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

Description

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.

Conditions

Influenza

Study Overview

Study Details

Study overview

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.

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

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

Condition
Influenza
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Alabama at Birmingham,

James J Kobie, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2025-05