Trial reportAntimicrobial agents and chemotherapy2020
Phase 2 Study of Anti-Human Cytomegalovirus Monoclonal Antibodies for Prophylaxis in Hematopoietic Cell Transplantation.
Trial report in Antimicrobial agents and chemotherapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02268526 (A Multi-center, Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of CSJ148 Compared to Placebo to Prevent Human Cytomegalovirus), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-center, Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of CSJ148 Compared to Placebo to Prevent Human Cytomegalovirus (HCMV) Replication in Stem Cell Transplant Patients
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Antiviral Agents for Preventing Cytomegalovirus Disease in Recipients of Hematopoietic Cell Transplantation.Viruses · 2024Pooled it
- Comparative evaluation of screening approaches for antiviral monoclonal antibody combinations.Journal of virology · 2026Article
- Mapping the monoclonal antibody landscape of human cytomegalovirus.Journal of virology · 2026Review
- Human Cytomegalovirus Infection in Haematopoietic Stem Cell Transplant Recipients and CAR T Cell Recipients - PART 1: Risk Factors, Clinical Impact and Immune Response.Reviews in medical virology · 2026Review
- Innovation in active and passive immunisation of people who are immunocompromised: a call to action.The Lancet. Infectious diseases · 2026Review
- Progress and prospects for herpesvirus vaccination using gB antigens.Frontiers in immunology · 2026Review
- T cell receptor-like antibody specifically targets and eliminates cells infected with cytomegalovirus.Journal of translational medicine · 2025Article
- Review
- Human Cytomegalovirus Immune Evasion of Natural Killer Cells: A Virus for All Seasons?Pathogens (Basel, Switzerland) · 2025Review
- Evaluation of the In Vitro Capacity of Anti-Human Cytomegalovirus Antibodies to Initiate Antibody-Dependent Cell Cytotoxicity.Microorganisms · 2024Article
- Article
- Antiviral Approach to Cytomegalovirus Infection: An Overview of Conventional and Novel Strategies.Microorganisms · 2023Review
- Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies.Pharmaceutics · 2023Review
- Fibroblast, Epithelial and Endothelial Cell-Derived Human Cytomegalovirus Strains Display Distinct Neutralizing Antibody Responses and Varying Levels of gH/gL Complexes.International journal of molecular sciences · 2023Article
- A fully human neutralizing monoclonal antibody targeting a highly conserved epitope of the human cytomegalovirus glycoprotein B.PloS one · 2023Article
- Anti-CMV therapy, what next? A systematic review.Frontiers in microbiology · 2023Review
- Antibodies to combat viral infections: development strategies and progress.Nature reviews. Drug discovery · 2022Review
- Development of broadly neutralizing antibodies targeting the cytomegalovirus subdominant antigen gH.Communications biology · 2022Article
- Neutralizing Antibodies Limit Cell-Associated Spread of Human Cytomegalovirus in Epithelial Cells and Fibroblasts.Viruses · 2022Article
- Immune Prophylaxis and Therapy for Human Cytomegalovirus Infection.International journal of molecular sciences · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 18 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
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. (This study has been registered at ClinicalTrials.gov under identifier NCT02268526 and at EudraCT under number 2017-002047-15.).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.