Specialty pharmaceutical company Emergent BioSolutions has dosed the first subject in the Phase 2 trial evaluating anthrax vaccine NuThrax, which is adsorbed in combination with CPG 7909 immunostimulatory adjuvant.
The randomised, parallel-group study will assess the safety and immunogenicity of NuThrax for the prevention before exposure to anthrax infection employing two and three dose immunisation schedules in addition to two dose levels.
Emergent BioSolutions biodefense division EVP and president Adam Havey said the Phase 2 trial of NuThrax supports the US Department of Health and Human Services’ priority to develop advanced anthrax vaccines, which can produce enhanced immune response in fewer doses.
"We thank HHS for their continued trust and partnership as we work together to accomplish elements of its public health emergency medical countermeasures enterprise implementation plan set forth to strengthen the nation’s biodefense capabilities," Havey added.
Around168 healthy adult volunteers are expected to be enrolled in the active-controlled, double-blind study that is being conducted in various US sites.
Company anticipates reporting the study’s preliminary data in the fourth quarter of 2013.
The safety and immunogenicity of NuThrax in preventing anthrax infection before exposure, with a two dose immunisation schedule and four formulations, were established in the Phase 1 study.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) of HHS, is supporting the Phase 2 trial under development contract number HHSN272201000035C.
Image: A photomicrograph of Bacillus anthracis bacteria using Gram-stain technique. Photo: CDC.