Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff. (FLU-HOP)
Primary Purpose
Influenza A Virus, H1N1 Subtype
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Anti-H1N1v Vaccine
Sponsored by
About this trial
This is an interventional basic science trial for Influenza A Virus, H1N1 Subtype
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
- Age superior or equal to 20 years
- Women with childbearing potential using contraception
Exclusion Criteria:
- Documented immune depression
- Current immunosuppressive therapy
- Pregnancy (documented by a positive pregnancy test)
- Breast feeding women
- Documented allergy or hypersensitivity to vaccines
- Documented acute or chronic inflammatory disease
- Concomitant participation to another clinical trial
Sites / Locations
- Hopital Pitie Salpetriere
- Centre d'Investigations Cliniques (CIC), Hopital Cochin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anti-H1N1v Vaccine
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of the intensity of the humoral and cellular immune responses of the anti-A(H1N1)v vaccine in a medical care population as a function of the age and of the prior seasonal anti-influenza vaccinations.
Secondary Outcome Measures
Investigate the quality of the humoral and cellular immune responses induced by the seasonal anti-influenza vaccine as a function of the age and of the prior seasonal vaccinations.
Determine the cross-reactivity of the humoral and cellular immune responses as a function of the age and of the prior seasonal vaccinations
Assess the tolerance to the seasonal and pandemic vaccines
Assess the occurence of flu episodes and their severity during the 2009-2010 season as a function of the age of the population. Then, the correlation between the flu episodes and and the immunologic results is to be evaluated.
Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.
Full Information
NCT ID
NCT01063608
First Posted
February 4, 2010
Last Updated
March 15, 2010
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01063608
Brief Title
Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff.
Acronym
FLU-HOP
Official Title
Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Clinical Staff (FLU-HOP)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
February 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project may help to answer several fundamental questions related to public health regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy:
What is the immunologic efficacy in terms of antibodies response of the vaccination against the seasonal (2009-2010) influenza virus and against the A(H1N1)v virus in the clinical staff?
Moreover, it may help to answer questions related to the use of a vaccine against influenza virus variants emerging in the French population:
Before the vaccination:
What is the status of the residual anti-H1N1 seasonal viruses immunity and of the anti-A(H1N1)v immunity in the population stratified by age and taking into account the multiplicity of the prior seasonal vaccinations?
What is the level of the cellular and humoral cross-reactivity between the different H1N1 strains?
After the vaccination:
What is the intensity of the anti-vaccine immune response as a function of the age of the population ad of the prior seasonal vaccinations?
What is the level of the cellular and humoral cross-reactivity after vaccination as a function of the age of the population and of the multiplicity of the prior seasonal vaccinations?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A Virus, H1N1 Subtype
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anti-H1N1v Vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Anti-H1N1v Vaccine
Intervention Description
Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.
Primary Outcome Measure Information:
Title
Evaluation of the intensity of the humoral and cellular immune responses of the anti-A(H1N1)v vaccine in a medical care population as a function of the age and of the prior seasonal anti-influenza vaccinations.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Investigate the quality of the humoral and cellular immune responses induced by the seasonal anti-influenza vaccine as a function of the age and of the prior seasonal vaccinations.
Time Frame
5 months
Title
Determine the cross-reactivity of the humoral and cellular immune responses as a function of the age and of the prior seasonal vaccinations
Time Frame
5 months
Title
Assess the tolerance to the seasonal and pandemic vaccines
Time Frame
5 months
Title
Assess the occurence of flu episodes and their severity during the 2009-2010 season as a function of the age of the population. Then, the correlation between the flu episodes and and the immunologic results is to be evaluated.
Time Frame
5 months
Title
Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Age superior or equal to 20 years
Women with childbearing potential using contraception
Exclusion Criteria:
Documented immune depression
Current immunosuppressive therapy
Pregnancy (documented by a positive pregnancy test)
Breast feeding women
Documented allergy or hypersensitivity to vaccines
Documented acute or chronic inflammatory disease
Concomitant participation to another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Jaureguiberry, MD
Organizational Affiliation
Groupe Hospitalier Pitié-Salpêtrière
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Behazine Combadiere, PhD
Organizational Affiliation
INSERM U945
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Pitie Salpetriere
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75013
Country
France
Facility Name
Centre d'Investigations Cliniques (CIC), Hopital Cochin
City
Paris
State/Province
Ile de france
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
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Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff.
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