Government and Regulations

Clinical Trials Begin for Another Anthrax Vaccine

Upcoming studies will test the safety of the latest anthrax vaccine in a small number of healthy human volunteers.


 

A vaccine that will protect against anthrax after exposure is entering initial clinical studies. The project is one of several next-generation anthrax vaccines in development under the HHS Biomedical Advanced Research and Development Authority (BARDA). Each vaccine candidate uses different vaccine technology or is administered differently.

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The latest vaccine, manufactured by Pfenex Inc., has performed well in nonclinical studies. It was shown to be effective after 2 doses administered 28 days apart. The new studies will test safety in a small number of healthy human volunteers. Replicating that finding would mean fewer doses would be needed than the 3 administered over 4 weeks used for postexposure prophylaxis with the current licensed vaccine.

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Under the agreement with BARDA, Pfenex will also compare the safety and efficacy of a vaccine that incorporates an adjuvant and one that does not. Adjuvants stimulate the immune system with less of the active antigen ingredient, which means fewer doses are needed.

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Studies of the company’s manufacturing indicate that millions of doses could be produced using Pfenex’s novel recombinant technology, HHS says. Moreover, that technology could be transferred easily to BARDA’s Centers for Innovation in Advanced Development and Manufacturing to produce even greater quantities.

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