PET-CT Scans in Healthy Volunteers After Flu Vaccination

Not Applicable

Terminated

Conditions: Flu

Interventions: Biological: FluShield
Biological: FluShield - opposite arm
Biological: FluShield - same arm
Procedure: Blood Draws
Procedure: FDG PET-CT Scan
Genetic: Cytokine Profiling

Registration Number: NCT00769002

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 18

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural Infection	FluShield	previously naturally infected
FluShield - influenza positivity2	FluShield - opposite arm	prior FluShield contralateral vaccinated
FluShield - influenza positivity	FluShield - same arm	prior FluShield ipsilateral vaccinated
FluMist	FDG PET-CT Scan	prior FluMist vaccinated.
FluShield - influenza positivity	FDG PET-CT Scan	prior FluShield ipsilateral vaccinated
FluShield - influenza positivity2	Cytokine Profiling	prior FluShield contralateral vaccinated
Natural Infection	Blood Draws	previously naturally infected
Natural Infection	Cytokine Profiling	previously naturally infected
FluShield - influenza positivity	Cytokine Profiling	prior FluShield ipsilateral vaccinated
Natural Infection	FDG PET-CT Scan	previously naturally infected
FluShield - influenza positivity	FluShield	prior FluShield ipsilateral vaccinated
FluShield - influenza positivity	Blood Draws	prior FluShield ipsilateral vaccinated
FluShield - influenza positivity2	FluShield	prior FluShield contralateral vaccinated
FluShield - influenza positivity2	Blood Draws	prior FluShield contralateral vaccinated
FluShield - influenza positivity2	FDG PET-CT Scan	prior FluShield contralateral vaccinated
FluMist	FluShield	prior FluMist vaccinated.
FluMist	Blood Draws	prior FluMist vaccinated.
FluMist	Cytokine Profiling	prior FluMist vaccinated.

Primary Outcome Measures

Name	Time	Method
PET Scan AB Response	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.

Secondary Outcome Measures