{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T05:43:13Z","timestamp":1790660593548,"version":"4.1.0"},"reference-count":25,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2023,8,1]],"date-time":"2023-08-01T00:00:00Z","timestamp":1690848000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Dalian Aleph Biomedical Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Objective: In this paper, we aim to show that the immunogenicity of the lyophilized human rabies vaccine (Vero cells) (investigational vaccine) developed by Dalian Aleph Biomedical Co., Ltd. in healthy participants aged 10\u201360 years old is non-inferior to the lyophilized PVRV (positive control) manufactured by Liaoning Chengda Biotechnology Co., Ltd. (Shenyang, China), and that its safety is clinically acceptable. Method: A total of 2776 participants were enrolled in this study and divided into four groups: a five-dose test group, a five-dose control group, a four-dose test group, and a four-dose control group. The patients in the four-dose groups (Zagreb) were vaccinated on Days 0 (two doses), 7 (one dose), and 21 (one dose), and those in the five-dose groups (Essen) were vaccinated on Days 0, 3, 7, 14, and 28 (one dose each). The rabies-virus-neutralizing antibody assay with the RFFIT was used to assess the immunogenicity, and the adverse events (AEs) and serious adverse events (SAEs) were identified and collated. Results: The positive seroconversion rate was up to 100% on Days 14 and 35\/42 after vaccination following any procedures in pre-immunization antibody-negative participants, and the positive seroconversion rate and geometric mean concentration (GMC) of the test groups (Zagreb and Essen vaccination procedures) was not inferior to that of the control groups. On Day 7 after vaccination, the immunogenicity of the Zagreb procedure with two doses of the vaccine on Day 0 was superior to the Essen procedure with one dose of vaccine, that is, the former had a higher seroconversion rate and RVNA titer. The non-inferiority criterion of immunogenicity was met for the whole population, the population aged 10\u201318 years and \u226518 years, and the pre-immunization antibody-positive population. The incidences of all AEs, solicited AEs, and unsolicited AEs in both groups were not statistically significant, and no vaccination-related SAEs were observed. Conclusion: The investigated vaccine is safe, its immunogenicity is non-inferior to that of the control vaccine, and the efficacy of the Zagreb procedure is superior to that of the Essen procedure 7 days after the first dose.<\/jats:p>","DOI":"10.3390\/vaccines11081311","type":"journal-article","created":{"date-parts":[[2023,8,1]],"date-time":"2023-08-01T09:06:44Z","timestamp":1690880804000},"page":"1311","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A Randomized, Double-Blind, Controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of a Lyophilized Human Rabies Vaccine (Vero Cells) in Healthy Participants Aged 10\u201360 Years Following Essen and Zagreb Vaccination Procedures"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-6471-1285","authenticated-orcid":false,"given":"Xiaohong","family":"Wu","sequence":"first","affiliation":[{"name":"Arbovirus Vaccine Department, National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Li","sequence":"additional","affiliation":[{"name":"Arbovirus Vaccine Department, National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lei","family":"Zhou","sequence":"additional","affiliation":[{"name":"School of Chemical Engineering, Dalian University of Technology, Dalian 116023, China"},{"name":"General Manager Office, Dalian Aleph Biomedical Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianmin","family":"Chen","sequence":"additional","affiliation":[{"name":"General Manager Office, Dalian Aleph Biomedical Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhongqiang","family":"Jin","sequence":"additional","affiliation":[{"name":"Vaccine Clinical Research Center of Sichuan Center for Disease Control and Prevention, Chengdu 610044, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qingwei","family":"Meng","sequence":"additional","affiliation":[{"name":"School of Chemical Engineering, Dalian University of Technology, Dalian 116023, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Chai","sequence":"additional","affiliation":[{"name":"General Manager Office, Dalian Aleph Biomedical Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongxia","family":"Gao","sequence":"additional","affiliation":[{"name":"Quality Control Department, Dalian Aleph Biomedical Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunpeng","family":"Wang","sequence":"additional","affiliation":[{"name":"Arbovirus Vaccine Department, National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danhua","family":"Zhao","sequence":"additional","affiliation":[{"name":"Arbovirus Vaccine Department, National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heng","family":"Wu","sequence":"additional","affiliation":[{"name":"Rabies Vaccine Production Workshop, Dalian Aleph Biomedical Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jieran","family":"Yu","sequence":"additional","affiliation":[{"name":"Filling and Packaging Workshop, Dalian Aleph Biomedical Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nan","family":"Chen","sequence":"additional","affiliation":[{"name":"Quality Control Department, Dalian Aleph Biomedical Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanan","family":"Wang","sequence":"additional","affiliation":[{"name":"R&D Department, Dalian Aleph Biomedical Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Scientific Affairs, Simoon Record Beijing Co., Ltd., Beijing 100025, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peifang","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Project Management, Simoon Record Beijing Co., Ltd., Beijing 100025, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3806-8046","authenticated-orcid":false,"given":"Yuhua","family":"Li","sequence":"additional","affiliation":[{"name":"Arbovirus Vaccine Department, National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6650-3423","authenticated-orcid":false,"given":"Yuhui","family":"Zhang","sequence":"additional","affiliation":[{"name":"General Manager Office, Dalian Aleph Biomedical Co., Ltd., Dalian 116620, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,8,1]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2022, October 27). 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