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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21AI077102-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study is being done to learn how previous flu vaccination or previous infection with flu virus affects the immune response to vaccination.
Until recently, all recipients of influenza vaccine received a killed form of virus, typically in the same nondominant arm, each year before flu season. We hypothesize that natural infection, and some forms of vaccination, could allow vaccine induced responses to spread beyond the local lymph nodes near the vaccination site. From a practical perspective, if vaccine induced proliferation of specific immune cells in sites distant from the vaccination site lead to beneficial immune memory, it would suggest vaccination strategies that could be as simple as alternating the injected arm from year to year, or alternating inhaled vs. injected forms of vaccine.
This will be a 4 armed prospective study of individuals receiving unilateral FluShield i.m. Healthy adult volunteers 21-55 will be grouped according to the following criteria: I. Documented history of prior natural infection with influenza A or B within the past 5 years (diagnostic test or high titer hemagglutinin HA Ab in absence of vaccination); II. History of FluMist vaccination within the past 2 years; III. History of TIV (Trivalent (Inactivated) Influenza Vaccine) vaccination, any number of times, but only in a single (e.g., non-dominant) arm. Within one month of screening and baseline blood draws for PBMCs (Peripheral blood mononuclear cells) and Ab (antibody) titers, individuals will receive FluShield injections. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa). The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb).
Upon entering the study, 50cc of heparinized blood and 10 cc of serum will be drawn by antecubital venipuncture. Within 4 weeks of this blood draw, volunteers will receive a standard dose of i.m. TIV (FluShield). Four-seven days later they will have an FDG PET-CT scan performed after an 8 hour fast.
Additional blood draws of 50cc heparinized blood and 10 cc serum will be obtained at 2, 4, and 6 weeks post vaccination, and at 10-12 months post vaccination. After the last blood draw, volunteers will also be asked questions pertaining to flu-like symptoms during the past 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural Infection | Active Comparator | previously naturally infected |
|
| FluShield - influenza positivity | Active Comparator | prior FluShield ipsilateral vaccinated |
|
| FluShield - influenza positivity2 | Active Comparator | prior FluShield contralateral vaccinated |
|
| FluMist | Active Comparator | prior FluMist vaccinated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluShield | Biological | Flu vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| PET Scan AB Response | Natural infection but not ipsilateral IM injection of FluShield, will prime the host for a specific activation of spleen and bilateral lymph nodes following a subsequent i.m injection of FluShield, as detected by PET-CT performed 4-7 days post- FluShield immunization. | 4-7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Schwartz, MD, PhD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack Univarsity medical Center | Hackensack | New Jersey | 07601 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PET-CT Scan Influenza Vaccine Response | Previous influenza positivity FluShield, FluMist: Flu vaccine Previous influenza positivity Primary Outcome Measure:
Primary Outcome Measure:
|
| FG001 | Cytokine Profiling | No previous influenza positivity FluShield, FluMist: Flu vaccine Primary Outcome Measure:
Primary Outcome Measure:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This study was not completed as planned, and data collected is not available despite all efforts as the PI has left the institution. Additionally, no manuscript, or study report was developed and therefore no data available to confirm the validity of or address the comments in relation to the previously entered results information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Vaccine FluShield, FluMist | Group I - Previous influenza positivity A or B within the past 5 years |
| BG001 | Cytokine Profiling FluShield, FluMist | Group II - History of FluMist vaccination within the past 2 years |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Men and women ages 21-55 |
| 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 | PET Scan AB Response | Natural infection but not ipsilateral IM injection of FluShield, will prime the host for a specific activation of spleen and bilateral lymph nodes following a subsequent i.m injection of FluShield, as detected by PET-CT performed 4-7 days post- FluShield immunization. | This study was not completed as planned, and data collected is not available despite all efforts as the PI has left the institution. Additionally, no manuscript, or study report was developed and therefore no data available to confirm the validity of or address the comments in relation to the previously entered results information. | Posted | 4-7 days |
|
1 year
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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 | Influenza Vaccine FluShield, FluMist | Previous influenza positivity Primary Outcome Measure:
FluShield, FluMist: Flu vaccine](streamdown:incomplete-link) |
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This study was not completed and data collected is not available despite all efforts as PI has left the institution. No manuscript/study report was developed and there are no data to confirm validity or address comments in previously entered results
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Schwartz | Hackensack University Medical Center | 551-996-2000 | DSchwartz@hackensackumc.org |
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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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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| FluShield - same arm | Biological | Flu vaccine |
|
| FluShield - opposite arm | Biological | Flu vaccine |
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| Blood Draws | Procedure | 50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination |
|
| FDG PET-CT Scan | Procedure | PET scan |
|
| Cytokine Profiling | Genetic | Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination |
|
| BG002 | Unilateral TIV Injections FluShield | Group III a - History of TIV vaccination, any number of times, but only in a single (e.g., non-dominant) arm. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa). |
| BG003 | Opposite Arm FluShield | Group IIIb - Within one month of screening and baseline blood draws for PBMCs and Ab titers, individuals will receive FluShield injections. The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb). |
| BG004 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Cytokine Profiling FluShield, FluMist | No previous influenza positivity Primary Outcome Measure:
FluShield, FluMist: Flu vaccine](streamdown:incomplete-link) | 0 | 8 | 0 | 8 | 0 | 8 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D013048 |
| Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |