The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: FLUARIX QUADRIVALENT
Intervention description: The FDA-approved, quadrivalent seasonal influenza vaccine that will be administered contains four distinct strains, two influenza A viruses and two influenza B viruses.
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 42 Years
Maximum age: 71 Years
Healthy volunteers: No
Keywords: Flu vaccine; Influenza vaccine; Immune response; Influenza strain

Summary:

      The goal of this study is to understand the impact on the human immune system's response to
      the four strain flu vaccine in individuals who have "imprinted" on specific influenza
      strains. It will also consider the effects of repeated prior annual influenza vaccination on
      the immune system.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Capable of informed consent and provision of written informed consent before any study
             procedures.

          2. Capable of attending all study visits according to the study schedule.

          3. Males or females born between 1968-1977 or 1948-1957.

          4. Are in good health, as determined by medical history and targeted physical exam
             related to this history.

          5. Oral temperature is less than 38 degrees Celsius.

          6. Resting pulse rate is between 50 and 100 beats per minute.

          7. Female subjects of childbearing age must have a negative urine pregnancy test within
             24 hours before study vaccination.

          8. Have received the influenza vaccine at least 3 of the past 5 years or have received
             the influenza vaccine in 2 or less of the past 5 years.

        Exclusion Criteria:

          1. Have an acute illness within 72 hours before vaccination.

          2. Have any condition that, in the opinion of the principal investigator, would place the
             subject at an unacceptable risk of harm or confound the interpretation of the study
             results.

          3. Have any acute or chronic medical condition that, in the opinion of the principal
             investigator, would make vaccination unsafe or interfere with the evaluation of immune
             response to study vaccination.

          4. Have a suppressed immune system as a result of illness, immunosuppressive medication,
             chemotherapy, or radiation therapy within 3 years prior to study vaccination.

          5. Have known HIV, hepatitis B, or hepatitis C infection.

          6. Have a known history of autoimmune disease.

          7. Have taken oral or parenteral corticosteroids of any dose within 30 days before study
             vaccination.

          8. Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.

          9. Have received, or plan to receive, any licensed live vaccine within 30 days, or any
             licensed inactivated vaccine within 14 days, prior to, or after, study vaccination.

         10. Have planned receipt of any unlicensed or investigational medications, biologics, or
             vaccines for the duration of subject study participation.

         11. Have received immunoglobulin or other blood products, with the exception of Rho D
             immunoglobulin, within 90 days prior to study vaccination.

         12. Have donated blood or blood products within 30 days before study vaccination, or
             within 60 days after study vaccination, or plan to donate blood within 30 days of the
             last blood draw.

         13. Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other
             compounds of the study vaccine.

         14. Have a history of severe reactions following vaccination with influenza virus
             vaccines.