Cell Mediated Immunity in Older Adults

NCT ID: NCT01189123

Last Updated: 2014-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-08-31

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.

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.

Conditions

Immunity to Influenza Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Standard dose influenza vaccine

Fluzone (Sanofi Pasteur)

Group Type: ACTIVE_COMPARATOR

fluzone by sanofi pasteur

Intervention Type: BIOLOGICAL

standard dose fluzone

High Dose Vaccine

High Dose Fluzone by sanofi pasteur

Group Type: ACTIVE_COMPARATOR

High dose influenza vaccine Sanofi-Pasteur

Intervention Type: BIOLOGICAL

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

Interventions

High dose influenza vaccine Sanofi-Pasteur

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

Intervention Type: BIOLOGICAL

fluzone by sanofi pasteur

standard dose fluzone

Intervention Type: BIOLOGICAL

Other Intervention Names

High dose fluzone (Sanofi-Pasteur)

Eligibility Criteria

Inclusion Criteria

• healthy
• aged 65+ years

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Keipp Talbot

Assistant Professor, Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

H. Keipp Talbot, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

Kim JH, Talbot HK, Mishina M, Zhu Y, Chen J, Cao W, Reber AJ, Griffin MR, Shay DK, Spencer SM, Sambhara S. High-dose influenza vaccine favors acute plasmablast responses rather than long-term cellular responses. Vaccine. 2016 Aug 31;34(38):4594-4601. doi: 10.1016/j.vaccine.2016.07.018. Epub 2016 Jul 26.

Reference Type: DERIVED

PMID: 27473306 (View on PubMed)

Other Identifiers

5U18IP000184-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

080925

Identifier Type: -

Identifier Source: org_study_id