Role of Interferon-λ and Vaccine Response

Completed

• Conditions: Vaccine Response Impaired; Allogeneic Stem Cell Transplantation

• Registration Number: NCT03467074
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

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 Timeline

• Study Start: 2014-09-01
• Primary Completion: 2017-08-31
• Study Completion: 2017-12-31
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccination	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	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)

Trial Locations

Locations (1)

Department of Clinical Microbiology; 🇨🇭 Basel, Switzerland