Vaccine Response ImpairedNCT03467074
Role of Interferon-λ and Vaccine Response
An observational study of Vaccine Response Impaired and Allogeneic Stem Cell Transplantation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine Response Impaired, Allogeneic Stem Cell Transplantation
- What is being tested?
- influenza A/B vaccine
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2014to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- held allogeneic stem cell transplantation over 1 year ago
Who cannot join
- Known vaccine intolerance (e.g. Protein allergy or severe vaccine-associated side effects, e.g. Guillian Barré syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Genetic Polymorphisms in the Interferon-λ Signaling Cascade and Immune Response After Vaccination
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.
Read the 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.
- Being tested
- influenza A/B vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza A/B vaccineBiological
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Change from baseline PBMCs at day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Sep 2014
- Primary completion31 Aug 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine Response ImpairedStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Egli, PD MD, Principal investigator, Department of Clinical Microbiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467074
- Sponsor's protocol ID
- 2014-141; me15Egli
- Status last verified
- Oct 2019
- First submitted
- 6 Mar 2018
- Last updated
- 17 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34415049
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Genetic Polymorphisms in the Interferon-λ Signaling Cascade and Immune Response After Vaccination
- ClinicalTrials.gov ID
- NCT03467074
- Acronym / sponsor ID
- 2014-141; me15Egli
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- held allogeneic stem cell transplantation over 1 year ago
Key exclusion criteria (1 listed)
- Known vaccine intolerance (e.g. Protein allergy or severe vaccine-associated side effects, e.g. Guillian Barré syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| influenza A/B vaccineRegardless 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 | Biological | – |
Primary outcome
Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccination
Time frame: 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)
Peripheral Blood Mononuclear Cells (PBMCs) in blood after vaccination
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Derived from this study: PubMed 34415049Linnik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Egli, PD MD principal investigator
Department of Clinical Microbiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Response Impaired and Allogeneic Stem Cell Transplantation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Blood Mononuclear Cells (PBMCs) in blood before vaccination (time frame: Change from baseline PBMCs at day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03467074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.