Role of Interferon-λ and Vaccine Response

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vaccine Response Impaired, Allogeneic Stem Cell Transplantation

Intervention / Treatment
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* Biological: influenza A/B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: held allogeneic stem cell transplantation over 1 year ago Exclusion Criteria: Known vaccine intolerance (e.g. Protein allergy or severe vaccine-associated side effects, e.g. Guillian Barré syndrome)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: influenza A/B vaccine|Regardless of the study enrollment, a two-time influenza vaccination at the start of the flu season is recommended every 4 weeks for all patients after stem cell transplantation. The vaccine is a trivalent inactivated non-adjuvanted influenza virus vaccine containing two influenza A viruses: pandemic H1N1, and H3N2, and an influenza B virus|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccination | 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) | Change from baseline PBMCs at day 60 | 
| Peripheral Blood Mononuclear Cells (PBMCs) in blood after vaccination | 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) | Change from baseline PBMCs at day 60 |