{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T13:33:31Z","timestamp":1759412011915},"reference-count":28,"publisher":"American Society for Microbiology","issue":"2","license":[{"start":{"date-parts":[[2012,2,1]],"date-time":"2012-02-01T00:00:00Z","timestamp":1328054400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Clin Vaccine Immunol"],"published-print":{"date-parts":[[2012,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            A phase 1 study of a recombinant mutant protective antigen (rPA) vaccine was conducted in 186 healthy adults aged 18 to 45 years. Volunteers were randomized to receive one of three formulations of rPA (formalin treated, alum adsorbed, or both), in 10- or 20-\u03bcg dosages each, or the licensed vaccine, AVA. Three injections were given at 2-month intervals and a 4th 1 year after the 3rd. Vaccinees were examined at the clinic once following each injection, at 48 to 72 h postinjection. Adverse reactions were recorded in diaries for 7 days. Sera were collected before each injection and 1 week after the 1st, 2 weeks after the 3rd and 4th, and 1 year after the 4th. Serum anti-PA IgG was assayed by enzyme-linked immunosorbent assay (ELISA) and toxin neutralization assay (TNA). All formulations at both dosages were safe and immunogenic, inducing booster responses, with the highest antibody levels following the 4th injection (354 to 732 \u03bcg\/ml). The lowest levels were induced by the formalin-only-treated rPA; there was no statistical difference between levels induced by alum-adsorbed and formalin-treated\/alum-adsorbed rPA or by the two dosages. The antibody levels declined in all groups during the 1-year intervals after the 3rd and 4th injections but less so during the 2nd year, after the 4th injection (fold decreases were 10 to 25 versus 3.4 to 7.0,\n            <jats:italic>P<\/jats:italic>\n            &lt; 0.001). There were too few AVA recipients for statistical comparisons, but their antibody levels followed those of rPA. Anti-rPA measured by ELISA correlated with TNA titers (\n            <jats:italic>r<\/jats:italic>\n            = 0.97). These data support studying alum-adsorbed rPA in children.\n          <\/jats:p>","DOI":"10.1128\/cvi.05556-11","type":"journal-article","created":{"date-parts":[[2011,12,22]],"date-time":"2011-12-22T05:07:55Z","timestamp":1324530475000},"page":"140-145","update-policy":"http:\/\/dx.doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":21,"title":["Phase 1 Study of a Recombinant Mutant Protective Antigen of Bacillus anthracis"],"prefix":"10.1128","volume":"19","author":[{"given":"Joseph A.","family":"Bellanti","sequence":"first","affiliation":[{"name":"International Center for Interdisciplinary Studies of Immunology at Georgetown University Medical Center and Georgetown University School of Medicine, Washington, DC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Feng-Ying C.","family":"Lin","sequence":"additional","affiliation":[{"name":"Program in Developmental and Molecular Immunity, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiayung","family":"Chu","sequence":"additional","affiliation":[{"name":"Program in Developmental and Molecular Immunity, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Shiloach","sequence":"additional","affiliation":[{"name":"Biotechnology Unit, Laboratory of Cellular and Developmental Biology, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen H.","family":"Leppla","sequence":"additional","affiliation":[{"name":"Bacterial Toxins &amp; Therapeutics Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"German A.","family":"Benavides","sequence":"additional","affiliation":[{"name":"International Center for Interdisciplinary Studies of Immunology at Georgetown University Medical Center and Georgetown University School of Medicine, Washington, DC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arthur","family":"Karpas","sequence":"additional","affiliation":[{"name":"Program in Developmental and Molecular Immunity, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mahtab","family":"Moayeri","sequence":"additional","affiliation":[{"name":"Bacterial Toxins &amp; Therapeutics Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chunyan","family":"Guo","sequence":"additional","affiliation":[{"name":"Program in Developmental and Molecular Immunity, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John B.","family":"Robbins","sequence":"additional","affiliation":[{"name":"Program in Developmental and Molecular Immunity, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachel","family":"Schneerson","sequence":"additional","affiliation":[{"name":"Program in Developmental and Molecular Immunity, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"crossref","first-page":"603","DOI":"10.1038\/nbt0607-603","article-title":"US biodefence\u2014shocking and awful","volume":"25","author":"Anonymous","year":"2007","unstructured":"Anonymous. 