NCT04059991

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 28, 2021

Status Verified

November 1, 2020

Enrollment Period

3.4 years

First QC Date

August 15, 2019

Last Update Submit

September 27, 2021

Conditions

Vaccine Response Impaired

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Plasmablast generation

    Day 7 post-vaccination

  • BCR Repertoire composition

    Cross sectional comparison of the BCR repertoire characteristics day 0 and day 28

Interventions

Influenza VaccinationBIOLOGICAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

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

You may not qualify if:

  • no vaccination
  • current acute illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells, serum and RNA is collected

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Christoph T Berger, MD

    University Hospital Basel, Medical Outpatient Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 16, 2019

Study Start

November 1, 2017

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

September 28, 2021

Record last verified: 2020-11

Locations

CH(1)