ArticleEClinicalMedicine2021
A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients.
Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01877655 (A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus), which is not on this map. Cited by 23 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 Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Association Between Cytomegalovirus Infection and Tuberculosis Disease: A Systematic Review and Meta-Analysis of Epidemiological Studies.The Journal of infectious diseases · 2023Pooled it
- Cytomegalovirus Vaccines in Transplantation: History, Hurdles, and Hope.Transplant infectious disease : an official journal of the Transplantation Society · 2026Review
- Congenital Cytomegalovirus Infection in Pregnancy: Challenges in Early Diagnosis, Reinfection, and Secondary Prevention.Viruses · 2026Review
- Why do we have a vaccine for measles, but not cytomegalovirus (CMV)?PLoS pathogens · 2026Article
- Human Cytomegalovirus Infection in Haematopoietic Stem Cell Transplant Recipients and CAR-T Cell Recipients-PART 2: Antiviral Therapy and Virus-Specific T Cell Therapy for HCMV in Allo-HSCT.Reviews in medical virology · 2026Review
- Advances in immunotherapy for cytomegalovirus infection following allogeneic hematopoietic stem cell transplantation.Immunotherapy · 2026Review
- Progress and prospects for herpesvirus vaccination using gB antigens.Frontiers in immunology · 2026Review
- A phase 1, single-center, randomized, dose finding study to evaluate the safety, tolerability, and immunogenicity of a prophylactic COVID-19 pDNA vaccine after single ascending doses in healthy adults.Frontiers in medicine · 2026Article
- Cytomegalovirus in Pregnancy: Effects on the Developing Embryo and Fetus, Diagnosis and Treatment: Where to Go Now? A Narrative Review.International journal of molecular sciences · 2025Review
- T cell receptor-like antibody specifically targets and eliminates cells infected with cytomegalovirus.Journal of translational medicine · 2025Article
- Developing a Vaccine Against Human Cytomegalovirus: Identifying and Targeting HCMV's Immunological Achilles' Heel.Vaccines · 2025Review
- Modulation of lipid nanoparticle-formulated plasmid DNA drives innate immune activation promoting adaptive immunity.Cell reports. Medicine · 2025Article
- Safety, Immunogenicity, and Efficacy of Cytomegalovirus Vaccines: A Systematic Review of Randomized Controlled Trials.Vaccines · 2025Review
- A vaccine against cytomegalovirus: how close are we?The Journal of clinical investigation · 2025Article
- Human cytomegalovirus: pathogenesis, prevention, and treatment.Molecular biomedicine · 2024Review
- Proceedings of the Conference "CMV Vaccine Development-How Close Are We?" (27-28 September 2023).Vaccines · 2024Article
- Therapeutic vaccines for herpesviruses.The Journal of clinical investigation · 2024Review
- Cytomegalovirus infection is associated with impaired myocardial flow reserve after heart transplantation.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2024Article
- Indirect effects of cytomegalovirus infection: Implications for vaccine development.Reviews in medical virology · 2023Review
- DNA and mRNA Vaccines for Chronic Viral Infections and Cancer: Rationale, Mechanisms, and Progress.Cancers · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 17 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients.
methodsIn this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who received ≥1 dose of ASP0113/placebo. The primary efficacy endpoint was the proportion of allo-HCT recipients with composite all-cause mortality and adjudicated CMV end-organ disease (EOD) by 1 year post-transplant. ClinicalTrials.gov: NCT01877655 (not recruiting).
findingsPatients were recruited between Sept 11, 2013 and Sept 21, 2016. Overall, 501 patients received ≥1 dose of ASP0113 (
interpretationASP0113 did not reduce overall mortality or CMV EOD by 1 year post-transplant. Safety findings were similar between groups.
fundingAstellas Pharma Global Development, Inc .
Identifiers
What OpenQuestion holds
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.