Role of Interferon-λ and Vaccine Response
Association of Genetic Polymorphisms in the Interferon-λ Signaling Cascade and Immune Response After Vaccination
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFirst Submitted
Initial submission to the registry
March 6, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedOctober 17, 2019
October 1, 2019
3 years
March 6, 2018
October 15, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- held allogeneic stem cell transplantation over 1 year ago
You may not qualify if:
- Known vaccine intolerance (e.g. Protein allergy or severe vaccine-associated side effects, e.g. Guillian Barré syndrome)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Microbiology
Basel, 4031, Switzerland
Related Publications (1)
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.
PMID: 34415049DERIVED
Biospecimen
blood sample
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian Egli, PD MD
Department of Clinical Microbiology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2018
First Posted
March 15, 2018
Study Start
September 1, 2014
Primary Completion
August 31, 2017
Study Completion
December 31, 2017
Last Updated
October 17, 2019
Record last verified: 2019-10