RECRUITING

A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults

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Conditions

AgingInfluenza VaccineDendritic CellVaccine Response

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.

Official Title

A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults

Quick Facts

Study Start:2022-08-31
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05518500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to speak and read English
  2. * Male or Female, 65 years and older by date of enrollment
  3. * Weight of 110 lbs or greater
  4. * Has received influenza vaccine in the past seasons without severe adverse reactions
  5. * 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
  6. * 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
  7. * Willing and available to participate in 19 study visits over three years around influenza vaccination
  8. * Willing to provide blood samples at sixteen visits over three years
  9. * Willing to agree to genomic testing of samples and sharing of de-identified genomic data generated from samples at the conclusion of the research
  1. * 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.
  2. * Has already received an influenza vaccine for the approaching influenza season (2022-23)
  3. * Has known allergy to eggs or any component of the flu vaccine. \[Although the Advisory Committee on Immunization Practices (ACIP) has concluded that a history of anaphylactic/anaphylactoid or severe allergic reaction to eggs should no longer be considered a contraindication to vaccination with any age-appropriate vaccine, for the purposes of this research study we elected to exclude individuals with these allergies\]
  4. * History of Guillain-Barre syndrome (GBS)
  5. * 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)
  6. * Rockwood Frailty Index score of \>0.21
  7. * Known history of any of the following co-morbid conditions:
  8. * Chronic or recent (within past 2 months) infection requiring oral or intravenous antibiotics, antifungals, or antivirals
  9. * Cancer other than basal cell carcinoma requiring active surgical or medical treatment (chemotherapy or radiation therapy)
  10. * Congestive Heart Failure
  11. * Ischemic Heart Disease
  12. * Congenital abnormalities (PI to evaluate)
  13. * Paget's disease
  14. * Renal failure requiring ongoing dialysis
  15. * Chronic obstructive pulmonary disease, emphysema, or asthma
  16. * Severe autoimmune disease requiring biological therapy
  17. * Diabetes mellitus requiring insulin
  18. * Use of medicines during past 6 months known to alter immune response such as high-dose corticosteroids (≥ 10 mg/day of prednisone or equivalent)
  19. * HIV, AIDS or other immunodeficiency disorders
  20. * Recent (≤ 3 months) severe trauma or major surgery (PI to evaluate)
  21. * Current substance and/or alcohol abuse
  22. * Patients currently residing in the Department of Correction
  23. * Inability to comply with the protocol requirements
  24. * Any other condition that, in the opinion of the PI, might interfere with study objectives

Contacts and Locations

Study Contact

Lisa Kenyon-Pesce, MPH
CONTACT
860-679-2305
kenyon-pesce@uchc.edu
George Kuchel, MD, FRCP
CONTACT
860-679-6796
kuchel@uchc.edu

Principal Investigator

George Kuchel, MD, FRCP
PRINCIPAL_INVESTIGATOR
UConn Center on Aging

Study Locations (Sites)

UConn Health, Center On Aging
Farmington, Connecticut, 06030
United States

Collaborators and Investigators

Sponsor: The Jackson Laboratory

  • George Kuchel, MD, FRCP, PRINCIPAL_INVESTIGATOR, UConn Center on Aging

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-31
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-08-31
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Aging
  • Influenza Vaccine
  • Dendritic Cell
  • Vaccine Response