ASP-0113(ASP-0113) - 药物靶点：CMV pp65_专利_临床

概要

基本信息

药物类型

DNA疫苗、预防性疫苗

别名

ASP0113 CMV Therapeutic Vaccine、Cytomegalovirus DNA vaccine bivalent、TransVax

+ [2]

靶点

CMV pp65

作用机制

CMV pp65调节剂(巨细胞病毒pp65抗原调节剂)

治疗领域

感染其他疾病肿瘤+ [2]

在研适应症-

非在研适应症

急性淋巴细胞白血病急性髓性白血病巨细胞病毒感染+ [6]

原研机构

Vical, Inc.

在研机构-

非在研机构

Astellas Pharma Global Development, Inc.

Vical, Inc.

Astellas Pharma, Inc.

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

7

项与 ASP-0113 相关的临床试验

KCT0000990 / Active, not 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 CMV-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant(HCT)

开始日期2014-08-16

申办/合作机构

Astellas Pharma, Inc.

NCT02103426 / Completed临床1期

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]

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 ; Kakihana, Kazuhiko ; Selleslag, Dominik ; Bermudez, Arancha ; Wang, Xuegong ; Wulf, Gerald ; Kharfan-Dabaja, Mohamed A ; Young, James ; Logan, Aaron C ; Fredericks, Christine ; Langston, Amelia ; Lee, Dong-Gun ; Martino, Rodrigo ; Wingard, John R ; Maertens, Johan ; Lademacher, Christopher ; Smith, Larry R ; Okamoto, Shinichiro ; 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 ; Wyburn, Kate ; Cassuto-Viguier, Elisabeth ; Lee, Misun ; 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

10 条进展最快的记录,

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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	美国	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
造血干细胞移植	临床3期	日本	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	澳大利亚	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	加拿大	Astellas Pharma Global Development, Inc.	2013-09-11
巨细胞病毒感染	临床3期	-	Vical, Inc.	-
巨细胞病毒感染	临床3期	-	Vical, Inc.	-
造血干细胞移植	药物发现	西班牙	Astellas Pharma Global Development, Inc.	2013-09-11

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临床结果

适应症

分期

评价

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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


NCT01974206 (CTgov)	临床2期	巨细胞病毒感染	150	Placebo (Placebo)	鹹遞顧觸製膚憲衊鹹艱(夢廠憲糧選遞襯範膚醖) = 獵鹹鹹製遞衊選積窪糧壓鬱築壓鑰網壓網獵築 (簾繭窪鹹鑰膚製壓網艱, 廠齋艱積顧膚蓋醖鹽膚 ~ 範網廠觸選壓觸顧願鬱) 更多	-	2022-01-04
				ASP0113 (ASP0113)	醖積艱簾範憲鑰壓簾夢(網網築膚襯廠糧衊壓構) = 艱簾艱壓繭繭築觸鏇範憲網鏇選廠鏇餘製壓築 (鏇憲積繭淵衊醖夢襯觸, 觸壓窪廠膚鏇夢選餘餘 ~ 襯築糧憲淵糧遞鬱築簾) 更多
NCT01877655 (Pubmed) 人工标引	临床3期	巨细胞病毒感染	501	ASP0113	(顧遞蓋廠鹽觸餘顧鏇網) = 窪顧艱願選襯鹽鹽糧蓋鹹繭積廠顧廠糧醖壓獵 (糧積膚製餘憲遞觸廠簾 )	不佳	2021-03-19
				Placebo	(顧遞蓋廠鹽觸餘顧鏇網) = 鹽獵製衊範廠蓋願網簾鹹繭積廠顧廠糧醖壓獵 (糧積膚製餘憲遞觸廠簾 )
NCT01974206 (Pubmed \| MMWR Morb Mortal Wkly Rep) 人工标引	临床2期	巨细胞病毒感染	149	ASP0113	(窪築艱積衊鬱選顧衊範): OR = 0.79 (95% CI, 0.43 ~ 1.47), P-Value = 0.307 更多	不佳	2018-12-01
				Placebo
NCT01877655 (HELIOS, CTgov)	临床3期	巨细胞病毒感染 \| 造血干细胞移植	514	Placebo (Placebo)	選範蓋蓋繭衊醖夢壓醖(廠窪淵醖襯廠淵鬱醖獵) = 糧積鬱簾網鏇窪窪襯蓋獵蓋壓範鹹鬱醖網構齋 (築廠夢鹹觸餘鑰淵鏇鏇, 窪壓窪構鬱築鬱廠蓋構 ~ 蓋繭窪膚艱鬱獵窪餘遞) 更多	-	2018-11-28
				ASP0113 (ASP0113)	選範蓋蓋繭衊醖夢壓醖(廠窪淵醖襯廠淵鬱醖獵) = 壓鏇淵願鹽網範餘憲廠獵蓋壓範鹹鬱醖網構齋 (築廠夢鹹觸餘鑰淵鏇鏇, 選積壓鏇蓋鏇醖蓋積選 ~ 簾鑰鬱製艱艱選壓築選) 更多