Immunity to Influenza Vaccine
Conditions
Keywords
influenza, vaccine, cell mediated immunity, elderly, high dose influenza vaccine
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALHigh dose influenza vaccine Sanofi-Pasteur
High dose influenza vaccine Sanofi-Pasteur at standard dosing intramuscular injection
BIOLOGICALfluzone by sanofi pasteur
standard dose fluzone
Sponsors
Centers for Disease Control and Prevention
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy * aged 65+ years
Exclusion criteria
* \<65 years * influenza vaccine allergy * Guillain-Barre * weight \<110 pounds
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cellular Immune Response | 3 years | comparison of CMI in high vs standard dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Responses | 2 years | Hemagglutination inhibition antibody titers measured for standard vs high dose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Dose Influenza Vaccine Fluzone (Sanofi Pasteur)
fluzone by sanofi pasteur: standard dose fluzone | 52 |
| 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) | 53 |
| Total | 105 |
Baseline characteristics
| Characteristic | Standard Dose Influenza Vaccine | High Dose Vaccine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 52 Participants | 53 Participants | 105 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 74 years | 72 years | 73 years |
| Region of Enrollment United States | 52 participants | 53 participants | 105 participants |
| Sex: Female, Male Female | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Male | 27 Participants | 27 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 53 |
| serious Total, serious adverse events | 0 / 52 | 0 / 53 |
Outcome results
Primary
Cellular Immune Response
comparison of CMI in high vs standard dose
Time frame: 3 years
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Dose Influenza Vaccine | Cellular Immune Response | CD4+ IFNgamma at Visit 4 | 0.239 percentage of Stimulated cells |
| Standard Dose Influenza Vaccine | Cellular Immune Response | CD4+ TNF alpha Visit 4 | 0.243 percentage of Stimulated cells |
| Standard Dose Influenza Vaccine | Cellular Immune Response | CD4+ IL2 Visit 4 | 0.174 percentage of Stimulated cells |
| Standard Dose Influenza Vaccine | Cellular Immune Response | CD8+ IFNgamma at Visit 4 | 0.162 percentage of Stimulated cells |
| Standard Dose Influenza Vaccine | Cellular Immune Response | CD8+ TNF alpha Visit 4 | 0.344 percentage of Stimulated cells |
| Standard Dose Influenza Vaccine | Cellular Immune Response | CD8+ IL2 Visit 4 | 0.200 percentage of Stimulated cells |
| High Dose Vaccine | Cellular Immune Response | CD8+ TNF alpha Visit 4 | 0.277 percentage of Stimulated cells |
| High Dose Vaccine | Cellular Immune Response | CD4+ IFNgamma at Visit 4 | 0.137 percentage of Stimulated cells |
| High Dose Vaccine | Cellular Immune Response | CD8+ IFNgamma at Visit 4 | 0.191 percentage of Stimulated cells |
| High Dose Vaccine | Cellular Immune Response | CD4+ TNF alpha Visit 4 | 0.160 percentage of Stimulated cells |
| High Dose Vaccine | Cellular Immune Response | CD8+ IL2 Visit 4 | 0.167 percentage of Stimulated cells |
| High Dose Vaccine | Cellular Immune Response | CD4+ IL2 Visit 4 | 0.147 percentage of Stimulated cells |
Secondary
Antibody Responses
Hemagglutination inhibition antibody titers measured for standard vs high dose
Time frame: 2 years
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Standard Dose Influenza Vaccine | Antibody Responses | H1N1 | 40 GMT |
| Standard Dose Influenza Vaccine | Antibody Responses | H3N2 | 20 GMT |
| Standard Dose Influenza Vaccine | Antibody Responses | B | 40 GMT |
| High Dose Vaccine | Antibody Responses | B | 40 GMT |
| High Dose Vaccine | Antibody Responses | H1N1 | 80 GMT |
| High Dose Vaccine | Antibody Responses | H3N2 | 80 GMT |