Gene Signatures of Influenza Vaccine Responses in Older Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluad Vaccine; Fluzone High-Dose
Intervention description: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.; FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects who consent and enroll will be randomly assigned to receive either the Fluad Vaccine or Fluzone High-Dose vaccine.
Masking: None (Open Label)
Enrollment: 241.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fluad, MF59, Fluzone, HDFlu, Influenza, Vaccine

Summary:

      The purpose of this research study is to better understand the immune response to the
      Adjuvanted Subunit flu vaccine (MF59) and the High Dose flu vaccine (HDFlu) in people 65
      years of age and older. The research team will be studying why immune response diminishes as
      people get older in both men and women. The ultimate goal is to understand how flu immunity
      develops after vaccination. This information may lead to the development of more effective
      flu vaccines in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults ages 18-40 or of 65 and or older at the time of enrollment

          -  Eligible to receive Fluad® (MF59Flu) or Fluzone® (HDFlu) if age 65 or older

          -  No history of anaphylactic reaction to gelatin, neomycin, or other vaccine component

          -  Not pregnant

          -  No immunosuppression or immunodeficiency

          -  No acute illness at time of vaccination

          -  Determined by medical history and clinical judgment to be eligible for the study, by
             being generally healthy, with no autoimmune or immunosuppressive conditions and having
             stable current medical conditions (subjects with preexisting stable disease, defined
             as disease not requiring significant change in therapy or hospitalization for
             worsening disease 12 weeks before receipt of study vaccine, will be eligible. A change
             in dose or therapy within a category (e.g., change from one nonsteroidal
             anti-inflammatory drug to another) is allowed. A change to a new therapy category
             (e.g., surgery or addition of a new pharmacological class) is only allowed if it is
             not caused by worsening disease. A change to a new therapy category caused by
             worsening disease is considered significant and therefore ineligible for enrollment.

          -  Patients with diabetes mellitus are eligible for inclusion if they have had a
             hemoglobin A1c measurement of <8.0 within the past 6 months prior to enrollment. These
             hemoglobin A1c measurements are recommended at least twice yearly by the American
             Diabetes Association (ADA), and the target levels here are representative of the goals
             of the ADA. These hemoglobin A1c levels will ensure that these participants have good
             glycemic control. (American Diabetes Association. American Diabetes Association
             Position Statement: Standards of Medical Care in Diabetes- 2015. Diabetes Care
             2015;38(Suppl. 1): S1-S94)

          -  Able to follow study procedures in the opinion of the investigator

          -  Expected to be available for the duration of the study

          -  Weighs >110 lbs

        Exclusion Criteria:

          -  Known or suspected immunodeficiency or receiving treatment with immunosuppressive
             therapy including cytotoxic agents or systemic corticosteroids (e.g., for cancer, HIV,
             or autoimmune disease). If systemic corticosteroids have been administered short term
             for treatment of an acute illness, subjects will be included if corticosteroid therapy
             (inhaled, intranasal, and intra-articular corticosteroid therapy is permitted) has
             been discontinued for at least 30 days.

          -  Serious chronic medical conditions including metastatic malignancy, severe chronic
             obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease
             with or without dialysis, clinically unstable cardiac disease, or any other disorder
             that, in the investigator's opinion, precludes the subject from participating in the
             study. Diabetic patients will be excluded if they do not have a hemoglobin A1c
             measurement within the past 6 months or if they had a hemoglobin A1c measurement of an
             A1c >8.0

          -  Receipt of any blood products, including immunoglobulin, within 6 months of study
             enrollment.

          -  Current anticoagulant therapy or a history of bleeding diathesis that would
             contraindicate intramuscular (IM) injection. (Note: antiplatelet drugs such as aspirin
             and clopidogrel are permitted.)

          -  Receipt of any vaccines within the past 30 days prior to enrollment

          -  Receipt of the current seasonal influenza vaccine other than in this study

          -  Acute illness within the last 30 days

          -  Blood donation within the last 58 days prior to study enrollment

          -  Any medical condition that would, in the opinion of the investigator, interfere with
             the evaluation of the study objectives

          -  Pregnant patients will be excluded

          -  Any condition (e.g. allergic reaction, Guillain-Barre Syndrome) that precludes their
             receipt of the influenza vaccine