Cytomegalovirus peptide vaccine(City of Hope National Medical Center)(Cytomegalovirus peptide vaccine(City of Hope National Medical Center)) - 在研适应症：成人急性淋巴细胞白血病，成人急性髓性白血病，淋巴母细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

合成肽疫苗、预防性疫苗

别名

CMV fusion peptide vaccines、CMVPepVax、CMVpp65-A*0201 peptide vaccine

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

肿瘤免疫系统疾病感染+ [2]

在研适应症

成人急性淋巴细胞白血病成人急性髓性白血病淋巴母细胞淋巴瘤+ [8]

非在研适应症-

原研机构

City of Hope National Medical Center

在研机构

City of Hope National Medical Center

National Cancer Institute

非在研机构

University of Minnesota

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 1120173650

关联

2

项与 Cytomegalovirus peptide vaccine(City of Hope National Medical Center) 相关的临床试验

NCT02396134 / Active, not recruiting临床2期IIT

A Phase II Randomized, Placebo-Controlled, Multicenter Trial to Evaluate Protective Function of an Optimized Dose of CMVPepVax in Recipients of an Allogeneic Hematopoietic Stem Cell Transplant

This randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the body build an effective immune response and may reduce cytomegalovirus events after donor stem cell transplant.

开始日期2015-05-21

申办/合作机构

City of Hope National Medical Center

[+1]

NCT00712634 / Completed临床1期IIT

A Phase I Dose Escalation Study of Lipopeptide Vaccines With Activity Against Human Cytomegalovirus

RATIONALE: Vaccines may help the body build an effective immune response against cytomegalovirus.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of cytomegalovirus vaccine in healthy participants.

开始日期1997-11-01

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与 Cytomegalovirus peptide vaccine(City of Hope National Medical Center) 相关的临床结果

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100 项与 Cytomegalovirus peptide vaccine(City of Hope National Medical Center) 相关的转化医学

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100 项与 Cytomegalovirus peptide vaccine(City of Hope National Medical Center) 相关的专利（医药）

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12

项与 Cytomegalovirus peptide vaccine(City of Hope National Medical Center) 相关的文献（医药）

2021-04-01·Biosensors and Bioelectronics1区 · 工程技术

Detection of tetanus toxoid with fluorescent tetanus human IgG-AuNC–based immunochromatography test strip

1区 · 工程技术

Article

作者: Zheng, Yi-Jing ; Chen, Wei ; Deng, Hao-Hua ; Peng, Hua-Ping ; Zhuang, Quan-Quan ; Xia, Xing-Hua ; Huang, Kai-Yuan ; Chen, Rui-Ting ; Lin, Zhen

Assays for detecting tetanus toxoid are of great significance to be applied in the research of the safety testing of tetanus vaccine. Currently, guinea pigs or mice are usually used to evaluate the toxicity in these assays. Herein, a facile and quick biomineralization process was carried out to generate tetanus human immunoglobulin G (Tet-IgG)-functionalized Au nanoclusters (Tet-IgG-AuNCs). The obtained Tet-IgG-AuNCs exhibited strong red emission with a photoluminescence quantum yield of 13%. Based on surface plasmon resonance measurements, the apparent dissociation constant of the Tet-IgG-AuNC-tetanus toxoid complexes was measured to be 2.27 × 10^-8 M. A facile detection approach was developed using a fluorescent Tet-IgG-AuNC-based immunochromatography test strip. By utilizing the high-brightness fluorescent Tet-IgG-AuNCs, this immunosensor showed favorable sensitivity with a detection limit at the level of 0.03 μg/mL. Further results demonstrated that this assay can reliably detect tetanus toxoid and therefore might provide a novel method to replace animal tests for the quantification of tetanus toxicity. Moreover, the antibody-AuNC-based immunochromatography test strip platform serves as a promising candidate to develop new approaches for detecting targeted antigens and biological events of interest.

2019-04-01·Biology of Blood and Marrow Transplantation2区 · 医学

Rapid Acquisition of Cytomegalovirus-Specific T Cells with a Differentiated Phenotype, in Nonviremic Hematopoietic Stem Transplant Recipients Vaccinated with CMVPepVax

2区 · 医学

Article

作者: Longmate, Jeffrey ; Zhou, Qiao ; La Rosa, Corinna ; Aldoss, Ibrahim ; Hardwick, Nicola ; Diamond, Don J ; Kaltcheva, Teodora ; Nakamura, Ryotaro ; Lingaraju, Chetan Raj

Early cytomegalovirus (CMV) reactivation remains a significant cause of morbidity and mortality in allogeneic hematopoietic cell transplant (HCT) recipients. CMVPepVax is an investigational peptide vaccine designed to control CMV infection in HCT recipients seropositive for CMV by stimulating the expansion of T cell subsets that target the CMV tegument protein pp65. In a randomized Phase Ib pilot trial (ClinicalTrials.gov NCT01588015), two injections of CMVPepVax (at days 28 and 56 post-HCT) demonstrated safety, immunogenicity, increased relapse-free survival, and reduced CMV reactivation and use of antivirals. In the present study, we assessed the phenotypes and time courses of the pp65-specific CD8 T cell subsets that expanded in response to CMVPepVax vaccination. The functionality and antiviral role of CMV-specific T cells have been linked to immune reconstitution profiles characterized predominantly by differentiated effector memory T (TEM) subsets that have lost membrane expression of the costimulatory molecule CD28 and often reexpress the RA isoform of CD45 (TEMRA). Major histocompatibility complex class I pp65₄₉₅_-₅₀₃ multimers, as well as CD28 and CD45 memory markers, were used to detect immune reconstitution in blood specimens from HCT recipients enrolled in the Phase Ib clinical trial. Specimens from the 10 (out of 18) vaccinated patients who had adequate (≥.2%) multimer binding to allow for memory analysis showed highly differentiated TEM and TEMRA phenotypes for pp65_495-503-specific CD8 T cells during the first 100days post-transplantation. In particular, by day 70, during the period of highest risk for CMV reactivation, combined TEM and TEMRA phenotypes constituted a median of 90% of pp65_495-503-specific CD8 T cells in these vaccinated patients. CMV viremia was not detectable in the patients who received CMVPepVax, although their pp65_495-503-specific CD8 T cell profiles were strikingly similar to those observed in viremic patients who did not receive the vaccine. Collectively, our findings indicate that in the absence of clinically relevant viremia, CMVPepVax reconstituted significant levels of differentiated pp65_495-503-specific CD8 TEMs early post-HCT. Our data indicate that the rapid reconstitution of CMV-specific T cells with marked levels of effector phenotypes may have been key to the favorable outcomes of the CMVPepVax clinical trial.

2018-06-01·Transplant International2区 · 医学

Cytomegalovirus reactivation in liver transplant recipients due to hepatitis C cirrhosis is associated with higher cardiovascular risk - an observational, retrospective study

2区 · 医学

Article

作者: Prieto, Martin ; Gonzalez-Dieguez, Luisa ; Molina, Jose Miguel ; Cubells, Almudena ; López-Labrador, F. Xavier ; Fornés-Ferrer, Victoria ; Puchades, Lorena ; Di Maira, Tommaso ; Vinaixa, Carmen ; Pallarés, Carmen ; Benlloch, Salvador ; Aguilera, Victoria ; Rubín, Ángel ; Conde, Isabel ; Berenguer, Marina ; Carvalho-Gomes, Angela ; García, María

The association between cytomegalovirus (CMV) reactivation and cardiovascular risk has been reported in solid organ transplant populations; however, it has yet to be assessed in liver transplantation (LT). We aim to evaluate whether CMV reactivation is associated with cardiovascular events (CVE) in HCV-LT patients. LT patients (2010 and 2014) due to HCV cirrhosis were included. Clinically significant CMV (CS-CMV) was defined as viral load (VL) >5000 copies/ml, need of therapy or CMV disease. Baseline variables and endpoint measures (CVE, survival, severe recurrent hepatitis C, de novo tumors, and diabetes) were collected. One hundred and forty patients were included. At LT, a history of AHT was present in 23%, diabetes 22%, tobacco use 45%, obesity 20%, and renal impairment (eGFR < 60 ml/min) in 26.5%. CS-CMV reactivation occurred in 25% of patients. Twenty-six patients (18.5%) developed a CVE. Cox regression analysis revealed two factors significantly associated with CVE: Pre-LT DM [HR = 4.6 95% CI (1.6, 13), P = 0.004] and CS-CMV [HR = 4.7 95% CI (1.8, 12.5), P = 0.002]. CS-CMV was not independently associated with the remaining endpoints except for survival (P = 0.03). In our series, CS-CMV reactivation was associated with a greater risk of developing CVE, thus confirming data from other solid organ transplant populations and emphasizing the need for adequate CMV control.

