Clinical trial NCT01189123: Cell Mediated Immunity in Older Adults
Official title: Evaluation of Cell-mediated Immunity and Antibody Response to Influenza Vaccination and Correlates of Protection in Seniors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunity to Influenza Vaccine
Keywords: influenza
vaccine
cell mediated immunity
elderly
high dose influenza vaccine
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2010-08-26
Enrollment: 105
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* healthy
* aged 65+ years

Exclusion Criteria:

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

Primary outcomes:
measure: Cellular Immune Response
timeFrame: 3 years
Secondary outcomes:
measure: Antibody Responses
timeFrame: 2 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: H. Keipp Talbot, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.