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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
pneumococcal polysaccharide vaccine
pneumococcal conjugate vaccine
Abatacept
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Vaccination against Pneumococcal, Naïve Abatacept patients

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHRU de Montpellier
  • CHU Nord
  • CHU Pellegrin
  • CHU Montpied
  • CHU Bicêtre
  • CHRU Roger Salengro
  • CHU Carémeau
  • CHU Orléans
  • CHU La pitié salpétriere
  • CHU Hautepierre
  • CHPG Monaco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

pneumococcal polysaccharide vaccine

pneumococcal conjugate vaccine

Arm Description

Patients are vaccinated vith Peumo23/Pneumovax on the first day. Abatacept started on frst day.

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

Outcomes

Primary Outcome Measures

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)
To compare the rate of responders, at one month after vaccination, between patients vaccinated with PCV and patient vaccinated with PPSV.

Secondary Outcome Measures

Side Effect frequency (number of side effect at each patient's visit for both groups)
Comparison of the frequency of side effects between the 2 groups at 1, 2, 6 and 12 months
Prime boost strategy efficacity evaluation (number of responder in the PCV group)
Calculation of the rate of responders, in the PCV group, at 4 month after re-vaccination by a dose of PPSV
Long term immune response after vaccination
Comparison between the 2 groups of the rate of responders at 6 and 12 months after vaccination
Comparison between the 2 groups of the opsonophagocytosis activity of the antibodies produced
Comparison between the 2 groups of the opsonophagocytic titers (OPA) at 1, 2, 6 and 12 months after vaccination
Pneumococcal vaccination predictive factor identification
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

Full Information

First Posted
September 7, 2015
Last Updated
December 30, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02547493
Brief Title
Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients
Acronym
VACINA
Official Title
Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2016 (Actual)
Primary Completion Date
January 18, 2021 (Actual)
Study Completion Date
January 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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®).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Vaccination against Pneumococcal, Naïve Abatacept patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pneumococcal polysaccharide vaccine
Arm Type
Active Comparator
Arm Description
Patients are vaccinated vith Peumo23/Pneumovax on the first day. Abatacept started on frst day.
Arm Title
pneumococcal conjugate vaccine
Arm Type
Active Comparator
Arm Description
Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later. Abatacept started on frst day.
Intervention Type
Biological
Intervention Name(s)
pneumococcal polysaccharide vaccine
Other Intervention Name(s)
Pneumo23/Pneumovax
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
pneumococcal conjugate vaccine
Other Intervention Name(s)
Prevenar13
Intervention Description
Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
Orencia
Intervention Description
Abatacept started on frst day
Primary Outcome Measure Information:
Title
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)
Description
To compare the rate of responders, at one month after vaccination, between patients vaccinated with PCV and patient vaccinated with PPSV.
Time Frame
1 month after vaccination
Secondary Outcome Measure Information:
Title
Side Effect frequency (number of side effect at each patient's visit for both groups)
Description
Comparison of the frequency of side effects between the 2 groups at 1, 2, 6 and 12 months
Time Frame
1, 2,6 ans 12 months after inclusion
Title
Prime boost strategy efficacity evaluation (number of responder in the PCV group)
Description
Calculation of the rate of responders, in the PCV group, at 4 month after re-vaccination by a dose of PPSV
Time Frame
6 months after inclusion
Title
Long term immune response after vaccination
Description
Comparison between the 2 groups of the rate of responders at 6 and 12 months after vaccination
Time Frame
6 and 12 months after vaccination
Title
Comparison between the 2 groups of the opsonophagocytosis activity of the antibodies produced
Description
Comparison between the 2 groups of the opsonophagocytic titers (OPA) at 1, 2, 6 and 12 months after vaccination
Time Frame
1, 2, 6 and 12 months after vaccination
Title
Pneumococcal vaccination predictive factor identification
Description
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
Time Frame
12 month after last patient inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Morel, MD PhD
Organizational Affiliation
CHRU de Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Montpellier
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHU Bicêtre
City
Le Kremlin-bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
CHRU Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
CHU Orléans
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
CHU La pitié salpétriere
City
Paris
ZIP/Postal Code
78013
Country
France
Facility Name
CHU Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
CHPG Monaco
City
Monaco
ZIP/Postal Code
98012
Country
Monaco

12. IPD Sharing Statement

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Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients

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