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Pneumococcal polysaccharide serotype 6B conjugated to CRM197 is a vaccine component. It consists of the capsular polysaccharide from Streptococcus pneumoniae serotype 6B, chemically linked (conjugated) to a carrier protein called CRM197, which is a non-toxic variant of diphtheria toxin.[2] The registry name for this substance in the EU Clinical Trials Information System lists it as one of 21 pneumococcal polysaccharide serotypes conjugated to CRM197, including serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.[1]
The substance is part of fixed combination products: in two product records it is listed as a component of a pneumococcal conjugate vaccine along with other serotypes.[1] The product names associated with these records are Pneumococcal Conjugate Vaccine (PCV) and Vaxneuvance, the latter being a 15-valent pneumococcal polysaccharide conjugate vaccine that is already authorised in the European Union under authorisation number EU/1/21/1591/003.[1] The marketing authorisation holders are Sanofi Pasteur Inc. and Merck Sharp & Dohme B.V.[1]
A paediatric investigation plan for a related 15-valent conjugate vaccine containing this substance has been agreed with the UK Medicines and Healthcare products Regulatory Agency (MHRA), covering prevention of disease caused by Streptococcus pneumoniae.[2]
Pneumococcal conjugate vaccines work by presenting the sugar coating (capsular polysaccharide) of the pneumococcal bacterium to the immune system. By linking the polysaccharide to the CRM197 carrier protein, the vaccine turns a weak immune stimulus into a strong one: the immune system recognises the protein and, in doing so, also learns to recognise the attached polysaccharide.[2] This produces antibodies of the immunoglobulin G (IgG) type that are specific for each pneumococcal serotype included in the vaccine. In the Phase 3 trial, the antibody response is measured as the seroresponse rate — the proportion of infants who develop a sufficient antibody response — and as the geometric mean concentration (GMC) of serotype-specific IgG antibodies.[1]
Streptococcus pneumoniae is a bacterium whose outer capsule exists in many different serotypes, and immunity against one serotype does not necessarily protect against another. That is why vaccines include polysaccharides from multiple serotypes.[4]
The substance is formulated as a suspension for injection and is given by intramuscular injection.[1] In the authorised product Synflorix, which contains pneumococcal polysaccharide serotype 6B conjugated to a different carrier protein (protein D from Haemophilus influenzae), one 0.5 ml dose contains 1 microgram of serotype 6B polysaccharide.[3] In the Phase 3 trial, the study vaccine is given as a 0.5 ml intramuscular injection in a pre-filled syringe.[1] A paediatric formulation is available: the substance is included in two product records with paediatric formulations.[1]
One Phase 3 trial in the EU Clinical Trials Information System investigates this substance as part of a 21-valent pneumococcal conjugate vaccine (PCV21).[1] The trial is authorised and plans to enrol 1,113 healthy infants from approximately 2 months of age.[1] In this trial, the substance appears both as the test product and as a comparator: PCV21 is compared with the authorised 15-valent vaccine Vaxneuvance.[1]
The main goal of the trial is to show that PCV21 produces an antibody response that is non-inferior to Vaxneuvance for the 15 serotypes the two vaccines share, and superior for the 6 serotypes that are unique to PCV21.[1] These responses are assessed 30 days after the toddler dose, using the seroresponse rate and the geometric mean concentration of IgG antibodies.[1]
The trial includes both full-term and preterm infants; the toddler dose is the third dose for full-term infants and the fourth dose for preterm infants.[1]
The supplementary sources provided for this page do not include a side-effect profile specific to pneumococcal polysaccharide serotype 6B conjugated to CRM197. The trial record and the product information documents supplied do not list adverse reactions for this substance.[3][2]
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