PET-CT Scans in Healthy Volunteers After Flu Vaccination

This study is currently recruiting participants.

Verified by Hackensack University Medical Center, October 2008

Sponsors and Collaborators:	Hackensack University Medical Center National Institutes of Health (NIH)
Information provided by:	Hackensack University Medical Center
ClinicalTrials.gov Identifier:	NCT00769002

Purpose

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

Condition	Intervention
Immune Response to Influenza Vaccination	Biological: FluShield, FluMist

MedlinePlus related topics: CT Scans Flu Nuclear Scans

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Open Label, Historical Control, Parallel Assignment
Official Title:	Impact of Bilateral Priming on Response to Unilateral Flu Vaccination

Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:

PET-CT scan [ Time Frame: 4-7 days after flu vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cytokine profiling [ Time Frame: 2-6 weeks and 10-12 months post flu vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Previous influenza positivity	Biological: FluShield, FluMist Flu vaccine
2: Active Comparator No previous influenza positivity	Biological: FluShield, FluMist Flu vaccine

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769002

Contacts

Contact: David Schwartz, MD, PhD

(201)-996-3261

dschwartz@humed.com

Locations

United States, New Jersey
Hackensack Univarsity medical Center	Recruiting
Hackensack, New Jersey, United States, 07601
Sub-Investigator: Sujatha Iyengar, PhD

Sponsors and Collaborators

Hackensack University Medical Center

National Institutes of Health (NIH)

Investigators

Principal Investigator:

David Schwartz, MD, PhD

Hackensack University Medical Center

More Information

Responsible Party:	Hackensack University Medical Center ( David Schwartz MD, PhD )
Study ID Numbers:	R21AI077102, R21AI077102
Study First Received:	October 7, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00769002
Health Authority:	United States: Institutional Review Board

Keywords provided by Hackensack University Medical Center:

influenza
flu
vaccine
vaccination
immune response

FluShield
FluMist
PET-CT
Healthy Volunteers

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 15, 2009