Systems Investigation of Vaccine Responses in Aging and Frailty

Recruiting now · Phase 2

Conditions studied: Influenza

In brief

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).

Key facts

Study ID

NCT05291676

Run by

Yale University

People needed

96

Starts

2023-11-06

Expected to finish

2027-04-01

Last updated by the study team

2025-06-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Yale School of Medicine — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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