Auto-immunity in Lupus Patients After Influenza Vaccine

NCT01072734 | Completed Phase 2 DMC

• 1 other identifier: P090104
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

Lupus; CXCR4 on leucocytes of patients with SLE; Influenza vaccine

Outcome Measures

Primary Outcomes (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

  7 and 30 days post-vaccination

Secondary Outcomes (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

  one year after

Study Arms (1)

Vaccine group

EXPERIMENTAL

single group: all included patients will receive the vaccine

Drug: Vaccine

Interventions

Vaccine DRUG

Influenza vaccine

Also known as: Influenza vaccine

Vaccine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Administration of blood products such as immunoglobulins within the last 90 days before J0
• Progressive cancer, cirrhoses
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

CIC Vaccinologie Hopital Cochin

Paris, 75014, France

Location

Related Publications (1)

• Launay O, Paul S, Servettaz A, Roguet G, Rozenberg F, Lucht F, Lambert C, Presles E, Goulvestre C, Meritet JF, Galtier F, Dubray C, Lebon P, Weill B, Batteux F. Control of humoral immunity and auto-immunity by the CXCR4/CXCL12 axis in lupus patients following influenza vaccine. Vaccine. 2013 Aug 2;31(35):3492-501. doi: 10.1016/j.vaccine.2013.05.095. Epub 2013 Jun 11.

  PMID: 23764537 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Influenza, Human

Interventions

Vaccines; Influenza Vaccines

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Viral Vaccines

Study Officials

• Odile Launay, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: September 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: October 13, 2010

Record last verified: 2010-10

Locations

FR (1)