Cell Mediated Immunity in Older Adults
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Immunity to Influenza Vaccine
Intervention: High dose influenza vaccine Sanofi-Pasteur (Biological); fluzone by sanofi pasteur (Biological)
Phase: N/A
Status: Completed
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s): H. Keipp Talbot, MD MPH, Principal Investigator, Affiliation: Vanderbilt University
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.
Clinical Details
Official title: Evaluation of Cell-mediated Immunity and Antibody Response to Influenza Vaccination and Correlates of Protection in Seniors
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Cellular Immune Response
Secondary outcome: Antibody Responses
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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- healthy
- aged 65+ years
Exclusion Criteria:
- <65 years
- influenza vaccine allergy
- Guillain-Barre
- weight <110 pounds
Locations and Contacts
Vanderbilt University Medical Center, Nashville, Tennessee 37215, United States
Additional Information
Starting date: August 2010
Last updated: April 3, 2014
|