Plasmablast Trafficking and Antibody Response in Influenza Vaccination (SLVP021 2011-2014)

Not Recruiting

Trial ID: NCT02141581


The purpose of this study is to investigate the responses to licensed trivalent, inactivated influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all given to generally healthy male and female adult volunteers.

Official Title

Vaccination and Infection: Indicators of Immunological Health and Responsiveness. Project 1: Plasmablast Trafficking and Antibody Response in Influenza Vaccination;


Inclusion Criteria:

   - Otherwise healthy, ambulatory between the ages of 8-33 years, inclusively.

   - 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 and vital signs

Exclusion Criteria:

   - Prior vaccination with seasonal TIV or LAIV

   - Prior off-study vaccination with TIV or LAIV in the current flu season

   - 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

   - Asthma or history of wheezing (for volunteers receiving LAIV only)

   - Participants in close contact with anyone who has a severely weakened immune system
   should not receive LAIV (for volunteers receiving LAIV only)

   - 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

   - Chronic Hepatitis B or C

   - Recent or current use of immunosuppressive medication, including systemic
   glucocorticoids (corticosteroid nasal sprays, inhaled steroids and topical steroids
   are permissible in both 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

   - 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

   - Pregnant or lactating woman

   - 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 blood within 6 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


biological: 2011-2012 Flumist®

biological: Fluzone® (IM)

biological: Fluzone® Intradermal (ID)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305