biostudies-literatureUnknown31(8)Liang ZTetanus remains an important global public health concern. Currently, the only recommended passive immunization therapy for tetanus prophylaxis is plasma-derived human tetanus immunoglobulin (HTIG), which faces a global supply shortage and can transmit infectious pathogens. Despite not being endorsed by WHO due to safety concerns, equine tetanus antitoxin remains widely used in some countries. We conducted a randomized, double-blind, phase 3 trial to evaluate siltartoxatug-a first-in-class recombinant monoclonal antibody-for tetanus postexposure prophylaxis. Participants (n = 675) were randomized (2:1) to receive a single intramuscular injection of siltartoxatug 10 mg or HTIG 250 IU. The study met its primary outcome, with siltartoxatug demonstrating superiority to HTIG in the proportion oNature medicine2673-2681https://www.ebi.ac.uk/biostudies/studies/S-EPMC12353795biostudies-literatureRecombinant monoclonal antibody siltartoxatug versus plasma-derived human tetanus immunoglobulin for tetanus: a randomized, double-blind, active-controlled, phase 3 trial.PMC12353795Wu LZhang DDing BWang CLiang ZGuo WZhang MLiu SDing JBin WGuo QWang JZhao YLiu XXu BLiao HDeng ZZhan HWang WLi HCheng DHe LKuang XZheng WYan XLi WLi XLi ZLi SHu JZhang ZHuang WYu AOuyang YXiang WCai WfalseRecombinant monoclonal antibody siltartoxatug versus plasma-derived human tetanus immunoglobulin for tetanus: a randomized, double-blind, active-controlled, phase 3 trial.Tetanus remains an important global public health concern. Currently, the only recommended passive immunization therapy for tetanus prophylaxis is plasma-derived human tetanus immunoglobulin (HTIG), which faces a global supply shortage and can transmit infectious pathogens. Despite not being endorsed by WHO due to safety concerns, equine tetanus antitoxin remains widely used in some countries. We conducted a randomized, double-blind, phase 3 trial to evaluate siltartoxatug-a first-in-class recombinant monoclonal antibody-for tetanus postexposure prophylaxis. Participants (n = 675) were randomized (2:1) to receive a single intramuscular injection of siltartoxatug 10 mg or HTIG 250 IU. The study met its primary outcome, with siltartoxatug demonstrating superiority to HTIG in the proportion o2025-01-01T00:00:00Z2025 Aug2026-07-15T06:26:41.493Z2026-07-01T03:07:09.992ZS-EPMC123537954062896510.1038/s41591-025-03791-8