Phase 3 Study Comparing Three Meningococcal B Vaccine Strategies in Adults with Asplenia to Evaluate Immune Response and Safety

What this Trial Is About

This research aims to evaluate the immune response and tolerance of three different vaccine strategies against meningococcus B in adults with asplenia, a condition where the spleen is absent or not functioning. Asplenic patients are at high risk for this serious infection, and data on how well meningococcal B vaccines work in this group are currently lacking. The study also explores how long the immune response lasts in these patients, as little is known about this in the general population. Participants will receive one of three vaccine schedules involving either Trumenba4 or Bexsero4 vaccines. Two schedules include three doses administered at months 0, 1, and 6, while one schedule involves two doses given one month apart. Vaccines are given by intramuscular injection. The study compares these different strategies to assess which provides the best immune response and safety profile. During the study, participants will be followed for four years to monitor their immune response and safety. Blood samples will be collected to measure antibody levels one month after completing vaccinations and at several points up to 48 months. Researchers will also record any adverse events within a week after each vaccination and track overall safety and vaccine effectiveness throughout the study. The main measurement is the proportion of participants who develop a strong immune response one month after the full vaccine course.

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