Flu VaccinePhase 4NCT04077424
Senescent Immunity in Elders and Vaccine Responses (SILVER)
A Phase 4 study testing Fluzone-High Dose Quadrivalent, Fluad and Flublock in people with Flu Vaccine, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
To study the effects of age on the immune system's response to flu vaccine and to study the connection between the immune system and physical and cognitive changes associated with aging. Read more about this study
- Who is it for?
- Ages 65 to 125 yearsHealthy volunteers can take part
- Conditions the study is for
- Flu Vaccine
- What is being tested?
- Fluzone-High Dose Quadrivalent, Fluad and Flublock
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2019to 1 Feb 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 125 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years and over
- Independent Living (including Assisted Living)
Who cannot join
- Unable to understand the consent or the study.
- Allergic to any vaccine components, excluding eggs.
- History of Guillain-Barre.
- Residing in a long -term care facility such as a nursing home.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37211
About this study
Official title: Single Cell Molecular Analysis of Influenza Vaccine Induced T Cell Responses in Adults 65 Years of Age or Older
To study the effects of age on the immune system's response to flu vaccine and to study the connection between the immune system and physical and cognitive changes associated with aging.
- Conditions
- Flu Vaccine
- Being tested
- Fluzone-High Dose Quadrivalent, Fluad, Flublock
- Keywords
- adult 65 and older
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone-High Dose QuadrivalentBiological
Also called High-dose flu vaccine
Seasonal influenza vaccination with FDA approved vaccines for this age group.
FluadBiological
Also called standard-dose, inactivated influenza (flu) vaccine
Adjuvanted (MF59) inactivated influenza vaccine
FlublockBiological
Also called Recombinant Hemagglutinin vaccine
Recombinant hemagglutinin vaccine
| Study group | Role | What they receive |
|---|---|---|
| Fluzone-High Dose | Active comparator | FDA approved high dose inactivated influenza vaccine (HD-Fluzone) Receives: Biological: Fluzone-High Dose Quadrivalent |
| Fluad | Active comparator | Adjuvanted (MF59) inactivated influenza vaccine (Fluad) Receives: Biological: Fluad |
| Recombinant Hemagglutinin vaccine (Flublok) | Active comparator | Recombinant hemagglutinin vaccine Receives: Biological: Flublock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemagglutinin Antigen Inhibition Assay Titers at Baseline
2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination.
Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
Measured: Baseline Baseline
Hemagglutinin Antigen Inhibition Assay Titers at Day 28
2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination.
Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
Measured: Day 28 Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start21 Oct 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Flu VaccineStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spyros Kalams, Vanderbilt University Medical Center
- Investigators
- Spyros Kalams, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077424
- Sponsor's protocol ID
- single cell
- Status last verified
- Jun 2022
- First submitted
- 30 Aug 2019
- Last updated
- 12 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All relevant findings will be published in peer-reviewed journals and data generated will be presented at national and international meetings. research articles will be deposited in the NIH National Library of Medicine's PubMed Central upon acceptance for publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Cell Molecular Analysis of Influenza Vaccine Induced T Cell Responses in Adults 65 Years of Age or Older
- ClinicalTrials.gov ID
- NCT04077424
- Acronym / sponsor ID
- single cell
- Conditions
- Flu Vaccine
- Keywords
- adult 65 and older
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Posted 12 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effects of age on the immune system's response to flu vaccine and to study the connection between the immune system and physical and cognitive changes associated with aging.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluzone-High Dose | Active comparator | Biological: Fluzone-High Dose QuadrivalentFDA approved high dose inactivated influenza vaccine (HD-Fluzone) |
| Fluad | Active comparator | Biological: FluadAdjuvanted (MF59) inactivated influenza vaccine (Fluad) |
| Recombinant Hemagglutinin vaccine (Flublok) | Active comparator | Biological: FlublockRecombinant hemagglutinin vaccine |
Who may qualify
- Ages
- 65 to 125 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years and over
- Independent Living (including Assisted Living)
Key exclusion criteria (4 listed)
- Unable to understand the consent or the study.
- Allergic to any vaccine components, excluding eggs.
- History of Guillain-Barre.
- Residing in a long -term care facility such as a nursing home.
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 |
|---|---|---|
| Fluzone-High Dose QuadrivalentAlso: High-dose flu vaccineSeasonal influenza vaccination with FDA approved vaccines for this age group. | Biological | Fluzone-High Dose |
| FluadAlso: standard-dose, inactivated influenza (flu) vaccineAdjuvanted (MF59) inactivated influenza vaccine | Biological | Fluad |
| FlublockAlso: Recombinant Hemagglutinin vaccineRecombinant hemagglutinin vaccine | Biological | Recombinant Hemagglutinin vaccine (Flublok) |
Primary outcome
Hemagglutinin Antigen Inhibition Assay Titers at Baseline
Time frame: Baseline Baseline
2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
Hemagglutinin Antigen Inhibition Assay Titers at Day 28
Time frame: Day 28 Baseline
2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All relevant findings will be published in peer-reviewed journals and data generated will be presented at national and international meetings. research articles will be deposited in the NIH National Library of Medicine's PubMed Central upon acceptance for publication.
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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.
Spyros Kalams principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluzone-High Dose Quadrivalent, Fluad and Flublock in people with Flu Vaccine, run by Vanderbilt University Medical Center at 1 site in United States.
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 4 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 12 Jul 2022. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemagglutinin Antigen Inhibition Assay Titers at Baseline (time frame: Baseline Baseline). The study lists 2 primary outcomes in all. 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 12 Jul 2022.