{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T22:22:24Z","timestamp":1793226144784,"version":"4.5.0"},"reference-count":35,"publisher":"American Medical Association (AMA)","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n Dengue outbreaks are increasing in frequency and intensity. In the absence of any specific treatment, a pan-serotype recombinant monoclonal antibody (Dengue-mAb) was tested in adult patients with dengue as a therapeutic option.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess the safety and effect of a single dose of Dengue-mAb on dengue viremia at different dose levels among patients with dengue.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n \n A phase 2, single-blind, randomized, placebo-controlled clinical trial was conducted from September 19, 2021, to May 13, 2023, at 12 hospitals in India. Study participants were aged 18 to 60 years with dengue and a history of fever onset within 48 hours. Key exclusion criteria were severe dengue, hemoglobin less than 10 g\/dL, absolute neutrophil count less than 500\/mm\n 3<\/jats:sup>\n , total leukocyte count less than 1500\/mm\n 3<\/jats:sup>\n , platelet count less than 50\u202f000\/mm\n 3<\/jats:sup>\n , and any other clinically significant disorders. Data were analyzed from January 11, 2024, to March 26, 2024.\n <\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Participants were randomly allocated 1:1:1:1:1 using an interactive web response system to receive 1 of 4 dose levels of Dengue-mAb (3, 5, 7, or 9 mg\/kg) or placebo by slow intravenous infusion.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Primary outcomes were reduction in viremia at 24 hours and causally related serious adverse events (SAEs). Secondary outcomes were RNAemia, fever, and hematologic and pharmacokinetic parameters.<\/jats:p>\n <\/jats:sec>\n \n Findings<\/jats:title>\n \n A total of 250 participants were randomized, with 50 participants in each group. The overall median age was 30 years (IQR, 24-37 years), and 180 participants (72.3%) were male. There were no causally related SAEs. The adjusted mean (SE) viral log reduction at 24 hours was significantly higher with Dengue-mAb\u2014from 1.93 (0.23) with 3 mg\/kg (\n P<\/jats:italic>\n \u2009=\u2009.04) to 2.35 (0.27) with 9 mg\/kg (\n P<\/jats:italic>\n \u2009=\u2009.003)\u2014compared with placebo (1.29 [0.22]), using a mixed model for repeated measures. Participants with detectable viremia (n\u2009=\u200932) at baseline were negative for dengue virus by 8 hours when treated with a 5- to 9-mg\/kg dose of Dengue-mAb compared with 72 hours with placebo. Median time to fever clearance was 3.5 (95% CI, 1.0-24.0) hours (hazard ratio [HR], 2.6 [95% CI, 1.0-6.4]) with Dengue-mAb 5 mg\/kg (n\u2009=\u200914) and 2.0 (95% CI, 0.5-6.0) hours (HR, 2.8 [95% CI, 1.2-6.8]) with Dengue-mAb 7 mg\/kg (n\u2009=\u200914), compared with 26.8 (95% CI, 1.0-50.5) hours with placebo (n\u2009=\u200912). At 24 hours, between 13 of 14 participants (92.9%; 95% CI, 66.1%-99.8%) with Dengue-mAb (3 mg\/kg), 14 of 14 participants (100.0%; 95% CI, 76.8%-100.0%) with Dengue-mAb (5 mg\/kg and 7 mg\/kg), and 16 of 17 participants (94.1%; 95% CI 71.3%-99.9%) with Dengue-mAb (9 mg\/kg); and 7 of 12 participants (58.3%; 95% CI, 27.7%-84.8%) with placebo had fever clearance.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this randomized clinical trial, Dengue-mAb was safe and well tolerated. Dengue-mAb rapidly reduced dengue viremia and fever at doses of 5 mg\/kg and 7 mg\/kg, making this the first therapeutic against wild-type dengue virus to show preliminary efficacy in humans.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n Clinical Trial Registry-India Identifier:\n CTRI\/2021\/07\/035290<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2026.29979","type":"journal-article","created":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T15:00:16Z","timestamp":1787670016000},"page":"e2629979","source":"Crossref","is-referenced-by-count":1,"title":["Safety and Preliminary Efficacy of Dengue Monoclonal Antibody in Adult Patients"],"prefix":"10.1001","volume":"9","author":[{"given":"Prasad S.","family":"Kulkarni","sequence":"first","affiliation":[{"name":"Serum Institute of India Private Limited, Pune, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anirudha 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