Clinical trial NCT03467074: Role of Interferon-λ and Vaccine Response
Official title: Association of Genetic Polymorphisms in the Interferon-λ Signaling Cascade and Immune Response After Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Response Impaired
Allogeneic Stem Cell Transplantation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccination
timeFrame: Change from baseline PBMCs at day 60
measure: Peripheral Blood Mononuclear Cells (PBMCs) in blood after vaccination
timeFrame: Change from baseline PBMCs at day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Clinical Microbiology
Study officials:
affiliation: Department of Clinical Microbiology
name: Adrian Egli, PD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.