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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01063608
First received: February 4, 2010
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

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?

Condition Intervention Phase
Influenza A Virus, H1N1 Subtype
Biological: Anti-H1N1v Vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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)

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

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. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assess the tolerance to the seasonal and pandemic vaccines [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: October 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-H1N1v Vaccine Biological: Anti-H1N1v Vaccine
Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063608

Locations
France
Hopital Pitie Salpetriere
Paris, Ile de France, France, 75013
Centre d'Investigations Cliniques (CIC), Hopital Cochin
Paris, Ile de france, France, 75014
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Stephane Jaureguiberry, MD Groupe Hospitalier Pitié-Salpêtrière
Study Director: Behazine Combadiere, PhD INSERM U945
  More Information

No publications provided

Responsible Party: Peggy TAOUI / Project Director, INSERM
ClinicalTrials.gov Identifier: NCT01063608     History of Changes
Other Study ID Numbers: FLU-HOP
Study First Received: February 4, 2010
Last Updated: March 15, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014