drugset / Trial / NCT01011335
Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
Phase 1/2
Completed
176 enrolled
Henry M. Jackson Foundation for the Advancement of Military Medicine
Nabi Biopharmaceuticals · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body. The purpose of this study is to find the right dose of a new vaccine that is safe and produces a good immune response (how well your body recognizes and defends itself against harmful foreign substances). There are two Staphylococcus aureus toxoids (components or antigens) under investigation in this study; one of them is a protein known as rAT and the other is a protein known as rLukS-PV. They are being developed to see if they are effective at preventing infections caused by the bacteria Staphylococcus aureus.
Timeline
- Start
- 2009-11
- Primary completion
- 2011-03
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bivalent rLukS-PV / rAT | Unknown | 10 ug | — |
| Subject | Bivalent rLukS-PV / rAT | Unknown | 25 ug | — |
| Subject | Bivalent rLukS-PV / rAT | Unknown | 50 ug | — |
| Subject | rAT | Unknown | 10 ug | — |
| Subject | rAT | Unknown | 25 ug | — |
| Subject | rAT | Unknown | 50 ug | — |
| Subject | rAT | Unknown | 100 ug | — |
| Subject | rLukS-PV | Unknown | 10 ug | — |
| Subject | rLukS-PV | Unknown | 25 ug | — |
| Subject | rLukS-PV | Unknown | 50 ug | — |
| Subject | rLukS-PV | Unknown | 100 ug | — |