Health Management Training to Enhance Influenza Vaccine Immunogenicity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Immunoglobin antibody response
研究概览
简要总结
The goal of this study is to assess the immunogenicity of inactivated influenza vaccination (IIV) in healthy elderly volunteers aged 50 years and older receiving one of two different health management trainings.
详细描述
We will obtain preliminary data on the time it takes to achieve a protective immune response, durability of response and occurrence of influenza in the following influenza season. Promising results in this age group will provide preliminary data for expanded future studies in the elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General Inclusion criteria are the following:
- •age 50 years or older
- •Infectious Disease tests - negative HIV test; hepatitis B surface antigen; anti-hepatitis C virus (HCV)
- •Routine Laboratory tests
- •able and willing to complete the informed consent process
- •able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact
排除标准
- •self report of any medical conditions for which the Center for Disease Control (CDC) states should not be vaccinated with IIV
- •self-reported vaccination with the seasonal influenza vaccine for the current 2010-2011 influenza season (vaccination with the H1N1 influenza vaccine before, during, or after the study will not be exclusionary)
- •history of hypersensitivity to any influenza vaccine components including thimerosal or egg
- •history of Guillain-Barre syndrome
- •self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins (IL), corticosteroids (oral or inhaled)), G(M)- cerebrospinal fluid (CSF)) in 4 weeks before enrollment or self reported history of IL-2 administration within 5 years
- •self-reported use of theophylline preparations or warfarin because of the theoretical possibilities of enhanced drug effects and toxicities following influenza vaccination
- •any clinically significant abnormalities found during a routine physical examination
- •self-reported history of any autoimmune disease
- •acute febrile illness on the day of intended immunization - immunization deferred until illness resolved
- •self report of current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with compliance and ability to make study visits (such as severe attention deficit hyperactivity disorder (ADHD) and current major depressive episode)
研究组 & 干预措施
Health Education Training Group 1
One form of health education training
干预措施: Health Education (Behavioral)
Health Education Training Group 1
One form of health education training
干预措施: Health Education Training (Behavioral)
Health Education Training Group 2
Another form of health education training
干预措施: Health Education (Behavioral)
Health Education Training Group 2
Another form of health education training
干预措施: Health Education Training (Behavioral)
结局指标
主要结局
Immunoglobin antibody response
时间窗: pre and post following 8 weeks of health management training
次要结局
未报告次要终点
研究者
John W. Denninger, MD, PhD
Director of Research, Benson-Henry Institute
Massachusetts General Hospital