Safety and immunogenicity of rabies vaccine (PVRV-WIBP) in healthy Chinese aged 10–50 years old: Randomized, blinded, parallel controlled phase III clinical study
This phase III clinical trial aimed to assess the safety and demonstrate the immunogenicity of a candidate freeze-dried purified Vero cell-based rabies vaccine (PVRV-WIBP) developed for human use. A cohort of 40 participants in stage 1 and 1956 subjects in stage 2 with an age range of 10–50 years we...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-01-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2023.2211896 |
| _version_ | 1827806315175477248 |
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| author | Xiaoyuan Huang Jing Liang Lili Huang Xuanxuan Nian Wei Chen Jiayou Zhang Xiao Xu Xuan Lin Yue Wang Jinrong Shi Lanxin Jia Qingliang Li Qianxi Wang Kai Duan Xinguo Li Yaqi Ji Feixia Peng Wei Zhang Zhiqiang Xie Yanxia Wang Xiaoming Yang |
| author_facet | Xiaoyuan Huang Jing Liang Lili Huang Xuanxuan Nian Wei Chen Jiayou Zhang Xiao Xu Xuan Lin Yue Wang Jinrong Shi Lanxin Jia Qingliang Li Qianxi Wang Kai Duan Xinguo Li Yaqi Ji Feixia Peng Wei Zhang Zhiqiang Xie Yanxia Wang Xiaoming Yang |
| author_sort | Xiaoyuan Huang |
| collection | DOAJ |
| description | This phase III clinical trial aimed to assess the safety and demonstrate the immunogenicity of a candidate freeze-dried purified Vero cell-based rabies vaccine (PVRV-WIBP) developed for human use. A cohort of 40 participants in stage 1 and 1956 subjects in stage 2 with an age range of 10–50 years were recruited for the phase III clinical trial. For safety analysis in stage 1, 20 participants received either 4-dose or 5-dose regimen of PVRV-WIBP. In stage 2, 1956 subjects were randomly divided into the 5-dose PVRV-WIBP, 5-dose PVRV-LNCD, and 4-dose PVRV-WIBP groups. The serum neutralizing antibody titer against rabies was determined on day 7 or 14 and day 35 or 42. Adverse reactions were recorded for more than 6 months. Most adverse reactions, which were mild and moderate in severity, occurred and resolved within 1 week after each injection in the PVRV-WIBP (4 and 5 doses) and PVRV-LNCD (5 doses) groups. All three groups achieved complete seroconversion 14 days after the initial dose and 14 days after completing the full vaccination schedule, the susceptible subjects in the PVRV-WIBP group (4-dose or 5-dose regimen) displayed higher neutralizing antibody titers against the rabies virus compared to those in the PVRV-LNCD group (5-dose regimen). PVRV-WIBP induced non-inferior immune responses versus PVRV-LNCD as assessed by seroconversion rate. PVRV-WIBP was well tolerated and non-inferior to PVRV-LNCD in healthy individuals aged 10–50 years. The results indicated that PVRV-WIBP (both 4- and 5-dose schedules) could be an alternative to rabies post-exposure prophylaxis. |
| first_indexed | 2024-03-11T21:39:26Z |
| format | Article |
| id | doaj.art-0fdd32ef718c47b78bbb074f13df0ef0 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:39:26Z |
| publishDate | 2023-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-0fdd32ef718c47b78bbb074f13df0ef02023-09-26T13:25:49ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2023-01-0119110.1080/21645515.2023.22118962211896Safety and immunogenicity of rabies vaccine (PVRV-WIBP) in healthy Chinese aged 10–50 years old: Randomized, blinded, parallel controlled phase III clinical studyXiaoyuan Huang0Jing Liang1Lili Huang2Xuanxuan Nian3Wei Chen4Jiayou Zhang5Xiao Xu6Xuan Lin7Yue Wang8Jinrong Shi9Lanxin Jia10Qingliang Li11Qianxi Wang12Kai Duan13Xinguo Li14Yaqi Ji15Feixia Peng16Wei Zhang17Zhiqiang Xie18Yanxia Wang19Xiaoming Yang20National Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesHenan Provincial Center for Disease Control and PreventionNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesNational Engineering Technology Research Center for Combined VaccinesHenan Provincial Center for Disease Control and PreventionHenan Provincial Center for Disease Control and PreventionHenan Provincial Center for Disease Control and PreventionNational Engineering Technology Research Center for Combined VaccinesThis phase III clinical trial aimed to assess the safety and demonstrate the immunogenicity of a candidate freeze-dried purified Vero cell-based rabies vaccine (PVRV-WIBP) developed for human use. A cohort of 40 participants in stage 1 and 1956 subjects in stage 2 with an age range of 10–50 years were recruited for the phase III clinical trial. For safety analysis in stage 1, 20 participants received either 4-dose or 5-dose regimen of PVRV-WIBP. In stage 2, 1956 subjects were randomly divided into the 5-dose PVRV-WIBP, 5-dose PVRV-LNCD, and 4-dose PVRV-WIBP groups. The serum neutralizing antibody titer against rabies was determined on day 7 or 14 and day 35 or 42. Adverse reactions were recorded for more than 6 months. Most adverse reactions, which were mild and moderate in severity, occurred and resolved within 1 week after each injection in the PVRV-WIBP (4 and 5 doses) and PVRV-LNCD (5 doses) groups. All three groups achieved complete seroconversion 14 days after the initial dose and 14 days after completing the full vaccination schedule, the susceptible subjects in the PVRV-WIBP group (4-dose or 5-dose regimen) displayed higher neutralizing antibody titers against the rabies virus compared to those in the PVRV-LNCD group (5-dose regimen). PVRV-WIBP induced non-inferior immune responses versus PVRV-LNCD as assessed by seroconversion rate. PVRV-WIBP was well tolerated and non-inferior to PVRV-LNCD in healthy individuals aged 10–50 years. The results indicated that PVRV-WIBP (both 4- and 5-dose schedules) could be an alternative to rabies post-exposure prophylaxis.http://dx.doi.org/10.1080/21645515.2023.2211896rabies vaccinesafetyimmunogenicity |
| spellingShingle | Xiaoyuan Huang Jing Liang Lili Huang Xuanxuan Nian Wei Chen Jiayou Zhang Xiao Xu Xuan Lin Yue Wang Jinrong Shi Lanxin Jia Qingliang Li Qianxi Wang Kai Duan Xinguo Li Yaqi Ji Feixia Peng Wei Zhang Zhiqiang Xie Yanxia Wang Xiaoming Yang Safety and immunogenicity of rabies vaccine (PVRV-WIBP) in healthy Chinese aged 10–50 years old: Randomized, blinded, parallel controlled phase III clinical study Human Vaccines & Immunotherapeutics rabies vaccine safety immunogenicity |
| title | Safety and immunogenicity of rabies vaccine (PVRV-WIBP) in healthy Chinese aged 10–50 years old: Randomized, blinded, parallel controlled phase III clinical study |
| title_full | Safety and immunogenicity of rabies vaccine (PVRV-WIBP) in healthy Chinese aged 10–50 years old: Randomized, blinded, parallel controlled phase III clinical study |
| title_fullStr | Safety and immunogenicity of rabies vaccine (PVRV-WIBP) in healthy Chinese aged 10–50 years old: Randomized, blinded, parallel controlled phase III clinical study |
| title_full_unstemmed | Safety and immunogenicity of rabies vaccine (PVRV-WIBP) in healthy Chinese aged 10–50 years old: Randomized, blinded, parallel controlled phase III clinical study |
| title_short | Safety and immunogenicity of rabies vaccine (PVRV-WIBP) in healthy Chinese aged 10–50 years old: Randomized, blinded, parallel controlled phase III clinical study |
| title_sort | safety and immunogenicity of rabies vaccine pvrv wibp in healthy chinese aged 10 50 years old randomized blinded parallel controlled phase iii clinical study |
| topic | rabies vaccine safety immunogenicity |
| url | http://dx.doi.org/10.1080/21645515.2023.2211896 |
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