AgingPhase 4FluVax3NCT05518500
A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults
A Phase 4 study testing Flu Vaccine (Year 1), Flu Vaccine (Year 2) and Flu Vaccine (Year 3) in people with Aging and Influenza Vaccine, run by The Jackson Laboratory at 1 site in United States.
Trial summary
This is a prospective, single-arm study designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults. The investigators will recruit and longitudinally follow a cohort of 75 older adults (65 years and older) who will receive three different influenza vaccines over three… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Influenza Vaccine, Dendritic Cell
- What is being tested?
- Flu Vaccine (Year 1), Flu Vaccine (Year 2) and Flu Vaccine (Year 3)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2022to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to speak and read English
- Male or Female, 65 years and older by date of enrollment
- Weight of 110 lbs or greater
- Has received influenza vaccine in the past seasons without severe adverse reactions
- Willing to receive an FDA-approved age-appropriate and CDC-recommended influenza vaccine for each of the 2022-23, 2023-24, and 2024-25 influenza seasons
- Willing to withhold all other vaccinations 2 weeks prior and 2 weeks after flu vaccination for the 2022-23, 2023-24, and 2024-25 influenza seasons
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- Willing and available to participate in 19 study visits over three years around influenza vaccination
- Willing to provide blood samples at sixteen visits over three years
- Willing to agree to genomic testing of samples and sharing of de-identified genomic data generated from samples at the conclusion of the research
Who cannot join
- Received any vaccine (shingles, pneumococcal, COVID, etc.) within 2 weeks of anticipated flu vaccination for the 2022-23, 2023-24, and 2024-25 influenza seasons.
- Has already received an influenza vaccine for the approaching influenza season (2022-23)
- Has known allergy to eggs or any component of the flu vaccine. [Although the Advisory Committee on Immunization Practices (ACIP) has concluded that a history of anaphylactic/anaphylactoid or severe allergic reaction to eggs should no longer be considered a contraindication to vaccination with any age-appropriate vaccine, for the purposes of this research study we elected to exclude individuals with these allergies]
- History of Guillain-Barre syndrome (GBS)
- Body temperature greater than 100.3°F (38°C) on date of vaccination or within 2 days prior to vaccination by participant report (study entry may be delayed to meet this requirement)
- Rockwood Frailty Index score of >0.21
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- Known history of any of the following co-morbid conditions:
- Chronic or recent (within past 2 months) infection requiring oral or intravenous antibiotics, antifungals, or antivirals
- Cancer other than basal cell carcinoma requiring active surgical or medical treatment (chemotherapy or radiation therapy)
- Congestive Heart Failure
- Ischemic Heart Disease
- Congenital abnormalities (PI to evaluate)
- Paget's disease
- Renal failure requiring ongoing dialysis
- Chronic obstructive pulmonary disease, emphysema, or asthma
- Severe autoimmune disease requiring biological therapy
- Diabetes mellitus requiring insulin
- Use of medicines during past 6 months known to alter immune response such as high-dose corticosteroids (≥ 10 mg/day of prednisone or equivalent)
- HIV, AIDS or other immunodeficiency disorders
- Recent (≤ 3 months) severe trauma or major surgery (PI to evaluate)
- Current substance and/or alcohol abuse
- Patients currently residing in the Department of Correction
- Inability to comply with the protocol requirements
- Any other condition that, in the opinion of the PI, might interfere with study objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
UConn Health, Center On Aging
Farmington, Connecticut, 06030
About this study
This is a prospective, single-arm study designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults. The investigators will recruit and longitudinally follow a cohort of 75 older adults (65 years and older) who will receive three different influenza vaccines over three annual influenza seasons. Blood samples will be collected from the participants at sixteen study visits over three years. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. After completion of study visits other than the End of Study visit around vaccination in Year 3, participants will be offered the opportunity to be vaccinated with a different FDA approved influenza vaccine and participate in study visits for Year 4. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.
