Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017)
Trial ID or NCT#
NCT01827462
Status
NOT RECRUITING
Purpose
In this study the investigators are trying to understand how immune function declines in the elderly using annual influenza vaccinations as a model system. The longitudinal study began in 2007 and continued through early 2017.
Official Title
Immune Senescence in the Elderly: Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages
Eligibility Criteria
Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- - Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment - General good health and ambulatory at time of enrollment - No acute illness at time of vaccination - Willing and able to sign Informed Consent - Available for follow-up for the planned duration of the study - Acceptable medical history by screening evaluation and brief clinical assessment - All female subjects of childbearing potential must use an acceptable method of contraception and not become pregnant for the duration of the clinical phase of the study (approximately 1 month to completion of Visit 3). (Acceptable contraception may include implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).
Exclusion Criteria:
- - Prior off-study vaccination with trivalent or quadrivalent (depending no year) influenza vaccine (TIV or IIV4) or live attenuated influenza vaccine (LAIV) in the current flu season - Allergy to egg or egg products - Allergy to vaccine components, including thimerosal - Active systemic or serious concurrent illness, including febrile illness on the day of vaccination - History of immunodeficiency - Any 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 Visit 1 - Chronic Hepatitis B or C. - Recent or current use of systemic immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays and inhaled steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator. - 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 or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year - Use of anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin, Plavix, 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 - Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol - Receipt of inactivated vaccine within 14 days prior to vaccination - Receipt of live, attenuated vaccine within 60 days of vaccination - History of Guillain-Barré Syndrome - Pregnant or lactating woman - Use of investigational agents within 30 days prior to enrollment - Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment - 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.
Investigator(s)
Mark M. Davis
Cornelia L. Dekker, M.D.
View on ClinicalTrials.gov
