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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hackensack University Medical Center
ClinicalTrials.gov Identifier:
NCT00769002
First received: October 7, 2008
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Immune Response to Influenza Vaccination
Biological: FluShield, FluMist

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:
  • PET-CT scan [ Time Frame: 4-7 days after flu vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cytokine profiling [ Time Frame: 2-6 weeks and 10-12 months post flu vaccination ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Previous influenza positivity
Biological: FluShield, FluMist
Flu vaccine
Active Comparator: 2
No previous influenza positivity
Biological: FluShield, FluMist
Flu vaccine

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769002

Locations
United States, New Jersey
Hackensack Univarsity medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack University Medical Center
Investigators
Principal Investigator: David Schwartz, MD, PhD Hackensack University Medical Center
  More Information

No publications provided

Responsible Party: Hackensack University Medical Center
ClinicalTrials.gov Identifier: NCT00769002     History of Changes
Other Study ID Numbers: R21AI077102, R21AI077102
Study First Received: October 7, 2008
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hackensack University Medical Center:
influenza
flu
vaccine
vaccination
immune response
FluShield
FluMist
PET-CT
Healthy Volunteers

ClinicalTrials.gov processed this record on September 16, 2014