Antibody Responses to Influenza Vaccine in Pre- and Post-lung Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Antibody response to influenza vaccine
研究概览
简要总结
This 5-year study was 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.
详细描述
[Note: there are 6 ClinicalTrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see NCT04533061, NCT04533139, NCT04531787, NCT04530786, and NCT04531657 for related data]
Although pre-transplant immunization is routinely recommended, this recommendation is based on little data. The primary objective of this study is to compare antibody responses in lung transplant patients who receive influenza vaccine before transplant, within the first six months of transplant, between 13 and 60 months post-transplant, and 110 months or beyond transplant.
This prospective cohort study is to include immunization events performed over five years to measure H1N1, H3N2, and B antibody responses to the influenza vaccine in pre- and post-lung transplant patients. The pre-transplant patients will move to the post-transplant group as the study progressed. Similarly, participants are allowed to move to the next time-since-transplant group as time elapsed.
Serum was collected from participants prior to and two-four weeks following trivalent inactivated influenza immunization for each season.
Geometric mean titers, seroprotection (antibody titer at least 1:40), seroconversion (fourfold increase between pre and post), and mean fold increases will be compared.
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
Pre-transplant Vaccine
Cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually.
干预措施: Influenza vaccine (Drug)
0-6 Months Post-transplant Vaccine
Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 0-6 months post transplant.
干预措施: Influenza vaccine (Drug)
13-60 months Post-transplant Vaccine
Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 13-60 months post transplant.
干预措施: Influenza vaccine (Drug)
Greater than 110 months Post-transplant Vaccine
Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine greater than 110 months post transplant.
干预措施: Influenza vaccine (Drug)
Healthy Controls
Healthy controls to measure normal immune response to the influenza vaccine
干预措施: Influenza vaccine (Drug)
结局指标
主要结局
Antibody response to influenza vaccine
时间窗: Each season
次要结局
- T cell response to influenza vaccine antigens(Each season for the first two seasons)