RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-04-01

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04101838

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

James J Kobie, PhD

CONTACT

205-975-2760

jjkobie@uabmc.edu

Principal Investigator

James J Kobie, PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01

Study Completion Date2025-05

Study Record Updates

Study Start Date2021-04-01

Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

vaccine

Additional Relevant MeSH Terms

Influenza