PET-CT Scans in Healthy Volunteers After Flu Vaccination

Flu Clinical Trial

— Pro00000226  

Official title:

Impact of Bilateral Priming on Response to Unilateral Flu Vaccination

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00769002
• Other study ID #: Pro00000226 - R21AI077102
• Secondary ID: 5R21AI077102-03
• Status: Terminated
• Phase: N/A
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: October 2020
• Source: Hackensack Meridian Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Flu

Intervention

Biological:
• FluShield
Flu vaccine
• FluShield - same arm
Flu vaccine
• 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
• FDG PET-CT Scan
PET scan

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

Locations

Country	Name	City	State
United States	Hackensack Univarsity medical Center	Hackensack	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Hackensack Meridian Health	National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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