Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff. (FLU-HOP)
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|ClinicalTrials.gov Identifier: NCT01063608|
Recruitment Status : Unknown
Verified March 2010 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Active, not recruiting
First Posted : February 5, 2010
Last Update Posted : March 16, 2010
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?
|Condition or disease||Intervention/treatment||Phase|
|Influenza A Virus, H1N1 Subtype||Biological: Anti-H1N1v Vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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)|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||February 2011|
|Estimated Study Completion Date :||February 2011|
|Experimental: Anti-H1N1v Vaccine||
Biological: Anti-H1N1v Vaccine
Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.
- 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 ]
- 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 ]
- 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 ]
- Assess the tolerance to the seasonal and pandemic vaccines [ Time Frame: 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 ]
- Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context. [ Time Frame: 5 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063608
|Hopital Pitie Salpetriere|
|Paris, Ile de France, France, 75013|
|Centre d'Investigations Cliniques (CIC), Hopital Cochin|
|Paris, Ile de france, France, 75014|
|Principal Investigator:||Stephane Jaureguiberry, MD||Groupe Hospitalier Pitié-Salpêtrière|
|Study Director:||Behazine Combadiere, PhD||INSERM U945|