RECRUITING

Systems Investigation of Vaccine Responses in Aging and Frailty

Talk to us

Conditions

Influenzavaccineinfluenza vaccineolder adultsvaccine responsetoll-like receptorsimmune response

Quick Navigation

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 study will compare the immune response signatures (including immunologic, transcriptomic and metabolomic) of the two influenza vaccines approved for use in adults age 65 and over (Fluad and Fluzone High-Dose).

Official Title

Systems Investigation of Vaccine Responses in Aging and Frailty

Quick Facts

Study Start:2023-11-06
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05291676

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:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 21-40 or 65 and older
  2. * Ability to understand and give informed consent (surrogate consent may apply to nursing home subjects who are decisionally impaired, with verbal assent to be obtained from subject)
  3. * Plan to be in the New Haven, CT area for the next 4-6 weeks
  1. * Current use of medication, such as antibiotics in past two weeks. To clarify, patients taking antibiotics for the reason of a current acute infection will not be eligible. Those potential participants receiving antibiotics for prophylaxis purposes will be eligible to participate. The intention is not to create a separate group to drawn conclusions, but not to exclude these participants who are not acutely ill.
  2. * Evidence of acute infection, identified by self- report of fever or symptoms in past two weeks
  3. * Treatment for cancer in past three months.
  4. * Previous adverse reaction to influenza vaccine requiring medical attention, such as allergic response (rash, anaphylaxis) or Guillain-Barré syndrome.
  5. * Pregnant/possibly pregnant.
  6. * History of organ, bone marrow or stem cell transplant, liver cirrhosis, kidney disease requiring dialysis, HIV/AIDS, hepatitis C or active hepatitis B
  7. * Blood donation of 1 pint or more in past 2 months
  8. * Treatment with clinical trial medication
  9. * Presence of any other condition (e.g., geographical or social), actual or projected, that the investigator feels would restrict or limit the patient's participation for the duration of the study. This provision includes participants who have 50% or more missed appointments in the last three months.

Contacts and Locations

Study Contact

Irene Matos, RN
CONTACT
(203) 737-4739
irene.matos@yale.edu

Principal Investigator

Albert Shaw, MD, PhD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale School of Medicine
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Albert Shaw, MD, PhD, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2023-11-06
Study Completion Date2027-04

Study Record Updates

Study Start Date2023-11-06
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • vaccine
  • influenza vaccine
  • older adults
  • vaccine response
  • toll-like receptors
  • immune response

Additional Relevant MeSH Terms

  • Influenza