A Phase IV, Randomized, Controlled Study of the Safety and Immunogenicity of Rabishield, Rabivax-S Post-exposure Prophylaxis regimen in Patients with Potential Rabies Exposure

开始日期2019-07-08

申办/合作机构

Serum Institute of India Pvt Ltd.

CTRI/2012/05/002709

/ Completed临床2/3期

A Phase II/III, Randomized, Multi-centric, Comparator-controlled Study of the Safety and Neutralizing Activity of a Human Monoclonal Antibody to Rabies (SII RMAb) Administered in Conjunction with Rabies Vaccine for Post-exposure Prophylaxis in Patients following Potential Rabies Exposure

开始日期2012-06-04

申办/合作机构-

CTRI/2009/091/000465

/ Completed临床1期

Open-Label, Randomized, Dose Escalation Phase I Study in Healthy Adult Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody to Rabies (SII RMab) in Comparison to Human Rabies Immune Globulin Administered in Conjunction with Rabies Vaccine (RABIVAXÂ®).

开始日期2009-09-02

申办/合作机构-

100 项与 Anti-rabies monoclonal antibody(MassBiologics) 相关的临床结果

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100 项与 Anti-rabies monoclonal antibody(MassBiologics) 相关的转化医学

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100 项与 Anti-rabies monoclonal antibody(MassBiologics) 相关的专利（医药）

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项与 Anti-rabies monoclonal antibody(MassBiologics) 相关的文献（医药）

2026-03-01·VACCINE

Effectiveness of rabies immunoglobulins and monoclonal antibodies infiltrated into animal bite wounds after dilution: Real-world evidence from an anti-rabies clinic in India

Article

作者: Ashwath Narayana, D H ; Chiranthan, C M ; Sudarshan, M K ; Ravish, H S ; Isloor, Shrikrishna ; Poornima, M K ; Sharada, R ; Mani, Reeta S

BACKGROUND:

WHO recommends infiltration of category III bite wounds, and category II wounds in immunocompromised individuals, with rabies immunoglobulins (RIG) to neutralize the virus at the site of exposure. Dilution with sterile normal saline is advised to ensure adequate wound infiltration. However, data on the extent of dilution across various RIGs and rabies monoclonal antibodies (RmAbs), and their effectiveness are lacking. This study aimed to generate evidence on dilution practices and outcomes following full-dose infiltration.

OBJECTIVES:

To review the dilution ratios of RIGs and RmAbs used for full-dose wound infiltration in routine practice, and assess the clinical outcomes of the exposed individuals.

METHODS:

A desk review was conducted on 223 animal bite cases managed at an Anti-Rabies Clinic, Bengaluru, India from January 2022 to December 2024. All animal bite victims received full-dose RIG or RmAb, diluted with normal saline as required for complete wound infiltration. Survival status was verified through telephonic follow-up.

RESULTS:

Of the 223 cases, 133 (60%) were males, 210 (94%) cases had dog bites, 71 (31.8%) had bite from suspect rabid animals.Among 210 cases who had dog bites, 65 (31%) were attributed to suspect rabid dogs. Dilution ratios reached up to 1:1 for HRIG, 1:5.4 for ERIG, 1:20.7 for Rabishield, and 1:8.2 for Twinrab. Special groups included one pregnant woman (Twinrab) and one woman on antiretroviral therapy (Rabishield). Survival was 100%, with no rabies cases observed during 6-42 months of follow-up.

CONCLUSION:

Diluted RIGs and RmAbs were found to be effective in preventing rabies when used for adequate infiltration of multiple and severe animal bite wounds, supporting the feasibility and safety of dilution practices in real-world clinical settings.

2026-01-02·International Journal of Transgender Health

The evolution of pediatric transgender healthcare in Flanders: Trends in referrals, intakes and gender-affirming interventions over the last 15 years

Article

作者: Bruneel, Laura ; Ciancia, Silvia ; Klink, Daniel ; Dhondt, Karlien ; Heyse, Robin ; Cools, Martine ; Motmans, Joz ; Van Schuylenbergh, Judith

Purpose:

The expanding number of minors questioning their gender identity and seeking care has led to the constitution of pediatric gender clinics in several countries. The activity of the multidisciplinary Pediatric Gender Team at Ghent University Hospital, Belgium started in 2007. We report on the evolution of referrals, psychological intakes, and trends in the start of gender-affirming medical and surgical interventions from 2007 to 2023.

