Role of Interferon-λ and Vaccine Response

October 15, 2019 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Clinical Microbiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline PBMCs at day 60
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)
Change from baseline PBMCs at day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Adrian Egli, PD MD, Department of Clinical Microbiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2014-141; me15Egli

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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