Vaccine Response ImpairedARIVANCT04059991
Antibodies in Repeated Influenza Vaccination (ARIVA) Study
An observational study of Vaccine Response Impaired, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Response Impaired
- What is being tested?
- Influenza Vaccination
- Type of treatment
- Vaccines
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2017to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- influenza vaccination (QIIV) independent of the study
- age >18 yo
Who cannot join
- no vaccination
- current acute illness
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Vaccine Response Impaired
- Being tested
- Influenza Vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccinationBiological
Only subjects vaccinated against influenza will be enrolled. The study itself is observational
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change between baseline and 28 days post-vaccination will be compared
Secondary outcomes (2)
Plasmablast generation
Frequency of plasmablasts in the peripheral blood will be assessed and compared between study subjects stratified by number of previous vaccinations
Measured: 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
Measured: Cross sectional comparison of the BCR repertoire characteristics day 0 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Nov 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Response ImpairedStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University of Oxford, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Christoph Berger, University Hospital, Basel, Switzerland
- Investigators
- Christoph T Berger, MD, Principal investigator, University Hospital Basel, Medical Outpatient Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059991
- Sponsor's protocol ID
- ARIVA_me17Berger
- Acronym
- ARIVA
- Status last verified
- Nov 2020
- First submitted
- 15 Aug 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibodies in Repeated Influenza Vaccination (ARIVA) Study
- ClinicalTrials.gov ID
- NCT04059991
- Acronym / sponsor ID
- ARIVA / ARIVA_me17Berger
- Conditions
- Vaccine Response Impaired
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Oslo, University of Oxford, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- influenza vaccination (QIIV) independent of the study
- age >18 yo
Key exclusion criteria (2 listed)
- no vaccination
- current acute illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza VaccinationOnly subjects vaccinated against influenza will be enrolled. The study itself is observational | Biological | – |
Primary outcome
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
2 secondary outcomes
Plasmablast generation
Time frame: Day 7 post-vaccination
BCR Repertoire composition
Time frame: Cross sectional comparison of the BCR repertoire characteristics day 0 and day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph T Berger, MD principal investigator
University Hospital Basel, Medical Outpatient Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Response Impaired, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza specific Antibody Responses (time frame: Change between baseline and 28 days post-vaccination will be compared). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.