A Study to Examine Immunological Response in HIV-Infected Patients Receiving the Seasonal Influenza Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in antibody levels
研究概览
简要总结
Investigators in the Division of Infectious Diseases are carrying out a study to determine if human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza vaccination develop an adequate antibody response. The study group will consist of individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the Seasonal Influenza vaccine.
详细描述
This is a study to establish the immunologic response in HIV-seropositive individuals to the FDA approved seasonal influenza vaccine when it is available. HIV-seropositive individuals seen in the Infectious Diseases Clinic at George Washington University, Medical Faculty Associates and receive this vaccination, on label, as part of standard of care will be invited to participate.
The study will require a 10-ml sample of whole blood to be drawn from each participant prior to the dose of the seasonal influenza vaccine and at 3 weeks after the vaccine dose and at 3 months after the vaccine dose. No additional samples are envisioned. Serum will be separated and will frozen and stored in the Clinical Trials Unit until all patient samples have been obtained. At that time the antibody levels to the vaccine antigens will be measured.
Data that will be collected from the subject's medical record includes the following:
- Age, gender, race
- CD4 count
- HIV viral load
- History of prior influenza immunization including the 2009-2010 trivalent vaccine
- HIV antiviral medication history
Data that will be collected from the subject during participation in study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or female patients ages 18 or older
- •Diagnosis of HIV infection
- •No contraindications to being able to receive influenza vaccine by the treating physician
- •No acute active illness
- •Able to provide informed consent
排除标准
- •Previous history of hypersensitivity reaction to influenza vaccine
- •Unable to return for follow-up blood draw
结局指标
主要结局
Change in antibody levels
时间窗: Pre-, 3 weeks post-, 3 months post- vaccine
The primary endpoint will be to measure the change from baseline in vaccine-strain specific antibody levels. Titers of \> or = 40 U will be considered protective and a \> 4-fold rise in antibody titer will be considered an adequate response in previously antibody-negative patients. Data from this study will assist in defining the efficacy of the influenza vaccine in the HIV-infected population and the ability of HIV-infected patients to generate an appropriate immune response, as well as maintain an appropriate response, to the influenza vaccine.
次要结局
未报告次要终点