Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

Summary

Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.

Timeline

Start

2003-09

Primary completion

—

Completion

2005-09

Outcome

Missed primary endpoint

paper No significant difference in the incidence of S. aureus bacteremia was observed between vaccine and placebo groups between weeks 3-35 weeks post-dose 1 PMID 25483694 ↗

paper These data do not show a protective effect of either 1 or 2 vaccine doses against S. aureus bacteremia in ESRD patients. PMID 25483694 ↗

Publications

• Fattom A, Matalon A, Buerkert J, Taylor K, Damaso S, Boutriau D. Efficacy profile of a bivalent Staphylococcus aureus glycoconjugated vaccine in adults on hemodialysis: Phase III randomized study. Hum Vaccin Immunother. 2015;11(3):632-41. doi: 10.4161/hv.34414.
• Li Y, Friedman JY, O'Neal BF, Hohenboken MJ, Griffiths RI, Stryjewski ME, Middleton JP, Schulman KA, Inrig JK, Fowler VG Jr, Reed SD. Outcomes of Staphylococcus aureus infection in hemodialysis-dependent patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):428-34. doi: 10.2215/CJN.03760708. Epub 2008 Dec 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	StaphVAX	Vaccine	—	—

Indications