Intradermal Influenza Vaccine Study in Elders

This is an interventional prevention trial for Influenza focused on measuring influenza, prevention, intradermal, vaccine, delivery, elderly Read More

Inclusion Criteria:

• Ambulatory, medically stable persons 65 years of age or older
• Able to read and understand informed consent
• Available during the trial period and for follow-up
• Able to understand and comply with planned study procedures
• Able to be contacted by telephone for follow-up of adverse events

Exclusion Criteria:

• Known allergy to eggs or other components of vaccine (i.e., thimerosal)
• History of Guillain-Barré Syndrome (GBS)
• Has a confirmed or suspected immunodeficient or immunosuppressive condition (including congenital or acquired immunosuppressive therapy, and human immunodeficiency virus [HIV])
• End-stage renal disease requiring hemodialysis
• Active neoplastic disease or history of any hematologic malignancy (except localized skin or prostate cancer that is stable in the absence of therapy)
• Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin controlled diabetes mellitus)
• Use of experimental vaccines within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the duration of the study.
• Receipt of immunoglobulin or other blood product within 3 months prior to enrollment
• Receipt of other licensed vaccines within the preceding 4 weeks
• History of a severe reaction following influenza vaccination
• Current or planned participation in a research study of an investigational drug. Participation in research studies that involve use of licensed drugs, for either approved or investigational indications, will be permitted with the approval of the PI, as will participation in research studies that do not involve vaccines or medications.
• Current use or previous chronic administration, defined as >14 days during the previous six months, of immunosuppressants or other immune-modifying drugs. (For oral or injected corticosteroids, the immune-modifying dose is defined as prednisone or its equivalent >10 mg/day or >800mcg per day of inhaled beclomethasone dipropionate or equivalent ). Topical steroids are allowed.
• Use of cytotoxic therapy in the previous 2 years.
• Plans to receive cytotoxic therapy during the study period.
• Concurrent moderate to severe illness. Need to defer vaccination until recovery. (Vaccination is not contraindicated in subjects with mild illnesses or with low-grade fever).