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Phase 1 trial of a 13-valent pneumococcal conjugate vaccine in healthy adults
Authors:Scott Daniel A  Komjathy Steven F  Hu Branda T  Baker Sherryl  Supan Lois A  Monahan Carol A  Gruber William  Siber George R  Lockhart Stephen P
Affiliation:Wyeth Vaccines Research, 401 N. Middletown Road, Pearl River, NY 10965, USA.
Abstract:In a Phase 1 study, 15 healthy subjects were randomized to receive a 13-valent pneumococcal conjugate vaccine (PCV13) and 15 to receive a 23-valent pneumococcal polysaccharide vaccine (23vPS). Antibody responses were measured immediately before and approximately one month after vaccination. Serotype-specific antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) for immunoglobulin G (IgG) and an opsonophagocytic assay (OPA) for functional antibodies. PCV13 was as immunogenic or more immunogenic than 23vPS and was well tolerated.
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