2007. US biodefence\u2014shocking and awful. Nat. Biotechnol. 25:603.","journal-title":"Nat. Biotechnol."},{"key":"e_1_3_2_3_2","doi-asserted-by":"crossref","first-page":"1565","DOI":"10.1086\/314759","article-title":"Safety and immunogenicity of Shigella sonnei and Shigella flexneri 2a O-specific polysaccharide conjugates in children","volume":"179","author":"Ashkenazi S","year":"1999","unstructured":"AshkenaziS. 1999. Safety and immunogenicity of Shigella sonnei and Shigella flexneri 2a O-specific polysaccharide conjugates in children. J. Infect. Dis. 179:1565\u20131568.","journal-title":"J. Infect. Dis."},{"key":"e_1_3_2_4_2","doi-asserted-by":"crossref","first-page":"414","DOI":"10.1086\/510429","article-title":"Fatal pneumonia among metal workers due to inhalation exposure to Bacillus cereus containing Bacillus anthracis toxin genes","volume":"44","author":"Avashia SB","year":"2007","unstructured":"AvashiaSB. 2007. Fatal pneumonia among metal workers due to inhalation exposure to Bacillus cereus containing Bacillus anthracis toxin genes. Clin. Infect. Dis. 44:414\u2013416.","journal-title":"Clin. Infect. Dis."},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.52.4.632"},{"key":"e_1_3_2_6_2","doi-asserted-by":"crossref","first-page":"205","DOI":"10.4161\/hv.3.5.4459","article-title":"Safety, reactogenicity and immunogenicity of a recombinant protective antigen anthrax vaccine given to healthy adults","volume":"3","author":"Campbell JD","year":"2007","unstructured":"CampbellJD. 2007. Safety, reactogenicity and immunogenicity of a recombinant protective antigen anthrax vaccine given to healthy adults. Hum. Vaccin. 3:205\u2013211.","journal-title":"Hum. Vaccin."},{"key":"e_1_3_2_7_2","unstructured":"Centers for Disease Control and Prevention. 2000. Use of anthrax vaccine in the United States. Advisory Committee on Immunization Practices (ACIP). MMWR Recommend. 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Defining a serological correlate of protection in rabbits for a recombinant anthrax vaccine. 22:422\u2013430.","DOI":"10.1016\/j.vaccine.2003.07.004"},{"key":"e_1_3_2_16_2","doi-asserted-by":"crossref","first-page":"1532","DOI":"10.1001\/jama.300.13.1532","article-title":"Effects of a reduced dose schedule and intramuscular administration of anthrax vaccine adsorbed on immunogenicity and safety at 7 months","volume":"81","author":"Morano N","year":"2008","unstructured":"MoranoN. 2008. Effects of a reduced dose schedule and intramuscular administration of anthrax vaccine adsorbed on immunogenicity and safety at 7 months. JAMA 81:1532\u20131543.","journal-title":"JAMA"},{"key":"e_1_3_2_17_2","doi-asserted-by":"crossref","unstructured":"PittML. 2001. 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Antibodies to anthrax toxin in humans and guinea pigs and their relevance to protective immunity. Med. Microbiol. Immunol. 177:293\u2013303.","journal-title":"Med. Microbiol. Immunol."},{"key":"e_1_3_2_29_2","doi-asserted-by":"crossref","first-page":"1447","DOI":"10.5858\/2011-0362-SAIR.1","article-title":"Rapidly progressive, fatal, inhalation anthrax-like infection in a human: case report, pathogen genome sequencing, pathology, and coordinated response","volume":"135","author":"Wright AM","year":"2011","unstructured":"WrightAM. 2011. Rapidly progressive, fatal, inhalation anthrax-like infection in a human: case report, pathogen genome sequencing, pathology, and coordinated response. Arch. Pathol. Lab. Med. 135:1447\u20131459.","journal-title":"Arch. Pathol. Lab. Med."}],"container-title":["Clinical and Vaccine Immunology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/CVI.05556-11","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/CVI.05556-11","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T20:46:53Z","timestamp":1627591613000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/CVI.05556-11"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,2]]},"references-count":28,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2012,2]]}},"alternative-id":["10.1128\/CVI.05556-11"],"URL":"https:\/\/doi.org\/10.1128\/cvi.05556-11","relation":{},"ISSN":["1556-6811","1556-679X"],"issn-type":[{"value":"1556-6811","type":"print"},{"value":"1556-679X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,2]]},"assertion":[{"value":"2011-10-31","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2011-12-06","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2012-01-30","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}