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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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, 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

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 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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Flucelvax, Fluvirin, or Fluzone High Dose
Healthy Volunteer between ages 18-65 receiving Flucelvax
Biological: Flucelvax
Seasonal influenza vaccine

Biological: Fluvirin
Seasonal influenza vaccine

Biological: Fluzone High Dose
Seasonal influenza vaccine for adults ages 65 and older




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Individuals must meet all of the following criteria to be eligible for study participation:

  1. Aged 18 years and older (no upper age limit).
  2. Able to provide informed consent.
  3. Willing to have samples and data stored for future research.
  4. Able to proficiently speak, read, and write English.

EXCLUSION CRITERIA:

Individuals meeting any of the following criteria will be excluded from study participation:

  1. 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.
  2. 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.
  3. Prior receipt of a current seasonal influenza vaccine (for the season of participation).
  4. History of allergy or hypersensitivity to any components of the study vaccine (e.g., egg protein, latex).
  5. History of severe reactions to vaccines.
  6. Use of an oral glucocorticoid within the past 30 days.
  7. Receipt of a live-attenuated vaccine within the past 30 days.
  8. Receipt of any experimental vaccine.
  9. Receipt of any other type of vaccine (non-live and non-experimental, e.g., tetanus, diphtheria, and pertussis [TDaP]) within the past 14 days.
  10. Planned vaccination before day 180 after study vaccination.
  11. Current or recent use (within the past 90 days) of immunoglobulin therapy.
  12. Surgery within the past 8 weeks, or planned surgery before day 180.
  13. Current (within the past 30 days) treatment for active malignancy.
  14. Cancer chemotherapy in the past 5 years.
  15. Administration of any blood products within 90 days of the screening, or planned administration before day 180.
  16. History of parasitic, amebic, fungal, or mycobacterial infections within the past 5 years.
  17. Diabetes mellitus.
  18. History of autoimmune or autoinflammatory disease.
  19. History of a bleeding disorder.

Information from the National Library of Medicine

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


Contacts
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Contact: Laura E Failla, C.R.N.P. (240) 669-5323 laura.failla@nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Rachel D Sparks, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04025580     History of Changes
Other Study ID Numbers: 190126
19-I-0126
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 19, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Systems Biology
Immunology

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs