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Role of Interferon-λ and Vaccine Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03467074
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Vaccine Response Impaired Allogeneic Stem Cell Transplantation Biological: influenza A/B vaccine

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Genetic Polymorphisms in the Interferon-λ Signaling Cascade and Immune Response After Vaccination
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccination [ Time Frame: 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)

  2. Peripheral Blood Mononuclear Cells (PBMCs) in blood after vaccination [ Time Frame: 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)


Biospecimen Retention:   Samples With DNA
blood sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients after allogeneic stem cell transplantation, which are in control at the University Hospital Basel, Cantonal Hospital Aarau, Lucerne Cantonal Hospital, University Hospital Zurich, Inselspital Bern or the Regional Hospital Bellinzona.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467074


Locations
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Switzerland
Department of Clinical Microbiology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Adrian Egli, PD MD Department of Clinical Microbiology
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03467074    
Other Study ID Numbers: 2014-141; me15Egli
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No