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Pneumococcal polysaccharide serotype 14 conjugated to CRM197 is an active component of pneumococcal conjugate vaccines (PCVs). These vaccines protect against infections caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus. The substance consists of the polysaccharide (sugar) coating from pneumococcal serotype 14 chemically linked (conjugated) to CRM197, a non-toxic carrier protein derived from diphtheria toxin. This conjugation helps the immune system, particularly in young children, to mount a stronger response against the polysaccharide.[3]
The substance is part of the authorised medicine Vaxneuvance, a 15-valent pneumococcal polysaccharide conjugate vaccine (adsorbed), which is authorised in the European Union under marketing authorisation number EU/1/21/1591/003.[1] It is also a component of an investigational 21-valent pneumococcal conjugate vaccine (PCV21) being developed to provide broader protection against additional pneumococcal serotypes.[1]
Pneumococcal polysaccharide serotype 14 conjugated to CRM197 works by stimulating the immune system to produce antibodies against the polysaccharide capsule of pneumococcal serotype 14. The CRM197 carrier protein enhances this immune response by converting the polysaccharide from a T-cell-independent antigen into a T-cell-dependent antigen. This produces a stronger and longer-lasting antibody response, including immune memory, which is particularly important in infants whose immune systems respond poorly to unconjugated polysaccharides.[3]
The antibodies generated against serotype 14 polysaccharide help the body recognise and eliminate pneumococcal bacteria bearing this serotype, thereby preventing invasive pneumococcal disease such as pneumonia, meningitis and bacteraemia, as well as non-invasive disease such as otitis media.[2]
Pneumococcal polysaccharide serotype 14 conjugated to CRM197 is given as part of a pneumococcal conjugate vaccine in the form of a suspension for injection. It is administered by intramuscular injection, typically in a 0.5 ml dose. In the authorised product Vaxneuvance, the vaccine is supplied in pre-filled syringes.[1] The Synflorix vaccine, which also contains pneumococcal polysaccharide serotype 14 (conjugated to protein D in that product), is likewise a suspension for injection for intramuscular use, available in pre-filled syringes or vials.[3]
One Phase 3 trial (EU CT number 2023-507600-32-00) is studying a 21-valent pneumococcal conjugate vaccine (PCV21) that contains pneumococcal polysaccharide serotype 14 conjugated to CRM197. The trial involves 1,113 healthy infants from approximately 2 months of age and is currently authorised.[1]
The trial aims to demonstrate that PCV21 is non-inferior to the existing 15-valent vaccine Vaxneuvance (15vPCV) for the shared serotypes between the two vaccines, including serotype 14. It also aims to demonstrate superiority of PCV21 for the six serotypes unique to PCV21. The primary outcomes are the seroresponse rate (the proportion of participants achieving a defined antibody response) and the IgG antibody concentration (geometric mean concentration, GMC) against the pneumococcal serotypes, measured 30 days after the toddler dose.[1]
The Phase 3 trial enrols healthy infants from approximately 2 months of age. The trial includes both full-term and preterm infants, with the vaccination schedule adjusted accordingly: full-term infants receive three doses before the toddler dose, while preterm infants receive four doses. Participants receive either the investigational PCV21 or the comparator 15-valent PCV (Vaxneuvance) by intramuscular injection.[1]
The supplementary sources provided do not contain specific side effect information for pneumococcal polysaccharide serotype 14 conjugated to CRM197. Side effect information is available in the product information for authorised vaccines containing this component, such as Vaxneuvance, but is not included in the data provided for this page.
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