The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics

The goal of this study is to understand the impact on the human immune system's response to
the 4 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. This trial may hopefully lead to larger trials that advance understanding of
flu vaccines and hopefully lead to a more effective flu vaccine that does not rely on annual
updates, provides broad protection, and is durable; i.e., a universal influenza vaccine.

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 38C.

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 (between September
2013-June 2018) or have received the influenza vaccine in 2 or less of the past 5
years (between September 2013-June 2018).

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.