PET-CT Scans in Healthy Volunteers After Flu Vaccination (Pro00000226)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Impact of Bilateral Priming on Response to Unilateral Flu Vaccination|
- PET-CT scan [ Time Frame: 4-7 days after flu vaccine ] [ Designated as safety issue: No ]
- cytokine profiling [ Time Frame: 2-6 weeks and 10-12 months post flu vaccination ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Previous influenza positivity
Biological: FluShield, FluMist
Active Comparator: 2
No previous influenza positivity
Biological: FluShield, FluMist
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769002
|United States, New Jersey|
|Hackensack Univarsity medical Center|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||David Schwartz, MD, PhD||Hackensack University Medical Center|