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THE IMMUNOGENICITY AND SAFETY OF A NOVEL STAPHYLOCOCCUS AUREUS VACCINE (V710) IN ADULTS WITH END-STAGE RENAL DISEASE RECEIVING HEMODIALYSIS -A PHASE IIA STUDY Moustafa Moustafa, John Buerkert, Tarek Sobeih, Claude Galphin, Gaspar Barreto-Torrella, George Aronoff, Jonathan Hartzel, Elizabeth Brown, Steven Smugar, Nicholas Kartsonis, Dalya Guris South Carolina Nephrology & Hypertension Center, Orangeburg, SC; Columbia Nephrology Associates, PA, Columbia, SC; Nephrology Associates, Chattanooga, TN; Nephrology Associates of South Miami PA, Miami, FL; University of Louisville, Louisville, KY; Merck Sharp & Dohme Corp., Whitehouse Station, NJ Patients with ESRD on hemodialysis are at increased risk for severe S. aureus infections, including septicemia. In Phase I studies, V710, a vaccine containing a surface protein (IsdB) was immunogenic after a single dose in healthy adults. This Phase II study was a randomized, double-blind, placebo-controlled study in adults aged 18-80 years with ESRD on hemodialysis (N=206 randomized, 201 vaccinated). Patients were randomized to receive V710 as a 60-μg dose (with or without adjuvant) or a 90-μg dose (with adjuvant) or placebo. Patients received two doses 28 days apart (V710/V710; V710/placebo; placebo/placebo), and a third dose at Day 180. Blood samples were collected at different intervals through Day 360. The primary hypothesis was that at least 1 of the 3 groups receiving 2 doses of V710 would have a ≥2.5-fold rise in anti-IsdB IgG titers 28 days after the second dose (i.e., Day 56) compared to baseline. All 3 grou ps receiving 2 doses of V710 had significant increases of anti-IsdB titers (15.1-18.9-fold) from baseline (p