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Cell Mediated Immunity in Older Adults (CMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189123
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : March 3, 2014
Last Update Posted : April 24, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Keipp Talbot, Vanderbilt University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Immunity to Influenza Vaccine Biological: High dose influenza vaccine Sanofi-Pasteur Biological: fluzone by sanofi pasteur Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Evaluation of Cell-mediated Immunity and Antibody Response to Influenza Vaccination and Correlates of Protection in Seniors
Study Start Date : August 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard dose influenza vaccine
Fluzone (Sanofi Pasteur)
 Biological: fluzone by sanofi pasteur
standard dose fluzone
Active Comparator: High Dose Vaccine
High Dose Fluzone by sanofi pasteur
 Biological: High dose influenza vaccine Sanofi-Pasteur
High dose influenza vaccine Sanofi-Pasteur at standard dosing intramuscular injection
Other Name: High dose fluzone (Sanofi-Pasteur)


Outcome Measures
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Primary Outcome Measures :
  1. Cellular Immune Response [ Time Frame: 3 years ]
    comparison of CMI in high vs standard dose


Secondary Outcome Measures :
  1. Antibody Responses [ Time Frame: 2 years ]
    Hemagglutination inhibition antibody titers measured for standard vs high dose


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy
  • aged 65+ years

Exclusion Criteria:

  • <65 years
  • influenza vaccine allergy
  • Guillain-Barre
  • weight <110 pounds
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189123


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Vanderbilt University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: H. Keipp Talbot, MD MPH Vanderbilt University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Keipp Talbot, Assistant Professor, Infectious Diseases, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01189123    
Other Study ID Numbers: 080925
5U18IP000184-03 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2010    Key Record Dates
Results First Posted: March 3, 2014
Last Update Posted: April 24, 2014
Last Verified: March 2014
Keywords provided by Keipp Talbot, Vanderbilt University:
influenza
vaccine
cell mediated immunity
elderly
high dose influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases