Actively Recruiting
Characterization of Humoral and Cellular Immune Responses Elicited by Influenza Vaccination in Healthy Adults
Led by University of Pennsylvania · Updated on 2026-02-09
700
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the immune system responds to seasonal influenza vaccination in healthy adults of different birth years. The study aims to understand how early life exposure to influenza viruses influences antibody and cellular immune responses later in life. This investigation focuses on the differences in immune responses caused by the initial influenza virus someone was exposed to, which may affect vaccine response and effectiveness. Participants will receive a seasonal, inactivated, quadrivalent influenza vaccine administered intramuscularly at a dose of 15 micrograms of hemagglutinin (HA) per component, as approved by the FDA. Up to 100 participants will be enrolled each year to capture a range of birth years. The study will observe immune responses before and after vaccination over a period of up to seven years. During the study, participants will have their blood samples collected to measure both cellular and humoral immune responses to the vaccine. Researchers will evaluate neutralizing antibody levels as the primary outcome, along with secondary measures such as serum antibody changes, levels of specific antibodies binding to viral components, and T follicular helper cell responses. Participants will be monitored throughout the study duration to assess these immune responses and ensure safety.
CONDITIONS
Brief Title
Characterization of Humoral and Cellular Immune Responses Elicited by Influenza Vaccination in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Willingness to comply with all study procedures and availability for all study visits
- Aged 18 years and older
- In good health based on self-reported medical conditions via an online survey
You will not qualify if you...
- Known allergic reactions to components of the study vaccine
- Known latex allergy
- History of severe reactions following previous influenza vaccinations
- History of Guillain-Barré syndrome within 6 weeks of a previous influenza vaccine
- Immunosuppression due to illness or treatment, including chemotherapy or radiation therapy within 36 months
- Treatment with immunoglobulin or blood products within 3 months prior to enrollment
- Active neoplastic disease or recent hematological malignancy treatment within 5 years
- Long-term use of oral, parenteral, or high-dose inhaled steroids
- Influenza vaccination within 2 months prior to enrollment
- Any acute or chronic medical condition that may make vaccination unsafe or interfere with response evaluation
- Participation in another study involving experimental agents within 1 month prior or expected during the study
- Intent to donate blood during the study period
- Any condition posing unacceptable risk or inability to meet protocol requirements
- Pregnancy
- Known HIV, hepatitis B, or hepatitis C infection
- Any condition believed by the investigator to affect successful study completion
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 - Single day
Participants receive a seasonal influenza vaccine administered intramuscularly at a dose of 15 ug of HA per component.
1 vaccination visit
Duration - Up to 7 years
Participants are monitored for immune responses to influenza vaccination over time.
Multiple follow-up visits over several years
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
S
Scott Hensley, PhD
E
Elizabeth Drapeau, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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