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 18-40 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 four doses (5, 25, 50 or 75 microg). 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 four-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. CONCLUSIONS: This recombinant Protective Antigen anthrax vaccine, when given with the adjuvant Alhydrogel to healthy adults in two intramuscular injections four weeks apart, is very well-tolerated and highly immunogenic.
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 18-40 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 four doses (5, 25, 50 or 75 microg). 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 four-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. CONCLUSIONS: This recombinant Protective Antigen anthrax vaccine, when given with the adjuvant Alhydrogel to healthy adults in two intramuscular injections four weeks apart, is very well-tolerated and highly immunogenic.
Authors: Joseph A Bellanti; Feng-Ying C Lin; Chiayung Chu; Joseph Shiloach; Stephen H Leppla; German A Benavides; Arthur Karpas; Mahtab Moayeri; Chunyan Guo; John B Robbins; Rachel Schneerson Journal: Clin Vaccine Immunol Date: 2011-12-21
Authors: Leslie W J Baillie; Ana L Rodriguez; Stephen Moore; Helen S Atkins; Chiguang Feng; James P Nataro; Marcela F Pasetti Journal: Vaccine Date: 2008-09-19 Impact factor: 3.641
Authors: Eric K Dumas; Lori Garman; Hannah Cuthbertson; Sue Charlton; Bassam Hallis; Renata J M Engler; Shyamal Choudhari; William D Picking; Judith A James; A Darise Farris Journal: Vaccine Date: 2017-05-11 Impact factor: 3.641
Authors: Bruce K Brown; Josephine Cox; Anita Gillis; Thomas C VanCott; Mary Marovich; Mark Milazzo; Tanya Santelli Antonille; Lindsay Wieczorek; Kelly T McKee; Karen Metcalfe; Raburn M Mallory; Deborah Birx; Victoria R Polonis; Merlin L Robb Journal: PLoS One Date: 2010-11-05 Impact factor: 3.240