Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects. Issue 8 (2nd August 2016)

• Record Type: Journal Article
• Authors: Ciprero, Karen; Zykov, Kirill A.; Briko, Nikolay I.; Shekar, Tulin; Sterling, Tina M.; Bitieva, Elizaveta; Stek, Jon E.; Musey, Luwy
• Is Part Of: Human vaccines & immunotherapeutics. Volume 12:Issue 8(2016)
• Page Start: 2142
• Page End: 2147
• Publication Date: 2016-08-02
• Subjects: immunogenicity -- pneumococcal vaccine -- pneumococcal polysaccharide vaccine -- Russian population -- safety; Vaccines -- Periodicals; 615.372
• DOI: 10.1080/21645515.2016.1165373
• Languages: English
• ISSNs: 2164-5515

Abstract

ABSTRACT: 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 49 y of age with increased risk for PD or ≥50 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 14 days, respectively. Serious AEs were collected for 28 d postvaccination. Blood samples were collected immediately prior to vaccination and 28 d 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 50 y of age and older, as well as Russian individuals 2 to 49 y of age who are at high risk for PD.