Conditions: Bacillus Anthracis (Anthrax) Infection
Keywords: AVA AV7909 Anthrax vaccine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 105
Healthy volunteers: yes

Brief summary:
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.

Detailed description:
AV7909 is a new vaccine which is a combination of BioThrax (also called anthrax vaccine, adsorbed or AVA), a FDA-licensed vaccine, and CPG 7909. CPG 7909 is a synthetic short DNA sequence that has been shown to be an effective vaccine adjuvant, and one which increases the speed and the degree of the immune response to Protective Antigen (PA), the major vaccine antigen. In the current study, the safety, tolerability, and antibody response to PA will be studied for four different combinations of AVA and CPG 7909, and compared to both AVA and a saline placebo. All formulations of AV7909 have the same or less AVA than the licensed AVA vaccine and all have less CPG 7909 per dose than the formulation used in the first Phase I volunteer study of CPG 7909 combined with AVA.

Arms:
arm 1: BioThrax, 0.5 mL AVA per dose arm 2: 0.5 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose arm 3: 0.5 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose arm 4: 0.25 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose arm 5: 0.25 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose arm 6: Saline control

Interventions: intervention 1: BioThrax intervention 2: AV7909 Formulation 1 intervention 3: AV7909 Formulation 2 intervention 4: AV7909 Formulation 3 intervention 5: AV7909 Formulation 4 intervention 6: Control
Intervention descriptions: intervention 1: BioThrax intervention 2: AV7909 Formulation 1 intervention 3: AV7909 Formulation 2 intervention 4: AV7909 Formulation 3 intervention 5: AV7909 Formulation 4 intervention 6: Saline control

Protocol document: