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

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ClinicalTrials.gov Identifier: NCT02547493
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : March 2, 2021
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

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®).


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: pneumococcal polysaccharide vaccine Biological: pneumococcal conjugate vaccine Drug: Abatacept Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept
Actual Study Start Date : March 3, 2016
Actual Primary Completion Date : January 18, 2021
Actual Study Completion Date : January 18, 2021


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 Name: Pneumo23/Pneumovax

Drug: Abatacept
Abatacept started on frst day
Other Name: 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.

Biological: pneumococcal conjugate vaccine
Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.
Other Name: Prevenar13

Drug: Abatacept
Abatacept started on frst day
Other Name: Orencia




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547493


Locations
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France
CHRU de Montpellier
Montpellier, Hérault, France, 34295
CHU Nord
Amiens, France, 80054
CHU Pellegrin
Bordeaux, France, 33076
CHU Montpied
Clermont-Ferrand, France, 63000
CHU Bicêtre
Le Kremlin-bicêtre, France, 94275
CHRU Roger Salengro
Lille, France, 59037
CHU Carémeau
Nîmes, France, 30029
CHU Orléans
Orléans, France, 45000
CHU La pitié salpétriere
Paris, France, 78013
CHU Hautepierre
Strasbourg, France, 67200
Monaco
CHPG Monaco
Monaco, Monaco, 98012
Sponsors and Collaborators
University Hospital, Montpellier
Bristol-Myers Squibb
Investigators
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Principal Investigator: Jacques Morel, MD PhD CHRU de Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02547493    
Other Study ID Numbers: 9419
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021
Keywords provided by University Hospital, Montpellier:
Vaccination against Pneumococcal
Naïve Abatacept patients
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Antirheumatic Agents