Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients
VACINA
Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept
1 other identifier
interventional
80
2 countries
11
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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable rheumatoid-arthritis
Started Mar 2016
Longer than P75 for not_applicable rheumatoid-arthritis
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedStudy Start
First participant enrolled
March 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2021
CompletedJanuary 3, 2022
December 1, 2021
4.9 years
September 7, 2015
December 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
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 Outcomes (5)
Side Effect frequency (number of side effect at each patient's visit for both groups)
1, 2,6 ans 12 months after inclusion
Prime boost strategy efficacity evaluation (number of responder in the PCV group)
6 months after inclusion
Long term immune response after vaccination
6 and 12 months after vaccination
Comparison between the 2 groups of the opsonophagocytosis activity of the antibodies produced
1, 2, 6 and 12 months after vaccination
Pneumococcal vaccination predictive factor identification
12 month after last patient inclusion
Study Arms (2)
pneumococcal polysaccharide vaccine
ACTIVE COMPARATORPatients are vaccinated vith Peumo23/Pneumovax on the first day. Abatacept started on frst day.
pneumococcal conjugate vaccine
ACTIVE COMPARATORPatients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later. Abatacept started on frst day.
Interventions
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.
Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.
Abatacept started on frst day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- age \< 18 or \> 85 year
- dementia
- patients subjects to legal protection measures
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- Bristol-Myers Squibbcollaborator
Study Sites (11)
CHRU de Montpellier
Montpellier, Hérault, 34295, France
CHU Nord
Amiens, 80054, France
CHU Pellegrin
Bordeaux, 33076, France
CHU Montpied
Clermont-Ferrand, 63000, France
CHU Bicêtre
Le Kremlin-Bicêtre, 94275, France
CHRU Roger Salengro
Lille, 59037, France
CHU Carémeau
Nîmes, 30029, France
CHU Orléans
Orléans, 45000, France
CHU La pitié salpétriere
Paris, 78013, France
CHU Hautepierre
Strasbourg, 67200, France
CHPG Monaco
Monaco, 98012, Monaco
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques Morel, MD PhD
CHRU de Montpellier
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2015
First Posted
September 11, 2015
Study Start
March 3, 2016
Primary Completion
January 18, 2021
Study Completion
January 18, 2021
Last Updated
January 3, 2022
Record last verified: 2021-12