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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05997264 | Anthrax AV7909 Boost Evaluation Study | PHASE2 | ACTIVE NOT_RECRUITING | 220 | — | — | Dec 5, 2023 | Aug 1, 2026 | Feb 24, 2026 | 7 | United States |
| Arm | Type | Description |
|---|---|---|
| Full Dose Schedule 1 | EXPERIMENTAL | This study group will receive full dose AV7909 (0.5mL) at study days 1, 15, 181 and 366. A placebo full dose (0.5 mL) will be administered between the second and third dose of AV7909 at study day 29. Update: Enrollment to this treatment arm was closed on 13 May 2024. |
| Full Dose Schedule 2 | EXPERIMENTAL | This study group will receive of AV7909 full dose (0.5 mL) at study days 1, 29, 181 and 366. A placebo full dose (0.5 mL) will be administered between the first and second dose of AV7909 at study day 15. Update: Enrollment to this treatment arm was closed on 13 May 2024. |
| Half Dose Schedule 1 | EXPERIMENTAL | This study group will receive of AV7909 half dose (0.25 mL) at study days 1, 15, 181 and 366. A placebo half dose (0.25 mL) will be administered between the second and third dose of AV7909 at study day 29. |
| Half Dose Schedule 2 | EXPERIMENTAL | This study group will receive of AV7909 half dose (0.25 mL) at study days 1, 29, 181 and 366. A placebo full dose (0.25 mL) will be administered between the first and second dose of AV7909 at study day 15. |
| Name | Type | Description |
|---|---|---|
| AV7909 Full Dose (0.5 mL) | BIOLOGICAL | AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for post-exposure prophylaxis (PEP) of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines. |
| AV7909 Half Dose (0.25 mL) | BIOLOGICAL | AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for PEP of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines. |
| Placebo: Sodium Chloride Injection, USP 0.9% (0.5 mL) | BIOLOGICAL | Sodium chloride 9 mg water for injection Quantum satis (q.s.). It contains no bacteriostat, antimicrobial agent, or added buffer. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment (pH 4.5-7.0). |
| Placebo: Sodium Chloride Injection, USP 0.9% (0.25 mL) | BIOLOGICAL | Sodium chloride 9 mg water for injection Quantum satis (q.s.). It contains no bacteriostat, antimicrobial agent, or added buffer. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment (pH 4.5-7.0). |
Inclusion Criteria: 1. Male or non-pregnant females, 18 through 65 years of age, inclusive. 2. Willing and able to provide written informed consent prior to initiation of study procedures. 3. In relatively stable health, as determined by medical history and physical examination. Any chronic medical...