The Influence of Chronic CMV Infection on Influenza Vaccine Responses
Condition: Cytomegalovirus Infections; Influenza
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Cytomegalovirus Infections
Intervention: Fluzone® 2012-2013 Formula NDC No 498281-012-50
Intervention description: This vaccine is given intramuscularly
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this study we are trying to understand whether previous infection with a particular virus,
      namely cytomegalovirus (CMV), influences the ability of the immune system to respond to new
      infections or vaccinations with age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Otherwise healthy, ambulatory adult 60 years of age or above.

          -  Self-identified by a participant after notification by Stanford Blood Center (SBC) of
             their group assignment based review of SBC CMV data:

               -  CMV-negative: Donor has donated at least twice during the last 3 years AND
                  donor's most recent two donations tested CMV antibody negative.

               -  CMV positive longstanding infection: Donor has donated at least once within the
                  "recent" timeframe (past three years) AND donor's most recent donation tested CMV
                  antibody positive AND donor had at least one donation prior to 2000 that tested
                  CMV antibody positive.

               -  Recent CMV converters: Donor has donated at least once within the "recent"
                  timeframe (past three years) AND donor's most recent two donations tested CMV
                  antibody positive AND donor had at least two CMV negative donations in the past.

          -  Willing to complete the informed consent process.

          -  Availability for follow-up for the planned duration of the study at least 28 days
             after immunization.

          -  Acceptable medical history by review of inclusion/exclusion criteria and vital signs.

        Exclusion Criteria:

          -  Prior off-study vaccination with the current 2012-2013 seasonal influenza vaccine

          -  Allergy to egg or egg products, or to vaccine components or thimerosal (TIV multidose
             vials only)

          -  Life-threatening reactions to previous influenza vaccinations.

          -  Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          -  Weight less than 110 lbs

          -  History of immunodeficiency (including HIV infection)

          -  Known or suspected impairment of immunologic function, including, but not limited to,
             clinically significant liver disease, diabetes mellitus treated with insulin, moderate
             to severe renal disease, or any other chronic disorder which, in the opinion of the
             investigator, might jeopardize volunteer safety or compliance with the protocol.

          -  Blood pressure >150 systolic or >95 diastolic at first study visit

          -  Hospitalization in the past year for congestive heart failure or emphysema.

          -  History of chronic Hepatitis B or C.

          -  Recent or current use of immunosuppressive medication, including systemic
             glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in
             all groups)

          -  Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors
             such as breast cancer or prostate cancer with recurrence in the past year, and any
             hematologic cancer such as leukemia).

          -  Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive
             medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion
             of the investigator, might jeopardize volunteer safety or compliance with the
             protocol.

          -  History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

          -  Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin (except up to 325 mg aspirin per day), Plavix, or Aggrenox must
             be reviewed by investigator to determine if this would affect the volunteer's safety.

          -  Receipt of blood or blood products within the past 6 months or planned receipt of
             blood products prior to completion of study visits.

          -  Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

          -  Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination
             prior to completion of Visit 03 (~Day 28 after the study vaccination)

          -  Live, attenuated vaccine within 60 days of vaccination or planned non-study
             vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)

          -  Need an allergy immunization (that cannot be postponed) during the study period V01 to
             V03 (~Day 28)

          -  History of Guillain-Barré Syndrome

          -  Use of investigational agents within 30 days prior to enrollment or planned use of
             investigational agents prior to completion of study visits

          -  Donation of the equivalent of a unit of whole blood within 6 weeks or a unit of
             platelets within 2 weeks prior to enrollment or planned blood donation prior to
             completion of study visits.

          -  Any condition which, in the opinion of the investigator, might interfere with
             volunteer safety, study objectives or the ability of the participant to understand or
             comply with the study protocol.