个月,每种9vHPV疫苗类型的血清阳性率保持在90%。根据3剂后最长8.2年(中位7.6年)的随访,在按方案人群(n = 1107)中未观察到hpv6 /11/16/18/31/33/45/52/58相关的高级别上皮内瘤变或生殖器疣病例。hpv6 /11/16/18/31/33/45/52/58相关的6个月持续感染在女性和男性中的发病率分别为49.2 / 10000人-年和37.3 / 10000人-年,这在接种疫苗队列的预期范围内。在本中期分析所涵盖的期间内,没有发生与疫苗有关的急性呼吸道感染或死亡。结论9vHPV疫苗在9-15岁的女孩和男孩接种后分别提供了大约7年和8年的持续免疫原性和持久有效性。
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Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up

Background

The nine-valent human papillomavirus (9vHPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The pivotal 36-month Phase III immunogenicity study of 9vHPV vaccine in 9- to 15-year-old girls and boys was extended to assess long-term immunogenicity and effectiveness through approximately 10 years after vaccination. We describe results of an interim analysis based on approximately 8 years of follow-up after vaccination.

Methods

Participants aged 9–15 years who received three doses of 9vHPV vaccine (at day 1, month 2, and month 6) in the base study and consented to follow-up were enrolled in the long-term follow-up study extension (N = 1272 [females, n = 971; males, n = 301]). Serum was collected at months 66 and 90 to assess antibody responses. For effectiveness analysis, genital swabs were collected (to assess HPV DNA by polymerase chain reaction [PCR]) and external genital examination was conducted (to detect external genital lesions) every 6 months starting when the participant reached 16 years of age. Cervical cytology tests were conducted annually when female participants reached 21 years of age; participants with cytological abnormalities were triaged to colposcopy based on a protocol-specified algorithm. External genital and cervical biopsies of abnormal lesions were performed, and histological diagnoses were adjudicated by a pathology panel. Specimens were tested by PCR to detect HPV DNA.

Results

Geometric mean titers for each 9vHPV vaccine HPV type peaked around month 7 and gradually decreased through month 90. Seropositivity rates remained >90% through month 90 for each of the 9vHPV vaccine types by HPV immunoglobulin Luminex Immunoassay. No cases of HPV6/11/16/18/31/33/45/52/58-related high-grade intraepithelial neoplasia or genital warts were observed in the per-protocol population (n = 1107) based on a maximum follow-up of 8.2 years (median 7.6 years) post-Dose 3. Incidence rates of HPV6/11/16/18/31/33/45/52/58-related 6-month persistent infection in females and males were 49.2 and 37.3 per 10,000 person-years, respectively, which were within ranges expected in vaccinated cohorts. There were no vaccine-related SAEs or deaths during the period covered by this interim analysis.

Conclusions

The 9vHPV vaccine provided sustained immunogenicity and durable effectiveness through approximately 7 and 8 years, respectively, following vaccination of girls and boys aged 9–15 years.

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期刊介绍: The official Journal of the International Papillomavirus Society Papillomavirus Research (PVR), the Journal of HPV and other Small DNA Tumor Viruses publishes innovative papers related to all aspects of papillomaviruses and other small DNA tumor viruses. The official journal of the International Papillomavirus Society, PVR is an open access publication that aims to bring together virologists, immunologists, epidemiologists and clinicians working in the booming field of HPV and animal papillomaviruses, polyomaviruses and other small DNA tumor viruses and their associated diseases, in order to foster and facilitate interdisciplinary communication. The journal welcomes original research articles, reviews, short communications, opinion articles and regional update reports on papillomaviruses and other tumor viruses in the following sections: a. Biology of papillomaviruses and related viruses from life cycle to cancer b. Epidemiology etiology and natural history studies c. Natural and induced immunity including vaccine research d. Intervention studies and strategies including i. Clinical studies and trials ii. HPV treatments iii. HPV vaccination programs iv. Diagnostics and screening e. Infection and disease prevention, modeling studies f. Guidelines and public health recommendations g. HPV Studies in special populations Regional and local studies on these viruses.
期刊最新文献
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