Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of 4 Formulations of Anthrax Vaccine Adsorbed Plus CPG 7909 (AV7909) in Healthy Adult Volunteers

Robert J. Hopkins; Nancy F. Daczkowski; Paulina E. Kaptur; Derek Muse; Eric Sheldon; Craig LaForce; Suha Sari; Thomas L. Rudge; Edward Bernton

doi:10.1016/j.vaccine.2013.04.063

Figure 1

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Subject Disposition Through Day 84. A total of 237 subjects were screened within 28 days of enrollment in the study. Subjects who met the entry criteria (N=105) were randomized to 1 of 6 study groups at a ratio of 6:6:6:6:6:5: BioThrax, AV7909 Formulation 1, AV7909 Formulation 2, AV7909 Formulation 3, AV7909 Formulation 4, or saline placebo. All randomized subjects received at least 1 injection of investigational product and were included in the safety population. One hundred subjects completed the study.