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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00611663
First received: January 28, 2008
Last updated: August 2, 2013
Last verified: July 2013

January 28, 2008
August 2, 2013
May 2008
June 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00611663 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with local or systemic reactions following vaccination [ Time Frame: 31 months ] [ Designated as safety issue: Yes ]
  • Comparison of serum antibodies titers obtained at W28 for each of the tested serotypes [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
  • Comparison of ELISA persistent responses six months and 2 years after vaccination with Pneumo23® (M12 and M30) [ Time Frame: 12 months + 30 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with local or systemic reactions following vaccination [ Time Frame: 55 months ] [ Designated as safety issue: Yes ]
  • Comparison of serum antibodies titers obtained at W28 for each of the tested serotypes [ Time Frame: 55 months ] [ Designated as safety issue: Yes ]
  • Comparison of ELISA persistent responses six months and 2 years after vaccination with Pneumo23® (M12 and M30) [ Time Frame: 55 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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"

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

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Lupus Erythematosus, Systemic
  • 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
  • Experimental: 1
    Vaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE) at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)
    Intervention: Biological: Prevenar® and Pneumo23®
  • Placebo Comparator: 2
    Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24
    Intervention: Biological: Placebo, Pneumo23®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
106
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00611663
P060241
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Odile Launay, MD, PhD CIC vaccinologie Cochin Hospital
Assistance Publique - Hôpitaux de Paris
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP