Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine
2 other identifiers
interventional
98
1 country
1
Brief Summary
Background: Vaccines help prevent disease by causing the body to have an immune response. Many parts of this response happen in the blood. This response happens over days and weeks after getting the vaccine. Researchers want to how the blood changes over time in response to vaccines. They want to find out why vaccines work better for some people than for others. This could help make more effective vaccines. Objective: To learn about how the body responds to vaccines. Eligibility: Healthy people ages 18 and older Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Participants will have 9 visits over 6 months. All visits will include blood tests and a physical exam. Participants will have the first visit 1 week before they get the vaccine. Participants will get the flu vaccine at the second visit. The vaccine will be injected into the muscle of the upper arm with a needle. They will be watched for side effects for 15 minutes. Participants will have the next 2 visits exactly 1 day and 1 week after they get the vaccine. They will have the other 5 visits about 14, 28, 70, and 100 days after they get the vaccine. Participants will take email questionnaires about whether they had any side effects. Participants may have optional extra study visits. These will be no more than once a month for up to 1 year after they get the vaccine. Optionally, they can also repeat the study each year through the 2023 - 2024 flu season
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedStudy Start
First participant enrolled
October 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedResults Posted
Study results publicly available
January 2, 2024
CompletedJanuary 2, 2024
January 31, 2023
3.3 years
July 18, 2019
October 3, 2023
December 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microneutralization Titers
Change in antibody titer response to vaccination, as measured by microneutralization titers at day 0 and day 70 and its relationship with novel baseline biomarkers
Day 0 and Day 28 Reported in Manuscript
Study Arms (1)
Flucelvax, Fluvirin, or Fluzone High Dose
EXPERIMENTALHealthy Volunteer between ages 18-65 receiving Flucelvax
Interventions
Seasonal influenza vaccine for adults ages 65 and older
Eligibility Criteria
You may qualify if:
- Individuals must meet all of the following criteria to be eligible for study participation:
- Aged 18 years and older (no upper age limit).
- Able to provide informed consent.
- Willing to have samples and data stored for future research.
- Able to proficiently speak, read, and write English.
You may not qualify if:
- Individuals meeting any of the following criteria will be excluded from study participation:
- CBC with differential, lymphocyte phenotyping with T, B, and natural killer cells (TBNK), acute care, mineral, and hepatic panels, anti-CMV immunoglobulin (Ig) G and IgM, and/or anti-Epstein-Barr virus (EBV) antibody panel values outside of the NIH Department of Laboratory Medicine normal reference ranges and deemed clinically significant by the PI at the time of screening.
- Positive result for anti-HIV 1/2 antibody, antibody to hepatitis B surface antigen, or anti-hepatitis C virus antibody screening at the time of screening.
- Prior receipt of a current seasonal influenza vaccine (for the season of participation).
- History of allergy or hypersensitivity to any components of the study vaccine (e.g., egg protein, latex).
- History of severe reactions to vaccines.
- Use of an oral glucocorticoid within the past 30 days.
- Receipt of a live-attenuated vaccine within the past 30 days.
- Receipt of any experimental vaccine.
- Receipt of any other type of vaccine (non-live and non-experimental, e.g., tetanus, diphtheria, and pertussis \[TDaP\]) within the past 14 days.
- Planned vaccination before day 100 after study vaccination.
- Current or recent use (within the past 90 days) of immunoglobulin therapy.
- Surgery within the past 8 weeks, or planned surgery before day 100.
- Current (within the past 30 days) treatment for active malignancy.
- Cancer chemotherapy in the past 5 years.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (1)
Sparks R, Lau WW, Liu C, Han KL, Vrindten KL, Sun G, Cox M, Andrews SF, Bansal N, Failla LE, Manischewitz J, Grubbs G, King LR, Koroleva G, Leimenstoll S, Snow L; OP11 Clinical Staff; Chen J, Tang J, Mukherjee A, Sellers BA, Apps R, McDermott AB, Martins AJ, Bloch EM, Golding H, Khurana S, Tsang JS. Influenza vaccination reveals sex dimorphic imprints of prior mild COVID-19. Nature. 2023 Feb;614(7949):752-761. doi: 10.1038/s41586-022-05670-5. Epub 2023 Jan 4.
PMID: 36599369RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rachel Sparks
- Organization
- National Institutes of Health
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel D Sparks, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2019
First Posted
July 19, 2019
Study Start
October 2, 2019
Primary Completion
January 31, 2023
Study Completion
January 31, 2023
Last Updated
January 2, 2024
Results First Posted
January 2, 2024
Record last verified: 2023-01-31