An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

Summary

This study is a first-in-human (Phase 1) study using three dose levels of an investigational vaccine directed against Staphylococcus aureus (SA3Ag). This study is primarily designed to assess how safe and well tolerated SA3Ag is, but will also describe the immune response over 12 months elicited by SA3Ag. Additionally, this study will assess the effect of SA3Ag vaccine on the number of Staphylococcus aureus bacteria that naturally occur on the skin and within the nose and throat.

Timeline

Start

2010-01

Primary completion

2011-01

Completion

2011-07

Outcome

Met primary endpoint

paper all (P<0.001) exceeding the pre-defined two-fold rise criteria. PMID 25707693 ↗

Publications

• Marshall H, Nissen M, Richmond P, Shakib S, Jiang Q, Cooper D, Rill D, Baber J, Eiden J, Gruber WC, Jansen KU, Anderson AS, Zito ET, Girgenti D. Safety and immunogenicity of a booster dose of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults: A randomized phase 1 study. J Infect. 2016 Nov;73(5):437-454. doi: 10.1016/j.jinf.2016.08.004. Epub 2016 Aug 9.
• Nissen M, Marshall H, Richmond P, Shakib S, Jiang Q, Cooper D, Rill D, Baber J, Eiden J, Gruber W, Jansen KU, Emini EA, Anderson AS, Zito ET, Girgenti D. 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. Vaccine. 2015 Apr 8;33(15):1846-54. doi: 10.1016/j.vaccine.2015.02.024. Epub 2015 Feb 21.

Drugs

Indications