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NCT Number: NCT01189123

Cell Mediated Immunity in Older Adults

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.

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Key information

Conditions

Immunity to Influenza Vaccine Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy
  • aged 65+ years

Exclusion criteria

  • <65 years
  • influenza vaccine allergy
  • Guillain-Barre
  • weight <110 pounds

Treatment and study plan

High dose influenza vaccine Sanofi-Pasteur

Biological

High dose influenza vaccine Sanofi-Pasteur at standard dosing intramuscular injection

Other names: High dose fluzone (Sanofi-Pasteur)

fluzone by sanofi pasteur

Biological

standard dose fluzone

Primary outcomes

  1. Cellular Immune Response

    Time frame: 3 years

    comparison of CMI in high vs standard dose

Secondary outcomes

  1. Antibody Responses

    Time frame: 2 years

    Hemagglutination inhibition antibody titers measured for standard vs high dose

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Acronym: CMI

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Aug 26, 2010
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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