Safety and immunogenicity of a booster dose of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults: A randomized phase 1 study

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

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    11 Citations (Scopus)

    Abstract

    © 2016 The British Infection AssociationObjective A 2-stage, phase 1, randomized, placebo-controlled study in healthy adults to assess immunogenicity and safety of a booster dose at three dose levels of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) containing recombinant clumping factor A (ClfA) and capsular polysaccharides 5 and 8 (CP5 and CP8) conjugated to a diphtheria toxoid. Methods Six months after initial single vaccination, in Stage 2, SA3Ag recipients were randomized (1:1) to booster vaccination or placebo, while Stage 1 placebo recipients received placebo again. Pre- and post-vaccination blood samples were analyzed. Results In Stage 2 (n = 345), pre-booster CP5 and CP8 titers remained high with no increase post-booster. ClfA titers remained high after initial vaccination and increased post-booster, approaching the peak response to the initial dose. Post-booster local reactions were more frequent and of greater severity than reported after the initial vaccination, particularly for the high-dose level recipients. Post hoc analysis showed no dose–response pattern and no obvious association between diphtheria toxoid titers and local reactions after initial or booster vaccination. Conclusion Immune responses after the initial vaccination persisted for the 12 months studied, with little additional response after the booster dose at 6 months. Post-booster injection site reactions were more frequent and more severe but self-limiting. Clinicaltrials.gov identifier NCT01018641.
    Original languageEnglish
    Pages (from-to)437-454
    Number of pages18
    JournalJournal of Infection
    Volume73
    Issue number5
    DOIs
    Publication statusPublished - 1 Nov 2016

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