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NCT Number: NCT01063608

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

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?

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Key information

Conditions

Influenza A Virus, H1N1 Subtype

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre d'Investigations Cliniques (CIC), Hopital Cochin, Paris, Île-de-France Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-H1N1v Vaccine

Biological

Inclusion of hospital personnel in the context of the anti-H1N1v prophylaxy plan.

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. Assess the tolerance to the seasonal and pandemic vaccines

    Time frame: 5 months

  4. 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

  5. Evaluate the perception of the anti-influenza vaccination in a medical care population in the current H1N1v pandemy context.

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: FLU-HOP

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Feb 5, 2010
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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