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

Influenza A Virus, H1N1 Subtype Clinical Trial

— FLU-HOP  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01063608
• Other study ID #: FLU-HOP
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 4, 2010
• Last updated: March 15, 2010
• Start date: October 2009
• Est. completion date: February 2011

Study information

• Verified date: March 2010
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 147
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Influenza A Virus, H1N1 Subtype
• Influenza, Human

Intervention

Biological:
• Anti-H1N1v Vaccine
Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.

Locations

Country	Name	City	State
France	Centre d'Investigations Cliniques (CIC), Hopital Cochin	Paris	Ile de france
France	Hopital Pitie Salpetriere	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Assess the tolerance to the seasonal and pandemic vaccines		5 months	Yes
Secondary	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	No
Secondary	Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.		5 months	No