Influenza A Virus, H1N1 Subtype
Conditions
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?
Interventions
BIOLOGICALAnti-H1N1v Vaccine
Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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. | 5 months |
Secondary
| 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. | 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 | 5 months |
| Assess the tolerance to the seasonal and pandemic vaccines | 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. | 5 months |
| Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context. | 5 months |
Countries
France
Outcome results
None listed