Phase I BioThrax study shows enhanced, accelerated response

A new Phase I study of healthy adults recently demonstrated that an adjuvanted anthrax vaccine, BioThrax, enhanced and accelerated an immune response when compared to the vaccine without the adjuvant.

BioThrax, produced by Emergent BioSolutions, Inc., is the only U.S. Food and Drug Administration approved vaccine for anthrax infection. In the study, BioThrax was paired with a CpG DNA adjuvant as a booster, according to CIDRAP News.

During the study, 69 subjects received three doses of either the adjuvanted vaccine, the adjuvant alone or the vaccine by itself. For 56 days, researchers monitored the subjects’ protective antibody and anthrax toxin-neutralizing antibodies. The drug’s safety was monitored for a total of six months.

The adjuvant appeared to be well tolerated and no adverse effects were reported during the duration of the study, CIDRAP News reports. With the adjuvant, antibody response increased six to eight fold and response time increased by three weeks.

Researchers said that an adjuvanted course of the vaccine might be able to shorten the time it takes for immunization to become active, which would be useful in post-exposure prophylaxis.

BioThrax is indicated for the immunization of adults with a high risk of exposure to anthrax. It is manufactured from a non-virulent strain of the bacteria Bacillus anthracis.

Emergent BioSolutions, Inc., has already delivered 42 million doses of the vaccine to the U.S. government and continues to do so under existing procurement contracts. Since 1998, 2.5 million military personnel have received 10 million doses of the vaccine.