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临床试验/NCT03467074
NCT03467074已完成不适用

Association of Genetic Polymorphisms in the Interferon-λ Signaling Cascade and Immune Response After Vaccination

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccination

研究概览

简要总结

The following observational study will investigate whether the vaccine response (antibodies, T and B cells) after allogeneic stem cell transplantation is influenced by genetic polymorphisms in the interferon lambda signal.

详细描述

The research project deals with one of the most important virological preventive measures after stem cell transplantation: vaccination against influenza viruses. Patients with allogeneic stem cell transplantation may experience serious complications of influenza and are at higher risk for inadequate response to the vaccine. The research project will make it possible, in a translational-medical orientation, to investigate the exact influence of genetic polymorphisms of the Interferon (IFN)-λ signalling cascade on the immune response after vaccination. This knowledge will make it possible to identify high-risk patients for a poor vaccination response before vaccination and to personalize the current vaccination strategy (intra-muscular injection), e.g. by subcutaneous vaccination, repeated administration of the vaccine or vaccine with adjuvants.

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

  • held allogeneic stem cell transplantation over 1 year ago

排除标准

  • Known vaccine intolerance (e.g. Protein allergy or severe vaccine-associated side effects, e.g. Guillian Barré syndrome)

结局指标

主要结局

Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccination

时间窗: Change from baseline PBMCs at day 60

Before vaccination, antibody titers for each influenza virus contained in the vaccine (Influenza A pH1N1, Influenza A H3N2 and Influenza B) are determined from the serum by means of a hemagglutination inhibition assay (HIA titer)

Peripheral Blood Mononuclear Cells (PBMCs) in blood after vaccination

时间窗: Change from baseline PBMCs at day 60

after vaccination, antibody titers for each influenza virus contained in the vaccine (Influenza A pH1N1, Influenza A H3N2 and Influenza B) are determined from the serum by means of a hemagglutination inhibition assay (HIA titer)

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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