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

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01072734
First received: February 19, 2010
Last updated: October 11, 2010
Last verified: October 2010

February 19, 2010
October 11, 2010
September 2009
January 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01072734 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Auto-immunity in Lupus Patients After Influenza Vaccine
Role of CXCR4/CXCL12 Axis on the Control of Humoral Immunity and Auto-immunity in Lupus Patients After Influenza Vaccine Challenge

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Systemic Lupus Erythematosus (SLE)
Drug: Vaccine
Influenza vaccine
Other Name: Influenza vaccine
Experimental: Vaccine group
single group: all included patients will receive the vaccine
Intervention: Drug: Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01072734
P090104
Yes
Valerie Millul, Department Clinical Reseach of Developpement
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Odile Launay, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP