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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Antibodies; Vaccines

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.