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Role of Interferon-λ and Vaccine Response

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03467074
Enrollment
200
Registered
2018-03-15
Start date
2014-09-01
Completion date
2017-12-31
Last updated
2019-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Stem Cell Transplantation, Vaccine Response Impaired

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.

Interventions

BIOLOGICALinfluenza 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

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccinationChange from baseline PBMCs at day 60Before 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 vaccinationChange from baseline PBMCs at day 60after 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)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026