Role of Interferon-λ and Vaccine Response

Allogeneic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467074
• Other study ID #: 2014-141; me15Egli
• Status: Completed
• Start date: September 1, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation
• Vaccine Response Impaired

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Clinical Microbiology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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