Task Order (Under BARDA MCM CSN Contract): Phase 2 Clinical Study to Assess the Safety and Immunogenicity of Anthrax Vaccine Adsorbed (BioThrax™) without and with CpG 7909 Adjuvant (AV7909 Anthrax Vaccine) in Individuals over 65.

Sponsor: Department of Health and Human Services (HHS)/Office of the Assistant Secretary for Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA)

Prime: Rho

Disease: Anthrax is a serious infectious disease caused by bacteria known as Bacillus anthracis. People become infected with anthrax when they breathe in spores, eat food or drink water that is contaminated with spores, or get spores in a cut or scrape in the skin. Additionally, people can get sick with anthrax if they come into contact with infected animals or contaminated animal products, although such instances are rare in the United States. In addition, Bacillus anthracis is one of the most likely agents to be used in a bioterrorist attack. As a result, people at the highest risk for anthrax include those who work with animals and animal-based products, military personnel, and postal workers.

Objective: Due to the potential of a bioterrorist attack with anthrax, one of BARDA’s goals is to develop countermeasures against anthrax. The only approved vaccine for anthrax is licensed for use in adults 18 through 65 years of age. To address this population gap, BARDA’s goal for this trial was to assess the safety and immunogenicity of investigational anthrax vaccines using a post-exposure prophylaxis dosing regimen in an elderly population.

Period of involvement: May 2017 – May 2020

Services: Rho provided full-service support for this clinical trial.