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Type: Journal article
Title: 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
Author: Nissen, M.
Marshall, H.
Richmond, P.
Shakib, S.
Jiang, Q.
Cooper, D.
Rill, D.
Baber, J.
Eiden, J.
Gruber, W.
Jansen, K.
Emini, E.
Anderson, A.
Zito, E.
Girgenti, D.
Citation: Vaccine, 2015; 33(15):1846-1854
Publisher: Elsevier
Issue Date: 2015
ISSN: 0264-410X
Statement of
Michael Nissen, Helen Marshall, Peter Richmond, Sepehr Shakib, Qin Jiang, David Cooper, Denise Rill, James Baber, Joseph Eiden, William Gruber, Kathrin U. Jansen, Emilio A. Emini, Annaliesa S. Anderson, Edward T. Zito, Douglas Girgenti
Abstract: Background: Staphylococcus aureus is a common cause of healthcare-acquired morbidity and mortalityand increased healthcare resource utilization. A prophylactic vaccine is being developed that may reducethis disease burden.Methods: Volunteers in good general health aged 50–85 (n = 312) and 18–24 (n = 96) years were random-ized 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 andCP8), 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 allthree SA3Ag dose levels. In the primary analysis population, the 50- to 85-year age stratum, geometricmean-fold-rises in competitive Luminex® immunoassay antibody titers from baseline ranged from 29.2to 83.7 (CP5), 14.1 to 31.0 (CP8), and 37.1 to 42.9 (ClfA), all (P < 0.001) exceeding the pre-defined two-fold rise criteria. Similar rises in opsonophagocytic activity assay titers demonstrated functionality ofthe immune response. Most injection-site reactions were mild in severity and there were no substantial differences (SA3Ag vs. placebo) with regard to systemic or adverse events.Conclusions: In this study of healthy adults aged 50–85 and 18–24 years, SA3Ag elicited a rapid and robustimmune response and was well tolerated, with no notable safety concerns.
Keywords: Staphylococcus aureus; vaccine; functional antibodies; capsule proteins
Rights: © 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-NDlicense (
DOI: 10.1016/j.vaccine.2015.02.024
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