title: Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects.
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.
  
  
  
  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.
  
  
  
  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 50 y of age and older, as well as Russian individuals 2 to 49 y of age who are at high risk for PD.
authors.affiliation: a Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Ciprero
authors.affiliation: b Moscow State University of Medicine and Dentistry , Moscow , Russian Federation.
authors.forename: Kirill A
authors.initials: KA
authors.lastname: Zykov
authors.affiliation: c I.M. Sechenov First Moscow State Medical University , Moscow , Russian Federation.
authors.forename: Nikolay I
authors.initials: NI
authors.lastname: Briko
authors.affiliation: a Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Tulin
authors.initials: T
authors.lastname: Shekar
authors.affiliation: a Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Tina M
authors.initials: TM
authors.lastname: Sterling
authors.affiliation: d Merck Sharp & Dohme (MSD) Pharmaceuticals LLC , Moscow , Russian Federation.
authors.forename: Elizaveta
authors.initials: E
authors.lastname: Bitieva
authors.affiliation: a Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Jon E
authors.initials: JE
authors.lastname: Stek
authors.affiliation: a Merck & Co., Inc. , Kenilworth , NJ , USA.
authors.forename: Luwy
authors.initials: L
authors.lastname: Musey
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D012426:Russia; D055815:Young Adult
chemical_list: C414006:23-valent pneumococcal capsular polysaccharide vaccine; D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines
keywords: Russian population; immunogenicity; pneumococcal polysaccharide vaccine; pneumococcal vaccine; safety