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

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ClinicalTrials.gov Identifier: NCT00769002
Recruitment Status : Terminated
First Posted : October 8, 2008
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Hackensack Meridian Health

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 Phase
Flu Biological: FluShield Biological: FluShield - same arm Biological: FluShield - opposite arm Procedure: Blood Draws Procedure: FDG PET-CT Scan Genetic: Cytokine Profiling Not Applicable

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 hemagglutinin HA Ab in absence of vaccination); II. History of FluMist vaccination within the past 2 years; III. History of TIV (Trivalent (Inactivated) Influenza Vaccine) 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 (Peripheral blood mononuclear cells) and Ab (antibody) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 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
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Natural Infection
previously naturally infected
Biological: FluShield
Flu vaccine

Procedure: Blood Draws
50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination

Procedure: FDG PET-CT Scan
PET scan

Genetic: Cytokine Profiling
Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination

Active Comparator: FluShield - influenza positivity
prior FluShield ipsilateral vaccinated
Biological: FluShield
Flu vaccine

Biological: FluShield - same arm
Flu vaccine

Procedure: Blood Draws
50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination

Procedure: FDG PET-CT Scan
PET scan

Genetic: Cytokine Profiling
Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination

Active Comparator: FluShield - influenza positivity2
prior FluShield contralateral vaccinated
Biological: FluShield
Flu vaccine

Biological: FluShield - opposite arm
Flu vaccine

Procedure: Blood Draws
50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination

Procedure: FDG PET-CT Scan
PET scan

Genetic: Cytokine Profiling
Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination

Active Comparator: FluMist
prior FluMist vaccinated.
Biological: FluShield
Flu vaccine

Procedure: Blood Draws
50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination

Procedure: FDG PET-CT Scan
PET scan

Genetic: Cytokine Profiling
Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination




Primary Outcome Measures :
  1. PET Scan AB Response [ Time Frame: 4-7 days ]
    Natural infection but not ipsilateral IM injection of FluShield, will prime the host for a specific activation of spleen and bilateral lymph nodes following a subsequent i.m injection of FluShield, as detected by PET-CT performed 4-7 days post- FluShield immunization.



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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)

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 ClinicalTrials.gov identifier (NCT number): NCT00769002


Locations
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United States, New Jersey
Hackensack Univarsity medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack Meridian Health
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: David Schwartz, MD, PhD Hackensack Meridian Health
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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT00769002    
Other Study ID Numbers: Pro00000226 - R21AI077102
5R21AI077102-03 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2008    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: October 2020
Keywords provided by Hackensack Meridian Health:
influenza
flu
vaccine
vaccination
immune response
FluShield
FluMist
PET-CT
Healthy Volunteers