NCT00769002

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2.9 years

First QC Date

October 7, 2008

Results QC Date

December 2, 2013

Last Update Submit

October 16, 2020

Conditions

Flu

Keywords

influenzafluvaccinevaccinationimmune responseFluShieldFluMistPET-CTHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Natural Infection

ACTIVE COMPARATOR

previously naturally infected

Biological: FluShieldProcedure: Blood DrawsProcedure: FDG PET-CT ScanGenetic: Cytokine Profiling

FluShield - influenza positivity

ACTIVE COMPARATOR

prior FluShield ipsilateral vaccinated

Biological: FluShieldBiological: FluShield - same armProcedure: Blood DrawsProcedure: FDG PET-CT ScanGenetic: Cytokine Profiling

FluShield - influenza positivity2

ACTIVE COMPARATOR

prior FluShield contralateral vaccinated

Biological: FluShieldBiological: FluShield - opposite armProcedure: Blood DrawsProcedure: FDG PET-CT ScanGenetic: Cytokine Profiling

FluMist

ACTIVE COMPARATOR

prior FluMist vaccinated.

Biological: FluShieldProcedure: Blood DrawsProcedure: FDG PET-CT ScanGenetic: Cytokine Profiling

Interventions

FluShieldBIOLOGICAL

Flu vaccine

FluMistFluShield - influenza positivityFluShield - influenza positivity2Natural Infection
FluShield - same armBIOLOGICAL

Flu vaccine

FluShield - influenza positivity
FluShield - opposite armBIOLOGICAL

Flu vaccine

FluShield - influenza positivity2
Blood DrawsPROCEDURE

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

FluMistFluShield - influenza positivityFluShield - influenza positivity2Natural Infection
FDG PET-CT ScanPROCEDURE

PET scan

FluMistFluShield - influenza positivityFluShield - influenza positivity2Natural Infection
Cytokine ProfilingGENETIC

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

FluMistFluShield - influenza positivityFluShield - influenza positivity2Natural Infection

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hackensack Univarsity medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza VaccinesBlood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Limitations and Caveats

This study was not completed and data collected is not available despite all efforts as PI has left the institution. No manuscript/study report was developed and there are no data to confirm validity or address comments in previously entered results

Results Point of Contact

Title
Dr. David Schwartz
Organization
Hackensack University Medical Center
DSchwartz@hackensackumc.org
551-996-2000

Study Officials

  • David Schwartz, MD, PhD

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 8, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 19, 2020

Results First Posted

October 19, 2020

Record last verified: 2020-10

Locations

US(1)