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N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE CONJUGATED CRM197 is a bacterial polysaccharide from Neisseria meningitidis serogroup C that is chemically linked (conjugated) to the CRM197 carrier protein, a non-toxic variant of diphtheria toxin. This conjugation turns the polysaccharide into a vaccine antigen that can generate a strong immune response, including immune memory.[4] The substance is a component of the authorised vaccine Menveo, a meningococcal group A, C, W-135 and Y conjugate vaccine held by GSK Vaccines S.R.L.[3] In the registry records it appears as part of a fixed combination product with serogroup A, W135 and Y oligosaccharides.[3]
The group C polysaccharide is recognised by the immune system as a foreign structure on the surface of Neisseria meningitidis. By linking this polysaccharide to the CRM197 protein, the vaccine enables the body to produce bactericidal antibodies that can kill the bacteria and neutralise diphtheria toxin. A 2005 study in volunteers showed that nasal administration of the serogroup C polysaccharide-CRM197 conjugate vaccine induced protective serum meningococcal bactericidal antibodies, diphtheria-neutralising antibodies and mucosal immunoglobulin A.[4] In the registered trials, the immune response is measured with the human serum bactericidal assay (hSBA), which tests whether antibodies in the blood can kill meningococcal bacteria.[3]
The substance is formulated as a solution for injection and is given by intramuscular use.[3] In the authorised product Menveo, it is provided as a powder and solution for solution for injection.[3] In the clinical trials, the MenABCWY investigational vaccines containing this substance are also administered intramuscularly.[3][2]
The registry contains 3 trials involving this substance. Two trials investigate MenABCWY combination vaccines for meningococcal disease prevention, and one trial uses a meningococcal vaccine as an auxiliary medicine in a myasthenia gravis study.
The meningococcal trials measure the percentage of participants with hSBA titres at or above the lower limit of quantitation for each serogroup, including serogroup B indicator strains and serogroups A, C, W and Y.[3][2] They also record solicited administration site and systemic events during the 7 days after each vaccination, unsolicited adverse events, serious adverse events, medically attended adverse events and adverse events of special interest.[3][2] The myasthenia gravis trial measures treatment-emergent adverse events, serious adverse events and changes in the MG-ADL total score for generalized myasthenia gravis and the MGII ocular score for ocular myasthenia gravis.[1]
The phase 2 MenABCWY trial NCT05087056 enrolls healthy adolescents.[3] The completed phase 1 trial NCT05082285 does not specify age restrictions in the registry record but evaluates the vaccine in a general population.[2] The myasthenia gravis trial 2025-522406-20-00 enrolls adult participants with AChR antibody-positive generalized myasthenia gravis, AChR antibody-negative generalized myasthenia gravis or ocular myasthenia gravis.[1]
The 2005 volunteer study of the serogroup C polysaccharide-CRM197 conjugate vaccine administered nasally reported the induction of protective antibodies and mucosal immunoglobulin A, but the provided source does not describe specific side effects in detail.[4] The clinical trial protocols for the MenABCWY vaccines include systematic collection of solicited administration site reactions such as pain, redness and swelling, and systemic events such as fever, during the 7 days after each vaccination.[3][2]
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