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

Impact of Bilateral Priming on Response to Unilateral Flu Vaccination

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

Study Overview

• Status: Terminated
• Conditions: Flu
• Intervention / Treatment: Biological: FluShield; Procedure: Blood Draws; Procedure: FDG PET-CT Scan; Genetic: Cytokine Profiling; Biological: FluShield - same arm; Biological: FluShield - opposite arm

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Univarsity medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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; 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; Biological: FluShield - same arm; Flu vaccine
Active Comparator: FluShield - influenza positivity2; prior FluShield contralateral 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; Biological: FluShield - opposite arm; Flu vaccine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET Scan AB Response	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.	4-7 days

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Investigators: Principal Investigator: David Schwartz, MD, PhD, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: October 7, 2008
• First Submitted That Met QC Criteria: October 7, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: vaccine; influenza; Healthy Volunteers; vaccination; flu; immune response; PET-CT; FluMist; FluShield
• Other Study ID Numbers: Pro00000226 - R21AI077102; 5R21AI077102-03 (U.S. NIH Grant/Contract)