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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Sep 22, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how different types of FDA-approved seasonal influenza vaccines affect the body’s immune response, specifically the antibodies that help fight the flu. Researchers want to see how these responses vary between younger adults (ages 18-50) and older adults (ages 65-80), as well as how previous vaccinations might influence these responses.

To be eligible for the study, participants must be between 18 and 50 years old for the first two groups or between 65 and 80 years old for the other groups, and they need to weigh at least 110 pounds. Participants will be asked to give informed consent and have blood drawn as part of the study. Those with certain health conditions, recent illnesses, or allergies to components of the vaccine will not be eligible. If you decide to join, you can expect to receive a flu vaccine and provide some health information, and your antibody response will be monitored over time. Overall, this study aims to improve our understanding of how the flu vaccine works in different age groups.

Gender

ALL

Eligibility criteria

• 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.