Comparative vaccine efficacy of different isoforms of recombinant protective antigen against Bacillus anthracis spore challenge in rabbits

Vaccine
W J RibotG P Andrews

Abstract

The next-generation human anthrax vaccine developed by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) is based upon purified Bacillus anthracis recombinant protective antigen (rPA) adsorbed to aluminum hydroxide adjuvant (Alhydrogel). In addition to being safe, and effective, it is important that such a vaccine be fully characterized. Four major protein isoforms detected in purified rPA by native PAGE during research and development were reduced to two primary isoforms in bulk material produced by an improved process performed under Good Manufacturing Practices (GMP). Analysis of both rPA preparations by a protein-isoaspartyl-methyl-transferase assay (PIMT) revealed the presence of increasing amounts of iso-aspartic acid correlating with isoform content and suggesting deamidation as the source of rPA charge heterogeneity. Additional purification of GMP rPA by anion exchange chromatography separated and enriched the two principal isoforms. The in vitro and in vivo biological activities of each isoform were measured in comparison to the whole GMP preparation. There was no significant difference in the biological activity of each isoform compared to GMP rPA when analyzed in the presence of leth...Continue Reading

Citations

Jul 31, 2007·Future Microbiology·Karla D Passalacqua, Nicholas H Bergman
Nov 10, 2006·Nature Biotechnology·Jeffrey B UlmerRino Rappuoli
Feb 10, 2010·Pharmaceutical Research·Mark Cornell ManningDerrick S Katayama
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Mar 20, 2013·Expert Opinion on Drug Delivery·Jan JezekIain Simpson
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Feb 26, 2016·Clinical and Vaccine Immunology : CVI·Anita VermaDrusilla L Burns
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May 16, 2020·Pathogens·Vladimir SavranskyJoshua Reece
Jun 25, 2015·Microbiology Spectrum·Susan WelkosChristopher Cote

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