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NMBPBAS1 is an investigational vaccine component. It is part of a fixed combination product called MenPenta, which is being developed as a pentavalent meningococcal ABCYW vaccine.[1] The substance belongs to the therapeutic area of bacterial infections and mycoses.[1] In the product records, NMBPBAS1 appears together with other meningococcal polysaccharide conjugate components, including serogroup A, C, W-135, and Y polysaccharides conjugated to tetanus toxoid carrier protein.[1] Other names for the substance in the registry include RNMB1, RNMB2, and RNMB3.[1] NMBPBAS1 has no marketing authorisation in the product records and remains an investigational substance.[1] The manufacturer is Sanofi Pasteur Inc.[1]
The registry data do not describe the exact molecular mechanism of NMBPBAS1. As part of a conjugate vaccine, the meningococcal polysaccharides are linked to a tetanus toxoid carrier protein. Conjugate vaccines are designed to help the immune system recognise and respond to the bacterial polysaccharides. The trial measures whether the vaccine produces antibodies against meningococcal serogroups A, B, C, W, and Y using a test called hSBA (serum bactericidal antibody assay).[1]
NMBPBAS1 is part of MenPenta, which is a suspension for injection. The route of administration is intramuscular injection.[1] In the trial, MenPenta SD and MenPenta fHD are given as 0.5 millilitre injections.[1]
One Phase 2 trial is registered in the EU Clinical Trials Information System. The trial is authorised and plans to enrol 750 participants.[1] It is an interventional study that tests the MenPenta vaccine formulations in healthy children, toddlers, and infants.[1] The trial compares MenPenta with several licensed vaccines, including Nimenrix, Bexsero, MenQuadfi, Hexyon, Prevenar 13, and RotaTeq.[1]
The main outcomes measured include the number of participants with immediate adverse events, solicited injection site reactions, systemic reactions, unsolicited adverse events, and serious adverse events.[1] The trial also measures the immune response using hSBA antibody titers and seroresponse against meningococcal serogroups A, B, C, W, and Y at several time points.[1]
The trial enrols healthy children, toddlers, and infants. The study is divided into three stages: Stage 1 for children, Stage 2 for toddlers, and Stage 3 for infants.[1] In Stage 3, infants receive the second dose at approximately 4 months of age and the third dose at 12 to 15 months of age.[1]
The registry record does not provide a list of known side effects for NMBPBAS1. The Phase 2 trial is designed to measure safety, including solicited injection site reactions, systemic reactions, unsolicited adverse events, and serious adverse events.[1]
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