Role of Interferon-λ and Vaccine Response

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03467074
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Actual Duration (Months): 40
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccine Response Impaired; Allogeneic Stem Cell Transplantation	Biological: influenza A/B vaccine

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Association of Genetic Polymorphisms in the Interferon-λ Signaling Cascade and Immune Response After Vaccination
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Aug 31, 2017
• Actual Study Completion Date: Dec 31, 2017

Outcome Measures

Primary Outcome Measures

1. Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccination [Change from baseline PBMCs at day 60]

   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)

2. Peripheral Blood Mononuclear Cells (PBMCs) in blood after vaccination [Change from baseline PBMCs at day 60]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Microbiology	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Adrian Egli, PD MD, Department of Clinical Microbiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03467074
• Other Study ID Numbers: 2014-141; me15Egli
• First Posted: Mar 15, 2018
• Last Update Posted: Oct 17, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 17, 2019