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: Completed
• Conditions: Vaccine Response Impaired
• Intervention / Treatment: Biological: Influenza Vaccination

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

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	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	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	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

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University of Oslo; University of Oxford; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Christoph T Berger, MD, University Hospital Basel, Medical Outpatient Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: November 1, 2020

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)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No