DynPort completes Phase II botulinum vaccine trial

DynPort Vaccine Company, LLC, has completed a vaccination and subsequent follow-up of all the volunteers of a double-blind placebo controlled Phase II clinical trial of its botulinum vaccine.

The trial evaluated issues of safety and immunogenicity in a recombinant botulinum neurotoxin vaccine now known as rBV A/B in healthy volunteers aged 18 to 55. The trial also aimed to assess the safety of the vaccine when compared to a placebo, according to PaharmaLive.com.

The volunteers were given a placebo at two different dosing schedules, with an observation time of seven months. Primarily, the focus of this part of the study was to evaluate the neutralizing antibody rate in volunteers given either the placebo or rBV A/B.

The dosing schedules had an 18 month observation period during which time botulinum neurotoxin antibodies were measured at previously established intervals, PaharmaLive.com reports.

The vaccine candidate is being developed to prevent fatal botulism following aerosolized exposure to botulinum neurotoxin serotype A, subtype A1 and serotype B, subtype B1.

“DVC plans to pursue licensure of this vaccine candidate under the U.S. Food and Drug Administration Animal Rule to support our client’s medical countermeasure development program,” Dr. Robert V. House, president of DVC, said, according to PharmaLive.com. “Botulinum neurotoxin is a key potential biothreat to our nation and its allies.”

In addition to the clinical trials, nonclinical testing to support the licensure of rBV A/B under the animal rule is currently moving forward.

Researchers working at the U.S. Army Medical Research Institute of Infectious Diseases originally developed the vaccine. DVC has since provided further development under a contract with the Department of Defense.