Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients (VACINA)

December 30, 2021 updated by: University Hospital, Montpellier

Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept

Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral response) in RA patients treated with abatacept, biotherapy targeting T-cells? The investigator propose to conduct a prospective, multicenter (11 centers), randomized, open-label study.

The patients are going to be randomized in 2 groups: patients of the first group will be vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®/Pneumovax®) whereas patients of the second group will be vaccinated with conjugate pneumococcal vaccine (Prevenar13®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study population will be all the RA patients between 18 and 85 years with instauration of a treatment by sub-cutaneous abatacept in association with methotrexate who agreed to participate to the study.

At the time of their inclusion, patients will be randomized for receiving either pneumococcal polysaccharide vaccine (PPSV) or pneumococcal conjugate vaccine (PCV).

The primary endpoint will be evaluated at one month after vaccination. The total of follow-up will be of 12 months.

For the patients of the group PCV, the prime-boost strategy will be applied in order to be in accordance with the current French recommendation and a revaccination at 2 months after the initial vaccine will be realized with PPSV.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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
      • Amiens, France, 80054
        • CHU Nord
      • Bordeaux, France, 33076
        • CHU Pellegrin
      • Clermont-Ferrand, France, 63000
        • Chu Montpied
      • Le Kremlin-bicêtre, France, 94275
        • CHU Bicêtre
      • Lille, France, 59037
        • CHRU Roger Salengro
      • Nîmes, France, 30029
        • CHU Caremeau
      • Orléans, France, 45000
        • CHU Orléans
      • Paris, France, 78013
        • Chu La Pitie Salpetriere
      • Strasbourg, France, 67200
        • CHU Hautepierre
    • Hérault
      • Montpellier, Hérault, France, 34295
        • CHRU de Montpellier
  • Monaco
      • Monaco, Monaco, 98012
        • CHPG Monaco

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • RA according to American College of Rheumatology (ACR)/European League Against rheumatism (EULAR) 2010 criteria
  • Disease Activity Score (DAS) 28 ≥ 3.2
  • Initiation of a treatment by sub-cutaneous abatacept in combination with methotrexate (MTX), whatever treatment they were receiving before (apart from rituximab (RTX) in the last year)
  • Patient has signed study consent form

Exclusion Criteria:

  • age < 18 or > 85 year
  • dementia
  • patients subjects to legal protection measures
  • Corticosteroids ≥ 10mg/d the day of inclusion
  • Patient who had a pneumococcal vaccination in the previous 3 years
  • Last pneumococcal vaccination < 3 year
  • rituximab in the last year
  • History of anaphylactic response to a vaccination
  • Contraindications to abatacept or methotrexate
  • Pregnancy or pregnancy wish
  • Breast feeding
  • Patient who currently abuse drugs or alcohol
  • Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication.
  • Subject who have receive any vaccine within 1 month of the anticipated first dose of the study medication and for all the duration of the study
  • Patient with contraindication to intramuscular injections
  • Subject with respiratory insufficiency
  • Subject at risk for Tuberculosis.
  • Blood transfusion within the 3 months previous to the study and for all the duration of the study.
  • Concomitant biologic disease-modifying antirheumatic drug (DMARD)
  • Within 4 weeks of receiving treatment with any investigational drug.
  • Patient positive for hepatitis B surface antigen
  • Patient who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pneumococcal polysaccharide vaccine
Patients are vaccinated vith Peumo23/Pneumovax on the first day. Abatacept started on frst day.
Biological: pneumococcal polysaccharide vaccine
Vaccination with PPSV on first day. NB : PPSV vaccine Pneumo23 has been replaced in September 2017 by the equivalent vaccine Pneumovax because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company.
Other Names:
  • Pneumo23/Pneumovax
Drug: Abatacept
Abatacept started on frst day
Other Names:
  • Orencia
Active Comparator: pneumococcal conjugate vaccine

Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.

Abatacept started on frst day.
Drug: Abatacept
Abatacept started on frst day
Other Names:
  • Orencia
Biological: pneumococcal conjugate vaccine
Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.
Other Names:
  • Prevenar13

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humoral response comparison after vaccination (number of patient with at least a two-fold increase of the antibody titer for at least 3 of the 5 serotypes of interest : 1,3 14, 7F, 19A)
Time Frame: 1 month after vaccination
To compare the rate of responders, at one month after vaccination, between patients vaccinated with PCV and patient vaccinated with PPSV.
1 month after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side Effect frequency (number of side effect at each patient's visit for both groups)
Time Frame: 1, 2,6 ans 12 months after inclusion
Comparison of the frequency of side effects between the 2 groups at 1, 2, 6 and 12 months
1, 2,6 ans 12 months after inclusion
Prime boost strategy efficacity evaluation (number of responder in the PCV group)
Time Frame: 6 months after inclusion
Calculation of the rate of responders, in the PCV group, at 4 month after re-vaccination by a dose of PPSV
6 months after inclusion
Long term immune response after vaccination
Time Frame: 6 and 12 months after vaccination
Comparison between the 2 groups of the rate of responders at 6 and 12 months after vaccination
6 and 12 months after vaccination
Comparison between the 2 groups of the opsonophagocytosis activity of the antibodies produced
Time Frame: 1, 2, 6 and 12 months after vaccination
Comparison between the 2 groups of the opsonophagocytic titers (OPA) at 1, 2, 6 and 12 months after vaccination
1, 2, 6 and 12 months after vaccination
Pneumococcal vaccination predictive factor identification
Time Frame: 12 month after last patient inclusion
Analysis of the collected date to search for predictive factors of immune response after pneumococcal vaccination by comparison of the rates of responders within each group, according to age, gender, RA activity, MTX dosage, corticosteroid, dosage, therapeutical history
12 month after last patient inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Jacques Morel, MD PhD, CHRU de Montpellier

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 (Actual)

March 3, 2016

Primary Completion (Actual)

January 18, 2021

Study Completion (Actual)

January 18, 2021

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9419

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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