Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to compare the immunological efficacy of two pneumococcal
      vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with
      corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost
      strategy using vaccination with conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic
      vaccine (Pneumo23®) after 6 months (W24)2) compared to the standard vaccination with Poly
      Saccharidic vaccine (Pneumo23®) at W24 after placebo at W0
    

Detailed description: 
      Infections are more frequent and potentially more serious in patients with SLE compared to
      healthy subjects. This risk increases when patients are treated with corticosteroids and/or
      immunosuppressive drugs.Among serious infections which can happen in this context,
      respiratory infections are among the most frequent and Streptococcus pneumoniae is one of the
      most often responsible germs.Although there are no specific study in SLE, these findings
      indicate that patients with SLE could benefit from a preventive vaccination against
      pneumococcal infections.Two pneumococcal vaccines are available: Pneumo23®, a Poly
      Saccharidic vaccine indicated for adults and children > 2 years at risk of pneumococcal
      infections; and Prevenar®, a conjugate vaccine, indicated for children < 2 years.Pneumo23®
      has been found to be safe in SLE but less immunogenic than in general population.Prevenar®
      has already been studied in immunocompromised patients (HIV-infected patients, patients after
      renal transplantation). It has been shown that immunological efficacy is better when
      Prevenar® is administrated prior to Pneumo23®, compared to Pneumo23® administrated alone.To
      our knowledge, this prime-boost strategy has not been assessed in patients with SLEThe
      primary objective of the study is to compare immunological efficacy of two pneumococcal
      vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with
      corticosteroids associated or not with other immunosuppressive drugs : 1) Vaccination with
      conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic vaccine (Pneumo23®) after 6
      months (W24)2) Vaccination with placebo at W0 and Poly Saccharidic vaccine (Pneumo23®) at
      W24Secondary objectives are:

        -  To compare the clinical and biological tolerance of the two vaccinal strategies·

        -  To evaluate the durability of sero protection at 6 and 24 months after vaccination by
           Pneumo23®

        -  To search predictive factors determinant of the pneumococcal vaccine response
    

Intervention name(s): Prevenar® and Pneumo23®; Placebo, Pneumo23®
Intervention type(s): Biological; Biological
Intervention description(s): Vaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE)at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)versus2); Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pneumococcal vaccine; SLE; Vaccination; Immunosuppression; SLE as defined by the ACR classification; Stable SLE; SLE treated by systemic corticosteroids