The phase II trial will evaluate the safety and immunogenic response of a new recombinant anthrax vaccine, known as rPA102. The vaccine candidate consists of recombinant Protective Antigen (rPA), a synthetic protein that induces antibodies designed to prevent illness by neutralizing anthrax toxins, and aluminum hydroxide to enhance the immune response. Different formulations of rPA102 will be given to 480 healthy volunteers. Each formulation will contain varying concentrations of rPA.
“The goal of this study is to determine the optimal combination to induce the most robust immune response,” said David Taylor, MD, MSc, the lead investigator of the anthrax vaccine evaluation at the Bloomberg School of Public Health and a research professor with the School’s Department of International Health. “If this vaccine candidate is successful, it could provide a safer vaccine for preventing anthrax with a more practical dosing schedule compared to the existing vaccine,” he added. The current anthrax vaccine requires six doses administered over an 18-month period.
The new vaccine candidate was developed by the VaxGen, Inc. and is based on research conducted by the U.S. Army Medical Research Institute of Infectious Diseases. The study is funded by an $80.3 million contract from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.
Additional studies will determine the optimal dosing schedule for the anthrax vaccine candidate for both prevention and treatment after exposure to anthrax spores.
The Johns Hopkins Bloomberg School of Public Health is looking for qualified volunteers to take part in the anthrax vaccine trail. Anyone wishing to participate may contact at 410-614-9702.
For more information on VaxGen, Inc., please visit the company’s web site at: www.vaxgen.com.