Influenza A
Conditions
Keywords
Influenza vaccine, Immune response
Brief summary
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).
Interventions
BIOLOGICALInfluenza Fluzone vaccine
Fluzone vaccine administered in both May-June and in September-October for each participant.
Sponsors
La Jolla Institute for Immunology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude of Antibody Response After the Late-season 2023 Vaccine | 0, 30, and 90 days after the 2023 vaccine | The antibody response will be measured by hemagglutination inhibition (HAI) in adults between 18 and 64 years old who have not had an influenza vaccination prior to the study. |
| Magnitude of the Antibody Response After the 2024 Vaccine | Day 0, 30, and 90 after the 2024 vaccine | The antibody response will be measured by hemagglutination inhibition (HAI) in adults between 18 and 64 years old who have not had an influenza vaccination prior to the study. This outcome was only performed on Arm 2. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTal Einav, PhD
La Jolla Institute for Immunology
Participant flow
Pre-assignment details
Participants were recruited into either Arm 1 (receiving only the late-season 2023 vaccine) or Arm 2 (receiving the late-season 2023 vaccine and then the 2024 vaccine three months later). 9 participants chose to participate in Arm 1 and 14 in Arm 2.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29 Years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 14 |
| other Total, other adverse events | 0 / 9 | 0 / 14 |
| serious Total, serious adverse events | 0 / 9 | 0 / 14 |
Outcome results
None listed