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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

2016-2017 Influenza Vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Vaccination

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Hope Clinic of the Emory Vaccine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Vaccination Naïve

Vaccination Experienced

Arm Description

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.

Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.

Outcomes

Primary Outcome Measures

Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer

Geometric mean serum HAI antibody titers 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.

Change in Mean Level of Circulating Follicular Helper T (TFH) Cells

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

Change in Mean Levels of Plasmablasts

Plasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29

Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells

Antigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells

CD8+T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

Full Information

NCT ID

NCT02876159

First Posted

August 4, 2016

Last Updated

December 11, 2018

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT02876159

Brief Title

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

Acronym

FLU1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

October 18, 2016 (Actual)

Study Completion Date

December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Vaccination

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaccination Naïve

Arm Type

Experimental

Arm Description

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.

Arm Title

Vaccination Experienced

Arm Type

Experimental

Arm Description

Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.

Intervention Type

Biological

Intervention Name(s)

2016-2017 Influenza Vaccine

Intervention Description

Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.

Primary Outcome Measure Information:

Title

Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer

Description

Time Frame

Baseline (Day 1), Day 29

Title

Change in Mean Level of Circulating Follicular Helper T (TFH) Cells

Description

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.

Time Frame

Up to 15 Days

Secondary Outcome Measure Information:

Title

Change in Mean Levels of Plasmablasts

Description

Plasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

Time Frame

Up to 29 Days

Title

Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29

Description

Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

Time Frame

Baseline (Day 1) and Day 29

Title

Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells

Description

Time Frame

Up to 29 Days

Title

Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells

Description

CD8+T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.

Time Frame

Up to 29 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Mulligan, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hope Clinic of the Emory Vaccine Center

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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