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Auto-immunity in Lupus Patients After Influenza Vaccine (GRIPLUP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01072734
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : October 13, 2010
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Annual influenza vaccination is recommended in patients with systemic lupus erythematosus (SLE). However some concerns remain about vaccination and the risk of lupus flare

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus (SLE) Drug: Vaccine Phase 2

Detailed Description:

SLE is a chronic autoimmune disease associated with the production of pathogenic anti-nuclear autoantibodies (ANAs) and characterized by the loss of self tolerance and the overexpression of B cells, leading to a high immunoglobulin production, 90% being autoantibodies.

There have been concerns about the safety of vaccination in patients with autoimmune diseases as it has been hypothesised that stimulation of the immune system via vaccination may lead to an increase in disease activity. Furthermore, SLE patients display a variety of immune dysfunctions which may influence their response to influenza vaccination.

Studies indicate that, although influenza vaccination in SLE may generate autoimmune phenomena, no clinically significant increase in SLE disease activity can be expected. Therefore, influenza vaccination can be considered safe in quiescent SLE, in accordance with previous reviews on this subject

The aim of this study is to evaluate if the level of CXCR4 on leucocytes of patients with SLE could be a good prognostic marker for the efficacy and the safety of influenza vaccine in SLE patients. For that purpose, we will assay in lupus patients the cellular level of CXCR4 before and after administration of influenza vaccine and correlate the expression levels of CXCR4 with: 1) the evolution of clinical and biological signs of autoimmunity and 2) the humoral immune response towards influenza. If influenza vaccine has not been associated so far with increased risk of lupus flare, it is important to determine if patients with elevated leucocytes levels of CXCR4, (due to the impact of this molecule in humoral immunity), are more at risk of vaccine side effects particularly of autoimmune origin.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of CXCR4/CXCL12 Axis on the Control of Humoral Immunity and Auto-immunity in Lupus Patients After Influenza Vaccine Challenge
Study Start Date : September 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vaccine group
single group: all included patients will receive the vaccine
Drug: Vaccine
Influenza vaccine
Other Name: Influenza vaccine

Primary Outcome Measures :
  1. The expression of CXCR4 on B cells, T cells, monocytes and granulocytes by FACS on LES patients will be measured the day of the vaccination and then 7 and 30 days post-vaccination [ Time Frame: 7 and 30 days post-vaccination ]

Secondary Outcome Measures :
  1. The biological signs of autoimmunity will be followed using the routine laboratory tests such as the complement exploration and the detection of total anti-nuclear antibodies detection [ Time Frame: one year after ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria :

  • 18 years of age and older
  • informed consent signed
  • LES patients who meet the American College of Rheumatology (ACR) diagnostic criteria of SLE
  • Patient able to attend all visit schedule during the month following influenza vaccine administration
  • Clinical examination performed prior final inclusion with results communicated to the patient

Exclusion criteria :

  • For women, being pregnant or positive pregnancy test
  • Positive for HCV, HIV and HBV
  • Patient treated with rituximab (anti-CD20) or stopped for less than a year.
  • Patient for whom a treatment majorization is suspected within the month following influenza vaccine administration.
  • Hypersensitivity to active substances, eggs and to one of the vaccine components
  • Other vaccinations within the last 30 days before the inclusion at J0
  • Administration of blood products such as immunoglobulins within the last 90 days before J0
  • Progressive cancer, cirrhoses
  • Acute severe illness within the last 30 days before inclusion at J0
  • Patient non affiliated to a health social security system
  • Planned participation to another clinical study during the present study period
  • patient deprived of freedom by an administrative or court order

Information from the National Library of Medicine

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 identifier (NCT number): NCT01072734

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CIC Vaccinologie Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
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Principal Investigator: Odile Launay, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Valerie Millul, Department Clinical Reseach of Developpement Identifier: NCT01072734    
Other Study ID Numbers: P090104
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010
Keywords provided by Assistance Publique - Hôpitaux de Paris:
CXCR4 on leucocytes of patients with SLE
Influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Lupus Erythematosus, Systemic
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs