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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccination Naïve | Experimental | 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. |
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| Vaccination Experienced | Experimental | Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2016-2017 Influenza Vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1), 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. | Up to 15 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 29 Days |
| Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Mulligan, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hope Clinic of the Emory Vaccine Center | Atlanta | Georgia | 30322 | United States |
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Participants for this study were enrolled from 07/01/2016 to 09/30/2016. Clinical study was conducted at Hope Clinic of Emory University.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose. |
| FG001 | 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. 2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | HAI antibody Titers | Baseline (Day 1), Day 29 |
|
Adverse Events (AE's) data was collected from the participant signing the informed consent to Day 29 post vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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The numbers of subjects in this pilot study are small. A larger study will be required for confirmation of the outcome measures
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark J. Mulligan, M.D., F.I.D.S.A | Emory University | 404-712-1370 | mmulli2@emory.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
| Baseline (Day 1) and 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. | Up to 29 Days |
| 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. | Up to 29 Days |
| BG001 | 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. 2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| 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. 2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1)/ Influenza A virus subtype H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose. |
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| Primary | 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. | Posted | Mean | Standard Deviation | cells/mm^3 | Up to 15 Days |
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| Secondary | 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. | Posted | Mean | Standard Deviation | cells/mm^3 | Up to 29 Days |
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| Secondary | 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. | only 9 participant samples were analyzed as 1 sample could not be analyzed | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline (Day 1) and Day 29 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | cells/mm^3 | Up to 29 Days |
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| Secondary | 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. | CD8+T cell assays were not collected since the split virus influenza vaccine was not likely to induce any detectable CD8+ T cell responses. | Posted | Up to 29 Days |
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| 0 |
| 10 |
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| 10 |
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| 10 |
| EG001 | 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. 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Day 15 |
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| Day 15 |
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