Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine
Condition: Healthy Volunteer
Intervention: Flucelvax; Fluvirin; Fluzone High Dose
Intervention description: Seasonal influenza vaccine; Seasonal influenza vaccine; Seasonal influenza vaccine for adults ages 65 and older
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Systems Biology; Immunology

Summary:

      Background:

      Vaccines help prevent disease by causing the body to have an immune response. Many parts of
      this response happen in the blood. This response happens over days and weeks after getting
      the vaccine. Researchers want to how the blood changes over time in response to vaccines.
      They want to find out why vaccines work better for some people than for others. This could
      help make more effective vaccines.

      Objective:

      To learn about how the body responds to vaccines.

      Eligibility:

      Healthy people ages 18 and older

      Design:

      Participants will be screened with a medical history, physical exam, and blood and urine
      tests.

      Participants will have 9 visits over 6 months. All visits will include blood tests and a
      physical exam.

      Participants will have the first visit 1 week before they get the vaccine.

      Participants will get the flu vaccine at the second visit. The vaccine will be injected into
      the muscle of the upper arm with a needle. They will be watched for side effects for 15
      minutes.

      Participants will have the next 2 visits exactly 1 day and 1 week after they get the vaccine.
      They will have the other 5 visits about 14, 28, 70, and 100 days after they get the vaccine.

      Participants will take email questionnaires about whether they had any side effects.

      Participants may have optional extra study visits. These will be no more than once a month
      for up to 1 year after they get the vaccine. Optionally, they can also repeat the study each
      year through the 2023 - 2024 flu season
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Individuals must meet all of the following criteria to be eligible for study participation:

          1. Aged 18 years and older (no upper age limit).

          2. Able to provide informed consent.

          3. Willing to have samples and data stored for future research.

          4. Able to proficiently speak, read, and write English.

        EXCLUSION CRITERIA:

        Individuals meeting any of the following criteria will be excluded from study
        participation:

          1. CBC with differential, lymphocyte phenotyping with T, B, and natural killer cells
             (TBNK), acute care, mineral, and hepatic panels, anti-CMV immunoglobulin (Ig) G and
             IgM, and/or anti-Epstein-Barr virus (EBV) antibody panel values outside of the NIH
             Department of Laboratory Medicine normal reference ranges and deemed clinically
             significant by the PI at the time of screening.

          2. Positive result for anti-HIV 1/2 antibody, antibody to hepatitis B surface antigen, or
             anti-hepatitis C virus antibody screening at the time of screening.

          3. Prior receipt of a current seasonal influenza vaccine (for the season of
             participation).

          4. History of allergy or hypersensitivity to any components of the study vaccine (e.g.,
             egg protein, latex).

          5. History of severe reactions to vaccines.

          6. Use of an oral glucocorticoid within the past 30 days.

          7. Receipt of a live-attenuated vaccine within the past 30 days.

          8. Receipt of any experimental vaccine.

          9. Receipt of any other type of vaccine (non-live and non-experimental, e.g., tetanus,
             diphtheria, and pertussis [TDaP]) within the past 14 days.

         10. Planned vaccination before day 100 after study vaccination.

         11. Current or recent use (within the past 90 days) of immunoglobulin therapy.

         12. Surgery within the past 8 weeks, or planned surgery before day 100.

         13. Current (within the past 30 days) treatment for active malignancy.

         14. Cancer chemotherapy in the past 5 years.

         15. Administration of any blood products within 90 days of the screening, or planned
             administration before day 100.

         16. History of parasitic, amebic, fungal, or mycobacterial infections within the past 1
             year with the exception of tinea pedis and onychomycosis.

         17. Diabetes mellitus.

         18. History of autoimmune or autoinflammatory disease.

         19. History of a bleeding disorder.

         20. Current use (within the past 30 days) of illicit drugs (per subject report).

         21. Current use (within the past 30 days) of nicotine-containing products, including
             cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.

         22. Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of
             Mental Disorders, fifth edition), within the past 30 days.

         23. Serious, ongoing, uncontrolled infection within the past 30 days as per the judgement
             of the PI.

         24. History of Guillain-Barre syndrome (GBS).

         25. BMI greater than or equal to 30.

         26. Known or suspected immunodeficiency within 1 year, including documented HIV infection.

         27. Pregnancy or planning to become pregnant during the study period. (Women of
             childbearing potential must have a negative urine or serum pregnancy test at
             screening.)

         28. Presence of conditions that, in the judgment of the PI, may put the individual at
             undue risk or compromise the scientific objectives of the study.