Flu Vaccine for Seasonal Influenza

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Tal Einav

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

23 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Tal Einav, PhD

Principal Investigator

La Jolla Institute for Immunology

Eligibility Criteria

This trial is for individuals who are interested in helping to compare the effectiveness of different seasonal flu vaccines. There aren't specific inclusion or exclusion criteria provided, but typically participants should be healthy, not have allergies to vaccine components, and must not have received the current season's flu vaccine.

Inclusion Criteria

Ability to provide signed informed consent

Weigh at least 85 pounds for whole blood draw

I plan to get the flu shot at the La Jolla Institute for Immunology.

Exclusion Criteria

I am infected with HIV, hepatitis B, or hepatitis C.

Received an influenza vaccine in the past year

Has ever had Guillain-Barré syndrome

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination Phase 1

Participants receive the 2023 influenza vaccine between May-June 2024

2 months

3 visits (in-person) for blood draws at Day 0, 30, and 90 post-vaccination

Vaccination Phase 2

Participants receive the 2024 influenza vaccine in September-October 2024

2 months

3 visits (in-person) for blood draws at Day 0, 30, and 90 post-vaccination

Follow-up

Participants are monitored for safety and effectiveness after the second vaccination

3 months

Treatment Details

Interventions

• Influenza Fluzone vaccine

Trial Overview The study aims to understand how effective the late-season administration of the 2023 influenza vaccine is compared to both its standard timing earlier in fall 2023 and next season's (2024) formulation given at standard times.

Participant Groups

Group I: Late season influenza vaccine Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Tal Einav

Lead Sponsor

Trials

1

Recruited

20+

La Jolla Institute for Immunology

Lead Sponsor

Trials

1

Recruited

20+