Karen Ciprero1, Kirill A Zykov2, Nikolay I Briko3, Tulin Shekar1, Tina M Sterling1, Elizaveta Bitieva4, Jon E Stek1, Luwy Musey1. 1. a Merck & Co., Inc. , Kenilworth , NJ , USA. 2. b Moscow State University of Medicine and Dentistry , Moscow , Russian Federation. 3. c I.M. Sechenov First Moscow State Medical University , Moscow , Russian Federation. 4. d Merck Sharp & Dohme (MSD) Pharmaceuticals LLC , Moscow , Russian Federation.
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.
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.
Authors: K A Robinson; W Baughman; G Rothrock; N L Barrett; M Pass; C Lexau; B Damaske; K Stefonek; B Barnes; J Patterson; E R Zell; A Schuchat; C G Whitney Journal: JAMA Date: 2001-04-04 Impact factor: 56.272
Authors: A Ortqvist; J Hedlund; L A Burman; E Elbel; M Höfer; M Leinonen; I Lindblad; B Sundelöf; M Kalin Journal: Lancet Date: 1998-02-07 Impact factor: 79.321
Authors: Susan B Manoff; Charles Liss; Michael J Caulfield; Rocio D Marchese; Jeffrey Silber; John Boslego; Sandra Romero-Steiner; Gowrisankar Rajam; Nina E Glass; Cynthia G Whitney; George M Carlone Journal: J Infect Dis Date: 2010-02-15 Impact factor: 5.226
Authors: Lisa A Jackson; Kathleen M Neuzil; Onchee Yu; Patti Benson; William E Barlow; Annette L Adams; Christi A Hanson; Lisa D Mahoney; David K Shay; William W Thompson Journal: N Engl J Med Date: 2003-05-01 Impact factor: 91.245
Authors: E D Shapiro; A T Berg; R Austrian; D Schroeder; V Parcells; A Margolis; R K Adair; J D Clemens Journal: N Engl J Med Date: 1991-11-21 Impact factor: 91.245
Authors: Redouane Abouqal; Maher Beji; Mohamed Chakroun; Kamal Marhoum El Filali; Jihane Rammaoui; Hela Zaghden Journal: Front Public Health Date: 2022-07-01
Authors: Tom Houben; Inês Magro Dos Reis; Yvonne Oligschlaeger; Hellen Steinbusch; Marion J J Gijbels; Tim Hendrikx; Christoph J Binder; David Cassiman; Marit Westerterp; Jos Prickaerts; Ronit Shiri-Sverdlov Journal: Front Immunol Date: 2019-01-07 Impact factor: 7.561