Status:
RECRUITING
Systems Investigation of Vaccine Responses in Aging and Frailty
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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 Fluzo...
Detailed Description
There are two vaccines currently approved for use in adults age 65 and greater: a high-dose (HD) influenza vaccine (Fluzone High-Dose) that contains 4 times the hemagglutinin dose found in the standar...
Eligibility Criteria
Inclusion
- Age 21-40 or 65 and older
- 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)
- Plan to be in the New Haven, CT area for the next 4-6 weeks
Exclusion
- 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.
- Evidence of acute infection, identified by self- report of fever or symptoms in past two weeks
- Treatment for cancer in past three months.
- Previous adverse reaction to influenza vaccine requiring medical attention, such as allergic response (rash, anaphylaxis) or Guillain-Barré syndrome.
- Pregnant/possibly pregnant.
- History of organ, bone marrow or stem cell transplant, liver cirrhosis, kidney disease requiring dialysis, HIV/AIDS, hepatitis C or active hepatitis B
- Blood donation of 1 pint or more in past 2 months
- Treatment with clinical trial medication
- 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.
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05291676
Start Date
November 6 2023
End Date
April 1 2027
Last Update
June 12 2025
Active Locations (1)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06520