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OpenTrials
Completed

NCT Number: NCT04059991

Antibodies in Repeated Influenza Vaccination (ARIVA) Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • influenza vaccination (QIIV) independent of the study
  • age >18 yo

Exclusion criteria

  • no vaccination
  • current acute illness

Treatment and study plan

Influenza vaccination

Biological

Only subjects vaccinated against influenza will be enrolled. The study itself is observational

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • University of Oslo
  • University of Oxford

Registry information

Acronym: ARIVA

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2019
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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