NCT04166656

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Splenectomy

Interventions

Type	Name	Description
BIOLOGICAL	Trumenba®	Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.
BIOLOGICAL	Bexsero®	Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe

Timeline

• Start date: 2022-09-15
• Primary completion: 2028-09-01
• Completion: 2028-10-01
• First posted: 2019-11-18
• Last updated: 2025-11-20

Locations

1 site across 1 country: France