Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.

ConditionSplenectomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.

Eligibility criteria

Qualifiers

Male or female, >=18 to <=75 years old.

Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film

Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up

Women of childbearing age must have an effective contraception during the first 9 months of the study.

Disqualifiers

History of meningococcal vaccination B.

History of anaphylaxis post vaccination.

Known allergy to any components (active substances or excipients) of both vaccines.

Patients who cannot stop antibiotics 3 days before blood collection.

Trial design

Treatments tested in this trial

  • Trumenba®
  • Bexsero®

Treatment groups

84 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

EUCLID Clinical Trial Platform

Collaborator

Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

Collaborator

CIC 1417 Cochin-Pasteur

Collaborator

Innovative clinical research in vaccinologie (I-REIVAC)

Collaborator

Institut Pasteur

Collaborator

URC-CIC Paris Descartes Necker Cochin

Collaborator