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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Late season influenza vaccine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Fluzone vaccine | Biological | Fluzone vaccine administered in both May-June and in September-October for each participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of Antibody Response After the Late-season 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. | 0, 30, and 90 days after the 2023 vaccine |
| Magnitude of the Antibody Response 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. | Day 0, 30, and 90 after the 2024 vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tal Einav, PhD | La Jolla Institute for Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla Institute for Immunology | La Jolla | California | 92037 | United States |
De-identified data will be included in all relevant publications.
Data will be available upon publication.
Data will be available with no restrictions.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Late-season 2023 Influenza Vaccine | Participants that had not been previously vaccinated for influenza during the 2023-24 season (i.e. no influenza vaccine since July 1, 2023) were given the 2023 vaccine in either May or June of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. |
| FG001 | Arm 2: Late-season 2023 Influenza Vaccine Followed by the 2024 Influenza Vaccine | As in Arm 1, participants that had not been previously vaccinated for influenza during the 2023-24 season were given the 2023 vaccine in either May or June of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. Following that, participants were given the 2024 influenza vaccine in September, October, or November of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Late-season 2023 Influenza Vaccine | Participants that had not been previously vaccinated for influenza during the 2023-24 season (i.e. no influenza vaccine since July 1, 2023) were given the 2023 vaccine in either May or June of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Magnitude of Antibody Response After the Late-season 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. | HAI titers were computed for all participants in each arm at every time point using the geometric mean and the geometric standard deviation, E^(standard deviation of log(titers)). For example, the value of 6±1.4 for Arm 1's H1N1 day 0 measurement should be interpreted as a geometric mean of 6, and a 1.4x standard error (so that values were generally between 6/1.4 and 6×1.4). | Posted | Geometric Mean | Standard Deviation | HAI Titer | 0, 30, and 90 days after the 2023 vaccine |
|
From receipt of the 2023 vaccine (day 0) through study completion, an average of 3 months for Arm 1 and 7 months for Arm 2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Late-season 2023 Influenza Vaccine | Participants that had not been previously vaccinated for influenza during the 2023-24 season (i.e. no influenza vaccine since July 1, 2023) were given the 2023 vaccine in either May or June of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tal Einav | La Jolla Institute for Immunology | (858) 752-6879 | tal.einav@lji.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2024 | Jan 26, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2024 | Jan 26, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Arm 2: Late-season 2023 Influenza Vaccine Followed by the 2024 Influenza Vaccine |
As in Arm 1, participants that had not been previously vaccinated for influenza during the 2023-24 season were given the 2023 vaccine in either May or June of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. Following that, participants were given the 2024 influenza vaccine in September, October, or November of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Arm 2: Late-season 2023 Influenza Vaccine Followed by the 2024 Influenza Vaccine | As in Arm 1, participants that had not been previously vaccinated for influenza during the 2023-24 season were given the 2023 vaccine in either May or June of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. Following that, participants were given the 2024 influenza vaccine in September, October, or November of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. |
|
|
| Primary | Magnitude of the Antibody Response 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. | Serum was only collected for Arm 2 participants. | Posted | Geometric Mean | Standard Error | HAI Titer | Day 0, 30, and 90 after the 2024 vaccine |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Arm 2: Late-season 2023 Influenza Vaccine Followed by the 2024 Influenza Vaccine | As in Arm 1, participants that had not been previously vaccinated for influenza during the 2023-24 season were given the 2023 vaccine in either May or June of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. Following that, participants were given the 2024 influenza vaccine in September, October, or November of 2024. Antibody HAI responses were measured 0, 30, and 90 days following this vaccination. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| H3N2, Day 0 |
|
| H3N2, Day 30 |
|
| H3N2, Day 90 |
|
| B Victoria, Day 0 |
|
| B Victoria, Day 30 |
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| B Victoria, Day 90 |
|
| B Yamagata, Day 0 |
|
| B Yamagata, Day 30 |
|
| B Yamagata, Day 90 |
|