Vaccine Response Impaired Clinical Trial
— ARIVAOfficial title:
Antibodies in Repeated Influenza Vaccination (ARIVA) Study
Verified date | November 2020 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - influenza vaccination (QIIV) independent of the study - age >18 yo Exclusion Criteria: - no vaccination - current acute illness |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Oslo, University of Oxford |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Influenza specific Antibody Responses | 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 | Plasmablast generation | 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 | |
Secondary | BCR Repertoire composition | 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 |
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