Status:
COMPLETED
Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- age 18 to 65 years
- SLE as defined by the ACR classification
- Stable SLE (treatment not modified during the 2 months preceding the inclusion date W0)
- SLE treated by immunosuppressant only or systemic corticosteroids at a dose ≥ 5 mg/j or systemic corticosteroids at any dose associated with one or more immunosuppressive drugs
- SLE treated by hydroxychloroquine only
- 31 months following
- females must have an effective method of contraception during the first 7 months of the study and with a negative serum or urinary pregnancy test
- females not wishing to have a child during the 7 months following W0
- physical examination
- signed written and informed consent
Exclusion
- pregnant females or females wishing to have a child during the 7 months following W0
- subjects infected with HIV and/or HBV( Ag HBs+) and or HVC
- medical history of allergy to any vaccine component
- receipt of any pneumococcal vaccine less than 5 years
- receipt of other vaccine within one month prior to enrolment (inclusion visit W0)
- receipt of immunoglobulin within three months prior to enrolment (inclusion visit W0)
- splenectomy
- hematopoietic disorders which give contra-indications to intramuscular and hypodermic route injections,
- active malignancy , cirrhosis
- intercurrent illness within one month prior to enrolment (inclusion visit W0)
- patients under biotherapy (anti-CD20)must not been included if the interval between vaccination and the end of the biotherapy is less than one year.
- participation to another clinical study during the first 7 months of the study
- subject not covered by Health Insurance
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00611663
Start Date
May 1 2008
End Date
April 1 2016
Last Update
September 8 2025
Active Locations (1)
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1
CIC Vaccinologie - Hopital Cochin
Paris, France, 75679