Aging Clinical Trial
— FluVax3Official title:
A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults
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 66 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 each of the 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. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Able to speak and read English - Male or Female, 65 years and older by September 1, 2022 - 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 - 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 Exclusion Criteria: - 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 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) occurring within 6 weeks following previous influenza vaccination. - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | UConn Health, Center On Aging | Farmington | Connecticut |
Lead Sponsor | Collaborator |
---|---|
The Jackson Laboratory | Icahn School of Medicine at Mount Sinai, National Institute of Allergy and Infectious Diseases (NIAID), UConn Health, University of Chicago, Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, Day 35, Day 180 | |
Primary | 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. | Baseline, Day 35, Day 180 | |
Primary | Change in Antibody Responses to Influenza Vaccine Year Three | In year three, healthy older participants will receive a CDC recommended FDA approved influenza 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. | Baseline, Day 35, Day 180 | |
Secondary | 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. | Baseline, Day 7, Day 35 | |
Secondary | 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. | Baseline, Day 7, Day 35 | |
Secondary | 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 CDC recommended FDA approved influenza 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. | Baseline, Day 7, Day 35 | |
Secondary | 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. | Baseline, Day1, Day 7 | |
Secondary | 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. | Baseline, Day 1, Day 7 | |
Secondary | 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 CDC recommended FDA approved influenza vaccination. | Baseline, Day1, Day 7 | |
Secondary | 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. | Baseline, Day1, Day 7 | |
Secondary | 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. | Baseline, Day1, Day 7 | |
Secondary | 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 CDC recommended FDA approved influenza vaccination. | Baseline, Day1, Day 7 | |
Secondary | 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. | Baseline, Day1, Day 7, Day 35, Day 180 | |
Secondary | 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. | Baseline, Day1, Day 7, Day 35, Day 180 | |
Secondary | 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 CDC recommended FDA approved influenza vaccination. | Baseline, Day1, Day 7, Day 35, Day 180 |
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