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

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.

Conditions

• Invasive Pneumococcal Infection

Interventions

BIOLOGICAL

PCV13

one dose of PCV13 at D0 (arm A) or two double doses at D0 and D7 (Arm B) or one quadruple dose at D0 (arm C)

BIOLOGICAL

PPV23

one dose of PPV23 at M5

DRUG

Rituximab

375 mg/m2/week for 4 consecutive weeks, at Days 0 ± 2 days, Day 7 ± 2 days, Day 14 ± 2 days and Day 21 ± 2 days, as induction therapy of vasculitis flare, followed by 500 mg-rituximab infusion every 6 months as maintenance therapy, i.e. at Month 6, Month 12 and Month 18

Sponsors & Collaborators

• EUCLID Clinical Trial Platform

  collaborator OTHER

• Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

  collaborator OTHER

• CIC 1417 Cochin-Pasteur

  collaborator OTHER

• Groupe Français d'Etude des Vascularites (GFEV)

  collaborator UNKNOWN

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Benjamin TERRIER, MD, PhD · Pôle de Médecine Interne, Centre de référence " Maladies systémiques et autoimmunes rares, en particulier Vascularites nécrosantes et Sclérodermies systémiques " Hôpital Cochin, Assistance Publique-Hôpitaux de Paris

• Fréderic BATTEUX, PhD · Laboratoire d'Immunologie Plateforme d'immunomonitoring vaccinal Hôpital Cochin, Assistance Publique-Hôpitaux de Paris

• Odile LAUNAY, MD, PhD · Centre d'Investigation Clinique Cochin Pasteur Hôpital Cochin, Assistance Publique-Hôpitaux de Paris

• Matthieu GROH, MD · Hôpital Foch

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-05

Primary Completion

2020-11-24

Completion

2021-11-21

Countries

• France

Study Locations