A randomized phase I study of the safety and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults

M.D. Nissen, H.S. Marshall, Peter Richmond, S. Shakib, Q. Jiang, D. Cooper, D. Rill, J. Baber, J.E. Eiden, W.C. Gruber, K.U. Jansen, E.A. Emini, A.S. Anderson, E.T. Zito, D.Q. Girgenti

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    Abstract

    © 2015 The Authors. Background: Staphylococcus aureus is a common cause of healthcare-acquired morbidity and mortality and increased healthcare resource utilization. A prophylactic vaccine is being developed that may reduce this disease burden. Methods: Volunteers in good general health aged 50-85 (n=312) and 18-24 (n=96) years were randomized to receive a single intramuscular dose of one of three dose levels of a non-adjuvanted, 3-antigen S. aureus vaccine (SA3Ag) or placebo. SA3Ag antigens included capsular polysaccharides 5 and 8 (CP5 and CP8), each conjugated to cross-reactive material 197 (CRM197), and recombinant clumping factor A (ClfA). Safety, tolerability, and immunogenicity were evaluated. Results: At day 29 post-vaccination, robust immune responses were observed in both age cohorts at all three SA3Ag dose levels. In the primary analysis population, the 50- to 85-year age stratum, geometric mean-fold-rises in competitive Luminex® immunoassay antibody titers from baseline ranged from 29.2 to 83.7 (CP5), 14.1 to 31.0 (CP8), and 37.1 to 42.9 (ClfA), all (P
    Original languageEnglish
    Pages (from-to)1846-1854
    JournalVaccine
    Volume33
    Issue number15
    DOIs
    Publication statusPublished - 2015

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