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）已批准在9-26岁的女性中使用，以预防宫颈/阴道/外阴癌和生殖器疣。在临床试验环境中已经证明了疫苗的功效，但是该疫苗的有效性尚未在临床实践环境中进行测试。承受更大压力的患者对其他类型的疫苗的免疫反应的能力降低。 Gardasil可能存在相同的现象，但没有数据。提议心理压力对疫苗免疫反应的影响通过健康行为（多个终生性伴侣，从不使用避孕套，先前的异常子宫颈抹片检查，吸烟和HPV感染）或直接对免疫系统失调。我们发现，与城市和郊区妇女相比，我们发现阿巴拉契亚俄亥俄州妇女的HPV发生率更高，异常宫颈细胞学率和心理压力的率更高。这项研究的目的是确定在Gardasil疫苗的18-26岁女性中，血清HPV 6/11/16/18是否会因压力改变抗体反应。这将通过对432名18-26岁妇女的研究来完成阿巴拉契亚俄亥俄州。所有参与者将在基线，两个月零六个月的时间接受Gardasil疫苗。在接受与HPV暴露风险行为和心理压力有关的疫苗接种问卷数据之前。将收集宫颈样品进行细胞学和HPV测试。在基线和第12个月时，将收集有关HPV 6、11、16和18抗体测定的血清样品。问卷数据和血清样品将在12个月时重复。主要结果度量是基线和第12个月在HPV 6、11、16和18的血清抗体的差异。感兴趣的变量是感知到的压力，性行为，社会经济状况，获得医疗保健（健康保险是/否），吸烟，阿巴拉契亚自我认同，Appalachian自我认同，基线的HPV宫颈状态和过去的历史异常宫颈细胞学，如心理肌免疫学模型中提出的那样。在这种模型中，提议阿巴拉契亚自我认同，社会经济地位，孤独，医疗保健和应对措施为妇女的感知压力做出贡献。感知压力对对Gardasil疫苗接种的免疫反应的影响可能是通过健康行为（例如多个终身性伴侣（>或= 4），从不使用避孕套，先前的异常子宫颈抹片检查，吸烟和HPV状态。感知压力可以通过产生通过增加的EBV VCA-IGG滴度来衡量的免疫失调，从而对免疫反应产生直接的生理影响。抑郁症状可以介导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Gardasil的免疫反应，那么我们可以确定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。