B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults

This is an interventional basic science trial for Influenza focused on measuring vaccine Read More

Inclusion Criteria:

• Participation in ancillary clinical research study
• Able to give informed consent
• Age 18-50 years old for Arm 1 and Arm 2
• Age 65-80 years old for Arm 3, Arm 4, and Arm 5
• Weight of at least 110 lbs as determined by self-reporting

Exclusion Criteria:

• Inability to give informed consent
• Refusal or inability to have blood drawn or participate in study procedures

• Previous adverse reaction to influenza vaccine or medical history contraindicated for receiving influenza vaccine, including but not limited to:

  1. History of Guillain-Barre Syndrome
  2. History of egg allergy
  3. History of gelatin allergy
  4. History of moderate to severe illness with or without fever within 6 weeks of receipt of influenza vaccine
• Previous receipt of influenza vaccine outside of study within current season
• Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
• Participant has any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgement of the investigator would interfere with, or serve as a contraindication to the planned procedure(s).

• These following criteria are used for scientific reasons, and not safety reasons. Specifically, the criteria are used to obtain a population that is healthy and less likely to have conditions that may influence the immune system:

  1. No recent respiratory infections in the past 4 weeks at time of vaccination
  2. Malignancy
  3. Evidence of Inflammation: Systemic Lupus Erythematosis, Rheumatoid Arthritis, Polymyositis, Dermatomyositis, Scleroderma, Crohn's Disease, Ulcerative Colitis.
  4. Lymphoproliferative Disorder
  5. Known Immunodeficiency
  6. Myocardial Infarction <6 months
  7. Cerebral Vascular Accident
  8. Peripheral Vascular Disease- recannulation <6months
  9. Cardiac Insufficiency - congestive heart failure
  10. Hypertension with increased blood urea nitrogen (BUN)
  11. Renal Failure
  12. Dementia
  13. Alcoholism (defined as >17 drinks/week)
  14. Drug Abuse (excluding marijuana)
  15. HIV positive
  16. History of hepatitis
  17. History of immunization within 4 weeks of study participation or plan to receive non- IIV vaccination within 4 weeks of receiving IIV
  18. Moderate to severe illness at time of enrollment
• Donations of blood in the 8 weeks prior to enrollment which, combined with expected volumes to be drawn for this study, would exceed 450 mL in an 8 week period.
• Current pregnancy at time of enrollment or pregnancy within last 4 months
• Active or planned breastfeeding during study participation
• Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.