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Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients

NCT02547493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-01-03

No results posted yet for this study

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®).

Conditions

Interventions

BIOLOGICAL

pneumococcal polysaccharide vaccine

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.

BIOLOGICAL

pneumococcal conjugate vaccine

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

DRUG

Abatacept

Abatacept started on frst day

Sponsors & Collaborators

Principal Investigators

  • Jacques Morel, MD PhD · CHRU de Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-03
Primary Completion
2021-01-18
Completion
2021-01-18

Countries

  • France
  • Monaco

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02547493 on ClinicalTrials.gov