Comparison of Silevimig, a Novel Bispecific Anti-Rabies Monoclonal Antibody, with Human Rabies Immunoglobulin for Post-Exposure Prophylaxis: A Phase III, Randomized, Double-Blind, Non-Inferiority Trial

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ID: 329386
2026
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Ranked #238 of 635 articles by views in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

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Abstract
This phase III randomized, double-blind, non-inferiority trial evaluated Silevimig, a bispecific anti-rabies monoclonal antibody targeting antigenic sites I and III, as a substitute for human rabies immunoglobulin (HRIG) in post-exposure prophylaxis. Adults (>18 years) with suspected WHO category III rabies exposure were randomly assigned (3:1) to receive Silevimig or HRIG. After wound cleansing, the study drug was administered on day 0, together with a rabies vaccine given on days 0, 3, 7, 14, and 28. The co-primary endpoints were the adjusted geometric mean concentration (GMC) of rabies virus-neutralizing antibodies (RVNAs) on day 7, the proportion of participants with an RVNA level of ≥ 0.5 IU/mL (seroresponse) by day 14, and the rabies-free survival rate in 1 year (D365). Safety was assessed through adverse events (AEs) and serious adverse events (SAEs). A total of 1,200 participants were enrolled. On day 7, the adjusted GMC of RVNAs was 0.40 IU/mL in the Silevimig group versus 0.36 IU/mL in the HRIG group, meeting the non-inferiority criterion (ratio 1.11; 95% CI: 1.01-1.21). Seroresponse rates on days 14 and 90 were slightly higher with Silevimig. No rabies cases occurred during the 1-year follow-up, yielding a 100% rabies-free survival rate in both groups. Most AEs were mild to moderate. Silevimig was non-inferior to HRIG in inducing early RVNA responses, was well tolerated, and did not interfere with vaccine-induced immunity. These findings support Silevimig as a safe and effective alternative for passive rabies post-exposure prophylaxis (ClinicalTrials, NCT05846568).
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Authors Xiuqing Wang, Jing He, Yongxian Zha, Ya Jiang, Shuzuo Tan, Qinghua Li, Ruichun Zhao, Hong Su, 世园 万, Zhongliang Yang, Shiming Zhang, Yaling Zhou, Xiang Yi, Raodong Pu, Xi He, Rui Chang, Yinfeng Ma, Yunxia Chen, Guoyu Yang, Youfei Zhang, Yan Yang, Xiaoxiao Li, Mei Li, Sisi Li, Wenmei Bao, Tingkui Li, Xiaoqiang Liu
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Journal Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Year 2026
DOI
10.1093/cid/ciag551
URL
https://doi.org/10.1093/cid/ciag551
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