Auto-immunity in Lupus Patients After Influenza Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01072734
• Date of registration: 19/02/2010
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Auto-immunity in Lupus Patients After Influenza Vaccine GRIPLUP
• Scientific title: Role of CXCR4/CXCL12 Axis on the Control of Humoral Immunity and Auto-immunity in Lupus Patients After Influenza Vaccine Challenge
• Date of first enrolment: September 2009
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01072734
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Odile Launay, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus (SLE)

Intervention(s)

Drug: Vaccine

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

P090104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institut National de la Santé Et de la Recherche Médicale, France