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AVA · 1 trial · 1 indication
Safety will be measured by looking at safety labs, Adverse Events (AEs) and vaccine reactogenicity data from Baseline through Day 211. Immunogenicity will be measured by the peak serum antibody response to the PA transgene defined as the highest toxin-neutralizing antibody (TNA) titer achieved by a subject at any time between the first post-vaccination visit though Day 85 (and Day 211 if Day 85 is positive).
| Arm | Type | Description |
|---|---|---|
| AVA | ACTIVE_COMPARATOR | Anthrax Vaccine Adsorbed (0.5 mL) as the placebo control on Days 1, 15 and 29 |
| Ad4-PA-1 | EXPERIMENTAL | Given at 10\^9, 10\^10 and 10\^11 vp Ad4-PA at Day 1 + oral placebo on Day 15 + AVA boost at Day 29 |
| Ad4-PA-2 | EXPERIMENTAL | Given at 10\^9, 10\^10 and 10\^11 vp Ad4-PA at Days 1, 15 and 29 |
| Ad4-PA-3 | EXPERIMENTAL | Ad4 given at 10\^9, 10\^10 and 10\^11 vp Ad4 PA-GPI at Day 1 + AVA boost at Day 15 + placebo on Day 29 |
| Ad4-PA-GPI-1 | EXPERIMENTAL | Given at 10\^9, 10\^10 and 10\^11 viral particles Ad4 PA-GPI at Day 1 + oral placebo on Day 29 + AVA boost at Day 15 |
| Ad4 PA-GPI-2 | EXPERIMENTAL | Given at 10\^9, 10\^10 and 10\^11 viral particles Ad4 PA-GPI at Day 1 + placebo on Day 15 + AVA boost at Day 29 |
| Ad4-PA-GPI -3 | EXPERIMENTAL | Given at 10\^9, 10\^10 and 10\^11 viral particles Ad4-PA-GPI at Days 1, 15 and 29 |
| Name | Type | Description |
|---|---|---|
| AVA | BIOLOGICAL | Anthrax Vaccine Adsorbed (0.5 mL) as the placebo control on Days 1, 15 and 29 |
| Ad4-PA-1 | BIOLOGICAL | Ad4-PA will be given at 10\^9, 10\^10 and 10\^11 on Day, followed by an oral placebo on Day 15 and an AVA boost on Day 29 |
| Ad4-PA-GPI-1 | BIOLOGICAL | Given at 10\^9, 10\^10 and 10\^11 viral particles Ad4 PA-GPI at Day 1 + oral placebo on Day 29 + AVA boost at Day 15 |
Inclusion Criteria: * Able to understand the study and give written informed consent. * Healthy men or women aged 18-40 years old, * BMI between 18 to 36 kg/m2 * Women of child bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to vacc...
AVA is an investigational monoclonal antibody being developed for the prevention or treatment of anthrax infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AVA is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS.
AVA is in Phase 1 clinical development. A Phase 1 ascending dose study has been completed, but the drug remains investigational and has not received regulatory approval.
AVA has been studied in one completed Phase 1 trial, NCT01979406, which assessed the safety and immunogenicity of adenovirus anthrax vector candidate vaccines. The trial enrolled 120 healthy volunteers in the United States.
AVA is a monoclonal antibody candidate for anthrax infection, distinct from traditional vaccines. The completed trial NCT01979406 evaluated adenovirus-based vector candidate vaccines, and AVA is being developed as a separate therapeutic approach.