Antibodies in Repeated Influenza Vaccination (ARIVA) Study | NCT04059991

Studies
Antibodies in Repeated Influenza Vaccination (ARIVA) Study

NCT04059991

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Sep 28, 2021Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Vaccine Response Impaired

Interventions

Influenza Vaccination

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Aug 15, 2019

First Submission Date that Met QC Criteria

Aug 15, 2019

First Posted Date

Aug 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2021

Last Update Posted Date

Sep 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christoph Berger, Principal Investigator, University Hospital, Basel, SwitzerlandPrincipal Investigator

Lead Sponsor

University Hospital, Basel, SwitzerlandOTHER

Collaborators

Name	Class
University of Oslo	OTHER
University of Oxford	OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Influenza Vaccination	Biological	Only subjects vaccinated against influenza will be enrolled. The study itself is observational

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

no vaccination
current acute illness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christoph T Berger, MD	University Hospital Basel, Medical Outpatient Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel			Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007252	Influenza Vaccines

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided