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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.

Related: Better Anthrax Vaccine on the Horizon

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.

Related: Vaccine Agencies Consolidate for More Effectiveness

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.

Related: Perceived Attitudes and Staff Roles of Disaster Management at CBOCs

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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anthrax vaccine, HHS Biomedical Advanced Research and Development Authority, BARDA, Pfenex Inc
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Upcoming studies will test the safety of the latest anthrax vaccine in a small number of healthy human volunteers.
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.

Related: Better Anthrax Vaccine on the Horizon

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.

Related: Vaccine Agencies Consolidate for More Effectiveness

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.

Related: Perceived Attitudes and Staff Roles of Disaster Management at CBOCs

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.

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.

Related: Better Anthrax Vaccine on the Horizon

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.

Related: Vaccine Agencies Consolidate for More Effectiveness

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.

Related: Perceived Attitudes and Staff Roles of Disaster Management at CBOCs

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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Federal Practitioner - 32(10)
Issue
Federal Practitioner - 32(10)
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e16
Page Number
e16
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Publications
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Display Headline
Clinical Trials Begin for Another Anthrax Vaccine
Display Headline
Clinical Trials Begin for Another Anthrax Vaccine
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anthrax vaccine, HHS Biomedical Advanced Research and Development Authority, BARDA, Pfenex Inc
Legacy Keywords
anthrax vaccine, HHS Biomedical Advanced Research and Development Authority, BARDA, Pfenex Inc
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