Trial Search Results

The Influence of Chronic CMV Infection on Influenza Vaccine Responses

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Stanford Investigator(s):

Intervention(s):

  • Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50

Phase:

Phase 4

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.

Ages Eligible for Study

60 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting