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

NCT04101838 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB-300003914
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 humans, and how these responses differ based on age and prior immunization history.

Conditions

Influenza

Keywords

vaccine

Outcome Measures

Primary Outcomes (2)

• Hemagglutinin antibody

  hemagglutinin plasma antibody titer

  3 months after vaccination

• Neuraminidase antibody

  Neuraminidase plasma antibody titer

  3 months after vaccination

Secondary Outcomes (2)

• Hemagglutinin Memory B cell ELISPOT Response

  3 months after vaccination

• Neuraminidase Memory B cell ELISPOT Response

  3 months after vaccination

Study Arms (5)

Fluzone Younger

ACTIVE COMPARATOR

10 adults 18-50 years old, will receive a single dose of the Fluzone influenza vaccine each year for two sequential years

Drug: Fluzone

Flucelvax

ACTIVE COMPARATOR

10 adults 18-50 years old, will receive a single dose of the Flucelvax influenza vaccine each year for two sequential years

Drug: Flucelvax

Fluzone Older

ACTIVE COMPARATOR

10 adults 65-80 years old, will receive a single dose of the Fluzone influenza vaccine

Drug: Fluzone

Fluzone High Dose

ACTIVE COMPARATOR

10 adults 65-80 years old, will receive a single dose of the Fluzone High-Dose influenza vaccine

Drug: Fluzone High-Dose

Fluad

ACTIVE COMPARATOR

10 adults 65-80 years old, will receive a single dose of the Fluad influenza vaccine

Drug: Fluad

Interventions

Fluzone DRUG

inactivated seasonal influenza vaccine

Also known as: influenza vaccine

Fluzone Older; Fluzone Younger

Flucelvax DRUG

inactivated seasonal influenza vaccine

Also known as: influenza vaccine

Flucelvax

Fluzone High-Dose DRUG

inactivated seasonal influenza vaccine

Also known as: high dose influenza vaccine

Fluzone High Dose

Fluad DRUG

inactivated seasonal influenza vaccine

Also known as: adjuvanted influenza vaccine

Fluad

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Fluzone High-Dose; fluad vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• James J Kobie, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James J Kobie, PhD

CONTACT

205-975-2760; jjkobie@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to which vaccine they receive until immediately after vaccination.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 24, 2019
• Study Start: April 1, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)