Role of Interferon-λ and Vaccine Response

NCT ID: NCT03467074

Last Updated: 2019-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Vaccine Response Impaired Allogeneic Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Egli, PD MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Microbiology

Locations

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Department of Clinical Microbiology

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Linnik J, Syedbasha M, Kaltenbach HM, Vogt D, Hollenstein Y, Kaufmann L, Cantoni N, Ruosch-Girsberger S, Muller AMS, Schanz U, Pabst T, Stussi G, Weisser M, Halter J, Stelling J, Egli A. Association of Host Factors With Antibody Response to Seasonal Influenza Vaccination in Allogeneic Hematopoietic Stem Cell Transplant Patients. J Infect Dis. 2022 Apr 19;225(8):1482-1493. doi: 10.1093/infdis/jiab391.

Reference Type DERIVED
PMID: 34415049 (View on PubMed)

Other Identifiers

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2014-141; me15Egli

Identifier Type: -

Identifier Source: org_study_id

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