Table 1.
Vaccine Formulations, Study Design and Number of Donor Samples
| Study Arm | AV7909 Formulation | Active Ingredients and Vaccine Amounts | Subjects per Arm (N) a | ELISpot Subjects per Arm b (N) | ELISA Subject Samples per Arm (N) |
|---|---|---|---|---|---|
| 1 | None | AVA 0.5 mL (BioThrax®) | 17 | 15 | 14–15 c |
| 2 | 1, or F1 | AVA 0.5 mL + CPG 7909 0.5 | 18 | 15 | 17 |
| 3 | 2, or F2 | AVA 0.5 mL + CPG 7909 0.25 | 17 | 15 | 16 |
| 4 | 3, or F3 | AVA 0.25 mL + CPG 7909 0.5 | 19 | 18 | 17–18 d |
| 5 | 4, or F4 | AVA 0.25 mL + CPG 7909 0.25 | 18 | 16 | 18 |
| 6 | None | None | 15 | 14 | 14–15 e |
The group sizes (n = 15 to 19) for samples used for determinations of early biomarkers were the same as number of enrolled subjects reported in [14], with the exception that a subject in Arm 1 was included for early biomarker determinations that did not continue in the study beyond Day 7.
ELISpot testing was performed using PBMC from blood collected on Days 0 and 21 if meeting criteria that Subject’s Day 0 and D21 samples passed Trypan blue viability.
One Subject’s ELISA samples were not available on Day 70.
One Subject’s ELISA samples were not available on Day 28.
One Subject’s ELISA samples were not available on Day 42.