Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects

Pneumococcal infection is a major cause of pneumonia, bacteremia, and meningitis. Incidence of pneumococcal disease (PD) varies worldwide. The 23-valent pneumococcal polysaccharide vaccine (PPV23) displays an acceptable safety profile and has been demonstrated cost-effective in reducing burden of PD.Methods: Approximately 100 subjects from the Russian Federation who were either 2 to 49y of age with increased risk for PD or 50years of age were enrolled into the study (NCT01734239) to receive a single dose of PPV23 administered intramuscularly. Each subject was followed for local and systemic adverse events (AEs) for 5 and 14days, respectively. Serious AEs were collected for 28d postvaccination. Blood samples were collected immediately prior to vaccination and 28d postvaccination for the measurement of IgG to serotypes 1, 6B, 14, 19F, and 23F.Results: High proportion of subjects had 2 -fold increase in IgG following receipt of PPV23. Rates were 92.0%, 83.0%, 89.0%, 81%, 84% for serotypes 1, 6B, 14, 19F, and 23F, respectively. Similar rates of responders and increases in the magnitude of immune responses were observed in both age groups (2-49, 50 ). PPV23 was generally safe and well tolerated. Injection site and systemic AEs were reported by 14.7% and 18.6% of study subjects, respectively.Conclusions: PPV23 is generally safe, well tolerated, and highly immunogenic when given as a single dose to Russian individuals 50y of age and older, as well as Russian individuals 2 to 49y of age who are at high risk for PD.