NCT00611663

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
BIOLOGICAL	Prevenar® and Pneumo23®	Vaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE)at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)versus2)
BIOLOGICAL	Placebo, Pneumo23®	Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24

Timeline

• Start date: 2008-05-01
• Primary completion: 2014-12-01
• Completion: 2016-04-01
• First posted: 2008-02-11
• Last updated: 2025-09-08

Locations

1 site across 1 country: France