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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04059991
Other study ID # ARIVA_me17Berger
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date March 31, 2021

Study information

Verified date November 2020
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Influenza Vaccination
Only subjects vaccinated against influenza will be enrolled. The study itself is observational

Locations

Country Name City State
Switzerland University Hospital Basel Basel

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Oslo, University of Oxford

Country where clinical trial is conducted

Switzerland, 

Outcome

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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