Cell Mediated Immunity in Older Adults

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Cell-mediated Immunity and Antibody Response to Influenza Vaccination and Correlates of Protection in Seniors

Conditions
-----------------
Immunity to Influenza Vaccine

Intervention / Treatment
-----------------
* Biological: High dose influenza vaccine Sanofi-Pasteur
* Biological: fluzone by sanofi pasteur


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy aged 65+ years Exclusion Criteria: <65 years influenza vaccine allergy Guillain-Barre weight <110 pounds

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dose influenza vaccine<br>Fluzone (Sanofi Pasteur) | Biological: fluzone by sanofi pasteur<br>* standard dose fluzone<br>|
| Active Comparator: High Dose Vaccine<br>High Dose Fluzone by sanofi pasteur | Biological: High dose influenza vaccine Sanofi-Pasteur<br>* High dose influenza vaccine Sanofi-Pasteur at standard dosing intramuscular injection<br>* Other names: High dose fluzone (Sanofi-Pasteur);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular Immune Response | comparison of CMI in high vs standard dose | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Responses | Hemagglutination inhibition antibody titers measured for standard vs high dose | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, vaccine, cell mediated immunity, elderly, high dose influenza vaccine