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.
Approximately 100 subjects from the Russian Federation who were either 2 to 49Â y of age with increased risk for PD or =50Â years 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 14Â days, respectively. Serious AEs were collected for 28Â d postvaccination. Blood samples were collected immediately prior to vaccination and 28Â d postvaccination for the measurement of IgG to serotypes 1, 6B, 14, 19F, and 23F.
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.
PPV23 is generally safe, well tolerated, and highly immunogenic when given as a single dose to Russian individuals 50Â y of age and older, as well as Russian individuals 2 to 49Â y of age who are at high risk for PD.