St. Louis -- A new study published this month by a Saint Louis University vaccine researcher scrutinizes what in the future could be an alternative to the presently available anthrax vaccine.
This new type of anthrax vaccine produced the immune response doctors were looking for, according to peer-reviewed research published in Vaccine.
In its first human testing, the vaccine was given to 100 volunteers at four sites around the United States, said Geoffrey Gorse, M.D., a Saint Louis University researcher who was the main author of the paper.
"This type of research, five years after 9/11, continues to be very important to pursue," Gorse said. "We need a better vaccine to help protect people from anthrax infection, whether the vaccine is given before or soon after exposure to anthrax spores."
Gorse said the study was able to answer some important questions about this candidate vaccine.
"We were able to demonstrate in this study that the investigational anthrax vaccine produced an immune response that justifies further testing in larger studies," he said. "We'll be using this data to help design strategies for testing of this vaccine in the future."
Gorse indicated that the investigational vaccine, made by VaxGen Inc., demonstrated a clear relationship between the amount of vaccine administered and the subsequent immune response.
The study was designed to evaluate the safety and immunogenicity of escalating doses of the new vaccine. A total of 100 healthy adults were randomized to receive either one of four different vaccine formulations, or AVA, the anthrax vaccine currently licensed for use in the United States. All vaccinations were administered intramuscularly.
Gorse, along with colleagues at Baylor College of Medicine, Emory University School of Medicine, Johns Hopkins University and VaxGen, conducted the research.
The Phase I study was funded by VaxGen's contract N01-AI-25494 with the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH).
The vaccine is a recombinant Protective Antigen (PA) protein vaccine that was initially developed by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). This vaccine cannot cause anthrax infection.
VaxGen, Inc. is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious diseases, including anthrax and smallpox. VaxGen has been awarded an $877.5 million contract by the U.S. Department of Health and Human Services to provide 75 million doses of a modern anthrax vaccine for civilian biodefense. Based in Brisbane, Calif., VaxGen operates a wholly owned manufacturing facility in California and owns a minority interest in Celltrion, Inc., a company in the Republic of Korea established to provide contract manufacturing to the global pharmaceutical industry. For more information, please visit the company's web site at www.vaxgen.com.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level.