(ASP-0113) - 药物靶点：CMV pp65_在研适应症：巨细胞病毒感染，造血干细胞移植_专利_临床

A Phase 1, Single-Blind, Parallel-Group, Pharmacokinetic and Immunogenicity Study With ASP0113 in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients

The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers, CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by the vaccine after repeated ASP0113 IM injection.

开始日期2013-12-30

申办/合作机构

Astellas Pharma Global Development, Inc.

[+1]

NCT01974206 / Completed临床2期

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of ASP0113 in this patient population.

开始日期2013-11-20

申办/合作机构

Astellas Pharma Global Development, Inc.

[+1]

EUCTR2013-000903-18-BE / Not yet recruiting临床3期

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)

开始日期2013-10-04

申办/合作机构

Astellas Pharma Global Development, Inc.

100 项与 ASP-0113 相关的临床结果

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100 项与 ASP-0113 相关的转化医学

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100 项与 ASP-0113 相关的专利（医药）

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15

项与 ASP-0113 相关的文献（医药）

2021-03-01·EClinicalMedicine

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

作者: Cywin, Beth ; Chevallier, Patrice ; Solano, Carlos ; Ljungman, Per ; Selleslag, Dominik ; Kakihana, Kazuhiko ; Bermudez, Arancha ; Wang, Xuegong ; Wulf, Gerald ; Young, James ; Kharfan-Dabaja, Mohamed A ; Fredericks, Christine ; Logan, Aaron C ; Langston, Amelia ; Maertens, Johan ; Martino, Rodrigo ; Wingard, John R ; Lee, Dong-Gun ; Lademacher, Christopher ; Okamoto, Shinichiro ; Smith, Larry R ; Boeckh, Michael

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 (n = 246) or placebo (n = 255). The proportion of patients with composite all-cause mortality and adjudicated CMV EOD by 1 year post-transplant was 35.4% (n = 87) with ASP0113 and 30•2% (n = 77) with placebo (odds ratio 1.27; 95% confidence interval: 0.87 to 1.85; p = 0.205). Incidence of injection site-related treatment-emergent adverse events (TEAEs) was higher with ASP0113 than placebo. Overall incidence and severity of other TEAEs was similar between groups. T-cell response to pp65 increased over time and was greater with placebo than ASP0113 (p = 0.027).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 .

2020-05-01·Clinical Pharmacology in Drug Development

Pharmacokinetics and Immunogenicity of ASP0113 in CMV‐Seronegative Dialysis Patients and CMV‐Seronegative and ‐Seropositive Healthy Subjects

Article

作者: Bonate, Peter L. ; Smith, Larry R. ; Rammelsberg, Diane ; Koester, Anne ; Van Sant, Charles ; Marbury, Thomas C. ; Goldwater, Ronald ; Cho, Kathy ; Boutsaboualoy, Sou ; Zook, Erin C. ; Wang, Xuegong ; Ye, Ming ; Wu, Ruishan

AbstractCytomegalovirus (CMV) infection causes significant morbidity and mortality in immunocompromised transplant patients. ASP0113, a first‐in‐class DNA vaccine containing plasmids encoding CMV phosphoprotein 65 and glycoprotein B (gB), was evaluated in a phase 1b, subject‐blinded study in CMV‐seropositive (n = 13) and CMV‐seronegative (n = 12) healthy and CMV‐seronegative dialysis subjects (n = 12) randomized to ASP0113 or placebo. End points included pharmacokinetics, anti‐gB antibody levels, phosphoprotein 65–specific T‐cell responses measured by ex vivo enzyme‐linked immune absorbent spot (ELISpot) assay and 10‐day cultured ELISpot and Stat T‐cell activation assays, and safety. ASP0113 concentrations peaked at 2‐10 and 24‐48 hours; the pharmacokinetics were similar across groups. No group demonstrated significant anti‐gB antibody responses. T‐cell responder rates in the cultured ELISpot assay were 8/12 (66.7%, 95%CI 35% to 90%) and 4/12 (33.3%, 95%CI 10% to 65%) in CMV‐seronegative healthy subjects and dialysis patients, respectively, whereas ex vivo ELISpot assay response rates were 4/11 (36.4%, 95%CI 11% to 69%) and 0/12, respectively. Responses peaked at week 27, with lower magnitude observed in CMV‐seronegative dialysis patients versus CMV‐seronegative healthy subjects. No serious adverse events occurred; the most common adverse event in ASP0113‐vaccinated patients was injection‐site pain (64.9%). Some CMV‐seronegative healthy subjects and dialysis patients had T‐cell responses; no humoral responses were detected.

