Quadrivalent Human Papillomavirus (HPV) Vaccine in Cancer Survivors

癌症幸存者的四价人乳头瘤病毒 (HPV) 疫苗

• 批准号: 8466941
• 负责人: James Klosky
• 金额: $ 56.02万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-05-07 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8466941
• 关键词: 17 year old; Accounting; Address; Adolescent; Advisory Committees; Affect; Age; Age-Years; Anogenital venereal warts; Antibody Formation; Area; Behavioral; Behavioral Sciences; Cancer Survivor; Cancer Survivorship; Cervical; Chemotherapy-Oncologic Procedure; Clinical; Clinical Trials Design; Commit; Competence; Cross-Sectional Studies; Data; Development; Discipline of Nursing; Dose; Dysplasia; Epidemiology; Evaluation; Female; Foundations; Future; General Population; Genital system; HPV-High Risk; Health Promotion; Hepatitis B; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 6; Immunization; Immunocompromised Host; Immunosuppression; Individual; Infection; Inferior; Institution; Integration Host Factors; Intervention; Laboratory Research; Lesion; Malignant Childhood Neoplasm; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Measures; Medical; Morbidity - disease rate; Mucous Membrane; Oncogenic; Oropharyngeal; Parents; Patients; Pediatric Oncology; Phase; Population; Premalignant; Prevalence; Primary Prevention; Radiation; Recommendation; Recurrence; Reporting; Research; Research Infrastructure; Research Priority; Risk; Safety; Schedule; Series; Sexually Transmitted Diseases; Subgroup; Survivors; United States; United States Food and Drug Administration; Vaccination; Vaccines; Vulnerable Populations; age group; arm; base; cancer prevention; cancer risk; cancer therapy; childhood cancer survivor; cohort; evidence base; evidence based guidelines; hematopoietic cell transplantation; high risk; immunogenic; immunogenicity; improved; indicated prevention; male; malignant mouth neoplasm; mortality; non-oncogenic; oncology; open label; prospective; respiratory; response; routine practice; sex; sexually active; theories; uptake; vaccination strategy; virology; young adult

DESCRIPTION (provided by applicant): Advances in treatment for childhood cancer over the past five decades have resulted in a rapidly growing population of young cancer survivors, a substantial number of whom are adolescent/young adults - the age group at highest risk for sexually transmitted infection. Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States today, with prevalence in young, sexually active individuals ranging from 44.8% in females to 51.2% in males. Persistent infection with oncogenic strains of HPV (e.g., types 16 and 18) is associated with the development of cancers affecting the genital tract and oropharyngeal mucosa. Immunosuppression increases persistence of HPV infection and risk of HPV-related malignancies. Systemic cancer treatment may result in immunosuppression for prolonged periods, placing cancer survivors at higher risk for HPV-related morbidity. The quadrivalent HPV (qHPV) vaccine is indicated for prevention of HPV-related cancers and precancerous or dysplastic lesions in males and females between 9 and 26 years of age. The safety, tolerability, immunogenicity, and efficacy of the qHPV vaccine have been demonstrated in healthy young individuals; however, vaccine uptake to date has been low in the general population and no studies to date have determined vaccine uptake in cancer survivors, or the immunogenicity or safety/tolerability of the qHPV vaccine in this vulnerable population. Thus, there is a critical need to develop evidence to inform optimal uptake and utilization of the HPV vaccine in cancer survivors. This proposal aims to (1) estimate the prevalence of HPV vaccine initiation in cancer survivors 9-26 years of age and examine the sociodemographic, behavioral, and medical determinants of non-initiation; and (2) among non-immunized survivors, evaluate the 3-dose qHPV vaccine series to determine the following: Immunogenicity following the third and final vaccine dose; clinical/host factors influencing immunogenicity; and the safety/tolerability of the qHPV vaccine. Evaluation of the antibody response persistence at 1 and 2 years post-vaccine initiation and clinical/host factors influencing response persistence will be explored. If rates of HPV vaccine initiation are low among cancer survivors, this study will inform development of theory-based interventions to improve vaccine uptake, and identify subgroups likely to derive the most benefit from targeted interventions. This study will also identify clinical factors associated with inadequate immunogenic response to the vaccine and the impact of humoral competence on response, providing a foundation for future development of alternative vaccination strategies in subgroups unable to mount an adequate response to the standard 3-dose series. The proposed research addresses the high priority areas of health promotion, cancer prevention, and cancer survivorship. Importantly, males - a population that has been significantly understudied in regard to HPV vaccination - will be included; and the study will be conducted across four geographically distinct institutions to assure representation from an ethnically and racially diverse cohort of cancer survivors.

描述（由申请人提供）：过去 50 年来，儿童癌症治疗的进步导致年轻癌症幸存者人数迅速增长，其中很大一部分是青少年，即性传播疾病风险最高的年龄组感染。人乳头瘤病毒 (HPV) 是当今美国最常见的性传播感染，在性活跃的年轻个体中的患病率从女性的 44.8% 到男性的 51.2% 不等。 HPV 致癌毒株（例如 16 型和 18 型）的持续感染与影响生殖道和口咽粘膜的癌症的发展有关。免疫抑制会增加 HPV 感染的持续性和 HPV 相关恶性肿瘤的风险。全身癌症治疗可能会导致长时间的免疫抑制，使癌症幸存者面临更高的 HPV 相关发病风险。四价 HPV (qHPV) 疫苗适用于预防 9 至 26 岁男性和女性的 HPV 相关癌症以及癌前或发育异常病变。 qHPV 疫苗的安全性、耐受性、免疫原性和有效性已在健康年轻人中得到证实；然而，迄今为止，普通人群的疫苗接种率较低，并且迄今为止还没有研究确定癌症幸存者的疫苗接种率，或 qHPV 疫苗在这一弱势群体中的免疫原性或安全性/耐受性。因此，迫切需要开发证据来告知癌症幸存者对 HPV 疫苗的最佳摄取和利用。该提案旨在 (1) 估计 9-26 岁癌症幸存者中开始接种 HPV 疫苗的流行率，并检查不接种疫苗的社会人口、行为和医学决定因素； (2) 在未免疫幸存者中，评估 3 剂 qHPV 疫苗系列以确定以下内容： 第三剂和最后一剂疫苗后的免疫原性；影响免疫原性的临床/宿主因素；以及 qHPV 疫苗的安全性/耐受性。评估疫苗接种后 1 年和 2 年的抗体反应持续性以及影响临床/宿主的因素 将探讨响应持久性。如果癌症幸存者中 HPV 疫苗的接种率较低，这项研究将为开发基于理论的干预措施提供信息，以提高疫苗的接种率，并确定可能从有针对性的干预措施中获得最大益处的亚组。这项研究还将确定与疫苗免疫原性反应不足相关的临床因素以及体液能力对反应的影响，为未来在无法对标准 3 剂系列产生充分反应的亚组中制定替代疫苗接种策略奠定基础。拟议的研究涉及健康促进、癌症预防和癌症生存等高度优先领域。重要的是，男性——在 HPV 疫苗接种方面尚未得到充分研究的人群——将被包括在内；该研究将在四个不同地理位置的机构中进行，以确保来自不同种族和种族的癌症幸存者群体的代表性。