Examining B Cell and Antibody Responses to Seasonal Influenza Vaccines in Different Age Groups

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

This study is testing how different flu vaccines work in younger and older adults by looking at how well they help the body make antibodies against the virus.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT04101838 on ClinicalTrials.gov

What this trial studies

This study investigates how various FDA-approved seasonal influenza vaccines affect the characteristics of influenza-specific antibodies in younger and older adults. It focuses on understanding the role of B cells, which produce antibodies in response to the vaccine, and how these responses vary based on age and prior immunization history. The research aims to identify the effectiveness of different vaccine types in inducing antibodies that target both the hemagglutinin and neuraminidase proteins of the influenza virus. This knowledge could inform the development of more effective influenza vaccines in the future.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-50 or 65-80 who can provide informed consent and meet specific health criteria.

Not a fit: Patients with a history of severe allergic reactions to influenza vaccines or certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved influenza vaccines that provide broader and more lasting protection against various strains of the virus.

How similar studies have performed: Other studies have explored antibody responses to influenza vaccines, but this specific focus on B cell responses and the comparison of different vaccine types is relatively novel.

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.

Where this trial is running

Birmingham, Alabama

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Principal investigator: James J Kobie, PhD — University of Alabama at Birmingham
• Study coordinator: James J Kobie, PhD

Conditions Influenza; vaccine