Read the detailed description
This prospective, single-arm study is designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults through the establishment of the FluVax3 cohort of healthy older adults. In this study, the investigators will perform comprehensive profiling of blood antibodies and immune cells over time, and associate specific age-related immune alterations with vaccine responder or non-responder status. This will allow the investigators to pinpoint biological pathways that can be targeted to enhance vaccine efficacy and that can also help the investigators progress towards developing a universal influenza vaccine. The results are expected to provide the foundation for new approaches to improve overall vaccine efficacy and protection in older adults, an outcome of significant public health relevance considering the vulnerability of this population.
In this study, up to seventy-five (75) healthy adults aged 65 years and older who have not received influenza vaccination for the approaching influenza season will be enrolled in the study and vaccinated with influenza vaccines approved by the U.S Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC) for individuals ≥65 years. All participants receive influenza vaccine during the 2022-23, 2023-24, and 2024-25 influenza seasons. Participants will receive Fluzone® Quadrivalent High-Dose vaccine during the 2022-23 flu season, FLUAD® Quadrivalent during the 2023-24 flu season and Flublok Quadrivalent in the 2024-2025 flu season. The study sample will be drawn from the population of healthy older participants in the catchment area of UConn Health in Farmington, CT.
Study participation will involve six study visits around the flu vaccine each year and one final study visit for a total of nineteen study visits over three years. Blood samples will be collected at sixteen study visits for transcriptional, epigenetic and biological analyses pre- and post-vaccination. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. These microbiome samples will be stored and used in future research. After completion of study visits other than the End of Study visit around vaccination in Year 3, participants will be offered the opportunity to be vaccinated with the FDA approved Fluzone High Dose (trivalent) vaccine during the 2025-26 flu season and participate in study visits for Year 4. Blood samples will be collected from participants at an additional 5 timepoints and nasal swabs at an additional 2 timepoints across Year 4. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this proposed study.
This project will yield an unparalleled dataset from healthy older adults that will be used to identify fundamental mechanisms, cell populations, and pathways associated with durable protective antibody immune responses, and lack thereof, upon influenza vaccination. In sum, this study will reveal the mechanistic alterations that explain the heterogeneity in response to vaccines observed in older individuals. Understanding this heterogeneity opens the possibility of stratifying older adults for personalized vaccines. In addition, understanding the mechanistic overlap between the correlates of responsiveness to four different influenza vaccines will advance the ultimate development of a universal influenza vaccine, which is a key focus of NIAID's influenza research program. Finally, this study will generate a considerable amount of transcriptional and functional data related to the outputs of key innate immune and T/B-cell subsets involved in responses to influenza vaccines in older adults. These data will collectively become an important resource for future studies focused on the older adult immune system in health and disease.
- Conditions
- Aging, Influenza Vaccine, Dendritic Cell, Vaccine Response
- Being tested
- Flu Vaccine (Year 1), Flu Vaccine (Year 2), Flu Vaccine (Year 3), Flu Vaccine (Year 4)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu Vaccine (Year 1)Biological
Also called Fluzone® Quadrivalent High-Dose
Participants will receive Fluzone® Quadrivalent High-Dose in the 2022-2023 flu season.
Flu Vaccine (Year 2)Biological
Also called FLUAD
Participants will receive FLUAD® Quadrivalent in the 2023-2024 flu season.
Flu Vaccine (Year 3)Biological
Also called Flublok Quadrivalent
Participants will receive Flublok Quadrivalent in the 2024-2025 flu season.
Flu Vaccine (Year 4)Biological
Also called Fluzone® High-Dose Trivalent
Participants will receive Fluzone® High-Dose Trivalent in the 2025-2026 flu season.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Older Adults | Experimental | Will receive FDA-approved influenza vaccine (Fluzone HD (Quadrivalent) Year 1, FLUAD Year 2, Flublok Quadrivalent Year 3, Fluzone HD (Trivalent) Year 4) Receives: Biological: Flu Vaccine (Year 1); Biological: Flu Vaccine (Year 2); Biological: Flu Vaccine (Year 3); Biological: Flu Vaccine (Year 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Antibody Responses to Influenza Vaccine Year One
In year one, healthy older participants will receive Fluzone Quadrivalent HD vaccine. Longitudinal blood samples will be collected and influenza-specific antibody responses will be assessed. Change in antibody response will be measured using Hemagglutination Inhibition (HAI) from baseline to day 35 and day 180.
