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

NCT00611663 | Completed Phase 2 DMC

• 1 other identifier: P060241
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Lupus Erythematosus, Systemic

Keywords

Pneumococcal vaccine; SLE; Vaccination; Immunosuppression; SLE as defined by the ACR classification; Stable SLE; SLE treated by systemic corticosteroids

Outcome Measures

Primary Outcomes (1)

• 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).

  31 months

Secondary Outcomes (5)

• 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

  13 months

• Proportion of patients with local or systemic reactions following vaccination

  31 months

• Comparison of serum antibodies titers obtained at W28 for each of the tested serotypes

  28 weeks

• Comparison of ELISA persistent responses six months and 2 years after vaccination with Pneumo23® (M12 and M30)

  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.

  31 months

Study Arms (2)

1

EXPERIMENTAL

Vaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE) at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)

Biological: Prevenar® and Pneumo23®

2

PLACEBO COMPARATOR

Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24

Biological: Placebo, Pneumo23®

Interventions

Prevenar® and Pneumo23® BIOLOGICAL

Vaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE)at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)versus2)

1

Placebo, Pneumo23® BIOLOGICAL

Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 to 65 years
• SLE as defined by the ACR classification
• 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
• 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

You may not qualify if:

• 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
• splenectomy
• hematopoietic disorders which give contra-indications to intramuscular and hypodermic route injections,
• active malignancy , cirrhosis
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

CIC Vaccinologie - Hopital Cochin

Paris, 75679, France

Location

Related Publications (1)

• Grabar S, Groh M, Bahuaud M, Le Guern V, Costedoat-Chalumeau N, Mathian A, Hanslik T, Guillevin L, Batteux F, Launay O; VACCILUP study group. Pneumococcal vaccination in patients with systemic lupus erythematosus: A multicenter placebo-controlled randomized double-blind study. Vaccine. 2017 Sep 5;35(37):4877-4885. doi: 10.1016/j.vaccine.2017.07.094. Epub 2017 Aug 4.

  PMID: 28784280 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Heptavalent Pneumococcal Conjugate Vaccine; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Odile Launay, MD, PhD

  CIC vaccinologie Cochin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 11, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2016
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

FR (1)