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The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics (FLU2)

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ClinicalTrials.gov Identifier: NCT03686514
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Nadine Rouphael, Emory University

Brief Summary:
The goal of this study is to understand the impact on the human immune system's response to the 4 strain flu vaccine in individuals who have "imprinted" on specific influenza strains. It will also consider the effects of repeated prior annual influenza vaccination on the immune system.

Condition or disease Intervention/treatment Phase
Influenza Biological: Seasonal influenza vaccine Phase 1

Detailed Description:
The goal of this study is to understand the impact on the human immune system's response to the 4 strain flu vaccine in individuals who have "imprinted" on specific influenza strains. It will also consider the effects of repeated prior annual influenza vaccination on the immune system. This trial may hopefully lead to larger trials that advance understanding of flu vaccines and hopefully lead to a more effective flu vaccine that does not rely on annual updates, provides broad protection, and is durable; i.e., a universal influenza vaccine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics (Version 1 23Aug2018)
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: H3N2 birth cohort
The H3N2 cohort consists of participants born between 1968-1977.
Biological: Seasonal influenza vaccine
The FDA-approved, quadrivalent seasonal influenza vaccine that will be administered contains four distinct strains, two IAVs and two influenza B viruses (IBVs)
Other Name: FLUARIX QUADRIVALENT

Experimental: H1N1 birth cohort
The H1N1 cohort consist of participants born between 1948-1957.
Biological: Seasonal influenza vaccine
The FDA-approved, quadrivalent seasonal influenza vaccine that will be administered contains four distinct strains, two IAVs and two influenza B viruses (IBVs)
Other Name: FLUARIX QUADRIVALENT




Primary Outcome Measures :
  1. The proportion of subjects achieving seroprotection (titer of ≥ 40) or seroconversion (four-fold rise in HAI post- compared to pre-vaccination, or a titer of ≥40 if the pre-vaccination titer was <10) against each strain [ Time Frame: 28 days after vaccination ]
    Seroprotection/seroconversion against each strain contained in the seasonal quadrivalent influenza vaccine will be measured by HAI antibody response.

  2. Geometric Mean Titers (GMTs) of serum HAI against each strain [ Time Frame: 28 days after vaccination ]
    The geometric scale is logarithmic. A geometric mean is calculated by averaging the logarithms of the test values and then converting the mean to a real number.


Secondary Outcome Measures :
  1. The proportion of subjects achieving seroprotection (titer of ≥ 40) or seroconversion (four-fold rise in NAb post- compared to pre-vaccination, or a titer of ≥40 if the pre-vaccination titer was <10) against each strain [ Time Frame: 28 days after vaccination ]
    Seroprotection/seroconversion against each strain contained in the seasonal quadrivalent influenza vaccine will be measured by HAI antibody response.

  2. Geometric Mean Titers (GMTs) of serum NAb against each strain [ Time Frame: 28 days after vaccination ]
    The geometric scale is logarithmic. A geometric mean is calculated by averaging the logarithms of the test values and then converting the mean to a real number.

  3. The proportion of subjects achieving seroprotection (titer of ≥ 40) or seroconversion (four-fold rise in HAI post- compared to pre-vaccination, or a titer of ≥40 if the pre-vaccination titer was <10) against each strain [ Time Frame: 180 days after vaccination ]
    Seroprotection/seroconversion against each strain contained in the seasonal quadrivalent influenza vaccine will be measured by HAI antibody response.

  4. The proportion of subjects achieving seroprotection (titer of ≥ 40) or seroconversion (four-fold rise in NAb post- compared to pre-vaccination, or a titer of ≥40 if the pre-vaccination titer was <10) against each strain [ Time Frame: 180 days after vaccination ]
    Seroprotection/seroconversion against each strain contained in the seasonal quadrivalent influenza vaccine will be measured by NAb antibody response.

  5. Geometric Mean Titers (GMTs) of serum HAI against each strain [ Time Frame: 180 days after vaccination ]
    The geometric scale is logarithmic. A geometric mean is calculated by averaging the logarithms of the test values and then converting the mean to a real number.

  6. Geometric Mean Titers (GMTs) of serum NAb against each strain [ Time Frame: 180 days after vaccination ]
    The geometric scale is logarithmic. A geometric mean is calculated by averaging the logarithms of the test values and then converting the mean to a real number.



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:   42 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Capable of informed consent and provision of written informed consent before any study procedures.
  2. Capable of attending all study visits according to the study schedule.
  3. Males or females born between 1968-1977 or 1948-1957.
  4. Are in good health, as determined by medical history and targeted physical exam related to this history.
  5. Oral temperature is less than 38C.
  6. Resting pulse rate is between 50 and 100 beats per minute.
  7. Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination.
  8. Have received the influenza vaccine at least 3 of the past 5 years (between September 2013-June 2018) or have received the influenza vaccine in 2 or less of the past 5 years (between September 2013-June 2018).

Exclusion Criteria:

  1. Have an acute illness within 72 hours before vaccination.
  2. Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of harm or confound the interpretation of the study results.
  3. Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
  4. Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
  5. Have known HIV, hepatitis B, or hepatitis C infection.
  6. Have a known history of autoimmune disease.
  7. Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
  8. Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
  9. Have received, or plan to receive, any licensed live vaccine within 30 days, or any licensed inactivated vaccine within 14 days, prior to, or after, study vaccination.
  10. Have planned receipt of any unlicensed or investigational medications, biologics, or vaccines for the duration of subject study participation.
  11. Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.
  12. Have donated blood or blood products within 30 days before study vaccination, or within 60 days after study vaccination, or plan to donate blood within 30 days of the last blood draw.
  13. Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine.
  14. Have a history of severe reactions following vaccination with influenza virus vaccines.

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): NCT03686514


Contacts
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Contact: Nadine Rouphael Nadine Rouphael, MD (404)712-1435 nroupha@emory.edu
Contact: Amy Sherman amy.sherman@emory.edu

Locations
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United States, Georgia
The Hope Clinic of the Emory Vaccine Center Recruiting
Atlanta, Georgia, United States, 30317
Contact: Nadine Rouphael, MD    404-712-1435    nroupha@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Nadine Rouphael Nadine Rouphael, MD Emory University

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Responsible Party: Nadine Rouphael, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03686514     History of Changes
Other Study ID Numbers: IRB00106407
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nadine Rouphael, Emory University:
Flu vaccine
Influenza vaccine
Immune response
Influenza strain
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs