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| ID | Type | Description | Link |
|---|---|---|---|
| 5U18IP000184-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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This study is to study the immune response to the flu vaccine in people 65 years old and older. Only adults 65 years old and older and who are getting their flu vaccine are being asked to join in this study. The investigators plan to enroll approximately 100 people in this study in the 2010-2011 flu season. Vanderbilt is working with the Centers for Disease Control and Prevention on this study.
There will be 5 study visits. Up to 4 tablespoons of blood from a vein will be obtained prior to the flu shot. Return visits will be 1, 2, and 4 weeks later,with up to 4 tablespoons of blood drawn again. Patients will be randomized to receive either the standard dose or the high dose flu vaccine. Both flu vaccines are FDA-approved.
During the 2010-2011 influenza season, approximately 100 adults ≥65 years of age will be enrolled. After consent, blood and serum will be collected and then subjects will be randomized to either standard or high dose influenza vaccine (both FDA approved vaccines). Vaccination will be done by an unblinded nurse. All further evaluations and analysis will be done by a blinded staff member. Medical history, relevant medications, and functional/nutritional status will be assessed at the first visit. Subjects will return (Table 3) for blood and serum draws on days 7, 14, 28 and for a serum blood draw after influenza season. No micronutrient samples will be drawn, but serum will be kept for possible vitamin D testing. During influenza season, subjects will answer a questionnaire about influenza-like illness (ILI) every two weeks (either by email or telephone) and will be asked to return for a nasal swab if an ILI is present. Comparisons will be made of the cell-mediated response of those vaccinated with standard versus high dose vaccines. Analyses will be done accounting for age, use of immunomodulating agents, and underlying medical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose influenza vaccine | Active Comparator | Fluzone (Sanofi Pasteur) |
|
| High Dose Vaccine | Active Comparator | High Dose Fluzone by sanofi pasteur |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose influenza vaccine Sanofi-Pasteur | Biological | High dose influenza vaccine Sanofi-Pasteur at standard dosing intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cellular Immune Response | comparison of CMI in high vs standard dose | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Responses | Hemagglutination inhibition antibody titers measured for standard vs high dose | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Keipp Talbot, MD MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27473306 | Derived | Kim JH, Talbot HK, Mishina M, Zhu Y, Chen J, Cao W, Reber AJ, Griffin MR, Shay DK, Spencer SM, Sambhara S. High-dose influenza vaccine favors acute plasmablast responses rather than long-term cellular responses. Vaccine. 2016 Aug 31;34(38):4594-4601. doi: 10.1016/j.vaccine.2016.07.018. Epub 2016 Jul 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dose Influenza Vaccine | Fluzone (Sanofi Pasteur) fluzone by sanofi pasteur: standard dose fluzone 1 dose of vaccine was given IM |
| FG001 | High Dose Vaccine | High Dose Fluzone by sanofi pasteur High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dose Influenza Vaccine | Fluzone (Sanofi Pasteur) fluzone by sanofi pasteur: standard dose fluzone |
| BG001 | High Dose Vaccine | High Dose Fluzone by sanofi pasteur High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Cellular Immune Response | comparison of CMI in high vs standard dose | A subset of samples were chosen for testing since not enough money was available to test samples from all subjects. The samples were divided by randomization group (blinded to study staff -- they were called group A or group B). From each group, samples were randomly pulled. | Posted | Median | Inter-Quartile Range | percentage of Stimulated cells | 3 years |
|
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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 | Standard Dose Influenza Vaccine | Fluzone (Sanofi Pasteur) fluzone by sanofi pasteur: standard dose fluzone |
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Due to cost and time limitations, a random sample from each treatment group were pulled for CMI testing. Hence not all samples were tested.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keipp Talbot | Vanderbilt University Medical Center | 6153222035 | keipp.talbot@vanderbilt.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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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| fluzone by sanofi pasteur | Biological | standard dose fluzone |
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Antibody Responses | Hemagglutination inhibition antibody titers measured for standard vs high dose | Posted | Geometric Mean | 95% Confidence Interval | GMT | 2 years |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | High Dose Vaccine | High Dose Fluzone by sanofi pasteur High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection) | 0 | 53 | 0 | 53 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| B |
|