HPV IMMUNIZATION RESPONSE AND STRESS

HPV 免疫反应和压力

基本信息

批准号：
8704279
负责人：
MACK T. RUFFIN
金额：
$ 12.97万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-09-30 至 2017-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8704279
关键词：
Address Affect Age Age-Years Anogenital venereal warts Antibodies Antibody Formation Appalachian Region Area Biological Assay Biological Models Cervical Cervical dysplasia Clinic Clinical Trials Clinical effectiveness Communities Cytology Data Development Disease Down-Regulation Effectiveness Event Exhibits Gardasil Genetic Goals Health Health Insurance Health Services Accessibility Health Status Health behavior Healthcare Hepatitis B Human Herpesvirus 4 Human Papilloma Virus Vaccine Human Papillomavirus Human papilloma virus infection Human papillomavirus 6 Immune Immune response Immune system Immunization Immunoglobulin G Individual Infection Influenza Lesion Life Link Loneliness Low Income Population Malignant neoplasm of cervix uteri Malignant neoplasm of vulva Measures Mediating Medical Methods Modeling Ohio Outcome Measure Pap smear Participant Pathway interactions Patients Physiological Population Proteins Psychological Stress Psychoneuroimmunology Psychosocial Stress Questionnaires Randomized Clinical Trials Recording of previous events Recruitment Activity Reporting Research Resource Sharing Risk Risk Behaviors Risk Factors Rural Sampling Series Serum Sex Behavior Sexual Partners Smoking Social support Socioeconomic Status Stress Study models T cell response Testing Time Training Vaccination Vaccines Vagina Virus-like particle Vulva Woman base biological adaptation to stress career development clinical practice cohort community based participatory research condoms coping cost effective depressive symptoms efficacy trial experience health disparity high risk sexual behavior immune function interest population health prevent primary outcome programs prophylactic psychological stressor psychosocial response sexually active social social health determinants socioeconomics stressor suburb vaccine effectiveness vaccine efficacy

项目摘要

Project Summary: A quadrivalent HPV 6, 11, 16, 18 vaccine (Gardasil) has been approved for use among women age 9-26 years to prevent cervical/vaginal/vulvar cancer and genital warts. The efficacy of the vaccine has been demonstrated in clinical trial settings, but the effectiveness of this vaccine has not been tested in clinical practice settings. Patients experiencing greater stress have a reduced capacity to mount an immune response to other types of vaccine. The same phenomenon is likely to exist for Gardasil, but there are no data. The impact of psychological stress on the immune response to a vaccine is proposed to act via health behaviors (multiple lifetime sexual partners, never using condoms, prior abnormal Pap smear, smoking, and HPV infection) or by direct dysregulation of the immune system. We have found higher rates of cerivical HPV in Appalachian Ohio women, higher rates of abnormal cervical cytology, and very high rates of psychological stress compared to urban and suburban women. The goal of this study is to determine if, in women age 18-26 years given Gardasil vaccine, serum HPV 6/11/16/18 antibody response is altered by stress. This will be accomplished by a study of 432 women age 18-26 years who report full range of life stressors recruited from Appalachian Ohio. All participants will receive the Gardasil vaccine at baseline, two months, and six months. Prior to vaccination questionnaire data related to HPV exposure risk behaviors and psychological stressors will be collected. Cervical samples will be collected for cytology and HPV testing. Serum samples will be collected for HPV 6, 11, 16 and 18 antibody assays at baseline and month 12. The questionnaire data and serum samples will be repeated at 12 months. The primary outcome measure is the difference in serum antibodies to HPV 6, 11, 16 and 18 at baseline and month 12. The variables of interest are perceived stress, sexual behaviors, socioeconomic status, access to health care (health insurance yes/no), smoking, Appalachian self-identity, HPV cervical status at baseline, and past history abnormal cervical cytology, as proposed in a psychoneuroimmunology model. In this model, Appalachian Self-Identity, socioeconomic status, loneliness, health care access, and coping are proposed to contribute to a woman's perceived stress. The impact of perceived stress on immune response to Gardasil vaccination can be by health behaviors such as multiple lifetime sexual partners (> or = 4), never using condoms, prior abnormal Pap smear, smoking, and HPV status at the time of vaccination. Perceived stress can have a direct physiologic impact on the immune response by creating immune dysregulation as measured by increased EBV VCA-IgG titers. Depressive symptoms can mediate the impact of perceived stress on immune function. If psychological stress is found to modulate the immune response to Gardasil, then we can determine if the modulation reduces the clinical effectiveness of the vaccine and examine methods to limit the impact of stress.

项目摘要：四价 HPV 6、11、16、18 疫苗（Gardasil）已被批准用于 9-26 岁的女性，以预防宫颈癌/阴道癌/外阴癌和尖锐湿疣。该疫苗的功效已在临床试验中得到证实，但该疫苗的有效性尚未在临床实践中得到测试。承受较大压力的患者对其他类型疫苗产生免疫反应的能力会降低。加卫苗 (Gardasil) 也可能存在同样的现象，但没有数据。心理压力对疫苗免疫反应的影响被认为是通过健康行为（一生有多个性伴侣、从不使用避孕套、既往子宫颈抹片检查异常、吸烟和 HPV 感染）或直接免疫系统失调来发挥作用。我们发现，与城市和郊区女性相比，阿巴拉契亚俄亥俄州女性的宫颈 HPV 感染率较高，宫颈细胞学异常率较高，心理压力也较高。本研究的目的是确定在 18-26 岁的女性中，接种 Gardasil 疫苗后，血清 HPV 6/11/16/18 抗体反应是否会因压力而改变。这将通过一项针对 432 名 18-26 岁女性的研究来完成，她们报告了从以下机构招募的全方位生活压力源：阿巴拉契亚俄亥俄州。所有参与者都将在基线、两个月和六个月时接种 Gardasil 疫苗。在接种疫苗之前，将收集与 HPV 暴露风险行为和心理压力源相关的问卷数据。将收集宫颈样本进行细胞学和 HPV 检测。将在基线和第 12 个月收集血清样本用于 HPV 6、11、16 和 18 抗体测定。问卷数据和血清样本将在 12 个月时重复。主要结果指标是基线和第 12 个月时 HPV 6、11、16 和 18 血清抗体的差异。感兴趣的变量是感知压力、性行为、社会经济地位、获得医疗保健的机会（健康保险是/否）、吸烟、阿巴拉契亚自我认同、基线 HPV 宫颈状态，以及既往宫颈细胞学异常史，如心理神经免疫学模型中提出的。在该模型中，阿巴拉契亚自我认同、社会经济地位、孤独感、医疗保健获取和应对方式被认为会影响女性的感知压力。感知压力对加德西疫苗接种免疫反应的影响可能是由健康行为造成的，例如一生有多个性伴侣 (> 或 = 4)、从不使用安全套、既往子宫颈抹片检查异常、吸烟和接种疫苗时的 HPV 状态。感知到的压力可以通过引起免疫失调（通过增加 EBV VCA-IgG 滴度来衡量）对免疫反应产生直接的生理影响。抑郁症状可以调节感知压力对免疫功能的影响。如果发现心理压力可以调节对加德西的免疫反应，那么我们就可以确定这种调节是否会降低疫苗的临床有效性，并检查限制压力影响的方法。