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