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

Institut National de la Santé Et de la Recherche Médicale, France

Status and phase: Completed; Phase 4

Conditions: Influenza A Virus, H1N1 Subtype

Treatments: Biological: Anti-H1N1v Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01063608

C09-30

2009-016267-11 (EudraCT Number)

Details and patient eligibility

About

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?

Enrollment: 147 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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147 participants in 1 patient group

Anti-H1N1v Vaccine

Experimental group

Treatment:

Biological: Anti-H1N1v Vaccine