{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T08:21:15Z","timestamp":1790324475375,"version":"4.1.0"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T00:00:00Z","timestamp":1759881600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004331","name":"Johnson & Johnson","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004331","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,12,24]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Influenza is a significant public health concern, especially in immunocompromised patients. CD388 is a novel multivalent zanamivir conjugate that is stably linked to a proprietary human immunoglobulin G1 Fc with a long half-life for prevention of influenza. Here we report a proof-of-concept study on the prophylactic activity of subcutaneously administered CD388 against influenza challenge.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In a randomized, double-blind, placebo-controlled, phase 2a human challenge study, a single dose of CD388 (50 or 150\u2005mg) was subcutaneously administered in healthy participants 5 days before intranasal challenge with influenza A (H3N2). Safety, pharmacokinetics, infection rate (by reverse transcription\u2013quantitative polymerase chain reaction methods [RT-qPCR]), intranasal viral load (VL), and symptoms were compared between the CD388 and placebo treatment groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The area under the VL\u2013time curve (VL-AUC), primary endpoint, was lower in the CD388 150\u2005mg group (n = 28) compared with the placebo group (n = 28; mean 10.70 log10 [copies\/mL] \u00d7 days vs mean 16.09 log10 [copies\/mL] \u00d7 days; P = .0390). Peak VL and the rate of RT-qPCR\u2013confirmed influenza infection were lower in the CD388 group versus the placebo group (P = .0185 and P = .0248, respectively). Clinical symptom scores were numerically lower among participants treated with CD388 compared with participants treated with placebo. There were a limited number of treatment-emergent adverse events. Anti-drug antibody development was rare and not clinically relevant.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>CD388 was well-tolerated and demonstrated prophylactic activity against RT-qPCR\u2013confirmed influenza infection in a human challenge study. The efficacy of CD388 in preventing influenza will be confirmed in larger studies.<\/jats:p>\n                    <jats:p>Clinical Trials Registration. \u00a0ClinicalTrials.gov identifier: NCT05523089.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciaf465","type":"journal-article","created":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T12:06:41Z","timestamp":1759320401000},"page":"e310-e318","source":"Crossref","is-referenced-by-count":3,"title":["Prophylactic Efficacy of CD388, a Novel Drug\u2013Fc Conjugate, in a Human Influenza A\/H3N2 Virus Challenge Model: A Randomized, Controlled Phase 2a Study"],"prefix":"10.1093","volume":"81","author":[{"given":"Roxana E","family":"Rojas","sequence":"first","affiliation":[{"name":"Communicable Diseases, Johnson & Johnson , Brisbane, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ozlem","family":"Equils","sequence":"additional","affiliation":[{"name":"Cidara Therapeutics , 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