Status:
RECRUITING
B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Influenza
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 h...
Detailed Description
This study is particularly focused on studying antibodies, a protein in blood that react with foreign substances (such as bacteria and viruses) to help eliminate them. This study will examine antibodi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04101838
Start Date
April 1 2021
End Date
May 1 2026
Last Update
September 17 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294