NCT01263691

Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults

A Parallel-arm, Double-blind, Randomized, Placebo-controlled, Dose-ranging Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of AV7909 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bacillus Anthracis (Anthrax) Infection

Interventions

Type	Name	Description
BIOLOGICAL	BioThrax	BioThrax
BIOLOGICAL	AV7909 Formulation 1	AV7909 Formulation 1
BIOLOGICAL	AV7909 Formulation 2	AV7909 Formulation 2
BIOLOGICAL	AV7909 Formulation 3	AV7909 Formulation 3
BIOLOGICAL	AV7909 Formulation 4	AV7909 Formulation 4
DRUG	Control	Saline control

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2010-12-21
• Last updated: 2024-03-18
• Results posted: 2014-08-20

Locations

3 sites across 1 country: United States