WASHINGTON, Dec. 29 (UPI) -- The next likely vaccine against anthrax poisoning either by accident or through acts of terrorism is going through initial clinical trials that will determine whether it can be used safely in case of an emergency.
Passage of the trial will determine the commercial prospects for the manufacturer, Emergent BioSolutions Inc., which has made investments in developing the vaccine.
Anthrax scares, mainly hoax incidents, caused frequent disruptions in the United States and other countries worldwide after the only genuine anthrax attack in the United States a week after the Sept. 11, 2001, attacks.
Letters containing anthrax spores were mailed to several news media offices and two Democratic U.S. senators, killing five people and infecting 17 others. Hundreds of hoax incidents followed, leading to arrests but no injuries from any kind of anthrax involved in the scares.
Anthrax is an acute disease, caused by the Bacillus anthracis, which affects both animals and humans. Most forms of the disease are lethal but some forms respond to antibiotic treatment. Effective vaccines against anthrax exist but new vaccines are frequently sought to cover all kinds of anthrax spores, some of which are more dangerous than others.
Anthrax spores produced in vitro as a biological weapon have kept pharmaceutical and security industries busy with offerings of new drugs that can counteract exposure to the spores.
One of the oldest recorded references to anthrax, 1500 B.C., was attributed to divine wrath that subjected the Egyptians to 10 plagues, one of which infected livestock with the deadly spores.
Emergent BioSolutions Inc. said it had begun a Phase I clinical trial for NuThraxTM, which it described as Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant. The vaccine is also known as AV7909.
The company said the proposed third-generation vaccine was being developed as part of Emergent's anthrax franchise, and consists of BioThrax -- Anthrax Vaccine Adsorbed -- in combination with a "novel immunostimulatory compound, CPG 7909."
It said the clinical trial was in support of the U.S. government's multiple product strategy to strengthen the nation's biodefense capabilities.
Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, said the proposed new vaccine "has the potential to exhibit advanced characteristics such as requiring fewer doses, generating an enhanced immune response and having a favorable shelf life."
If successful, this could be an attractive candidate for the government's growing arsenal of medical countermeasures, Abdun-Nabi said.
The Phase I clinical trial aims to evaluate the safety, tolerability and immunogenicity of the vaccine candidate. The study is being conducted in multiple sites within the United States and involves 105 healthy volunteers, said the company. Preliminary data from the study are expected to be available in late 2011.
Emergent BioSolutions Inc. is a global biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies. It has headquarters in Rockville, Md.
