| Eligibility |
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.
|
