Status:
COMPLETED
Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
Certain functions of the immune system are revealed only when the immune system is challenged. When a person is vaccinated, a coordinated response results: activation and interaction of distinct innat...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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.
- Administration of any blood products within 90 days of the screening, or planned administration before day 100.
- History of parasitic, amebic, fungal, or mycobacterial infections within the past 1 year with the exception of tinea pedis and onychomycosis.
- Diabetes mellitus.
- History of autoimmune or autoinflammatory disease.
- History of a bleeding disorder.
- Current use (within the past 30 days) of illicit drugs (per subject report).
- Current use (within the past 30 days) of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.
- Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition), within the past 30 days.
- Serious, ongoing, uncontrolled infection within the past 30 days as per the judgement of the PI.
- History of Guillain-Barre syndrome (GBS).
- BMI greater than or equal to 30.
- Known or suspected immunodeficiency within 1 year, including documented HIV infection.
- Pregnancy or planning to become pregnant during the study period. (Women of childbearing potential must have a negative urine or serum pregnancy test at screening.)
- Presence of conditions that, in the judgment of the PI, may put the individual at undue risk or compromise the scientific objectives of the study.
Exclusion
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04025580
Start Date
October 2 2019
End Date
January 31 2023
Last Update
January 2 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892