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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.