RecruitingPhase 4NCT04101838

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

Sponsor

University of Alabama at Birmingham

Enrollment

50 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

Influenza

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria33

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:
History of Guillain-Barre Syndrome
History of egg allergy
History of gelatin allergy
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:
No recent respiratory infections in the past 4 weeks at time of vaccination
Malignancy
Evidence of Inflammation: Systemic Lupus Erythematosis, Rheumatoid Arthritis, Polymyositis, Dermatomyositis, Scleroderma, Crohn's Disease, Ulcerative Colitis.
Lymphoproliferative Disorder
Known Immunodeficiency
Myocardial Infarction <6 months
Cerebral Vascular Accident
Peripheral Vascular Disease- recannulation <6months
Cardiac Insufficiency - congestive heart failure
Hypertension with increased blood urea nitrogen (BUN)
Renal Failure
Dementia
Alcoholism (defined as >17 drinks/week)
Drug Abuse (excluding marijuana)
HIV positive
History of hepatitis
History of immunization within 4 weeks of study participation or plan to receive non- IIV vaccination within 4 weeks of receiving IIV
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.