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. Author manuscript; available in PMC: 2015 Nov 28.
Published in final edited form as: Vaccine. 2014 Feb 13;32(50):6847–6854. doi: 10.1016/j.vaccine.2014.01.096

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
a

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.

b

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.

c

One Subject’s ELISA samples were not available on Day 70.

d

One Subject’s ELISA samples were not available on Day 28.

e

One Subject’s ELISA samples were not available on Day 42.