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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pneumococcal polysaccharide vaccine | Active Comparator | Patients are vaccinated vith Peumo23/Pneumovax on the first day. Abatacept started on frst day. |
|
| pneumococcal conjugate vaccine | Active Comparator | Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later. Abatacept started on frst day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pneumococcal polysaccharide vaccine | Biological | 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. |
| 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1, 2,6 ans 12 months after inclusion |
| Prime boost strategy efficacity evaluation (number of responder in the PCV group) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Morel, MD PhD | CHRU de Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Montpellier | Montpellier | Hérault | 34295 | France | ||
| CHU Nord |
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|
|
| pneumococcal conjugate vaccine | Biological | Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later. |
|
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| Abatacept | Drug | Abatacept started on frst day |
|
|
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 | 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 | 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 | 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 |
| 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| C538862 | 13-valent pneumococcal vaccine |
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
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