Measured: Baseline, Day 35, Day 180
Change in Antibody Responses to Influenza Vaccine Year Two
In year two, healthy older participants will receive FLUAD vaccine. Longitudinal blood samples will be collected and influenza-specific antibody responses will be assessed. Change in antibody response will be measured using Hemagglutination Inhibition (HAI) from baseline to day 35 and day 180.
Measured: Baseline, Day 35, Day 180
Change in Antibody Responses to Influenza Vaccine Year Three
In year three, healthy older participants will receive Flublok Quadrivalent vaccine. Longitudinal blood samples will be collected and influenza-specific antibody responses will be assessed. Change in antibody response will be measured using Hemagglutination Inhibition (HAI) from baseline to day 35 and day 180.
Measured: Baseline, Day 35, Day 180
Change in Antibody Responses to Influenza Vaccine Year Four
In year four, healthy older participants will receive Fluzone® High-Dose Trivalent vaccine. Longitudinal blood samples will be collected and influenza-specific antibody responses will be assessed. Change in antibody response will be measured using Hemagglutination Inhibition (HAI) from baseline to day 35 and day 180.
Measured: Baseline, Day 35, Day 180
Secondary outcomes (16)
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year One
Evaluate changes in functional status of immune cells in older participants following administration of Fluzone Quadrivalent HD vaccine. A longitudinal analysis of different cell populations (B Cells, Functional T/B Cells, and monoclonal antibodies) in whole blood samples will be analyzed at baseline and 35 days post vaccination using single cell assays and ELISA.
Measured: Baseline, Day 7, Day 35
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year Two
Evaluate changes in functional status of immune cells in older participants following administration of FLUAD vaccine. A longitudinal analysis of different cell populations (B Cells, Functional T/B Cells, and monoclonal antibodies) in whole blood samples will be analyzed at baseline and 35 days post vaccination using single cell assays and ELISA.
Measured: Baseline, Day 7, Day 35
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year Three
Evaluate changes in functional status of immune cells in older participants following administration of Flublok Quadrivalent vaccine. A longitudinal analysis of different cell populations (B Cells, Functional T/B Cells, and monoclonal antibodies) in whole blood samples will be analyzed at baseline and 35 days post vaccination using single cell assays and ELISA.
Measured: Baseline, Day 7, Day 35
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year Four
Evaluate changes in functional status of immune cells in older participants following administration of Fluzone High Dose Trivalent vaccine. A longitudinal analysis of different cell populations (B Cells, Functional T/B Cells, and monoclonal antibodies) in whole blood samples will be analyzed at baseline and 35 days post vaccination using single cell assays and ELISA.
Measured: Baseline, Day 7, Day 35
Number of genes upregulated in response to Influenza Vaccine in Year One
RNA-seq and scRNA-seq will be used to assess the number of genes upregulated in response to Fluzone Quadrivalent HD vaccination.
Measured: Baseline, Day1, Day 7
Number of genes upregulated in response to Influenza Vaccine in Year Two
RNA-seq and scRNA-seq will be used to assess the number of genes upregulated in response to FLUAD vaccination.
Measured: Baseline, Day 1, Day 7
Number of genes upregulated in response to Influenza Vaccine in Year Three
RNA-seq and scRNA-seq will be used to assess the number of genes upregulated in response to Flublok Quadrivalent vaccination.
Measured: Baseline, Day1, Day 7
Number of genes upregulated in response to Influenza Vaccine in Year Four
RNA-seq and scRNA-seq will be used to assess the number of genes upregulated in response to Fluzone High Dose Trivalent vaccination.
Measured: Baseline, Day1, Day 7
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year One
snATAC-seq will be used to assess the number of open chromatin regions activated in response to Fluzone Quadrivalent HD vaccination.
