Qisheng Hou , Si Liu , Cheng Liu , Xu Wang , Jirong Shi , Qingjun Chen , Xinjun Lv , Zhenggang Zhu , Chuanlin Wang , Wenwu Yin
{"title":"用于狂犬病暴露后预防的四剂埃森肌肉注射方案的免疫原性:一项在中国进行的多中心横断面研究。","authors":"Qisheng Hou , Si Liu , Cheng Liu , Xu Wang , Jirong Shi , Qingjun Chen , Xinjun Lv , Zhenggang Zhu , Chuanlin Wang , Wenwu Yin","doi":"10.1016/j.tmaid.2024.102735","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>The 4-dose Essen intramuscular (IM) regimen for rabies post-exposure prophylaxis (PEP) has been recommended by Advisory Committee on Immunization Practices (ACIP) and World Health Organization (WHO), but the large-sample clinical evidence is still limited.</p></div><div><h3>Method</h3><p>Rabies virus neutralizing antibodies of 11,752 patients were detected from 409 rabies prevention clinics in 27 provinces in China. Patients with serum collected before or no later than 1 h after injection on the day of the fifth dose (day 28) of 5-dose Essen regimen were included in Group A to observe the immune efficacy of 4-dose Essen IM regimen, and patients with serum collected 14–28 days after injection of the fifth dose were included in Group B to observe the immune efficacy of 5-dose Essen IM regimen.</p></div><div><h3>Results</h3><p>Finally, 2351 cases met the inclusion and exclusion criteria, including 2244 cases in Group A and 107 cases in Group B. The antibody titer of Group A was higher than that of Group B [12.21 (4.15, 32.10) IU/ml <em>vs.</em> 9.41 (3.87, 27.38) IU/ml] (<em>P</em> = 0.002). In Group A, the median antibody titers were 4.01IU/ml, 11.63IU/ml and 29.46IU/ml in patients vaccinated with purified hamster kidney cell vaccine (PHKCV), purified Vero cell vaccine (PVRV), and human diploid cell rabies vaccine (HDCV), respectively, with statistical significance (<em>P</em> < 0.001).</p></div><div><h3>Conclusions</h3><p>The 4-dose Essen IM regimen could provide satisfactory immune effect, and HDCV induced higher antibody titer than PHKCV or PVRV.</p></div>","PeriodicalId":23312,"journal":{"name":"Travel Medicine and Infectious Disease","volume":"60 ","pages":"Article 102735"},"PeriodicalIF":6.3000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1477893924000516/pdfft?md5=8b2fe93044c079ef9915e86c4cd6a62a&pid=1-s2.0-S1477893924000516-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Immunogenicity of 4-dose Essen intramuscular regimen for rabies post-exposure prophylaxis: A multi-center cross-sectional study in China\",\"authors\":\"Qisheng Hou , Si Liu , Cheng Liu , Xu Wang , Jirong Shi , Qingjun Chen , Xinjun Lv , Zhenggang Zhu , Chuanlin Wang , Wenwu Yin\",\"doi\":\"10.1016/j.tmaid.2024.102735\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>The 4-dose Essen intramuscular (IM) regimen for rabies post-exposure prophylaxis (PEP) has been recommended by Advisory Committee on Immunization Practices (ACIP) and World Health Organization (WHO), but the large-sample clinical evidence is still limited.</p></div><div><h3>Method</h3><p>Rabies virus neutralizing antibodies of 11,752 patients were detected from 409 rabies prevention clinics in 27 provinces in China. Patients with serum collected before or no later than 1 h after injection on the day of the fifth dose (day 28) of 5-dose Essen regimen were included in Group A to observe the immune efficacy of 4-dose Essen IM regimen, and patients with serum collected 14–28 days after injection of the fifth dose were included in Group B to observe the immune efficacy of 5-dose Essen IM regimen.</p></div><div><h3>Results</h3><p>Finally, 2351 cases met the inclusion and exclusion criteria, including 2244 cases in Group A and 107 cases in Group B. The antibody titer of Group A was higher than that of Group B [12.21 (4.15, 32.10) IU/ml <em>vs.</em> 9.41 (3.87, 27.38) IU/ml] (<em>P</em> = 0.002). In Group A, the median antibody titers were 4.01IU/ml, 11.63IU/ml and 29.46IU/ml in patients vaccinated with purified hamster kidney cell vaccine (PHKCV), purified Vero cell vaccine (PVRV), and human diploid cell rabies vaccine (HDCV), respectively, with statistical significance (<em>P</em> < 0.001).