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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine group | Experimental | single group: all included patients will receive the vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine | Drug | Influenza vaccine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Odile Launay, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC Vaccinologie Hopital Cochin | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23764537 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 2, 2013 | |
| Reset | Oct 11, 2013 | |
| Release | Apr 14, 2016 | |
| Reset | May 20, 2016 | |
| Release | Sep 22, 2021 | |
| Reset | Oct 19, 2021 | |
| Release | Nov 17, 2025 | |
| Reset | Dec 4, 2025 | |
| Release | Mar 4, 2026 | |
| Reset | Mar 24, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 2, 2013 | Oct 11, 2013 | |||
| Apr 14, 2016 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014765 | Viral Vaccines |
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| May 20, 2016 |
| Sep 22, 2021 | Oct 19, 2021 |
| Nov 17, 2025 | Dec 4, 2025 |
| Mar 4, 2026 | Mar 24, 2026 |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |