Characterizing Late-season Influenza Vaccine Responses to Compare the 2023 and 2024 Vaccine Formulations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-21

Study Completion Date

2025-02-06

Brief Summary

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Every 1-2 years, the seasonal influenza vaccine composition changes to include updated viruses, yet the precise effects of updating the vaccine remain understudied. Since the vaccine formulation for each season (with a season defined as starting in July and ending the following June) expires on June 30, vaccine formulations cannot be compared head-to-head. Thus, the 2023 and 2024 vaccines have only been compared by analyzing people given the former vaccine in the fall of 2023 and people given the latter vaccine in the fall of 2024, and baseline repertoires may have greatly changed over the course of that year. To that end, the investigators will vaccinate a cohort with the 2023 influenza vaccine between May-June 2024, in order to compare responses between individuals receiving the 2023 vaccine last fall, the 2023 vaccine late in the season (this cohort), and the 2024 vaccine next fall. The investigators will further assess whether the late-season 2023 vaccine primed this cohort to respond better to the standard 2024 vaccine with standard timing (vaccine administered around September-October).

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Detailed Description

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Conditions

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Influenza A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Late season influenza vaccine

Every participant receives the 2023 influenza vaccine between May-June 2024, and then the 2024 influenza vaccine in September-October 2024. Blood draws are taken at Day 0, 30, and 90 post-vaccination.

Group Type EXPERIMENTAL

Influenza Fluzone vaccine

Intervention Type BIOLOGICAL

Fluzone vaccine administered in both May-June and in September-October for each participant.

Interventions

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Influenza Fluzone vaccine

Fluzone vaccine administered in both May-June and in September-October for each participant.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Be between 18-64 years of age
* Males or non-pregnant, non-nursing females
* Weigh at least 85 pounds for whole blood draw
* Ability to provide signed informed consent
* Subjects must plan to receive the intramuscular influenza vaccine at the La Jolla Institute for Immunology

Exclusion Criteria

* Received an influenza vaccine in the past year
* Infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
* History of certain anemias
* Presence of significant cardiovascular disease, systemic diseases including, but not limited to, diabetes which is not controlled, renal disease, liver disease, malignancy, infection, or blood clotting disorder
* Inability to provide informed consent
* Recent whole blood donation within 56 days or leukapheresis within 112 days
* Children (under 18 years of age), elderly (65 years of age or older), pregnant or nursing females
* Individuals with egg allergies
* Has ever had Guillain-Barré syndrome

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes