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We utilized advanced technology to develop a novel DTacP vaccine that was previously unavailable in China. The nonclinical studies were performed to evaluate the immunogenicity, potential toxicity, and local tolerance of the vaccine in animal models. In the immunogenicity study, three batches of the vaccine were intraperitoneally administered to National Institutes of Health (NIH)\u00a0mice, resulting in 100% seropositivity for all three batches. Additionally, antibody levels notably increased as the immunization dosage increased. In acute toxicity study, no mortality was observed among the animals during the 14\u2010day observation period, and no abnormalities in clinical signs were reported. Active systemic anaphylaxis assessment in guinea pigs showed no evidence of serious allergic reactions in the vaccine groups. In the repeat\u2010dose toxicity study, where five intramuscular doses were administered every 2\u00a0weeks, gross autopsy and histopathological examination revealed no vaccine\u2010related systemic pathological changes in rats, with dose site irritant reactions mostly recovered at the end of recovery period. In conclusion, the vaccine demonstrated good local and systemic tolerance, supporting its clinical development.<\/jats:p>","DOI":"10.1002\/jat.4668","type":"journal-article","created":{"date-parts":[[2024,7,8]],"date-time":"2024-07-08T21:25:20Z","timestamp":1720473920000},"page":"1689-1699","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Nonclinical safety and immunogenicity assessment of a combined DTacP vaccine in animal models"],"prefix":"10.1002","volume":"44","author":[{"given":"Shihui","family":"Li","sequence":"first","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-5783-1979","authenticated-orcid":false,"given":"Hui","family":"Fu","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shouzhi","family":"Yu","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuxiu","family":"Zhao","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ting","family":"Liu","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ling","family":"Wang","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Na","family":"Zhang","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Wang","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Baifeng","family":"Yang","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peng","family":"He","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yancen","family":"Guo","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shaoting","family":"Qiu","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuntao","family":"Zhang","sequence":"additional","affiliation":[{"name":"Beijing Institute of Biological Products Company Limited  Beijing China"},{"name":"China National Biotec Group Company Limited  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,7,8]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/jat.3314"},{"issue":"3","key":"e_1_2_10_3_1","first-page":"1","article-title":"Preventing tetanus, diphtheria, and pertussis among adolescents: Use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines: Recommendations of the advisory committee on immunization practices (ACIP)","volume":"55","author":"Broder K. 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