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临床试验/NCT04530786
NCT04530786已完成不适用

Persistence of Influenza Vaccine-induced Antibody in Lung Transplant Patients and Healthy Individuals Beyond the Season

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Antibody response to influenza vaccine

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 beyond the season of vaccination.

详细描述

Every year influenza infection causes significant morbidity and mortality in the general population making it a serious public health concern. Among those at highest risk for complications from infection are the immunocompromised. Effective influenza immunization that confers protection throughout the season is critical for lung transplant recipients because in addition to aggressive immunosuppressive therapy, infection directly affects the transplanted organ. Studies of influenza vaccine response rates in lung transplant patients show generally lower antibody concentrations, but acceptable influenza vaccine response rates compared with healthy individuals. However, little is known about the persistence of influenza vaccine-induced antibody concentration in either healthy or immunosuppressed populations.

Influenza antibody concentrations persist at seroprotective levels (defined as antibody concentrations at least 40 hemagglutination units) up to a year post vaccination. However, the investigators could find no information regarding persistence beyond one year.

It is hypothesized that the high rates of persisting influenza vaccine antibody in immunosuppressed lung transplant individuals would match the rates of persisting vaccine-antibody in healthy individuals.

Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually (individual participants followed for 3 years). Samples were collected at 2-4 weeks post-vaccination. Seroprotection was defined as a titer of ≥ 1:40 and was compared between groups over the measured term using Fisher's exact tests.

[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results]

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

入选标准

  • Receiving care 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, 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 Control

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

Antibody response to influenza vaccine

时间窗: season 3 (up to 3 years on study)

Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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