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N. meningitidis group A oligosaccharide conjugated CRM197 is a bacterial sugar (oligosaccharide) from Neisseria meningitidis serogroup A, chemically linked to a carrier protein called CRM197. The full registry name in the CTIS product records is "meningococcal group Y oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein, N. meningitidis group C (strain C11) polysaccharide conjugated CRM197, N. meningitidis group A oligosaccharide conjugated CRM197, N. meningitidis group W135 oligosaccharide conjugated CRM197".[3]
The substance is a component of the authorised vaccine Menveo (meningococcal group A, C, W-135 and Y conjugate vaccine), which is marketed by GSK Vaccines S.R.L. under authorisation record EU/1/10/614/003.[3][2] In the US, the FDA describes Menveo as a meningococcal oligosaccharide diphtheria CRM197 conjugate vaccine licensed for use.[4] The FDA's UNII database lists "Neisseria meningitidis group A capsular oligosaccharide diphtheria CRM197 protein conjugate antigen" as a synonym for the Menveo component, with the UNII code 3O44U6XYQK.[5]
Meningococcal conjugate vaccines such as Menveo work by chemically linking bacterial polysaccharides (sugars from the capsule of the bacterium) to a carrier protein, in this case CRM197. According to a review published in Human Vaccines & Immunotherapeutics, this conjugation enables a T-cell dependent immune response, which induces immune memory and a booster response after repeated immunisation — a significant advantage over pure polysaccharide vaccines.[6] The review also notes that the carrier protein is not the sole determining factor of the vaccine's profile; the conjugate vaccine's immunogenicity results from multiple physico-chemical structures and characteristics.[6]
In the CTIS product records, the substance is described as a solution for injection for intramuscular use — meaning it is injected into a muscle.[3] As part of Menveo, it is given as a powder and solvent for solution for injection in a pre-filled syringe.[3] In the trials listed here, the MenABCWY combination vaccines containing this substance are given by intramuscular injection, with a volume of 0.5 ml reported in one trial.[3]
Three clinical trials in the registry involve this substance. Two of them investigate MenABCWY combination vaccines for meningococcal disease, and one uses Menveo as an auxiliary vaccine in a study of an investigational medicine for myasthenia gravis.
The trials measure immune responses using the human serum bactericidal assay (hSBA), which checks whether antibodies in the blood can kill meningococcal bacteria. The primary outcomes include the percentage of participants with hSBA titres at or above the lower limit of quantitation (LLOQ) for each serogroup, and geometric mean titres (GMTs), which describe the average antibody level.[3][2] Safety is assessed through solicited local and systemic reactions during the 7 days after each vaccination, and unsolicited adverse events, serious adverse events, and adverse events of special interest during longer follow-up periods.[3][2]
The two meningococcal vaccine trials enrolled healthy adolescents (NCT05087056, 300 participants) and participants in a broader age range in the Phase 1 study (NCT05082285, 703 participants).[3][2] The myasthenia gravis trial enrolled adults with AChR antibody-positive generalised myasthenia gravis, AChR antibody-negative generalised myasthenia gravis, and ocular myasthenia gravis.[1] The Menveo vaccine containing this substance is given as an auxiliary medicine in that trial, alongside the investigational drug IM-101 or placebo.[1]
The supplementary sources provided do not list side effects for this specific substance. The trials themselves measure solicited administration site and systemic events during the 7 days after vaccination, as well as unsolicited adverse events and serious adverse events, but no results are reported in the registry records.[3][2]
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