Methods:

The whole cohort of minors (age <17 years) having a psychological intake between 2007 and 2023 was included. Subgroups were analyzed based on sex registered at birth (female or male, RFAB and RMAB respectively), year and age at the psychological intake (below or above 10 years).

Results:

Referrals have increased in recent years. Between 2007 and 2023, 890 minors (65.5% RFAB) accessed our service. The ratio RFAB/RMAB has progressively increased, and RFAB with age at first intake >10 represented the greatest proportion. After 12 months, 19.5% were no longer in follow-up at our center; 28.1% of RFAB and 47.2% of RMAB did not start any medical treatment; 66.9% of RFAB and 52.8% of RMAB started gonadal hormone suppression (GHS), achieved with gonadotropin-releasing hormone analogues in 17.7% of RFAB and 34.6% of RMAB, with pro-androgenic progestins in 82.3% of RFAB and with anti-androgens in 65.4% of RMAB. 74.6% of RFAB and 86.4% of RMAB on GHS and older than 16 started gender-affirming hormones. Mastectomy was the most common gender-affirming surgery in RFAB, followed by hystero-gonadectomy. Gender-affirming surgery in RMAB was less frequent; vaginoplasty was the most frequent procedure.

Conclusions:

The care of minors with gender incongruence requires a multidisciplinary approach due to the complex psychological, social, and physical needs of this group. The timing and therapeutical options must be tailored to each adolescent.

2026-01-01·EClinicalMedicine

Effects of gender-affirming hormone therapy from adolescence to adulthood on bone mineral density, body composition and muscle strength

Article

作者: Klink, Daniel ; Ciancia, Silvia ; Vervalcke, Jeroen ; T'Sjoen, Guy ; Cools, Martine

Background:

The number of transgender and gender-diverse (TGD) minors seeking medical care continues to increase, however data on long-term effects of gender-affirming hormone therapy (GAHT) started in adolescence remain limited.

Methods:

This single center study (Ghent University Hospital, Belgium) included a cohort of TGD individuals registered female at birth (RFAB, n = 91) and registered male at birth (RMAB, n = 26) who commenced GAHT during adolescence and were followed into adulthood for up to 10 years. Participants were enrolled retrospectively between September 2023 and December 2024. Outcomes assessed cross-sectionally included areal bone mineral density (aBMD), body composition, handgrip strength, and overall life satisfaction. Lifestyle factors such as alcohol and tobacco use, illicit drug use, and physical inactivity were also examined. Retrospective longitudinal data on aBMD and body composition from the start of medical gender-affirming treatment to the moment of study participation were also analyzed.

Findings:

Median age at start of GAHT 17.2 (1.7) years for RFAB, 17.0 (2.2) years for RMAB; median GAHT duration at the enrollment 6.0 (2.4) years and 6.6 (3.4) years, respectively. aBMD z-scores remained within the normal range for both RFAB and RMAB participants, with scores aligning more closely to sex registered at birth (SRAB) in RFAB, and to affirmed gender (AG) in RMAB participants. Bone density was influenced by BMI, vitamin D levels, and smoking status, with those who had received GnRH agonists showing lower aBMD at specific sites. No pathological fractures were reported. Body composition shifted toward AG-typical fat and lean mass distribution, with some RFAB individuals exhibiting elevated visceral fat area. Handgrip strength in RFAB participants approached cisgender male reference values, while RMAB individuals showed intermediate values. Psychosocial outcomes indicated generally good self-rated health and life satisfaction, although a subset of participants, particularly among RMAB, reported lower life satisfaction.

Interpretation:

Long-term GAHT initiated during adolescence promotes alignment of bone density, body composition, and muscle strength consistent with gender identity, without evidence of clinically significant adverse effects. Modifiable lifestyle factors remain important determinants of skeletal health. Overall, participants reported good general health and life satisfaction.

Funding:

This work was supported by a project grant from the Research Foundation Flanders (FWO; GE065819N).

