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®).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
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
CHRU de Montpellier
Montpellier, Hérault, France
CHU Nord
Amiens, France
CHU Pellegrin
Bordeaux, France
CHU Montpied
Clermont-Ferrand, France
CHU Bicêtre
Le Kremlin-Bicêtre, France
CHRU Roger Salengro
Lille, France
CHU Carémeau
Nîmes, France
CHU Orléans
Orléans, France
CHU La pitié salpétriere
Paris, France
CHU Hautepierre
Strasbourg, France
...and 1 more locations
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.
Time frame: 1 month after vaccination
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
Time frame: 1, 2,6 ans 12 months after inclusion
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
Time frame: 6 months after inclusion
Long term immune response after vaccination
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
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
Time frame: 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
Time frame: 12 month after last patient inclusion
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