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The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination (FLU1)

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ClinicalTrials.gov Identifier: NCT02876159
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Mark Mulligan, Emory University

Brief Summary:
This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will be collected at standard time points. The duration of the study for each participant will be approximately 1 month.

Condition or disease Intervention/treatment Phase
Influenza Biological: 2016-2017 Influenza Vaccine Phase 4

Detailed Description:

This is a prospective pilot study in 20 males and non-pregnant females, 20 to 30 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to evaluate differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly.

Participants will be sorted to either Arm A (Naïve) or Arm B (Experienced) based on their vaccination history. Those vaccinated no more than 2 out of the past 5 years will be in Arm A. Those vaccinated 3 or more out of the past 5 years will be in Arm B. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. The duration of the study for each participant will be approximately 1 month. Subjects will return for clinic visits on Days 3, 8, 15, and 29 during the month follow-up period following vaccination.

The study has two primary objectives; to evaluate the antibody response to the influenza vaccine in people who are vaccinated regularly and those vaccinated less regularly; the second is to evaluate circulating follicular helper T cells (TFH) in people who are vaccinated regularly and those vaccinated less regularly.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 28, 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Vaccination Naïve
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
Biological: 2016-2017 Influenza Vaccine
Quadrivalent influenza A/H1N1, A/H3N2, B, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.

Experimental: Vaccination Experienced
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
Biological: 2016-2017 Influenza Vaccine
Quadrivalent influenza A/H1N1, A/H3N2, B, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.




Primary Outcome Measures :
  1. Change in Serum Hemagglutination Inhibition (HAI) Titer [ Time Frame: Baseline (Day 1), Day 29 ]
    Serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.

  2. Change in Mean Level of Circulating Follicular Helper T (TFH) Cells [ Time Frame: Up to 15 Days ]
    TFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.


Secondary Outcome Measures :
  1. Change in Mean Levels of Plasmablasts [ Time Frame: Up to 29 Days ]
    Plasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

  2. Change in Mean Levels of Memory B Cells [ Time Frame: Up to 29 Days ]
    Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

  3. Change in Mean Levels of antigen-specific CD4 T Cells [ Time Frame: Up to 29 Days ]
    CD4 T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

  4. Change in Mean Levels of antigen-specific CD8 T Cells [ Time Frame: Up to 29 Days ]
    CD8 T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Capable of informed consent and provision of written informed consent before any study procedures.
  • Capable of attending all study visits according to the study schedule.
  • Are in good health, as determined by medical history and targeted physical exam related to this history.
  • Oral temperature is less than 38 degrees Celsius.
  • Resting pulse rate is between 50 and 115 beats per minute.
  • Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination.
  • Have received the influenza vaccine at least 3 of the past 5 years or have received the influenza vaccine in 2 or less of the past 5 years.

Exclusion Criteria:

  • Have an acute illness within 72 hours before vaccination.
  • Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of injury or confound the interpretation of the study results.
  • 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.
  • Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
  • Have known HIV, hepatitis B, or hepatitis C infection.
  • Have a known history of autoimmune disease.
  • Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
  • Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
  • Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.
  • Have planned vaccination with any vaccine during the 29-day duration of subject study participation.
  • Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.
  • Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the 29-day duration of subject study participation, or plan to donate blood within 30 days after the last blood draw.
  • Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine.
  • 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): NCT02876159


Locations
United States, Georgia
The Hope Clinic of the Emory Vaccine Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Mark Mulligan, MD Emory University

Responsible Party: Mark Mulligan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02876159     History of Changes
Other Study ID Numbers: IRB00090196
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by Mark Mulligan, Emory University:
Vaccination

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs