Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response (HIPCVAX-010S)
Influenza A Subtype H5N1 Infection
About this trial
This is an interventional basic science trial for Influenza A Subtype H5N1 Infection focused on measuring Immune response
Eligibility Criteria
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.
Sites / Locations
- The Hope Clinic of Emory University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Participants that received AS03 Adjuvant
Participants that did not receive AS03 Adjuvant
Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).
Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).