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PET-CT Scans in Healthy Volunteers After Flu Vaccination (Pro00000226)

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. Identifier: NCT00769002
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : August 27, 2013
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Hackensack University Medical Center

Brief Summary:
This study is being done to learn how previous flu vaccination or previous infection with flu virus affects the immune response to vaccination.

Condition or disease Intervention/treatment
Immune Response to Influenza Vaccination Biological: FluShield, FluMist

Detailed Description:

Until recently, all recipients of influenza vaccine received a killed form of virus, typically in the same nondominant arm, each year before flu season. We hypothesize that natural infection, and some forms of vaccination, could allow vaccine induced responses to spread beyond the local lymph nodes near the vaccination site. From a practical perspective, if vaccine induced proliferation of specific immune cells in sites distant from the vaccination site lead to beneficial immune memory, it would suggest vaccination strategies that could be as simple as alternating the injected arm from year to year, or alternating inhaled vs. injected forms of vaccine.

This will be a 4 armed prospective study of individuals receiving unilateral FluShield i.m. Healthy adult volunteers 21-55 will be grouped according to the following criteria: I. Documented history of prior natural infection with influenza A or B within the past 5 years (diagnostic test or high titer HA Ab in absence of vaccination); II. History of FluMist vaccination within the past 2 years; III. History of TIV vaccination, any number of times, but only in a single (e.g., non-dominant) arm. Within one month of screening and baseline blood draws for PBMCs and Ab titers, individuals will receive FluShield injections. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa). The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb).

Upon entering the study, 50cc of heparinized blood and 10 cc of serum will be drawn by antecubital venipuncture. Within 4 weeks of this blood draw, volunteers will receive a standard dose of i.m. TIV (FluShield). Four-seven days later they will have an FDG PET-CT scan performed after an 8 hour fast.

Additional blood draws of 50cc heparinized blood and 10 cc serum will be obtained at 2, 4, and 6 weeks post vaccination, and at 10-12 months post vaccination. After the last blood draw, volunteers will also be asked questions pertaining to flu-like symptoms during the past 10 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Bilateral Priming on Response to Unilateral Flu Vaccination
Study Start Date : September 2008
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Previous influenza positivity
Biological: FluShield, FluMist
Flu vaccine
Active Comparator: 2
No previous influenza positivity
Biological: FluShield, FluMist
Flu vaccine

Primary Outcome Measures :
  1. PET-CT scan [ Time Frame: 4-7 days after flu vaccine ]

Secondary Outcome Measures :
  1. cytokine profiling [ Time Frame: 2-6 weeks and 10-12 months post flu vaccination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men and women 21-55 years old.
  • Willingness to participate in the study for a full year including multiple blood draws and PET-CT scanning

Exclusion Criteria:

  • Diabetes
  • Use of systemic steroids
  • Pregnancy or unwillingness to practice birth control of some kind through the PET-CT scanning period
  • Recent vaccination for other reasons (e.g., traveler's vaccines)
  • Significant intercurrent illness that might interfere with vaccination "take" or interpretation of PET-CT scanning (e.g., chemotherapy for cancer)

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 identifier (NCT number): NCT00769002

United States, New Jersey
Hackensack Univarsity medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack University Medical Center
National Institutes of Health (NIH)
Principal Investigator: David Schwartz, MD, PhD Hackensack University Medical Center

Responsible Party: Hackensack University Medical Center Identifier: NCT00769002     History of Changes
Other Study ID Numbers: R21AI077102 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013

Keywords provided by Hackensack University Medical Center:
immune response
Healthy Volunteers

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs