Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine
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|ClinicalTrials.gov Identifier: NCT04025580|
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : August 22, 2019
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.
To learn about how the body responds to vaccines.
Healthy people ages 18 and older
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, 100, and 180 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
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteer||Biological: Flucelvax Biological: Fluvirin Biological: Fluzone High Dose||Phase 2|
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 innate and adaptive immune cell populations and pathways, culminating in the formation of germinal centers from which antibody-producing plasma cells and memory B cells derive. By taking measurements at various time points before and after vaccination, we can build a comprehensive picture of how the immune system responds to a vaccine challenge.
The seasonal influenza vaccination provides an excellent model of coordinated immune activity involving innate and adaptive responses, as demonstrated in a past NIH study in 2009-2011; however, scientific advances and the possibility of multi-season responses in individuals warrant a new follow-up study with more comprehensive sampling. This is an open-label, prospective, exploratory study to assess the baseline and post-vaccination immune responses of healthy volunteers to an approved seasonal influenza vaccine. Subjects will undergo baseline blood collections on day -7 and on day 0 before receiving the study vaccine. After vaccination, blood will be collected on days 1, 7, 14, 28, 70, 100, and 180. Optionally, subjects may also give blood once a month, as requested, up until 1 year after vaccination. Blood samples will be used to assess short- and long-term immunological effects of immunization. Evaluations will include vaccine antibody titers. Additional evaluations may include peripheral immune cell phenotyping, RNA sequencing (RNA-seq) of whole blood and defined peripheral blood cell subsets, and measurement of serum proteins. Subjects may optionally continue study participation annually through the 2023-24 influenza season.
The goal of this protocol is to use the collective information gathered across all healthy volunteers to understand how the immune system works as a whole.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine|
|Estimated Study Start Date :||August 27, 2019|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Flucelvax, Fluvirin, or Fluzone High Dose
Healthy Volunteer between ages 18-65 receiving Flucelvax
Seasonal influenza vaccine
Seasonal influenza vaccine
Biological: Fluzone High Dose
Seasonal influenza vaccine for adults ages 65 and older
- Microneutralization titers [ Time Frame: Ongoing ]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
- Microneutralization titers [ Time Frame: Ongoing ]Change in antibody titer response to vaccination, as measured by microneutralization titers at day 0 and day 70 and its relationship with established baseline biomarkers (CD38+ CD20+ B cell frequencies and /or transcriptomic signatures) and post-vaccination biomarkers (plasmablast cell frequencies and/or transcriptomic signatures)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025580
|Contact: Laura E Failla, C.R.N.P.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Rachel D Sparks, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|