Actively Recruiting
Influenza Immunization in Adults Over Age 75
Led by Johns Hopkins University · Updated on 2026-03-16
1025
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the immune systems of adults over age 75 respond to the influenza vaccine, also known as the flu shot. This research focuses on understanding the impact of chronic cytomegalovirus (CMV) infection, a common virus in older adults, on the immune response to the flu vaccine. The study aims to improve knowledge about why vaccine failures occur in the frail elderly and to explore immune changes that happen with aging, especially in the oldest and most vulnerable groups. Participants will receive the Fluzone High-Dose trivalent inactivated influenza vaccine (TIV). The study includes several visits: an initial visit to collect medical history, vital signs, walking speed, grip strength, questionnaires, and blood and urine samples; a vaccination visit; a 7-day post-vaccination visit to collect a small blood sample and complete a symptom survey; and a 4-week post-vaccination visit with follow-up questionnaires, vital signs, and a larger blood sample to measure immune responses. Weekly phone calls will be made throughout the flu season to monitor health and flu-like symptoms, with extra testing if symptoms develop. Participants will be involved in regular health assessments including blood draws to check immune responses and nasal swabs to confirm influenza if symptoms appear. The study team will monitor the presence of CMV viral DNA and immune responses over four years. Results such as blood counts will be shared with participants. The total study duration covers several flu seasons with ongoing follow-up and data collection to better understand vaccine effectiveness and immune health in adults over 75 years old.
CONDITIONS
Brief Title
Influenza Immunization in Adults Over Age 75
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over age 75 years
You will not qualify if you...
- Allergies to egg or vaccine
- Active malignancies
- On radiation or chemotherapy
- Active systemic inflammatory diseases including rheumatoid arthritis, Crohn's disease, and ulcerative colitis
- Acute exacerbation of chronic cardiopulmonary conditions including decompensated CHF or COPD
- Taking oral steroids (such as prednisone) or immune modulating drugs (such as methotrexate)
- Lacking the capacity to consent (unable to understand or decide about the flu shot)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Annual immunization repeated each flu season for 4 years
Participants receive the high-dose trivalent inactivated influenza vaccine (TIV) immunization.
1 visit per flu season for up to 4 years
Duration - Up to 5 years including 4 years of vaccination and 1 additional year of follow-up
Participants are monitored for influenza-like illness and immune responses including presence of CMV viral DNA and T-cell responses after vaccination.
Post-vaccination surveillance and antibody testing at the end of each flu season for 4 years, with immune response testing at the end of the study
Trial Site Locations
Total: 1 location
1
Johns Hopkins University; JHAAC 5501 Hopkins Bayview Circle, 1B84
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
T
Trudymae Agboka, M.S. Biology
C
Cherise Young
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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