Safety, tolerability, and immunogenicity of a 31-valent pneumococcal conjugate vaccine (VAX-31) in healthy adults aged 50 years and older from the USA: a phase 1/2, double-blinded, active-controlled,
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- VAX-31, a 31-valent pneumococcal conjugate vaccine, was evaluated for safety, tolerability, and immunogenicity in healthy adults aged 50+ in a phase 1/2 clinical trial.
- The study was double-blinded, active-controlled, and randomized, comparing low, mid, and high doses of VAX-31 against PCV20.
- Primary safety outcomes included solicited and unsolicited adverse events, with most being mild or moderate. Serious adverse events were rare and unrelated to the vaccine.
- Immunogenicity was assessed via OPA GMTs and IgG concentrations, with VAX-31 meeting non-inferiority criteria for shared serotypes and superiority for unique serotypes.
- VAX-31 demonstrated robust immune responses across all 31 serotypes, suggesting potential for broad-spectrum coverage against pneumococcal disease.
- The study supports further phase 3 evaluation of VAX-31 for public health and vaccination policy implications.