100 项与 Cytomegalovirus peptide vaccine(City of Hope National Medical Center) 相关的药物交易

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外链

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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
巨细胞病毒感染	临床3期	-	University of Minnesota	-
慢性期慢性髓性白血病	临床2期	美国	City of Hope National Medical Center	2015-05-21
霍奇金淋巴瘤	临床2期	美国	City of Hope National Medical Center	2015-05-21
霍奇金淋巴瘤	临床2期	美国	National Cancer Institute	2015-05-21
骨髓增生异常综合征	临床2期	美国	City of Hope National Medical Center	2015-05-21
骨髓增生异常综合征	临床2期	美国	National Cancer Institute	2015-05-21
骨髓纤维化	临床2期	美国	National Cancer Institute	2015-05-21
骨髓纤维化	临床2期	美国	City of Hope National Medical Center	2015-05-21
非霍奇金淋巴瘤	临床2期	美国	National Cancer Institute	2015-05-21
非霍奇金淋巴瘤	临床2期	美国	City of Hope National Medical Center	2015-05-21

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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


NCT02396134 (CTgov)	临床2期	霍奇金淋巴瘤 \| 慢性期慢性髓性白血病 \| 慢性淋巴细胞白血病 \| 成人急性髓性白血病 \| 巨细胞病毒感染 \| 骨髓纤维化 \| 成人急性淋巴细胞白血病 \| 非霍奇金淋巴瘤 \| 加速期慢性骨髄性白血病 \| 骨髓增生异常综合征 \| 淋巴母细胞淋巴瘤	61	Laboratory Biomarker Analysis+CMVpp65-A0201 peptide vaccine (Arm I (CMVpp65-A0201 Peptide Vaccine))	餘衊壓網網鏇願獵膚鑰(遞憲蓋願窪衊積顧網範) = 糧築壓艱構簾艱廠繭獵鹹艱製願齋觸淵窪艱壓 (衊壓製襯鹹襯鏇製鑰蓋, 觸糧構夢獵膚鑰製憲淵 ~ 壓夢鏇艱選鹹積襯顧夢) 更多	-	2023-07-12
				Placebo (Arm II (Placebo))	餘衊壓網網鏇願獵膚鑰(遞憲蓋願窪衊積顧網範) = 築窪蓋蓋餘顧鏇廠顧齋鹹艱製願齋觸淵窪艱壓 (衊壓製襯鹹襯鏇製鑰蓋, 網餘積構鏇簾糧網獵糧 ~ 餘築窪構齋廠鑰憲獵築) 更多
NCT02396134 (ASH2021) 人工标引	临床2期	巨细胞病毒感染	61	Cmvpepvax	(壓廠製繭觸餘淵鏇餘範) = 選獵鹽糧壓衊觸衊齋膚獵築廠淵製築憲遞蓋壓 (襯蓋簾繭築艱網鏇製衊 )	不佳	2021-11-05
				Placebo	(壓廠製繭觸餘淵鏇餘範) = 繭鬱範積選積窪積夢憲獵築廠淵製築憲遞蓋壓 (襯蓋簾繭築艱網鏇製衊 )
Tandem Meetings ASTCT and CIBMTR2019	N/A	造血干细胞移植	-	CMVPepVax	窪憲糧壓衊淵醖蓋製壓(築鹽夢糧壓獵鏇構製窪) = 鹽窪膚繭襯膚鹹鹽衊鏇簾製鑰遞鏇餘壓壓觸鹹 (廠繭廠壓襯簾鹹範觸觸 )	-	2019-03-01