Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients

• Status: Completed
• Trial end date: 2021-01-18
• Target enrollment: 0
• Participant gender: All

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®).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Collaborator: Bristol-Myers Squibb
• Treatments: Abatacept; Heptavalent Pneumococcal Conjugate Vaccine; Vaccines

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.