The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: 2016-2017 Influenza Vaccine
Intervention description: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 20 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccination

Summary:

      This is a prospective pilot study designed to suggest differences in the immunologic response
      to the seasonal influenza vaccine in people with regular vaccination history compared to
      those vaccinated less regularly. Participants will receive one dose of the Food and Drug
      Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will
      be collected at standard time points. The duration of the study for each participant will be
      approximately 1 month.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  Oral temperature is less than 38 degrees Celsius.

          -  Resting pulse rate is between 50 and 115 beats per minute.

          -  Female subjects of childbearing age must have a negative urine pregnancy test within
             24 hours before study vaccination.

          -  Have received the influenza vaccine at least 3 of the past 5 years or have received
             the influenza vaccine in 2 or less of the past 5 years.

        Exclusion Criteria:

          -  Have an acute illness within 72 hours before vaccination.

          -  Have any condition that, in the opinion of the principal investigator, would place the
             subject at an unacceptable risk of injury or confound the interpretation of the study
             results.

          -  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.

          -  Have a suppressed immune system as a result of illness, immunosuppressive medication,
             chemotherapy, or radiation therapy within 3 years prior to study vaccination.

          -  Have known HIV, hepatitis B, or hepatitis C infection.

          -  Have a known history of autoimmune disease.

          -  Have taken oral or parenteral corticosteroids of any dose within 30 days before study
             vaccination.

          -  Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.

          -  Have received any licensed live vaccine within 30 days or any licensed inactivated
             vaccine within 14 days prior to study vaccination.

          -  Have planned vaccination with any vaccine during the 29-day duration of subject study
             participation.

          -  Have received immunoglobulin or other blood products, with the exception of Rho D
             immunoglobulin, within 90 days prior to study vaccination.

          -  Have donated blood or blood products within 30 days before study vaccination, plan to
             donate blood at any time during the 29-day duration of subject study participation, or
             plan to donate blood within 30 days after the last blood draw.

          -  Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other
             compounds of the study vaccine.

          -  Have a history of severe reactions following vaccination with influenza virus vaccines