Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response
Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response
The study is a prospective single site exploratory study to examine the impact of Food and
 Drug Administration (FDA) approved seasonal flu vaccine on the immune responses of H5N1
 vaccine previously received with or without the AS03 adjuvant.
Influenza, caused by the influenza virus, is a contagious respiratory disease that can result
 in mild to severe illness. It is estimated that up to 80,000 deaths and approximately 200,000
 Americans are hospitalized annually due to complications. Vaccination is the most effective
 way of controlling flu and preventing its illness and complications; however, antibody
 responses to seasonal influenza vaccines decrease over time and only target a small number of
 antibody binding sites In 2015, the Hope Clinic of the Emory Vaccine Center completed a study
 analyzing human immune responses to a pandemic H5N1, or "bird flu" vaccine, either alone or
 combined with the GlaxoSmithKline adjuvant system 03 (AS03).

 Participants that took part in the 2013 HIPCVAX-010 Systems Biology of Influenza A (H5N1)
 Virus Monovalent Vaccine with and without AS03 Adjuvant study will be enrolled in this study
 to assess the effect of seasonal influenza vaccine in shaping the immune responses. The study
 aims to address important immunological mechanisms that can assist scientists in the creation
 of a universal influenza vaccine.
Inclusion Criteria:

 -  Participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent
 Vaccine with and without AS03 Adjuvant study.

 -  Capable of informed consent and provision of written informed consent before any study
 procedures.

 -  Capable of attending all study visits according to the study schedule.

 -  Are in good health, as determined by medical history and targeted physical exam
 related to this history.

 -  Female subjects of childbearing age must have a negative urine pregnancy test before
 study vaccination, and must use at least one form of contraception to avoid pregnancy
 for 28 days before and 28 days after Fluarix Quadrivalent administration.

 Exclusion Criteria:

 -  Have an acute illness, including any fever (> 100.4 F [> 38 degrees C], regardless of
 the route) within 72 hours before vaccination.

 -  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.

 -  Alcohol or drug abuse and psychiatric conditions that, in the opinion of the
 investigator, would preclude compliance with the trial or interpretation of safety or
 endpoint data.

 -  Have a suppressed immune system as a result of illness, immunosuppressive medication,
 chemotherapy, or radiation therapy within 3 years prior to study vaccination.

 -  Are pregnant or breastfeeding or plan to within one month of vaccination.

 -  Have taken oral or parenteral corticosteroids of any dose within 28 days before study
 vaccination.

 -  Have a known history of autoimmune disease.

 -  Have a history of Guillain-Barre Syndrome.

 -  Have a history of bleeding disorders.

 -  Have known hypersensitivity or allergy to any component of the vaccine, including egg
 and latex allergies, or history of anaphylaxis with influenza vaccine or vaccine
 component.

 -  Have received blood or blood products 3 months prior to study entry or expected to
 receive through 6 months after study entry.

 -  Have received any live virus vaccines within 4 weeks prior to study entry or expected
 receipt within 4 weeks after study entry.

 -  Have received any inactivated vaccine within 2 weeks or expected receipt within 2
 weeks after study entry.

 -  Have received any experimental agents within 6 weeks prior to study or plan to through
 study duration.

 -  Have received the 2018-2019 influenza seasonal vaccine.

 -  Documented influenza infection during the 2018-2019 influenza season.

 -  Social, occupational, or any other condition that in the opinion of the investigator
 might interfere with compliance with the study and vaccine evaluation.