Clinical trial NCT00769002: PET-CT Scans in Healthy Volunteers After Flu Vaccination
Official title: Impact of Bilateral Priming on Response to Unilateral Flu Vaccination
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Flu
Keywords: influenza
flu
vaccine
vaccination
immune response
FluShield
FluMist
PET-CT
Healthy Volunteers
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2008-10-08
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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)

Primary outcomes:
measure: PET Scan AB Response
timeFrame: 4-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Univarsity medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: David Schwartz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: