Please use this identifier to cite or link to this item:
https://doi.org/10.1128/AAC.02467-19
DC Field | Value | |
---|---|---|
dc.title | Phase 2 study of anti-human cytomegalovirus monoclonal antibodies for prophylaxis in hematopoietic cell transplantation | |
dc.contributor.author | Maertens, J | |
dc.contributor.author | Logan, AC | |
dc.contributor.author | Jang, J | |
dc.contributor.author | Long, G | |
dc.contributor.author | Tang, JL | |
dc.contributor.author | Hwang, WYK | |
dc.contributor.author | Koh, LP | |
dc.contributor.author | Chemaly, R | |
dc.contributor.author | Gerbitz, A | |
dc.contributor.author | Winkler, J | |
dc.contributor.author | Yeh, SP | |
dc.contributor.author | Hiemenz, J | |
dc.contributor.author | Christoph, S | |
dc.contributor.author | Lee, DG | |
dc.contributor.author | Wang, PN | |
dc.contributor.author | Holler, E | |
dc.contributor.author | Mielke, S | |
dc.contributor.author | Akard, L | |
dc.contributor.author | Yeo, A | |
dc.contributor.author | Ramachandra, S | |
dc.contributor.author | Smith, K | |
dc.contributor.author | Pertel, P | |
dc.contributor.author | Segal, F | |
dc.date.accessioned | 2022-07-18T07:08:49Z | |
dc.date.available | 2022-07-18T07:08:49Z | |
dc.date.issued | 2020-01-01 | |
dc.identifier.citation | Maertens, J, Logan, AC, Jang, J, Long, G, Tang, JL, Hwang, WYK, Koh, LP, Chemaly, R, Gerbitz, A, Winkler, J, Yeh, SP, Hiemenz, J, Christoph, S, Lee, DG, Wang, PN, Holler, E, Mielke, S, Akard, L, Yeo, A, Ramachandra, S, Smith, K, Pertel, P, Segal, F (2020-01-01). Phase 2 study of anti-human cytomegalovirus monoclonal antibodies for prophylaxis in hematopoietic cell transplantation. Antimicrobial Agents and Chemotherapy 64 (4) : e02467-e02419. ScholarBank@NUS Repository. https://doi.org/10.1128/AAC.02467-19 | |
dc.identifier.issn | 0066-4804 | |
dc.identifier.issn | 1098-6596 | |
dc.identifier.uri | https://scholarbank.nus.edu.sg/handle/10635/228766 | |
dc.description.abstract | Human cytomegalovirus (HCMV) can cause significant disease in immunocompromised patients, and treatment options are limited by toxicities. CSJ148 is a combination of two anti-HCMV human monoclonal antibodies (LJP538 and LJP539) that bind to and inhibit the functions of viral HCMV glycoprotein B (gB) and the pentameric complex, consisting of glycoproteins gH, gL, UL128, UL130, and UL131. In this phase 2, randomized, placebo-controlled trial, we evaluated the safety and efficacy of CSJ148 for prophylaxis of HCMV in patients undergoing allogeneic hematopoietic stem cell transplantation. As would be expected in the study population, all the patients (100%) reported at least one treatment-emergent adverse event. There were 22 deaths during this study, and over 80% of the patients receiving placebo or CSJ148 developed at least one adverse event of grade 3 or higher severity. No subject who received antibody developed a hypersensitivity- or infusion-related reaction. CSJ148-treated patients showed trends toward decreased viral load, shorter median duration of preemptive therapy, and fewer courses of preemptive therapy. However, the estimated probability that CSJ148 decreases the need for preemptive therapy compared to placebo was 69%, with a risk ratio of 0.89 and a 90% credible interval of 0.61 to 1.31. The primary efficacy endpoint was therefore not met, indicating that CSJ148 did not prevent clinically significant HCMV reactivation in recipients of allogeneic hematopoietic cell transplants. | |
dc.publisher | American Society for Microbiology | |
dc.source | Elements | |
dc.subject | hematopoietic stem cell transplantation | |
dc.subject | human cytomegalovirus | |
dc.subject | prophylaxis | |
dc.subject | Administration, Intravenous | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Antibodies, Viral | |
dc.subject | Antiviral Agents | |
dc.subject | Cytomegalovirus Infections | |
dc.subject | Female | |
dc.subject | Graft vs Host Disease | |
dc.subject | Hematopoietic Stem Cell Transplantation | |
dc.subject | Humans | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Placebos | |
dc.subject | Treatment Outcome | |
dc.subject | Viral Load | |
dc.subject | Young Adult | |
dc.type | Article | |
dc.date.updated | 2022-07-14T03:49:10Z | |
dc.contributor.department | DEPT OF MEDICINE | |
dc.contributor.department | DUKE-NUS MEDICAL SCHOOL | |
dc.description.doi | 10.1128/AAC.02467-19 | |
dc.description.sourcetitle | Antimicrobial Agents and Chemotherapy | |
dc.description.volume | 64 | |
dc.description.issue | 4 | |
dc.description.page | e02467-e02419 | |
dc.published.state | Published | |
Appears in Collections: | Staff Publications Elements |
Show simple item record
Files in This Item:
File | Description | Size | Format | Access Settings | Version | |
---|---|---|---|---|---|---|
Phase 2 Study of Anti-Human Cytomegalovirus Monoclonal Antibodies for Prophylaxis in Hematopoietic Cell Transplantation. .pdf | 308.4 kB | Adobe PDF | OPEN | Published | View/Download |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.