2018-12-01·American Journal of Transplantation1区 · 医学

A randomized, phase 2 study of ASP0113, a DNA-based vaccine, for the prevention of CMV in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor

1区 · 医学

Article

作者: Shah, Malay ; Weidemann, Alexander ; Vincenti, Flavio ; Ram Peddi, V ; Wang, Xuegong ; Shihab, Fuad ; Merville, Pierre ; Budde, Klemens ; Lee, Misun ; Cassuto-Viguier, Elisabeth ; Wyburn, Kate ; Lademacher, Christopher ; Flegel, Teresa ; Erdman, Jay

Cytomegalovirus (CMV) is a latent infection in most infected individuals, but can be pathogenic in immunocompromised kidney transplant recipients. ASP0113 is a DNA-based vaccine for the prevention of CMV-related mortality and end-organ disease in transplant recipients. The efficacy, safety, and immunogenicity of ASP0113 was assessed in a phase 2, double-blind, placebo-controlled study in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor. Transplant recipients were randomized (1:1) to receive 5 doses of ASP0113 (5 mg; n = 75) or placebo (n = 74) on Days 30/60/90/120/180 posttransplant, and they received prophylactic valganciclovir/ganciclovir 10-100 days posttransplant. The primary endpoint was the proportion of transplant recipients with CMV viremia ≥1000 IU/mL from Day 100 through to 1 year after the first study vaccine injection. There was no statistically significant difference in the primary endpoint between the ASP0113 and placebo groups (odds ratio 0.79, 95% confidence interval 0.43-1.47; P = .307). There were similar numbers of transplant recipients with treatment-emergent adverse events between groups; however, more transplant recipients reported injection site pain in the ASP0113 group compared with placebo. ASP0113 did not demonstrate efficacy in the prevention of CMV viremia in this CMV-seronegative kidney transplant population, but demonstrated a safety profile similar to placebo. ClinicalTrials.gov registration number: NCT01974206.

100 项与 ASP-0113 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
造血干细胞移植	临床3期	加拿大	Astellas Pharma Global Development, Inc.	2013-09-11
造血干细胞移植	临床3期	中国台湾	Astellas Pharma Global Development, Inc.	2013-09-11
造血干细胞移植	临床3期	德国	Astellas Pharma Global Development, Inc.	2013-09-11
造血干细胞移植	临床3期	西班牙	Astellas Pharma Global Development, Inc.	2013-09-11
造血干细胞移植	临床3期	韩国	Astellas Pharma Global Development, Inc.	2013-09-11
造血干细胞移植	临床3期	美国	Astellas Pharma Global Development, Inc.	2013-09-11
造血干细胞移植	临床3期	法国	Astellas Pharma Global Development, Inc.	2013-09-11
造血干细胞移植	临床3期	瑞典	Astellas Pharma Global Development, Inc.	2013-09-11
造血干细胞移植	临床3期	比利时	Astellas Pharma Global Development, Inc.	2013-09-11
巨细胞病毒感染	临床2期	-	Vical, Inc.	-

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01877655 (Pubmed) 人工标引	临床3期	巨细胞病毒感染	501	ASP0113	(廠鹽憲網糧範醖顧積衊) = 糧願夢餘鹹窪衊鏇願壓衊鹹鏇顧淵鹽網糧顧範 (餘鏇齋觸夢糧齋構積鹽 )	不佳	2021-03-19
				Placebo	(廠鹽憲網糧範醖顧積衊) = 窪襯淵襯築窪築觸壓膚衊鹹鏇顧淵鹽網糧顧範 (餘鏇齋觸夢糧齋構積鹽 )
NCT01974206 (CTgov)	临床2期	巨细胞病毒感染	150	Placebo (Placebo)	襯築鬱獵獵範選淵構蓋(衊餘憲鹹壓壓鹽網願鹽) = 艱蓋夢簾齋醖淵獵遞衊艱網選鏇觸願鬱鹹襯憲 (夢構鏇憲簾襯鏇構蓋觸, 醖鏇餘壓壓膚繭鹹遞願 ~ 鏇範膚築鏇鏇窪鹽廠鏇) 更多	-	2022-01-04
				ASP0113 (ASP0113)	憲製餘築醖願憲鬱壓艱(製壓壓夢網觸願鏇淵憲) = 範蓋鏇鹽蓋壓夢遞構艱膚糧夢壓簾衊選蓋簾窪 (築範鹹顧願繭鑰鬱餘鹹, 壓廠築鏇遞鹹襯遞觸醖 ~ 蓋憲鑰鬱顧窪糧鹹獵選) 更多
NCT01974206 (Pubmed \| MMWR Morb Mortal Wkly Rep) 人工标引	临床2期	巨细胞病毒感染	149	ASP0113	(糧艱膚構憲衊衊艱鏇築): OR = 0.79 (95% CI, 0.43 ~ 1.47) 更多	不佳	2018-12-01
				Placebo
NCT01877655 (CTgov)	临床3期	巨细胞病毒感染 \| 造血干细胞移植	514	Placebo (Placebo)	築繭鏇糧獵鑰製積窪淵(夢夢淵鏇繭窪網衊壓網): Odds Ratio (OR) = 1.27 (95% CI, 0.87 ~ 1.85) 更多	-	2018-11-28
				ASP0113 (ASP0113)