CMI: Cell Mediated Immunity in Older Adults

• Sponsor: Vanderbilt University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01189123
• Collaborator: Centers for Disease Control and Prevention (U.S. Fed)
• Enrollment: 105
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Aug 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

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 Names: High dose fluzone (Sanofi-Pasteur)

Outcome Measures

Primary Outcome Measures

1. Cellular Immune Response [3 years]

   comparison of CMI in high vs standard dose

Secondary Outcome Measures

1. Antibody Responses [2 years]

   Hemagglutination inhibition antibody titers measured for standard vs high dose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy

• aged 65+ years

Exclusion Criteria:

• <65 years

• influenza vaccine allergy

• Guillain-Barre

• weight <110 pounds

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37215

Sponsors and Collaborators

• Vanderbilt University
• Centers for Disease Control and Prevention

Investigators

• Principal Investigator: H. Keipp Talbot, MD MPH, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keipp Talbot, Assistant Professor, Infectious Diseases, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT01189123
• Other Study ID Numbers: 080925; 5U18IP000184-03
• First Posted: Aug 26, 2010
• Last Update Posted: Apr 24, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Keipp Talbot, Assistant Professor, Infectious Diseases, Vanderbilt University: influenza; vaccine; cell mediated immunity; elderly; high dose influenza vaccine
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Arm/Group Title	Standard Dose Influenza Vaccine	High Dose Vaccine
Arm/Group Description	Fluzone (Sanofi Pasteur) fluzone by sanofi pasteur: standard dose fluzone 1 dose of vaccine was given IM	High Dose Fluzone by sanofi pasteur High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)
Period Title: Overall Study
STARTED	52	53
COMPLETED	50	47
NOT COMPLETED	2	6

Baseline Characteristics

Arm/Group Title	Standard Dose Influenza Vaccine	High Dose Vaccine	Total
Arm/Group Description	Fluzone (Sanofi Pasteur) fluzone by sanofi pasteur: standard dose fluzone	High Dose Fluzone by sanofi pasteur High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)	Total of all reporting groups
Overall Participants	52	53	105
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	74	72	73
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	52 100%	53 100%	105 100%
Sex: Female, Male (Count of Participants)
Female	25 48.1%	26 49.1%	51 48.6%
Male	27 51.9%	27 50.9%	54 51.4%
Region of Enrollment (participants) [Number]
United States	52 100%	53 100%	105 100%

Outcome Measures

1. Primary Outcome

Title	Cellular Immune Response
Description	comparison of CMI in high vs standard dose
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

A subset of samples were chosen for testing since not enough money was available to test samples from all subjects. The samples were divided by randomization group (blinded to study staff -- they were called group A or group B). From each group, samples were randomly pulled.

Arm/Group Title	Standard Dose Influenza Vaccine	High Dose Vaccine
Arm/Group Description	Fluzone (Sanofi Pasteur) fluzone by sanofi pasteur: standard dose fluzone	High Dose Fluzone by sanofi pasteur High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)
Measure Participants	22	26
CD4+ IFNgamma at Visit 4	0.239	0.137
CD4+ TNF alpha Visit 4	0.243	0.160
CD4+ IL2 Visit 4	0.174	0.147
CD8+ IFNgamma at Visit 4	0.162	0.191
CD8+ TNF alpha Visit 4	0.344	0.277
CD8+ IL2 Visit 4	0.200	0.167

2. Secondary Outcome

Title	Antibody Responses
Description	Hemagglutination inhibition antibody titers measured for standard vs high dose
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Dose Influenza Vaccine	High Dose Vaccine
Arm/Group Description	Fluzone (Sanofi Pasteur) fluzone by sanofi pasteur: standard dose fluzone	High Dose Fluzone by sanofi pasteur High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)
Measure Participants	50	47
H1N1	40	80
H3N2	20	80
B	40	40

Adverse Events

Arm/Group Title	Standard Dose Influenza Vaccine		High Dose Vaccine
Arm/Group Description	Fluzone (Sanofi Pasteur) fluzone by sanofi pasteur: standard dose fluzone		High Dose Fluzone by sanofi pasteur High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)
All Cause Mortality
	Standard Dose Influenza Vaccine		High Dose Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Dose Influenza Vaccine		High Dose Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Standard Dose Influenza Vaccine		High Dose Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/53 (0%)

Limitations/Caveats

Due to cost and time limitations, a random sample from each treatment group were pulled for CMI testing. Hence not all samples were tested.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.