drugset / Trial / NCT00098098
Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults
Non-randomizedSingle-groupOpen-labelPrevention
Summary
The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level.
Timeline
- Start
- 2004-08
- Primary completion
- —
- Completion
- 2005-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rBV A/B | Vaccine | 5 ug | Intramuscular |
| Subject | rBV A/B | Vaccine | 10 ug | Intramuscular |
| Subject | rBV A/B | Vaccine | 20 ug | Intramuscular |
| Subject | rBV A/B | Vaccine | 40 ug | Intramuscular |