Measured: Baseline, Day1, Day 7
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Two
snATAC-seq will be used to assess the number of open chromatin regions activated in response to FLUAD vaccination.
Measured: Baseline, Day1, Day 7
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Three
snATAC-seq will be used to assess the number of open chromatin regions activated in response to Flublok Quadrivalent influenza vaccination.
Measured: Baseline, Day1, Day 7
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Four
snATAC-seq will be used to assess the number of open chromatin regions activated in response to Fluzone High Dose Trivalent vaccination.
Measured: Baseline, Day1, Day 7
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year One
Flow cytometry will be used to assess cell compositional changes in PBMCs and immune cell subsets (cDCs, Tfh, Th10, and B lymphocytes) in response to Fluzone Quadrivalent HD vaccination.
Measured: Baseline, Day1, Day 7, Day 35, Day 180
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Two
Flow cytometry will be used to assess cell compositional changes in PBMCs and immune cell subsets (cDCs, Tfh, Th10, and B lymphocytes) in response to FLUAD vaccination.
Measured: Baseline, Day1, Day 7, Day 35, Day 180
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Three
Flow cytometry will be used to assess cell compositional changes in PBMCs and immune cell subsets (cDCs, Tfh, Th10, and B lymphocytes) in response to Flublok Quadrivalent influenza vaccination.
Measured: Baseline, Day1, Day 7, Day 35, Day 180
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Four
Flow cytometry will be used to assess cell compositional changes in PBMCs and immune cell subsets (cDCs, Tfh, Th10, and B lymphocytes) in response to Fluzone High Dose Trivalent influenza vaccination.
Measured: Baseline, Day1, Day 7, Day 35, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start31 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Jackson Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- UConn Health, Icahn School of Medicine at Mount Sinai, Weill Medical College of Cornell University, University of Chicago, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Duygu Ucar, Ph.D., The Jackson Laboratory
- Investigators
- George Kuchel, MD, FRCP, Principal investigator, UConn Center on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518500
- Sponsor's protocol ID
- 22-179J-1
- Other IDs
- U01AI165452
- Acronym
- FluVax3
- Status last verified
- Jul 2026
- First submitted
- 2 Aug 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will provide permission within the ICF for sharing their randomly recoded (new code that is different than the study code) genomic data in controlled access scientific databases. Participants will provide permission within the ICF for sharing of randomly recoded (new code that is different than the study code) residual samples and linked data with other researchers to be used in future research studies.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults
- ClinicalTrials.gov ID
- NCT05518500
- Acronym / sponsor ID
- FluVax3 / 22-179J-1
- Conditions
- Aging, Influenza Vaccine, Dendritic Cell, Vaccine Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The Jackson LaboratoryUniversity, hospital or other
- Collaborators
- UConn Health, Icahn School of Medicine at Mount Sinai, Weill Medical College of Cornell University, University of Chicago, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Aug 2022 (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.
This is a prospective, single-arm study designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults. The investigators will recruit and longitudinally follow a cohort of 75 older adults (65 years and older) who will receive three different influenza vaccines over three annual influenza seasons. Blood samples will be collected from the participants at sixteen study visits over three years. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. After completion of study visits other than the End of Study visit around vaccination in Year 3, participants will be offered the opportunity to be vaccinated with a different FDA approved influenza vaccine and participate in study visits for Year 4. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.
Detailed description
This prospective, single-arm study is designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults through the establishment of the FluVax3 cohort of healthy older adults. In this study, the investigators will perform comprehensive profiling of blood antibodies and immune cells over time, and associate specific age-related immune alterations with vaccine responder or non-responder status. This will allow the investigators to pinpoint biological pathways that can be targeted to enhance vaccine efficacy and that can also help the investigators progress towards developing a universal influenza vaccine. The results are expected to provide the foundation for new approaches to improve overall vaccine efficacy and protection in older adults, an outcome of significant public health relevance considering the vulnerability of this population.
