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

Status:	Archived
Conditions:	Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	December 2010
End Date:	December 2011

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

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.

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.

We found this trial at

sites

North Carolina Clinical Research

2615 Lake Drive
Meredith, North Carolina 27607

919-881-0309