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Safety testing for pediatric population is warranted to support the potential emergency use of AV7909 in children. This study was conducted to investigate the local tolerance and potential systemic toxicity and their reversibility in juvenile rats by repeat intramuscular injections of the AV7909 vaccine candidate. Animals were dosed on postnatal day (PND) 21 (at weaning), PND 28, and PND 35, with the test article (AV7909), the adjuvant alone (Alhydrogel + CPG 7909), or sterile water for injection. Core group animals were necropsied on PND 37 and recovery group on PND 49. Study end points included survival, clinical observations, injection site observations, body weights, clinical pathology (hematology, coagulation, and clinical chemistry), pro-inflammatory biomarker analysis (alpha-2 macroglobulin [A2M] and alpha-1 acid glycoprotein [AGP]), and anatomic pathology. Immune response to vaccination was measured using the high-throughput anthrax lethal toxin neutralization assay (htpTNA). The AV7909 vaccine candidate produced no apparent systemic or local toxicity. The AGP and A2M levels were elevated in both the adjuvant-alone and AV7909 groups at the end of treatment but were comparable to control levels by the end of the recovery period. All animals in the AV7909 group demonstrated a robust neutralizing antibody response. The results indicate that AV7909 has a favorable safety profile in juvenile rats.<\/jats:p>","DOI":"10.1177\/1091581820941412","type":"journal-article","created":{"date-parts":[[2020,7,21]],"date-time":"2020-07-21T06:15:03Z","timestamp":1595312103000},"page":"443-451","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Repeat Dose Toxicity Study of the AV7909 Anthrax Vaccine Candidate in Juvenile Rats"],"prefix":"10.1177","volume":"39","author":[{"given":"Amy","family":"Zmarowski","sequence":"first","affiliation":[{"name":"Battelle, West Jefferson, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2712-130X","authenticated-orcid":false,"given":"Jeff D.","family":"Ballin","sequence":"additional","affiliation":[{"name":"Battelle, Aberdeen, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Sharits","sequence":"additional","affiliation":[{"name":"Battelle, West Jefferson, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Carrico","sequence":"additional","affiliation":[{"name":"Battelle, West Jefferson, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Novak","sequence":"additional","affiliation":[{"name":"Battelle, West Jefferson, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3528-3544","authenticated-orcid":false,"given":"Jeffry","family":"Shearer","sequence":"additional","affiliation":[{"name":"Emergent BioSolutions Inc, Gaithersburg, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruna","family":"Blauth","sequence":"additional","affiliation":[{"name":"Emergent BioSolutions Inc, Gaithersburg, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Boris","family":"Ionin","sequence":"additional","affiliation":[{"name":"Emergent BioSolutions Inc, Gaithersburg, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshua","family":"Reece","sequence":"additional","affiliation":[{"name":"Emergent BioSolutions Inc, Gaithersburg, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6458-2690","authenticated-orcid":false,"given":"Vladimir","family":"Savransky","sequence":"additional","affiliation":[{"name":"Emergent BioSolutions Inc, Gaithersburg, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2020,7,21]]},"reference":[{"key":"bibr1-1091581820941412","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2014.01.096"},{"key":"bibr2-1091581820941412","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2016.03.006"},{"key":"bibr3-1091581820941412","unstructured":"BioThrax [package insert]. 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