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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


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.


Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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