Cell Mediated Immunity in Older Adults (CMI)
April 3, 2014 updated by: Keipp Talbot, Vanderbilt University
Evaluation of Cell-mediated Immunity and Antibody Response to Influenza Vaccination and Correlates of Protection in Seniors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37215
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy
- aged 65+ years
Exclusion Criteria:
- <65 years
- influenza vaccine allergy
- Guillain-Barre
- weight <110 pounds
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard dose influenza vaccine
Fluzone (Sanofi Pasteur)
|
standard dose fluzone
|
|
Active Comparator: High Dose Vaccine
High Dose Fluzone by sanofi pasteur
|
High dose influenza vaccine Sanofi-Pasteur at standard dosing intramuscular injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cellular Immune Response
Time Frame: 3 years
|
comparison of CMI in high vs standard dose
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antibody Responses
Time Frame: 2 years
|
Hemagglutination inhibition antibody titers measured for standard vs high dose
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: H. Keipp Talbot, MD MPH, Vanderbilt University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
August 23, 2010
First Submitted That Met QC Criteria
August 24, 2010
First Posted (Estimate)
August 26, 2010
Study Record Updates
Last Update Posted (Estimate)
April 24, 2014
Last Update Submitted That Met QC Criteria
April 3, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 080925
- 5U18IP000184-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.