drugset / Trial / NCT00922363
Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.
Timeline
- Start
- 2009-10
- Primary completion
- 2011-10
- Completion
- 2011-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AFO-18 | Vaccine | 25 ug | — |
| Subject | AFO-18 | Vaccine | 63 ug | — |
| Subject | AFO-18 | Vaccine | 125 ug | — |
| Subject | AFO-18 | Vaccine | 313 ug | — |
| Subject | AFO-18 | Vaccine | 625 ug | — |
| Background | Ag85B-ESAT-6 | Vaccine | 50 ug | — |