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
  Purpose

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 Intervention Phase
Systemic Lupus Erythematosus (SLE)
Drug: Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine group
single group: all included patients will receive the vaccine
Drug: Vaccine
Influenza vaccine
Other Name: Influenza vaccine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01072734

Locations
France
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
Investigators
Principal Investigator: Odile Launay, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Valerie Millul, Department Clinical Reseach of Developpement
ClinicalTrials.gov Identifier: NCT01072734     History of Changes
Other Study ID Numbers: P090104
Study First Received: February 19, 2010
Last Updated: October 11, 2010
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Lupus
CXCR4 on leucocytes of patients with SLE
Influenza vaccine

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014