项与 Anti-rabies monoclonal antibody(MassBiologics) 相关的新闻（医药）

2023-09-25

·生物制品圈

首次增加单克隆抗体 | 解读《狂犬病暴露预防处置工作规范（2023年版）》被动免疫制剂

2023年9月13日，国家疾控局综合司、国家卫生健康委办公厅发布《狂犬病暴露预防处置工作规范（2023年版）》，这是7年来该规范首次更新。全篇共有五章三十条，内容简明扼要、可操作性强。《狂犬病暴露预防处置工作规范（2023年版）》（下简称新版《规范》）较《狂犬病预防控制技术指南（2016 版）》内容大大精简，删掉了病原学和实验室检测等相关内容，全文从78页压缩到11页，把重点内容放在暴露预防处置临床操作上，更加注重实操，对门诊医护人员有很好的指导意义。新版《规范》中的第二十条将被动免疫制剂的范围首次由狂犬病人免疫球蛋白和狂犬病血清扩展到单克隆抗体。此外，新版《规范》在第二十九条中也明确要求狂犬预防处置门诊应具备必要的狂犬病疫苗及其被动免疫制剂、应急抢救药品等。疫苗联用被动免疫制剂的原理：疫苗诱导产生抗体需1-2周的时间，在第一针疫苗注射后至机体产生足量抗体(≥0.5IU/mL)之前为“主动免疫诱导的保护力空白区或称高风险感染期”。在高风险感染期，伤口周围浸润注射的被动免疫制剂可使伤口局部获得高浓度的中和抗体，从而阻断病毒在伤口中的扩散。新版《规范》明确，对于III级暴露者，或II级暴露且严重免疫功能低下者，或者II级暴露者其伤口位于头面部且不能确定致伤动物健康状况时，应处置伤口并注射狂犬病被动免疫制剂和接种狂犬病疫苗。WHO狂犬病专家咨询委员会此前也建议，对于狂犬病病毒Ⅲ级暴露者，应在接种疫苗的同时对伤口进行彻底清洗并在周围浸润注射被动免疫制剂，以阻止病毒进入神经组织从而获得快速保护作用。另外，对于免疫功能严重低下的暴露者，即使Ⅱ级暴露，也应联合应用被动免疫制剂。人类狂犬病免疫球蛋白(HRIG)和马狂犬病免疫球蛋白(ERIG)在过去几十年中被用于被动免疫，但是由于两者都是血液衍生产品，它们在质量、安全性以及可用性方面存在许多问题，比如ERIG会导致较高的不良事件(AE)发生率，包括血清病和过敏反应。新版《规范》第十六条还提到，注射了HRIG者应按照要求推迟接种其它减毒活疫苗。这是因为HRIG由血液制备而成，含杂蛋白，而HRIG中的抗体可能与疫苗中的抗原物质结合，干扰机体对疫苗的正常免疫应答。在发展中国家，可负担性是在暴露后中使用狂犬病人免疫球蛋白的一个重要因素。印度一项研究显示，783名III级暴露患者中只有2.7%开了HRIG，但只有10人能负担得起。ERIG比HRIG更便宜，由于成本和可获得性，在发展中国家使用更频繁。但在印度和泰国，分别只有2%和3%的III级暴露患者选择注射HRIG或ERIG。WHO关于狂犬病的立场文件指出，单克隆抗体中和了广泛的全球流行的狂犬病病毒分离株，并鼓励使用单克隆抗体产品代替免疫球蛋白（RIG），因其具有标准化质量的大规模生产、比RIG更有效、生产过程中不使用动物以及降低不良事件风险等优点。抗狂犬病毒单克隆抗体可持续化生产且无血源污染风险，具有更高的安全性和有效性，通过单克隆抗体替代传统的人免疫球蛋白和免疫抗血清产品，是近年来国际研究的一个重要方向。国内已有抗狂犬病毒单克隆抗体制剂获批使用。目前，国外已有两种含有抗狂犬病病毒(抗RABV)单克隆抗体产品可用，下面简要描述。首先，印度血清研究所（Serum Institute of India Pvt. Ltd）和麻省生物制品研究所(MassBiologics)联合开发了一种名为“Rabishield”的单克隆抗体，这种抗体是从含有人免疫球蛋白的转基因小鼠中开发出来，然后分离B细胞并选择最高的RABV特异性抗体。其安全性在1期临床研究中得到证实。在2/3期临床研究中在病人身上对于III类暴露，就狂犬病毒而言，含Rabishield的暴露后预防方案不劣于含HRIG的暴露后预防方案中和抗体活动。Rabishield于2016年在印度获批，2018年由WHO战略顾问专家小组(SAGE)推荐，2021年被列入WHO基本药物目录。另外一款则是卡迪拉保健有限公司 (Zydus Lifesciences Ltd.)