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

IRB-300003914

This study will examine how various FDA-approved seasonal influenza vaccine types, used in a manner consistent with their approved use, impact the characteristics of influenza specific antibodies in humans, and how these responses differ based on age and prior immunization history.

2021-04-01

2024-05-01

2025-05-01

Recruiting

Early phase I

50

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Participant will be blinded to which vaccine they receive until immediately after vaccination.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-06-09