Antibodies in Repeated Influenza Vaccination (ARIVA) Study

Vaccine Response Impaired Clinical Trial

— ARIVA  

Official title:

Antibodies in Repeated Influenza Vaccination (ARIVA) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059991
• Other study ID #: ARIVA_me17Berger
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Vaccine Response Impaired

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