Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax.
This study will be conducted in the United States (U.S.), in 200 healthy male and female volunteer subjects ages 18 to 65 years.
The duration of study participation for each individual subject will be approximately 128 days (4.25 months), including a screening period of approximately 28 days followed by 100 days on study.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults|
- Immunogenicity as measured by anti-protective antigen (PA) antibody responses using the toxin neutralization antibody assay [ Time Frame: 100 days ] [ Designated as safety issue: No ]Proportion of subjects acheiving a threshold response.
- Immunogenicity, as defined by a predicted vaccine efficacy at defined timepoints. [ Time Frame: 100 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Experimental: BioThrax (0.5 mL, on days 0, 14, and 28)||
BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.
Other Name: Anthrax Vaccine Adsorbed (AVA)
BioThrax® (also called Anthrax Vaccine Adsorbed or AVA) is the only FDA-licensed vaccine for the prevention of anthrax infection. This study will evaluate the immunogenicity of the vaccine using a post-exposure vaccination schedule. Correlations will be drawn to immunogenicity and survival data from animal models to demonstrate that BioThrax® can elicit a protective immune response for PEP.
|United States, Florida|
|Miami Research Associates|
|Miami, Florida, United States, 33143|
|United States, New York|
|Rochester Clinical Research|
|Rochester, New York, United States, 14609|
|United States, South Carolina|
|Coastal Carolina Research Center|
|Mt. Pleasant, South Carolina, United States, 29464|
|United States, Utah|
|Jean Brown Research|
|Salt Lake City, Utah, United States, 84124|
|Principal Investigator:||Robert Hopkins, MD, MPH, TM||Emergent BioSolutions Inc.|