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PET-CT Scans in Healthy Volunteers After Flu Vaccination

NCT ID: NCT00769002

Last Updated: 2020-10-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Flu

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Natural Infection

previously naturally infected

Group Type ACTIVE_COMPARATOR

FluShield

Intervention Type BIOLOGICAL

Flu vaccine

Blood Draws

Intervention Type PROCEDURE

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

FDG PET-CT Scan

Intervention Type PROCEDURE

PET scan

Cytokine Profiling

Intervention Type GENETIC

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

FluShield - influenza positivity

prior FluShield ipsilateral vaccinated

Group Type ACTIVE_COMPARATOR

FluShield

Intervention Type BIOLOGICAL

Flu vaccine

FluShield - same arm

Intervention Type BIOLOGICAL

Flu vaccine

Blood Draws

Intervention Type PROCEDURE

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

FDG PET-CT Scan

Intervention Type PROCEDURE

PET scan

Cytokine Profiling

Intervention Type GENETIC

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

FluShield - influenza positivity2

prior FluShield contralateral vaccinated

Group Type ACTIVE_COMPARATOR

FluShield

Intervention Type BIOLOGICAL

Flu vaccine

FluShield - opposite arm

Intervention Type BIOLOGICAL

Flu vaccine

Blood Draws

Intervention Type PROCEDURE

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

FDG PET-CT Scan

Intervention Type PROCEDURE

PET scan

Cytokine Profiling

Intervention Type GENETIC

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

FluMist

prior FluMist vaccinated.

Group Type ACTIVE_COMPARATOR

FluShield

Intervention Type BIOLOGICAL

Flu vaccine

Blood Draws

Intervention Type PROCEDURE

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

FDG PET-CT Scan

Intervention Type PROCEDURE

PET scan

Cytokine Profiling

Intervention Type GENETIC

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

Interventions

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FluShield

Flu vaccine

Intervention Type BIOLOGICAL

FluShield - same arm

Flu vaccine

Intervention Type BIOLOGICAL

FluShield - opposite arm

Flu vaccine

Intervention Type BIOLOGICAL

Blood Draws

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

Intervention Type PROCEDURE

FDG PET-CT Scan

PET scan

Intervention Type PROCEDURE

Cytokine Profiling

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

Intervention Type GENETIC

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Hackensack Meridian Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Schwartz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

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Hackensack Univarsity medical Center

Hackensack, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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5R21AI077102-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00000226 - R21AI077102

Identifier Type: -

Identifier Source: org_study_id

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