BACKGROUND: Pneumococcal disease remains a public health priority in adults. Safety and immunogenicity of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) containing 13 serotypes included in 13-valent pneumococcal conjugate vaccine (PCV13) plus 2 additional serotypes (22F and 33F) were evaluated in adults ≥ 50 years (V114-006; NCT02547649). METHODS: A total of 690 subjects (230/arm) received a single dose of either PCV15 Formulation A, PCV15 Formulation B, or PCV13 and were followed for safety for 14 days postvaccination. Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) and Immunoglobulin G (IgG) geometric mean concentrations (GMCs) were measured immediately prior and 30 days postvaccination. RESULTS: Both PCV15 formulations had generally comparable safety profiles to PCV13. Baseline IgG GMCs and OPA GMTs were comparable across vaccination groups. At 30 days postvaccination, both PCV15 formulations induced serotype specific antibodies to all 15 serotypes in the vaccine. IgG GMCs and OPA GMTs in recipients of either PCV15 formulation were non-inferior (≤ 2-fold margin) to those measured in recipients of PCV13 for shared serotypes and superior (> 1.0-fold difference) for serotypes unique to PCV15. Formulation B generally induced higher immune responses than Formulation A. CONCLUSION: In healthy adults ≥ 50 years of age, both new formulations of PCV15 displayed acceptable safety profiles and induced serotype-specific immune responses comparable to PCV13.
RCT Entities:
BACKGROUND:Pneumococcal disease remains a public health priority in adults. Safety and immunogenicity of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) containing 13 serotypes included in 13-valent pneumococcal conjugate vaccine (PCV13) plus 2 additional serotypes (22F and 33F) were evaluated in adults ≥ 50 years (V114-006; NCT02547649). METHODS: A total of 690 subjects (230/arm) received a single dose of either PCV15 Formulation A, PCV15 Formulation B, or PCV13 and were followed for safety for 14 days postvaccination. Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) and Immunoglobulin G (IgG) geometric mean concentrations (GMCs) were measured immediately prior and 30 days postvaccination. RESULTS: Both PCV15 formulations had generally comparable safety profiles to PCV13. Baseline IgG GMCs and OPA GMTs were comparable across vaccination groups. At 30 days postvaccination, both PCV15 formulations induced serotype specific antibodies to all 15 serotypes in the vaccine. IgG GMCs and OPA GMTs in recipients of either PCV15 formulation were non-inferior (≤ 2-fold margin) to those measured in recipients of PCV13 for shared serotypes and superior (> 1.0-fold difference) for serotypes unique to PCV15. Formulation B generally induced higher immune responses than Formulation A. CONCLUSION: In healthy adults ≥ 50 years of age, both new formulations of PCV15 displayed acceptable safety profiles and induced serotype-specific immune responses comparable to PCV13.
Authors: Alan Basset; Emma Wall; Daniela M Ferreira; Richard Malley; Elena Mitsi; Chloe Deshusses; Raecliffe Daly; Sherin Pojar; Jesús Reiné; Jose Afonso Guerra-Assuncao; Brigitte Denis; Simon P Jochems; Robert Heyderman; Jeremy Brown; Ying-Jie Lu Journal: Infect Immun Date: 2022-06-08 Impact factor: 3.609
Authors: Amgad Gamil; Miriam Y Lalas; Maria Rosario Z Capeding; Anna Lisa T Ong-Lim; Mary Ann C Bunyi; Angelica M Claveria Journal: Infect Dis Ther Date: 2021-04-24
Authors: Raul Isturiz; Lindsay Grant; Sharon Gray; Ronika Alexander-Parrish; Qin Jiang; Luis Jodar; Paula Peyrani; Kimbal D Ford; Michael W Pride; Wesley H Self; Francis Counselman; Gregory Volturo; Luis Ostrosky-Zeichner; Richard G Wunderink; Robert Sherwin; J Scott Overcash; Thomas File; Julio Ramirez Journal: Clin Infect Dis Date: 2021-10-05 Impact factor: 20.999
Authors: Heather L Platt; David Greenberg; Bruce Tapiero; Robert A Clifford; Nicola P Klein; David C Hurley; Tulin Shekar; Jianing Li; Kim Hurtado; Shu-Chih Su; Katrina M Nolan; Camilo J Acosta; Richard D McFetridge; Kara Bickham; Luwy K Musey Journal: Pediatr Infect Dis J Date: 2020-08 Impact factor: 3.806