Clinical Trial: Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: VACCILUP "A Multicenter, Randomized Double-blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus Erythematosus"

Brief 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 Summary:

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·
  • Sponsor: Assistance Publique - Hôpitaux de Paris

    Current Primary Outcome: Proportion of responders for more than 5 serotypes among the 7 serotypes common between conjugate and Poly Saccharidic vaccines (ie. serotypes 4, 6B, 9V, 14, 18C, 19F and 23F). [ Time Frame: 31 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Proportion of patients presenting a disease exacerbation(defined as an increase of ³3 points on the SLEDAI score and/or need to increase treatment with corticosteroids or immunosuppressive drugs) during the 12 months following the first vaccination [ Time Frame: 13 months ]
    • Proportion of patients with local or systemic reactions following vaccination [ Time Frame: 31 months ]
    • Comparison of serum antibodies titers obtained at W28 for each of the tested serotypes [ Time Frame: 28 weeks ]
    • Comparison of ELISA persistent responses six months and 2 years after vaccination with Pneumo23® (M12 and M30) [ Time Frame: 12 months + 30 months ]
    • Research of predictive factors of immunological response disease activity at M0 (defined by SLEDAI), SLE treatment and others variables witch can affect the response. [ Time Frame: 31 months ]


    Original Secondary Outcome:

    • Proportion of patients presenting a disease exacerbation(defined as an increase of ³3 points on the SLEDAI score and/or need to increase treatment with corticosteroids or immunosuppressive drugs) during the 12 months following the first vaccination [ Time Frame: 55 months ]
    • Proportion of patients with local or systemic reactions following vaccination [ Time Frame: 55 months ]
    • Comparison of serum antibodies titers obtained at W28 for each of the tested serotypes [ Time Frame: 55 months ]
    • Comparison of ELISA persistent responses six months and 2 years after vaccination with Pneumo23® (M12 and M30) [ Time Frame: 55 months ]
    • Research of predictive factors of immunological response disease activity at M0 (defined by SLEDAI), SLE treatment and others variables witch can affect the response. [ Time Frame: 55 months ]


    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: January 28, 2008
    Date Started: May 2008
    Date Completion:
    Last Updated: July 5, 2016
    Last Verified: December 2015