{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T10:35:14Z","timestamp":1777718114019,"version":"3.51.4"},"reference-count":24,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2013,8,1]],"date-time":"2013-08-01T00:00:00Z","timestamp":1375315200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Int J Toxicol"],"published-print":{"date-parts":[[2013,9]]},"abstract":"<jats:p>\n                    A recombinant vaccine (rF1V) is being developed to protect adults 18 to 55 years of age from fatal pneumonic plague caused by aerosolized Yersinia pestis. A comprehensive series of studies was conducted to evaluate the general toxicity and local reactogenicity of the rF1V vaccine prior to first use in humans. Toxicity was evaluated in CD-1 mice vaccinated with control material and three dosage concentrations of rF1V with or without Alhydrogel\n                    <jats:sup>\u00ae<\/jats:sup>\n                    by intramuscular (IM) injection on Study Days 1, 29, 57 and 71 in a volume of 0.1 mL. Total immunizing protein given in each dose was 0, 20 or 60 \u03bcg\/animal. Local reactogenicity was evaluated in mice at the dosages given and in New Zealand white (NZW) rabbits using the same injection volume and formulations (40, 80, 160 and 320 \u03bcg\/mL total antigen and 0.3% (w\/v) Alhydrogel\n                    <jats:sup>\u00ae<\/jats:sup>\n                    ) intended for human use (0.5 mL). The rF1V vaccine produced no apparent systemic toxicity and only transient edema and erythema at the injection site. Together these results indicated a favorable safety profile for rF1V and supported its use in a Phase 1 clinical trial.\n                  <\/jats:p>","DOI":"10.1177\/1091581813497405","type":"journal-article","created":{"date-parts":[[2013,8,1]],"date-time":"2013-08-01T20:50:28Z","timestamp":1375390228000},"page":"327-335","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Preclinical Safety Assessment of a Recombinant Plague Vaccine (rF1V)"],"prefix":"10.1177","volume":"32","author":[{"given":"Jessica L.","family":"Price","sequence":"first","affiliation":[{"name":"DynPort Vaccine Company LLC, A CSC Company, Frederick, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T. Scott","family":"Manetz","sequence":"additional","affiliation":[{"name":"Gene Logic Laboratories, Inc, Gaithersburg, MD, USA"},{"name":"Current Address: MedImmune, Inc, Gaithersburg, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffry D.","family":"Shearer","sequence":"additional","affiliation":[{"name":"DynPort Vaccine Company LLC, A CSC Company, Frederick, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert V.","family":"House","sequence":"additional","affiliation":[{"name":"DynPort Vaccine Company LLC, A CSC Company, Frederick, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2013,8,1]]},"reference":[{"key":"bibr1-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4615-5327-4_28"},{"key":"bibr2-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0050003"},{"key":"bibr3-1091581813497405","first-page":"107","volume-title":"Biodefense Research Methods and Animal Models","author":"Adamovicz JJ","year":"2006"},{"key":"bibr4-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1016\/j.jinf.2012.09.010"},{"key":"bibr5-1091581813497405","unstructured":"Centers for Disease Control 2010 Emergency Preparedness and Response.  http:\/\/www.bt.cdc.gov\/agent\/agentlist-category.asp.Accessed March 2013."},{"key":"bibr6-1091581813497405","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.1998.58.793"},{"key":"bibr7-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1016\/S0264-410X(98)80110-2"},{"key":"bibr8-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/129.Supplement_1.S19"},{"key":"bibr9-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/129.Supplement_1.S13"},{"key":"bibr10-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1586\/erv.09.129"},{"key":"bibr11-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1111\/j.1574-695X.1995.tb00196.x"},{"key":"bibr12-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/126.3.235"},{"key":"bibr13-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1128\/IAI.61.8.3105-3110.1993"},{"key":"bibr14-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1128\/IAI.64.6.2180-2187.1996"},{"key":"bibr15-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1128\/IAI.63.8.2854-2858.1995"},{"key":"bibr16-1091581813497405","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2007.01.071"},{"key":"bibr17-1091581813497405","first-page":"34","volume-title":"Business Briefing: Future Drug Discovery","author":"Sutkwoski EM","year":"2003"},{"key":"bibr18-1091581813497405","unstructured":"World Health Organization. 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