Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques

Effect of aluminum hydroxide adjuvant and formaldehyde in the formulation of rPA anthrax vaccine

“…Several concerns have been raised in regards to the vaccine, including the lot-to-lot variation in the amounts of PA in the vaccine [6] and occasional reactogenicity after vaccination, which may be related to the presence of uncharacterized components and possibly formaldehyde [7][8][9] that have served as a stimulus to develop a more fully characterized vaccine. Several studies have demonstrated the efficacy of PA in vaccines to protect against anthrax intoxication or infection [10][11][12][13]. The importance of anti-PA serum also has been shown in the identification of in vitro correlates of immunity [14][15][16][17] and in passive antibody studies [18][19][20].…”

“…During the development of an anthrax vaccine based upon rPA, numerous adjuvants were evaluated for their efficacy in guinea pigs [5,26] and non-human primates [12]. Aluminumbased adjuvants however, are the only class of adjuvants that have been approved for use in humans.…”

Safety, Reactogenicity, and Immunogenicity of a Recombinant Protective Antigen Anthrax Vaccine Given to Healthy Adults

“…This development began within the U.S. Department of Defense and has since expanded into the commercial arena. The recombinant PA (rPA) pilot lot vaccine tested in this trial underwent extensive laboratory and animal testing before clinical trials were begun, [11][12][13][14] and became the first rPA vaccine produced in the United States. Herein we describe our Phase I evaluation, in healthy young adults, of the safety, reactogenicity and immunogenicity of two intramuscular injections of four different dosages of rPA.…”

Development of an in vitro-based potency assay for anthrax vaccine

“…Thus, to further analyze PA, it should be affinity purified from the desorbed protein mixture. Vaccine preparations that contain PA, a component of the exotoxins from B. anthracis, can protect laboratory animals (mice, guinea pigs, rabbits, non-human primates) against intoxication or lethal anthrax infection [6][7][8]. PA is the component of the anthrax exotoxins that binds to cellular receptors [9] and undergoes proteolysis by the cell surface protease furin [10].…”