</p></div><div><h3>Conclusions</h3><p>The 4-dose Essen IM regimen could provide satisfactory immune effect, and HDCV induced higher antibody titer than PHKCV or PVRV.</p></div>\",\"PeriodicalId\":23312,\"journal\":{\"name\":\"Travel Medicine and Infectious Disease\",\"volume\":\"60 \",\"pages\":\"Article 102735\"},\"PeriodicalIF\":6.3000,\"publicationDate\":\"2024-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1477893924000516/pdfft?md5=8b2fe93044c079ef9915e86c4cd6a62a&pid=1-s2.0-S1477893924000516-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Travel Medicine and Infectious Disease\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1477893924000516\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Travel Medicine and Infectious Disease","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1477893924000516","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0
摘要
背景:狂犬病暴露后预防(PEP)的4剂埃森肌肉注射(IM)方案已被免疫实践咨询委员会(ACIP)和世界卫生组织(WHO)推荐,但大样本临床证据仍然有限:方法:在中国 27 个省的 409 个狂犬病预防门诊检测了 11,752 名患者的狂犬病毒中和抗体。方法:从中国 27 个省的 409 家狂犬病预防门诊中检测出 11 752 例狂犬病患者的狂犬病毒中和抗体,将 5 剂埃森方案注射第 5 剂(第 28 天)前或注射后 1 小时内采集血清的患者纳入 A 组,观察 4 剂埃森 IM 方案的免疫效果;将注射第 5 剂 14-28 天后采集血清的患者纳入 B 组,观察 5 剂埃森 IM 方案的免疫效果:A组的抗体滴度高于B组[12.21 (4.15, 32.10) IU/ml vs. 9.41 (3.87, 27.38) IU/ml](P=0.002)。在 A 组中,接种纯化仓鼠肾细胞疫苗(PHKCV)、纯化 Vero 细胞疫苗(PVRV)和人二倍体细胞狂犬病疫苗(HDCV)的患者的抗体滴度中位数分别为 4.01IU/ml、11.63IU/ml 和 29.46IU/ml,具有统计学意义(PConclusions:4剂埃森IM方案可提供令人满意的免疫效果,HDCV诱导的抗体滴度高于PHKCV或PVRV。
Immunogenicity of 4-dose Essen intramuscular regimen for rabies post-exposure prophylaxis: A multi-center cross-sectional study in China
Background
The 4-dose Essen intramuscular (IM) regimen for rabies post-exposure prophylaxis (PEP) has been recommended by Advisory Committee on Immunization Practices (ACIP) and World Health Organization (WHO), but the large-sample clinical evidence is still limited.
Method
Rabies virus neutralizing antibodies of 11,752 patients were detected from 409 rabies prevention clinics in 27 provinces in China. Patients with serum collected before or no later than 1 h after injection on the day of the fifth dose (day 28) of 5-dose Essen regimen were included in Group A to observe the immune efficacy of 4-dose Essen IM regimen, and patients with serum collected 14–28 days after injection of the fifth dose were included in Group B to observe the immune efficacy of 5-dose Essen IM regimen.
Results
Finally, 2351 cases met the inclusion and exclusion criteria, including 2244 cases in Group A and 107 cases in Group B. The antibody titer of Group A was higher than that of Group B [12.21 (4.15, 32.10) IU/ml vs. 9.41 (3.87, 27.38) IU/ml] (P = 0.002). In Group A, the median antibody titers were 4.01IU/ml, 11.63IU/ml and 29.46IU/ml in patients vaccinated with purified hamster kidney cell vaccine (PHKCV), purified Vero cell vaccine (PVRV), and human diploid cell rabies vaccine (HDCV), respectively, with statistical significance (P < 0.001).
Conclusions
The 4-dose Essen IM regimen could provide satisfactory immune effect, and HDCV induced higher antibody titer than PHKCV or PVRV.
期刊介绍:
Travel Medicine and Infectious Disease
Publication Scope:
Publishes original papers, reviews, and consensus papers
Primary theme: infectious disease in the context of travel medicine
Focus Areas:
Epidemiology and surveillance of travel-related illness
Prevention and treatment of travel-associated infections
Malaria prevention and treatment
Travellers' diarrhoea
Infections associated with mass gatherings
Migration-related infections
Vaccines and vaccine-preventable disease
Global policy/regulations for disease prevention and control
Practical clinical issues for travel and tropical medicine practitioners
Coverage:
Addresses areas of controversy and debate in travel medicine
Aims to inform guidelines and policy pertinent to travel medicine and the prevention of infectious disease
Publication Features:
Offers a fast peer-review process
Provides early online publication of accepted manuscripts
Aims to publish cutting-edge papers