Persistence of Influenza Vaccine-induced Antibodies in Lung Transplant Patients Between Seasons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Influenza Vaccine Seroprotection at 11 months post immunization
研究概览
简要总结
This a sub-study of a 5-year study designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.
This study is designed to investigate influenza vaccine-induced antibodies in lung transplant patients between seasons.
详细描述
In the recent past, immunization policy-making bodies advised against immunizing too early in the influenza season because vaccine-specific antibody may wane before the end of the influenza season. This recommendation was based on only a small amount of data in frail elderly individuals, and further examination of the evidence shows that influenza vaccine antibody may last much longer. The influenza immunization timing recommendation is now changed to immunize when vaccine is available and continue throughout the season.
These changes led the investigators to the question of duration of influenza vaccine-induced antibody in lung transplant patients. No published studies of antibody persistence in this population could be found.
As part of a 5-year study of influenza antibody response in lung transplant patients, in patients awaiting lung transplantation, and in healthy controls, serum was obtained before and 2-4 weeks after influenza immunization for each season. Therefore, a serum sample was collected on each participant approximately 11 months after influenza vaccine administration for each of 4 years.
To investigate duration of influenza antibody titers, antibody concentrations to the previous season's vaccine antigens were measured.
The hypothesis is that immunosuppressed lung transplant patients would maintain protective concentrations of influenza antigen-specific antibodies (an antibody titer of at least 1:40) beyond the influenza season.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Receiving care pre- or post-lung transplant at University of Wisconsin Hospital
- •Healthy adult
排除标准
- •Allergy to eggs
- •Moderate to severe febrile illness
- •Active treatment for acute rejection
- •Received season's influenza vaccine prior to enrollment
研究组 & 干预措施
Vaccine, Pre-transplant
cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually.
干预措施: Influenza vaccine (Drug)
Vaccine, Post-transplant
Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually.
干预措施: Influenza vaccine (Drug)
Vaccine, Healthy Controls
Cohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually.
干预措施: Influenza vaccine (Drug)
结局指标
主要结局
Influenza Vaccine Seroprotection at 11 months post immunization
时间窗: up to 11 months
A protective influenza antibody concentration is a titer of greater than or equal to 1:40. Influenza antibody concentrations were measured using hemagglutination inhibition assays.
次要结局
- Antibody Concentrations Measured by Geometric Mean Titer(2-4 weeks post immunization, up to 11 months)