Clinical trial NCT01063608: Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff.
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza A Virus, H1N1 Subtype
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2010-02-05
Enrollment: 147
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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:

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?


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

Primary outcomes:
measure: 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.
timeFrame: 5 months
Secondary outcomes:
measure: 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.
timeFrame: 5 months
measure: Determine the cross-reactivity of the humoral and cellular immune responses as a function of the age and of the prior seasonal vaccinations
timeFrame: 5 months
measure: Assess the tolerance to the seasonal and pandemic vaccines
timeFrame: 5 months
measure: 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.
timeFrame: 5 months
measure: Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.
timeFrame: 5 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Pitie Salpetriere
state: Ile De France
city: Paris
country: France
facility: Centre d'Investigations Cliniques (CIC), Hopital Cochin
state: Ile De France
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpêtrière
name: Stephane Jaureguiberry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM U945
name: Behazine Combadiere, PhD
role: STUDY_DIRECTOR
References: