Overview

This trial is active, not recruiting.

Condition influenza a virus, h1n1 subtype
Treatment anti-h1n1v vaccine
Phase phase 4
Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Start date October 2009
End date February 2011
Trial size 147 participants
Trial identifier NCT01063608, FLU-HOP

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
anti-h1n1v vaccine
Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.

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.
time frame: 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.
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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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)
Principal investigator Stephane Jaureguiberry, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Institut National de la Santé Et de la Recherche Médicale, France.