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

Splenectomy Clinical Trial

Official title: Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Currently, in France, no immunogenicity data on Meningococcal B vaccines, neither with Bexsero® nor with Trumenba®, are available in asplenic patients, population at high risk of infection.

As asplenic individuals (all causes) show less optimal immune response to conjugate meningococcal C vaccine compared to matched controls. [4], we hypothesize that a similar less optimal response may be expected for MenB vaccines among asplenic subjects. .

That is why, we proposed in this study to evaluate two reinforced strategies with 3 administrations (M0, M1, and M6) of Bexsero® or Trumenba ®. Moreover, the study will also allow exploring the persistence of the immune response in this population. Indeed, few data are available on this persistence in the general population. ;

Related Conditions & MeSH terms

• Splenectomy

• NCT number: NCT04166656
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Odile LAUNAY, MD,PhD
• Phone: +33(01)58 41 28 58
• Email: odile.launay@aphp.fr
• Status: Recruiting
• Phase: Phase 3
• Start date: September 15, 2022
• Completion date: October 2028