Recommend Human Vaccines to your librarian for 2008. Download form here.
Email this page
Print this page
Research Paper
Safety, Reactogenicity, and Immunogenicity of a Recombinant Protective Antigen Anthrax Vaccine Given to Healthy Adults
James D. Campbell, Kristin H. (Long) Clement, Steven S. Wasserman, Sarah Donegan, Lisa Chrisley and Karen L. Kotloff
volume 3 | issue 5
september/october 2007Pages: 205 - 211
We now provide open access to journal articles published online for one year or more. This article may be downloaded at the following link:
Download PDF If the document does not open, please right-click on the link (control-click on a Macintosh) and select the option to save the file to disk.
BACKGROUND: Bacillus anthracis causes anthrax, a vaccine-preventable zoonotic disease that may follow intentional or unintentional exposure to its spores. Although an anthrax vaccine is currently licensed in the USA, better vaccines are desirable for both pre- and post-exposure prophylaxis.
METHODS: Healthy adults, aged 18 to 40 years, received anthrax immunization with either licensed Anthrax Vaccine Adsorbed (AVA, BioThrax™), or an experimental recombinant Protective Antigen vaccine (rPA) produced from an avirulent, non-spore-forming strain of B. anthracis at one of 4 doses (5, 25, 50, or 75 μg). Volunteers were followed for safety, reactogenicity, and immunogenicity.
RESULTS: rPA vaccine was well tolerated with a low rate of local or systemic reactions. Although antibody responses were poor following unadjuvanted rPA administration, 89 and 100% of volunteers who received Alhydrogel-adjuvanted rPA given intramuscularly had 4-fold increases by enzyme-linked immunosorbent and toxin neutralization assays, respectively. Peak antibody responses to adjuvanted rPA given intramuscularly were equivalent to AVA, given either intramuscularly or subcutaneously, when measured by either assay.
CONCLUSION: This recombinant Protective Antigen anthrax vaccine, when given with the adjuvant Alhydrogel to healthy adults in 2 intramuscular injections 4 weeks apart, is very well-tolerated and highly immunogenic.
Authors
James D. Campbell
Center for Vaccine Development, University of Maryland School of Medicine; Baltimore, MD USA
Kristin H. (Long) Clement
Battelle Memorial Institute, Medical Research and Evaluation Facility, Columbus, Ohio USA
Steven S. Wasserman
University of Maryland School of Medicine, Center for Vaccine Development, Baltimore, Maryland USA
Sarah Donegan
University of Maryland Medical Systems, Investigational Drug Service, Baltimore, Maryland USA
Lisa Chrisley
University of Maryland School of Medicine, Center for Vaccine Development, Baltimore, Maryland USA
Karen L. Kotloff
University of Maryland School of Medicine, Center for Vaccine Development, Baltimore, Maryland USA
We now provide open access to journal articles published online for one year or more. This article may be downloaded at the following link:
Download PDF If the document does not open, please right-click on the link (control-click on a Macintosh) and select the option to save the file to disk.