Overview

Innovative Anti-pneumococcal Vaccine Strategies in Patients With ANCA-associated Vasculitis Receiving Rituximab Therapy

Status:
Active, not recruiting

Trial end date:
2021-11-01

Target enrollment:

Participant gender:

Summary

The study hypothesis is that a "reinforced" pneumococcal combined vaccine strategy in patients with ANCA-associated vasculitides treated with rituximab will induce a better immune response than the current standard regimen, with an acceptable safety profile. This study therefore aims at evaluating the immunogenicity and safety of two "reinforced" innovative pneumococcal vaccine regimen [one double dose at day0 and one double dose at day7 or a quadruple dose of 13-valent anti-pneumococcal conjugate vaccine (PCV13) followed by one dose of 23-valent unconjugated vaccine (PPV23) at month 5], compared to the standard regimen (one dose of PCV13 followed by one dose of PPV23 at month 5), in patients with ANCA-associated vasculitides receiving rituximab therapy.

Phase:

Phase 2

Details

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborators:

CIC 1417 Cochin-Pasteur
CIC Cochin-Pasteur
EUCLID Clinical Trial Platform
EUCLID Clinical Trials Platform
Groupe Français d'Etude des Vascularites (GFEV)
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
URC/CIC Cochin-Necker

Treatments:

Heptavalent Pneumococcal Conjugate Vaccine
Rituximab
Vaccines