Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff. (FLU-HOP)

March 15, 2010 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Clinical Staff (FLU-HOP)

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:

  1. 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?

  2. 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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75013
        • Hopital Pitie Salpetriere
    • Ile de france
      • Paris, Ile de france, France, 75014
        • Centre d'Investigations Cliniques (CIC), Hopital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti-H1N1v Vaccine
Biological: Anti-H1N1v Vaccine
Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 months
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
5 months
Assess the tolerance to the seasonal and pandemic vaccines
Time Frame: 5 months
5 months
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
5 months
Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Stephane Jaureguiberry, MD, Groupe Hospitalier Pitie-Salpetriere
  • Study Director: Behazine Combadiere, PhD, INSERM U945

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

March 16, 2010

Last Update Submitted That Met QC Criteria

March 15, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLU-HOP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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