Study of the Safety and Immune Response to Meningococcal B Vaccine Bexsero in Adults with No Spleen Compared to Healthy Adults

What this Trial Is About

Patients without a spleen have a higher risk of serious infections from certain bacteria, especially meningococcal bacteria of serogroup B, which is common in Europe. This research evaluates the meningococcal B vaccine called BEXSERO4 in adults with asplenia compared to healthy adults. The goal is to understand how well the vaccine triggers immune responses and to gather safety information for this high-risk group. Participants include 40 patients without a spleen and 40 healthy controls, each receiving two doses of BEXSERO4 injected into the muscle, spaced one month apart. The study includes four visits before vaccination, one month after the second dose, and six months later. Researchers will measure immune responses using blood tests that detect antibodies and assess immune cell activity. The study also tracks any adverse reactions after vaccination. During the study, participants will provide blood samples to measure antibody levels against three meningococcal strains using a special laboratory assay considered the gold standard. The study evaluates both antibody levels and cellular immune responses. Safety is monitored by documenting all side effects. The study lasts at least six months after vaccination to observe the persistence of immunity and overall vaccine safety in this population.

Meningococcal B Vaccine in Patients with Asplenia