开发的Twinrab，这是第一个商业化的狂犬病鼠源单抗混合制剂，于2019年在印度获批，含有单克隆抗体M777-16-3和单克隆抗体62-71-3，建议剂量为40 IU/kg。根据WHO建议，抗狂犬病病毒单克隆抗体制剂应将针对病毒不同抗原位点的多株单抗组合成“鸡尾酒式”制剂，以保证单抗制剂对不同病毒株或病毒的不同基因型的有效性。荷兰的Crucell公司开发了一种人单克隆抗体混合物，包含两种单克隆抗体，CR57和CR4098，来源于携带人免疫球蛋白的转基因小鼠。该产品已经在印度、菲律宾和美国进行了1期和2期临床试验, 然而它并没有走向商业化。国内方面，兴盟生物研发的克瑞毕®是一种包含两种人源化单克隆抗体的单克隆抗体组合制剂，该单克隆抗体混合物具有结合和中和北美来源的20株狂犬病毒街毒以及全球来源的25株狂犬病毒街毒和中国来源的15株狂犬病毒流行株以及中国狂犬病毒街毒库中不同种群的7个代表毒株的能力。克瑞毕®的3期临床试验接近完成，已经在中美两国递交新药上市申请，预计将成为国内首个同类获批产品。参考文献：Lumlertdacha B， Mahong B， Rattanapisit K， Bulaon CJI， Hemachudha T， Phoolcharoen W. Efficiency Comparative Approach of Plant-Produced Monoclonal Antibodies against Rabies Virus Infection. Vaccines (Basel). 2023 Aug 17;11(8):1377. doi: 10.3390/vaccines11081377. PMID: 37631945.Kang G， Lakhkar A， Bhamare C， Dharmadhikari A， Narwadkar J， Kanujia A， Kapse D， Gunale B， Poonawalla CS， Kulkarni PS. Active safety surveillance of rabies monoclonal antibody and rabies vaccine in patients with category III potential rabies exposure. Lancet Reg Health Southeast Asia. 2023 May 16;14:100207. doi: 10.1016/j.lansea.2023.100207. PMID: 37492421; PMCID: PMC10363514.国内首款狂犬抗体组合制剂克瑞毕®招商进行中识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

疫苗信使RNA

100 项与 Anti-rabies monoclonal antibody(MassBiologics) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J06BB05	-

研发状态

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适应症	国家/地区	公司	日期
狂犬病	印度	-	2016-01-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
免疫系统疾病	药物发现	巴西	PharmaPraxis	2012-04-23
炎症	药物发现	巴西	PharmaPraxis	2012-04-23
肿瘤	药物发现	巴西	PharmaPraxis	2012-04-23

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


CTRI/2012/05/002709 (Pubmed \| Clin Infect Dis)	临床2/3期	-	200	SII RMAb	積鬱簾鏇製壓窪選網膚(顧夢壓範選製鏇觸醖鏇) = 膚獵襯齋齋觸觸餘積鹹醖齋齋艱蓋糧餘簾鹽鹽 (廠獵蓋網夢鹹廠鬱糧鹹, 18.94 ~ 32.74)	积极	2018-01-18
				HRIG	積鬱簾鏇製壓窪選網膚(顧夢壓範選製鏇觸醖鏇) = 鬱積壓襯範鹽構壓顧選醖齋齋艱蓋糧餘簾鹽鹽 (廠獵蓋網夢鹹廠鬱糧鹹, 4.11 ~ 8.41)