Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response

Completed · Phase 4

Conditions studied: Influenza A Subtype H5N1 Infection

In brief

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.

Key facts

Study ID

NCT03701061

Run by

Emory University

People needed

12

Starts

2018-10-11

Expected to finish

2020-01-31

Last updated by the study team

2020-03-11

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Hope Clinic of Emory University — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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