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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 : Suspended (Recruitment and enrollment currently suspended due to COVID-19)
First Posted : September 27, 2018
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nadine Rouphael, Emory University

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 27, 2018
Last Update Posted Date August 18, 2020
Actual Study Start Date  ICMJE October 22, 2018
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics
Official Title  ICMJE The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics (Version 1 23Aug2018)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: H3N2 birth cohort
    The H3N2 cohort consists of participants born between 1968-1977.
    Intervention: Biological: Seasonal influenza vaccine
  • Experimental: H1N1 birth cohort
    The H1N1 cohort consist of participants born between 1948-1957.
    Intervention: Biological: Seasonal influenza vaccine
Publications * Sherman AC, Lai L, Bower M, Natrajan MS, Huerta C, Karmali V, Kleinhenz J, Xu Y, Rouphael N, Mulligan MJ. The Effects of Imprinting and Repeated Seasonal Influenza Vaccination on Adaptive Immunity after Influenza Vaccination. Vaccines (Basel). 2020 Nov 7;8(4). pii: E663. doi: 10.3390/vaccines8040663.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: August 6, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2018)
20
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Years to 71 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03686514
Other Study ID Numbers  ICMJE IRB00106407
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nadine Rouphael, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nadine Rouphael Nadine Rouphael, MD Emory University
PRS Account Emory University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP