- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059991
Antibodies in Repeated Influenza Vaccination (ARIVA) Study (ARIVA)
Viruses with high mutation rates, such influenza or HIV, pose a major challenge for vaccine design. The current influenza vaccination strategy of yearly vaccination with adapted strains aims to maximally diversify the antibody immune response to prevent viral escape. There is, however, growing evidence, that repeated vaccination with very similar viral proteins might limit, instead of broaden, diversification and thereby reduce vaccine efficacy.
The ARIVA Study prospectively studies the immunological impact of repeated influenza vaccination on viral variant recognition and antibody responses in healthy subjects cross-sectionally and over three consecutive vaccination seasons.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Basel, Switzerland
- University Hospital Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- influenza vaccination (QIIV) independent of the study
- age >18 yo
Exclusion Criteria:
- no vaccination
- current acute illness
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influenza specific Antibody Responses
Time Frame: Change between baseline and 28 days post-vaccination will be compared
|
Hemagglutination titers against different H3N2 Influenza strains will be measured and compared between study subjects stratified by number of previous vaccinations
|
Change between baseline and 28 days post-vaccination will be compared
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasmablast generation
Time Frame: Day 7 post-vaccination
|
Frequency of plasmablasts in the peripheral blood will be assessed and compared between study subjects stratified by number of previous vaccinations
|
Day 7 post-vaccination
|
BCR Repertoire composition
Time Frame: Cross sectional comparison of the BCR repertoire characteristics day 0 and day 28
|
Sorted B cell subsets will be sequenced to define the BCR repertoire.
Subjects will be compared stratified by vaccination status
|
Cross sectional comparison of the BCR repertoire characteristics day 0 and day 28
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christoph T Berger, MD, University Hospital Basel, Medical Outpatient Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ARIVA_me17Berger
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vaccine Response Impaired
-
University of California, IrvineMassachusetts General Hospital; Beckman Laser Institute University of California...CompletedVaccine Response ImpairedUnited States
-
Merck Sharp & Dohme LLCCompletedVaccine Response Impaired
-
The University of Texas Health Science Center at...Suspended
-
University Hospital, Basel, SwitzerlandCompletedAllogeneic Stem Cell Transplantation | Vaccine Response ImpairedSwitzerland
-
Persephone BiosciencesTerminatedVaccine Adverse Reaction | Vaccine Response ImpairedUnited States
-
University of AlbertaMerck Canada Inc.Not yet recruitingVaccine Response Impaired | Vaccination Failure
-
South Australian Health and Medical Research InstituteUniversity of Sydney; Telethon Kids Institute; Flinders University; Royal Adelaide... and other collaboratorsRecruiting
-
University of VermontInternational Centre for Diarrhoeal Disease Research, Bangladesh; Thrasher... and other collaboratorsCompletedRotavirus Infection | Vaccine Response Impaired | Vaccine Virus SheddingBangladesh
-
UConn HealthCompletedAging | Vaccine Response Impaired | Age-Related ImmunodeficiencyUnited States
-
Emory UniversityDefense Advanced Research Projects AgencyRecruitingVaccine ResponseUnited States
Clinical Trials on Influenza Vaccination
-
Fondazione Policlinico Universitario Agostino Gemelli...Completed
-
Assistance Publique - Hôpitaux de ParisCompletedCystic Fibrosis With Gastrointestinal ManifestationFrance
-
Korea University Guro HospitalCompletedPneumococcal Infections | Influenza, HumanKorea, Republic of
-
Radboud University Medical CenterCompletedChronic Fatigue Syndrome | Postcancer FatigueNetherlands
-
University of Colorado, DenverSeattle Children's Hospital; Agency for Healthcare Research and Quality (AHRQ)Not yet recruiting
-
University Hospital, SaarlandKlinikum WormsCompletedCoverage Rate of Vaccination for Influenza
-
University Medical Center GroningenZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknown
-
University of California, Los AngelesUniversity of Rochester; Agency for Healthcare Research and Quality (AHRQ)CompletedChildhood Influenza Vaccination | School-located Influenza Vaccination
-
Louisiana State University Health Sciences Center...Centers for Disease Control and PreventionUnknownHigh Risk for Serious Influenza | High Risk for PneumoniaUnited States
-
Jesús Moreno FernándezCastilla-La Mancha Health Service; University of Castilla-La ManchaCompletedType 1 Diabetes MellitusSpain