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N. meningitidis group W135 oligosaccharide conjugated CRM197 is a sugar molecule (oligosaccharide) from the outer coating of the bacterium Neisseria meningitidis serogroup W135, chemically linked to a non-toxic protein called CRM197 derived from Corynebacterium diphtheriae. The full registry name describes it as part of a combined antigen preparation together with meningococcal group Y oligosaccharide, group C polysaccharide and group A oligosaccharide, all conjugated to CRM197.[2] This substance is not given on its own; it is one component of multivalent meningococcal conjugate vaccines. The authorised product containing this component is Menveo, a vaccine for protection against four meningococcal serogroups: A, C, W-135 and Y.[4] In the NHS dictionary of medicines, the component is listed under the name "Meningococcal group W135 oligosaccharide protein conjugate".[5] Menveo received initial approval from the United States Food and Drug Administration (FDA) in 2010.[4]
Meningococcal conjugate vaccines work by presenting the bacterial sugar (oligosaccharide) to the immune system attached to a carrier protein, in this case CRM197. This linkage helps the immune system recognise the sugar and produce antibodies against it. The antibodies generated against the W135 oligosaccharide are intended to protect against invasive meningococcal disease caused by Neisseria meningitidis serogroup W135. The FDA label for Menveo states that the vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by serogroups A, C, Y, and W-135 in individuals 2 months through 55 years of age.[4] The vaccine does not prevent N. meningitidis serogroup B infections, because serogroup B has a different outer sugar structure that is not included in this vaccine.[4]
The substance is used as part of vaccines against invasive meningococcal disease. In the clinical trial records, it appears in studies of the following conditions:
The therapeutic area recorded in the registry for the substance is nervous system diseases, reflecting the focus on meningitis, an infection of the nervous system.[3] The substance also appears in a trial investigating generalised myasthenia gravis and ocular myasthenia gravis, where the Menveo vaccine containing this component is used as an auxiliary medicine alongside an investigational drug, not as the treatment under study.[1]
The substance is given as part of a vaccine by intramuscular injection. In the registry, the pharmaceutical form is recorded as a solution for injection and the route of administration as intramuscular use.[3] The Menveo product is supplied either as two vials that must be combined before administration (one vial with the MenCYW-135 liquid conjugate component and one vial with the MenA lyophilised conjugate component) or as a single vial that does not require reconstitution. The single-vial presentation is for use in individuals 10 through 55 years of age, while the two-vial presentation is for use in individuals 2 months through 55 years of age. The vaccine is given as a 0.5 mL intramuscular injection.[4]
Three clinical trials in the registry involve this substance. One trial is authorised but not yet completed, one is authorised and ongoing, and one has been completed. The substance appears in these trials as part of investigational combination vaccines and as an authorised comparator vaccine.
Two trials focus on meningococcal disease. The Phase 2 trial NCT05087056 is studying a MenABCWY combination vaccine in healthy adolescents, with the aim of describing safety, tolerability and immunogenicity on different dosing schedules.[3] The completed Phase 1 trial NCT05082285 evaluated two formulations of a MenABCWY second-generation vaccine, a first-generation MenABCWY vaccine, a MenB vaccine and a MenACWY-TT vaccine in the context of meningococcal infections.[2] The third trial, 2025-522406-20-00, investigates the drug IM-101 in generalised and ocular myasthenia gravis; in this trial, Menveo containing the W135 component is used as an auxiliary vaccine.[1]
The trial 2025-522406-20-00 is a Phase 1b/2 study recorded as authorised, with 135 participants planned.[1] The Phase 2 trial NCT05087056 is authorised, with 300 participants planned.[3] The Phase 1 trial NCT05082285 is completed, with 703 participants enrolled.[2] The substance itself is recorded as an auxiliary medicine in one trial and as a component of investigational vaccines in the other two records.
The meningococcal vaccine trials measure immune responses using a test called the human serum bactericidal assay (hSBA), which checks whether antibodies in the blood can kill the meningococcal bacteria. The Phase 2 trial measures the percentage of participants with hSBA titres at or above the lower limit of quantitation for each serogroup B indicator strain at baseline and one month after the second dose, as well as solicited administration site and systemic events during the 7 days after each vaccination.[3] The completed Phase 1 trial measured hSBA titres and geometric mean titres for each A, C, W and Y serogroup and each serogroup B indicator strain at several time points after vaccination.[2] The myasthenia gravis trial measures safety outcomes including treatment-emergent adverse events and serious adverse events, and efficacy outcomes using the MG-ADL total score and the MGII ocular score.[1]
The Phase 2 trial NCT05087056 enrols healthy adolescents.[3] The completed Phase 1 trial also enrolled paediatric participants, based on the inclusion of vaccines such as Rotarix and Infanrix hexa in the study.[2] The myasthenia gravis trial enrols adult participants with AChR antibody-positive generalised myasthenia gravis, AChR antibody-negative generalised myasthenia gravis, and ocular myasthenia gravis.[1]
The FDA label for Menveo, the authorised vaccine containing this component, describes the safety profile of the full vaccine. The trials in the registry measure solicited administration site and systemic events during the 7 days after each vaccination, as well as unsolicited adverse events, serious adverse events and adverse events of special interest during the 30 days after vaccination and beyond.[3][2] The prescribing information for Menveo provides detailed safety information for the complete four-component vaccine.[4] The FDA resources page for the meningococcal oligosaccharide diphtheria CRM197 conjugate vaccine confirms that Menveo is licensed for use in the United States.[6]
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