Status:
RECRUITING
A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults
Lead Sponsor:
The Jackson Laboratory
Collaborating Sponsors:
UConn Health
Icahn School of Medicine at Mount Sinai
Conditions:
Aging
Influenza Vaccine
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief 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 fo...
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 heal...
Eligibility Criteria
Inclusion Criteria:
- 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
- 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 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]
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History of Guillain-Barre syndrome (GBS)
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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
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Patients currently residing in the Department of Correction
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Inability to comply with the protocol requirements
-
Any other condition that, in the opinion of the PI, might interfere with study objectives
Key Trial Info
Start Date :
August 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05518500
Start Date
August 31 2022
End Date
December 31 2026
Last Update
September 19 2024
Active Locations (1)
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1
UConn Health, Center On Aging
Farmington, Connecticut, United States, 06030