This segment of our website is designed to give the interested participant more information about the nature of our experimental malaria vaccine study
Eligibility Criteria and Visit Schedule (SLVP website link)
Immune Senescence in the Elderly: Comparison of Immune Responses to
Influenza Vaccine in Adults of Different Ages
This segment of the Vaccine Program website is designed to provide more detailed information to volunteers who are interested in participating in the influenza vaccine study. There are three sections. In the first section you will find a list of requirements you will need to meet in order to be considered for participation. In the next section you will find events or conditions that might make you ineligible to participate. In the last section you will find a table of study visits and procedures. This will give you a better idea of the study requirements and the time commitment involved.
I. To be considered, you must meet these requirements:
1. Between the ages of 18-30, or 60-100 years, inclusive. 2. Good general health as determined by a screening medical history and brief physical
3. No acute illness at time of vaccination. 4. Willing and able to sign Informed Consent
5. Available for follow-up for the planned duration of the study
II. To be considered, you must not have any of these events or conditions that could put your health at risk if you were to participate in the study. The study doctors and nurses will also discuss this information in more detail during your screening visit.
1. Adult ages <18, 31-59 or >100 years 2. Allergy to egg or egg products 3. Allergy to vaccine components, including thimerosal 4. Active systemic or serious concurrent illness, including febrile illness on the day of
5. History of immunodeficiency 6. 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, blood pressure >150/95 at screening, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
7. Hospitalization in the past year for congestive heart failure or emphysema. 8. Chronic Hepatitis B or C.
9. Recent or current use of immunosuppressive medication, including glucocorticoids
(corticosteroid nasal sprays are permissible).
10. 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).
11. 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.
12. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
medical follow up or hospitalization during the preceding year
13. Use of any anti-coagulation medication such as Coumadin or Lovenox. Anti-platelet
agents such as aspirin, Plavix, Aggrenox may be acceptable after review by investigator
14. Receipt of blood or blood products within the past 6 months 15. Medical or psychiatric condition or occupational responsibilities that preclude subject
16. Inactivated vaccine 14 days prior to vaccination 17. Live, attenuated vaccine within 60 days of vaccination 18. History of Guillain–Barré Syndrome 19. Pregnant or lactating woman 20. Use of investigational agents within 30 days prior to enrollment 21. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment 22. 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.
III. Study Visits/ Schedule
There will be 3 clinic visits and 1 follow-up phone call six months after vaccination during each year of the study. You will receive the seasonal influenza vaccination at the first clinic visit each year. The second clinic appointment will be approximately 5-7 days after the vaccination. The third clinic visit will be between 21-35 days after the vaccination. There will be a blood draw at each of the three clinic visits. The first clinic visit will require approximately 1 hour to complete. The remaining 2 visits will take approximately 25 minutes each. The phone call will require no more than 15 minutes. Year 1- 2008:
Year 1: Phone Call ( 6 months after Visit 1) Phone Call
Year 2- 2009:
Year 2: Phone Call ( 6 months after Visit 1) Phone Call
Thank you for your interest in our research. Please contact the study staff at(650) 498-7284 if you have any questions. We look forward to talking with you.
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