Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00611663

Purpose

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

Condition	Intervention	Phase
Lupus Erythematosus, Systemic	Biological: Prevenar® and Pneumo23® Biological: Placebo, Pneumo23®	Phase II Phase III

MedlinePlus related topics: Lupus

Drug Information available for: Corticosteroids Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	VACCILUP "A Multicenter, Randomized Double-Blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus Erythematosus"

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	106
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vaccination with conjugate vaccine Prevenar® (Wyeth-Lederlé) at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)	Biological: Prevenar® and Pneumo23® Vaccination with conjugate vaccine Prevenar® (Wyeth-Lederlé) at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)versus2)
2: Placebo Comparator Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24	Biological: Placebo, Pneumo23® Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24

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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age 18 to 50 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 systemic corticosteroids at a dose ≥ 5 mg/j or systemic corticosteroids at any dose associated with other immunosuppressive drugs
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
prior receipt of any pneumococcal vaccine
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
current anticoagulant treatment or anticoagulant treatment within 7 days prior to enrolment (inclusion visit W0) or hematopoietic disorders
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611663

Contacts

Contact: Odile Launay, MD, PhD

0033158412858

odile.launay@cch.aphp.fr

Locations

France
CIC Vaccinologie - Hopital Cochin	Recruiting
Paris, France, 75679
Contact: Paula Duchet-Niedziolka, MD 0033158412860 paula.duchet-niedziolka@cch.aphp.fr
Contact: Raphael Serreau, MD, PhD 0033158411180 raphael.serreau@cch.aphp.fr
Principal Investigator: Odile Launay, MD, PhD
Sub-Investigator: Paula Duchet-Niedziolka, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Odile Launay, MD, PhD

CIC vaccinologie Cochin Hospital

More Information

Responsible Party:	Department clinical research ( Amel OUSLIMANY )
Study ID Numbers:	P060241
Study First Received:	January 28, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00611663
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Pneumococcal vaccine
SLE
Vaccination
Immunosuppression

SLE as defined by the ACR classification
Stable SLE
SLE treated by systemic corticosteroids

Study placed in the following topic categories:

Autoimmune Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009