title: Essential criteria for evaluation of pneumococcal conjugate vaccine candidates.
abstract: In 2003, the World Health Organization recommended a concentration of enzyme-linked immunosorbent assay (ELISA) immunoglobulin G (IgG) anti-capsular antibody of 0.35 microg/mL as a reference value that correlates to protection against invasive pneumococcal disease. This threshold can be used to demonstrate immunologic non-inferiority of a new vaccine in comparison trials that use pneumococcal conjugate vaccines (PCVs) as a comparator. An investigational 13-valent PCV (PCV13) compared with seven-valent PCV (PCV7) demonstrated that all of the pneumococcal serotypes contained in PCV13 were immunogenic, with 88-98% of vaccinees achieving antibody concentration > or = 0.35 microg/mL for serotypes shared with PCV7 and >96% for six additional serotypes.
authors.affiliation: Wyeth Vaccines, Wyeth Pharmaceuticals, 500 Arcola Road, Collegeville, PA 19426, USA. paradipr@wyeth.com
authors.forename: Peter
authors.initials: P
authors.lastname: Paradiso
mesh_terms: D000907:Antibodies, Bacterial / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology; D011008:Pneumococcal Infections / Q000276:immunology / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000276:immunology*; D012016:Reference Values; D018074:Vaccines, Conjugate / Q000276:immunology; D014944:World Health Organization
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate