{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T12:42:40Z","timestamp":1785156160855,"version":"3.55.0"},"reference-count":31,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,10,16]],"date-time":"2020-10-16T00:00:00Z","timestamp":1602806400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Birth Defects Research"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The AV7909 vaccine, consists of the Anthrax Vaccine Adsorbed (AVA) bulk drug substance and the immunostimulatory Toll\u2010like receptor 9 agonist oligodeoxynucleotide adjuvant CPG 7909. The purpose of this research was to evaluate the potential maternal, reproductive, and developmental toxicity of AV7909 in rats to support licensure for use in women of childbearing potential. Groups of first generation (F<jats:sub>0<\/jats:sub>) female Sprague Dawley rats were dosed by intramuscular injection with water for injection, adjuvant or AV7909 at a volume of 0.5 ml\/dose. Each rat received three vaccinations: 14\u2009days prior to start of the mating period, on the first day of the mating period and on gestation day (GD) 7. There was no maternal mortality. Body weights, weight gain, and food consumption were comparable between groups. Findings in F<jats:sub>0<\/jats:sub> females were limited to transient injection site edema and nodules consistent with immunostimulatory effects of the vaccine and adjuvant. Administration of AV7909 did not affect mating, fertility, pregnancy, embryo\u2010fetal viability, growth, or morphologic development, parturition, maternal care of offspring or postnatal survival, growth, or development. There was no evidence of systemic inflammation in pregnant rats, based on evaluation of serum concentrations of the acute phase proteins alpha\u20102\u2010macroglobulin and alpha\u20101\u2010acid glycoprotein on GD 21. Anthrax lethal toxin\u2010neutralizing antibodies were detected in AV7909\u2010vaccinated F<jats:sub>0<\/jats:sub> females. The antibodies were also detected in the sera of fetuses and F<jats:sub>1<\/jats:sub> pups. Exposure of the fetuses and pups to maternally derived anthrax lethal toxin\u2010neutralizing antibodies was not associated with developmental toxicity.<\/jats:p>","DOI":"10.1002\/bdr2.1815","type":"journal-article","created":{"date-parts":[[2020,10,17]],"date-time":"2020-10-17T07:03:12Z","timestamp":1602918192000},"page":"32-42","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Developmental and reproductive safety evaluation of <scp>AV7909<\/scp> anthrax vaccine candidate in rats"],"prefix":"10.1002","volume":"113","author":[{"given":"Eve","family":"Mylchreest","sequence":"first","affiliation":[{"name":"Battelle  West Jefferson Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"Ionin","sequence":"additional","affiliation":[{"name":"Emergent BioSolutions Inc.  Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6458-2690","authenticated-orcid":false,"given":"Vladimir","family":"Savransky","sequence":"additional","affiliation":[{"name":"Emergent BioSolutions Inc.  Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,10,16]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/tera.10067"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmor.1051270303"},{"key":"e_1_2_8_4_1","first-page":"1","article-title":"Use of anthrax vaccine in the United States: Recommendations of the advisory committee on immunization practices (ACIP), 2009","volume":"59","author":"CDC","year":"2010","journal-title":"MMWR"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2017.06.032"},{"key":"e_1_2_8_6_1","volume-title":"Wiley series in probability and mathematical statistics","author":"Conover W. 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