In this study, up to seventy-five (75) healthy adults aged 65 years and older who have not received influenza vaccination for the approaching influenza season will be enrolled in the study and vaccinated with influenza vaccines approved by the U.S Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC) for individuals ≥65 years. All participants receive influenza vaccine during the 2022-23, 2023-24, and 2024-25 influenza seasons. Participants will receive Fluzone® Quadrivalent High-Dose vaccine during the 2022-23 flu season, FLUAD® Quadrivalent during the 2023-24 flu season and Flublok Quadrivalent in the 2024-2025 flu season. The study sample will be drawn from the population of healthy older participants in the catchment area of UConn Health in Farmington, CT.
Study participation will involve six study visits around the flu vaccine each year and one final study visit for a total of nineteen study visits over three years. Blood samples will be collected at sixteen study visits for transcriptional, epigenetic and biological analyses pre- and post-vaccination. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. These microbiome samples will be stored and used in future research. After completion of study visits other than the End of Study visit around vaccination in Year 3, participants will be offered the opportunity to be vaccinated with the FDA approved Fluzone High Dose (trivalent) vaccine during the 2025-26 flu season and participate in study visits for Year 4. Blood samples will be collected from participants at an additional 5 timepoints and nasal swabs at an additional 2 timepoints across Year 4. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this proposed study.
This project will yield an unparalleled dataset from healthy older adults that will be used to identify fundamental mechanisms, cell populations, and pathways associated with durable protective antibody immune responses, and lack thereof, upon influenza vaccination. In sum, this study will reveal the mechanistic alterations that explain the heterogeneity in response to vaccines observed in older individuals. Understanding this heterogeneity opens the possibility of stratifying older adults for personalized vaccines. In addition, understanding the mechanistic overlap between the correlates of responsiveness to four different influenza vaccines will advance the ultimate development of a universal influenza vaccine, which is a key focus of NIAID's influenza research program. Finally, this study will generate a considerable amount of transcriptional and functional data related to the outputs of key innate immune and T/B-cell subsets involved in responses to influenza vaccines in older adults. These data will collectively become an important resource for future studies focused on the older adult immune system in health and disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Older Adults | Experimental | Biological: Flu Vaccine (Year 1), Biological: Flu Vaccine (Year 2), Biological: Flu Vaccine (Year 3), Biological: Flu Vaccine (Year 4)Will receive FDA-approved influenza vaccine (Fluzone HD (Quadrivalent) Year 1, FLUAD Year 2, Flublok Quadrivalent Year 3, Fluzone HD (Trivalent) Year 4) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Able to speak and read English
- Male or Female, 65 years and older by date of enrollment
- Weight of 110 lbs or greater
- Has received influenza vaccine in the past seasons without severe adverse reactions
- Willing to receive an FDA-approved age-appropriate and CDC-recommended influenza vaccine for each of the 2022-23, 2023-24, and 2024-25 influenza seasons
Key exclusion criteria (24 listed)
- Received any vaccine (shingles, pneumococcal, COVID, etc.) within 2 weeks of anticipated flu vaccination for the 2022-23, 2023-24, and 2024-25 influenza seasons.
- Has already received an influenza vaccine for the approaching influenza season (2022-23)
- Has known allergy to eggs or any component of the flu vaccine. [Although the Advisory Committee on Immunization Practices (ACIP) has concluded that a history of anaphylactic/anaphylactoid or severe allergic reaction to eggs should no longer be considered a contraindication to vaccination with any age-appropriate vaccine, for the purposes of this research study we elected to exclude individuals with these allergies]
- History of Guillain-Barre syndrome (GBS)
- Body temperature greater than 100.3°F (38°C) on date of vaccination or within 2 days prior to vaccination by participant report (study entry may be delayed to meet this requirement)
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 |
|---|---|---|
| Flu Vaccine (Year 1)Also: Fluzone® Quadrivalent High-DoseParticipants will receive Fluzone® Quadrivalent High-Dose in the 2022-2023 flu season. | Biological | Healthy Older Adults |
| Flu Vaccine (Year 2)Also: FLUADParticipants will receive FLUAD® Quadrivalent in the 2023-2024 flu season. | Biological | Healthy Older Adults |
| Flu Vaccine (Year 3)Also: Flublok QuadrivalentParticipants will receive Flublok Quadrivalent in the 2024-2025 flu season. | Biological | Healthy Older Adults |
| Flu Vaccine (Year 4)Also: Fluzone® High-Dose TrivalentParticipants will receive Fluzone® High-Dose Trivalent in the 2025-2026 flu season. | Biological | Healthy Older Adults |
Primary outcome
Change in Antibody Responses to Influenza Vaccine Year One
Time frame: Baseline, Day 35, Day 180
In year one, healthy older participants will receive Fluzone Quadrivalent HD vaccine. Longitudinal blood samples will be collected and influenza-specific antibody responses will be assessed. Change in antibody response will be measured using Hemagglutination Inhibition (HAI) from baseline to day 35 and day 180.
