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

July 5, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75679
        • CIC Vaccinologie - Hopital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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®
Vaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE)at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)versus2)
Placebo Comparator: 2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
31 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
13 months
Proportion of patients with local or systemic reactions following vaccination
Time Frame: 31 months
31 months
Comparison of serum antibodies titers obtained at W28 for each of the tested serotypes
Time Frame: 28 weeks
28 weeks
Comparison of ELISA persistent responses six months and 2 years after vaccination with Pneumo23® (M12 and M30)
Time Frame: 12 months + 30 months
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.
Time Frame: 31 months
31 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Odile Launay, MD, PhD, CIC vaccinologie Cochin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P060241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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