Comparing recombinant human rabies monoclonal antibody (ormutivimab) with human rabies immunoglobulin (HRIG) for postexposure prophylaxis: A phase III, randomized, double-blind, non-inferiority trial
Objectives: To evaluate the immunogenicity and safety of an anti-rabies monoclonal antibody (mAb), ormutivimab, compared with human rabies immunoglobulin (HRIG). Methods: This phase III trial was designed as a randomized, double-blind, non-inferiority clinical trial in patients aged ≥18 years with s...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-09-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971223005696 |
| _version_ | 1827875773351985152 |
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| author | Xiaoqiang Liu Yufeng Li Jingyu Li Jianmei Zhou Jiangshu Guo Yi Pu Ya Jiang Yaling Zhou Zhiwei Jiang Qun Shu Cha Wang Jingke Wang Yu Zhao Wei Zhao Hui Wang Jingshuang Wei Hancheng Yu Jian Gao Xiaona Li |
| author_facet | Xiaoqiang Liu Yufeng Li Jingyu Li Jianmei Zhou Jiangshu Guo Yi Pu Ya Jiang Yaling Zhou Zhiwei Jiang Qun Shu Cha Wang Jingke Wang Yu Zhao Wei Zhao Hui Wang Jingshuang Wei Hancheng Yu Jian Gao Xiaona Li |
| author_sort | Xiaoqiang Liu |
| collection | DOAJ |
| description | Objectives: To evaluate the immunogenicity and safety of an anti-rabies monoclonal antibody (mAb), ormutivimab, compared with human rabies immunoglobulin (HRIG). Methods: This phase III trial was designed as a randomized, double-blind, non-inferiority clinical trial in patients aged ≥18 years with suspected World Health Organization category Ⅲ rabies exposure. The participants were randomized 1:1 to ormutivimab and HRIG groups. After thorough wound washing and injection of ormutivimab/HRIG on day 0, the vaccination was administered on days 0, 3, 7, 14, and 28. The primary endpoint was the adjusted geometric mean concentration (GMC) of rabies virus-neutralizing activity (RVNA) on day 7. The endpoint of safety included the occurrence of adverse reactions and serious adverse events. Results: A total of 720 participants were recruited. The adjusted-GMC of RVNA (0.41 IU/ml) on day 7 in ormutivimab group was not inferior to that in the HRIG group (0.41 IU/ml), with ratio of adjusted-GMC of 1.01 (95% confidence interval: 0.91, 1.14). The seroconversion rate of the ormutivimab group was higher than that of the HRIG group on days 7, 14, and 42. Most local injection sites and systemic adverse reactions reported from both groups were mild to moderate in severity. Conclusion: ormutivimab + vaccine can protect victims aged ≥18 years with category Ⅲ suspected rabies exposure as a component of postexposure prophylaxis. ormutivimab has a weaker influence on the immunity response of rabies vaccines. Clinical trials registration: ChiCTR1900021478 (the Chinese Clinical Trial Registry of World Health Organization). |
| first_indexed | 2024-03-12T17:12:46Z |
| format | Article |
| id | doaj.art-d2d18a8978f940e78fb59f11686ea5fe |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-03-12T17:12:46Z |
| publishDate | 2023-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-d2d18a8978f940e78fb59f11686ea5fe2023-08-06T04:36:41ZengElsevierInternational Journal of Infectious Diseases1201-97122023-09-011345362Comparing recombinant human rabies monoclonal antibody (ormutivimab) with human rabies immunoglobulin (HRIG) for postexposure prophylaxis: A phase III, randomized, double-blind, non-inferiority trialXiaoqiang Liu0Yufeng Li1Jingyu Li2Jianmei Zhou3Jiangshu Guo4Yi Pu5Ya Jiang6Yaling Zhou7Zhiwei Jiang8Qun Shu9Cha Wang10Jingke Wang11Yu Zhao12Wei Zhao13Hui Wang14Jingshuang Wei15Hancheng Yu16Jian Gao17Xiaona Li18Vaccine Clinical Research Center, Yunnan Provincial Center for Disease Control and Prevention, Kunming, ChinaState Key Laboratory of Antibody Research & Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co., Ltd., Shijiazhuang, ChinaVaccine Clinical Research Center, Yunnan Provincial Center for Disease Control and Prevention, Kunming, ChinaMile County Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, ChinaKaiyuan County Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, ChinaGejiu County Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, ChinaMile County Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, ChinaGejiu County Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, ChinaStatistics Department, Beijing Key Tech Statistical Consulting Co., Ltd., Beijing, ChinaStatistics Department, Beijing Key Tech Statistical Consulting Co., Ltd., Beijing, ChinaState Key Laboratory of Antibody Research & Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co., Ltd., Shijiazhuang, ChinaState Key Laboratory of Antibody Research & Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co., Ltd., Shijiazhuang, ChinaState Key Laboratory of Antibody Research & Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co., Ltd., Shijiazhuang, ChinaState Key Laboratory of Antibody Research & Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co., Ltd., Shijiazhuang, ChinaState Key Laboratory of Antibody Research & Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co., Ltd., Shijiazhuang, ChinaState Key Laboratory of Antibody Research & Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co., Ltd., Shijiazhuang, ChinaDepartment of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Vaccine Clinical Research Center, Yunnan Provincial Center for Disease Control and Prevention, Kunming, ChinaState Key Laboratory of Antibody Research & Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co., Ltd., Shijiazhuang, China; Corresponding authors.State Key Laboratory of Antibody Research & Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co., Ltd., Shijiazhuang, China; Corresponding authors.Objectives: To evaluate the immunogenicity and safety of an anti-rabies monoclonal antibody (mAb), ormutivimab, compared with human rabies immunoglobulin (HRIG). Methods: This phase III trial was designed as a randomized, double-blind, non-inferiority clinical trial in patients aged ≥18 years with suspected World Health Organization category Ⅲ rabies exposure. The participants were randomized 1:1 to ormutivimab and HRIG groups. After thorough wound washing and injection of ormutivimab/HRIG on day 0, the vaccination was administered on days 0, 3, 7, 14, and 28. The primary endpoint was the adjusted geometric mean concentration (GMC) of rabies virus-neutralizing activity (RVNA) on day 7. The endpoint of safety included the occurrence of adverse reactions and serious adverse events. Results: A total of 720 participants were recruited. The adjusted-GMC of RVNA (0.41 IU/ml) on day 7 in ormutivimab group was not inferior to that in the HRIG group (0.41 IU/ml), with ratio of adjusted-GMC of 1.01 (95% confidence interval: 0.91, 1.14). The seroconversion rate of the ormutivimab group was higher than that of the HRIG group on days 7, 14, and 42. Most local injection sites and systemic adverse reactions reported from both groups were mild to moderate in severity. Conclusion: ormutivimab + vaccine can protect victims aged ≥18 years with category Ⅲ suspected rabies exposure as a component of postexposure prophylaxis. ormutivimab has a weaker influence on the immunity response of rabies vaccines. Clinical trials registration: ChiCTR1900021478 (the Chinese Clinical Trial Registry of World Health Organization).http://www.sciencedirect.com/science/article/pii/S1201971223005696RabiesPostexposure prophylaxisMonoclonal antibodyRabies passive immune preparationRabies immunoglobulinRabies vaccine |
| spellingShingle | Xiaoqiang Liu Yufeng Li Jingyu Li Jianmei Zhou Jiangshu Guo Yi Pu Ya Jiang Yaling Zhou Zhiwei Jiang Qun Shu Cha Wang Jingke Wang Yu Zhao Wei Zhao Hui Wang Jingshuang Wei Hancheng Yu Jian Gao Xiaona Li Comparing recombinant human rabies monoclonal antibody (ormutivimab) with human rabies immunoglobulin (HRIG) for postexposure prophylaxis: A phase III, randomized, double-blind, non-inferiority trial International Journal of Infectious Diseases Rabies Postexposure prophylaxis Monoclonal antibody Rabies passive immune preparation Rabies immunoglobulin Rabies vaccine |
| title | Comparing recombinant human rabies monoclonal antibody (ormutivimab) with human rabies immunoglobulin (HRIG) for postexposure prophylaxis: A phase III, randomized, double-blind, non-inferiority trial |
| title_full | Comparing recombinant human rabies monoclonal antibody (ormutivimab) with human rabies immunoglobulin (HRIG) for postexposure prophylaxis: A phase III, randomized, double-blind, non-inferiority trial |
| title_fullStr | Comparing recombinant human rabies monoclonal antibody (ormutivimab) with human rabies immunoglobulin (HRIG) for postexposure prophylaxis: A phase III, randomized, double-blind, non-inferiority trial |
| title_full_unstemmed | Comparing recombinant human rabies monoclonal antibody (ormutivimab) with human rabies immunoglobulin (HRIG) for postexposure prophylaxis: A phase III, randomized, double-blind, non-inferiority trial |
| title_short | Comparing recombinant human rabies monoclonal antibody (ormutivimab) with human rabies immunoglobulin (HRIG) for postexposure prophylaxis: A phase III, randomized, double-blind, non-inferiority trial |
| title_sort | comparing recombinant human rabies monoclonal antibody ormutivimab with human rabies immunoglobulin hrig for postexposure prophylaxis a phase iii randomized double blind non inferiority trial |
| topic | Rabies Postexposure prophylaxis Monoclonal antibody Rabies passive immune preparation Rabies immunoglobulin Rabies vaccine |
| url | http://www.sciencedirect.com/science/article/pii/S1201971223005696 |
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