Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01979406 | A Phase 1 Ascending Dose Study to Assess the Safety and Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines | PHASE1 | COMPLETED | 120 | — | — | Nov 1, 2013 | Sep 1, 2015 | Mar 18, 2024 | 4 | United States |
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...