Change in Antibody Responses to Influenza Vaccine Year Two
Time frame: Baseline, Day 35, Day 180
In year two, healthy older participants will receive FLUAD vaccine. Longitudinal blood samples will be collected and influenza-specific antibody responses will be assessed. Change in antibody response will be measured using Hemagglutination Inhibition (HAI) from baseline to day 35 and day 180.
Change in Antibody Responses to Influenza Vaccine Year Three
Time frame: Baseline, Day 35, Day 180
In year three, healthy older participants will receive Flublok Quadrivalent vaccine. Longitudinal blood samples will be collected and influenza-specific antibody responses will be assessed. Change in antibody response will be measured using Hemagglutination Inhibition (HAI) from baseline to day 35 and day 180.
Change in Antibody Responses to Influenza Vaccine Year Four
Time frame: Baseline, Day 35, Day 180
In year four, healthy older participants will receive Fluzone® High-Dose Trivalent vaccine. Longitudinal blood samples will be collected and influenza-specific antibody responses will be assessed. Change in antibody response will be measured using Hemagglutination Inhibition (HAI) from baseline to day 35 and day 180.
16 secondary outcomes
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year One
Time frame: Baseline, Day 7, Day 35
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year Two
Time frame: Baseline, Day 7, Day 35
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year Three
Time frame: Baseline, Day 7, Day 35
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year Four
Time frame: Baseline, Day 7, Day 35
Number of genes upregulated in response to Influenza Vaccine in Year One
Time frame: Baseline, Day1, Day 7
Number of genes upregulated in response to Influenza Vaccine in Year Two
Time frame: Baseline, Day 1, Day 7
Number of genes upregulated in response to Influenza Vaccine in Year Three
Time frame: Baseline, Day1, Day 7
Number of genes upregulated in response to Influenza Vaccine in Year Four
Time frame: Baseline, Day1, Day 7
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year One
Time frame: Baseline, Day1, Day 7
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Two
Time frame: Baseline, Day1, Day 7
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Three
Time frame: Baseline, Day1, Day 7
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Four
Time frame: Baseline, Day1, Day 7
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year One
Time frame: Baseline, Day1, Day 7, Day 35, Day 180
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Two
Time frame: Baseline, Day1, Day 7, Day 35, Day 180
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Three
Time frame: Baseline, Day1, Day 7, Day 35, Day 180
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Four
Time frame: Baseline, Day1, Day 7, Day 35, Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. Participants will provide permission within the ICF for sharing their randomly recoded (new code that is different than the study code) genomic data in controlled access scientific databases. Participants will provide permission within the ICF for sharing of randomly recoded (new code that is different than the study code) residual samples and linked data with other researchers to be used in future research studies.
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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.
George Kuchel, MD, FRCP principal investigator
UConn Center on Aging
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 Flu Vaccine (Year 1), Flu Vaccine (Year 2) and Flu Vaccine (Year 3) in people with Aging and Influenza Vaccine, run by The Jackson Laboratory 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 9 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Antibody Responses to Influenza Vaccine Year One (time frame: Baseline, Day 35, Day 180). The study lists 4 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 3 Aug 2026.