drugset / Trial / NCT05997264
Anthrax AV7909 Boost Evaluation Study
Phase 2
Active not recruiting
220 enrolled
Biomedical Advanced Research and Development Authority
ICON plc · collabRho Federal Systems Division, Inc. · collab
RandomizedParallel-groupQuadruple-blindOther
Summary
This randomized, phase 2, double-blinded, multicenter study is designed to assess the safety and immune response kinetics of CYFENDUS™ (henceforth AV7909) administered on 2 primary series vaccination schedules followed by 6- and 12-month boosters.
Timeline
- Start
- 2023-12-05
- Primary completion
- 2025-08-28
- Completion
- 2026-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BACILLUS ANTHRACIS PROTECTIVE ANTIGEN, ADSORBED | Vaccine | 0.25 ml | Intramuscular |
| Subject | BACILLUS ANTHRACIS PROTECTIVE ANTIGEN, ADSORBED | Vaccine | 0.5 ml | Intramuscular |