pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command)(pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command))

概要

基本信息

药物类型

DNA疫苗、预防性疫苗

别名

HTNV/PUU DNA vaccine、HTNV/PUUV DNA vaccine、Hantaan virus/puumala virus DNA vaccine

+ [7]

靶点

汉坦病毒M蛋白

作用机制

汉坦病毒M蛋白抑制剂

治疗领域

感染

在研适应症

病毒性出血热

非在研适应症

肾综合征出血热

原研机构

United States Army Medical Research and Materiel Command

在研机构

Ichor Medical Systems, Inc.

United States Army Medical Research and Materiel Command

非在研机构-

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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关联

2

项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的临床试验

NCT02116205

/ Completed临床2期IIT

A Phase 2a Double-Blind, Dose-optimizing Study to Evaluate the Immunogenicity of Hantaan/Puumala Virus DNA Vaccine Administered to Healthy Adult Volunteers by Electroporation for Prevention of Hemorrhagic Fever With Renal Syndrome

The purpose of this study is to compare the immune responses of two different doses (1.0 mg and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a blind, participants in the two-dose group will receive one dose of normal saline placebo. All of the groups will also receive a booster dose 6 months after first vaccination. The results will help to determine which dose and vaccination schedule will be best to move forward in the vaccine development process.

开始日期2014-07-09

申办/合作机构

U S Army Medical Research & Development Command

[+4]

NCT01502345

/ Completed临床1期IIT

Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines, pWRG/HTN-M(x) and pWRG/PUU-M(s2), for Prevention of Hemorrhagic Fever With Renal Syndrome Administered to Healthy Adult Volunteers Using the TDS-IM Electroporation Delivery Device

The purpose of this study is:
• To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device
Secondary:
• To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when administered with the TDS-IM electroporation.

开始日期2012-01-01

申办/合作机构

U S Army Medical Research & Development Command

[+4]

100 项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的临床结果

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100 项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的转化医学

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100 项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的专利（医药）

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14

项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的文献（医药）

2016-06-01·Vaccine3区 · 医学

A Phase 1 clinical trial of a DNA vaccine for Venezuelan equine encephalitis delivered by intramuscular or intradermal electroporation

3区 · 医学

Article

作者: Ellefsen, Barry ; Hannaman, Drew ; Dupuy, Lesley C ; Schmaljohn, Connie S

Venezuelan equine encephalitis virus (VEEV), a mosquito-borne alphavirus, causes periodic epizootics in equines and is a recognized biological defense threat for humans. There are currently no FDA-licensed vaccines against VEEV. We developed a candidate DNA vaccine expressing the E3-E2-6K-E1 genes of VEEV (pWRG/VEE) and performed a Phase 1 clinical study to assess the vaccine's safety, reactogenicity, tolerability, and immunogenicity when administered by intramuscular (IM) or intradermal (ID) electroporation (EP) using the Ichor Medical Systems TriGrid™ Delivery System. Subjects in IM-EP groups received 0.5mg (N=8) or 2.0mg (N=9) of pWRG/VEE or a saline placebo (N=4) in a 1.0ml injection. Subjects in ID-EP groups received 0.08mg (N=8) or 0.3mg (N=8) of DNA or a saline placebo (N=4) in a 0.15ml injection. Subjects were monitored for a total period of 360 days. No vaccine- or device-related serious adverse events were reported. Based on the results of a subject questionnaire, the IM- and ID-EP procedures were both considered to be generally acceptable for prophylactic vaccine administration, with the acute tolerability of ID EP delivery judged to be greater than that of IM-EP delivery. All subjects (100%) in the high and low dose IM-EP groups developed detectable VEEV-neutralizing antibodies after two or three administrations of pWRG/VEE, respectively. VEEV-neutralizing antibody responses were detected in seven of eight subjects (87.5%) in the high dose and five of eight subjects (62.5%) in the low dose ID-EP groups after three vaccine administrations. There was a correlation between the DNA dose and the magnitude of the resulting VEEV-neutralizing antibody responses for both IM and ID EP delivery. These results indicate that pWRG/VEE delivered by either IM- or ID-EP is safe, tolerable, and immunogenic in humans at the evaluated dose levels. Clinicaltrials.gov registry number NCT01984983.

2015-03-04·Human Vaccines & Immunotherapeutics3区 · 医学

A multi-head intradermal electroporation device allows for tailored and increased dose DNA vaccine delivery to the skin

3区 · 医学

Article

作者: Kate E Broderick ; Jay R McCoy ; Alan F Gomez ; Niranjan Y Sardesai ; Catherine Badger ; Kristin W Spik ; Connie S Schmaljohn ; Janess M Mendoza

The identification of an effective and tolerable delivery method is a necessity for the success of DNA vaccines in the clinic. This article describes the development and validation of a multi-headed intradermal electroporation device which would be applicable for delivering multiple DNA vaccine plasmids simultaneously but spatially separated. Reporter gene plasmids expressing green and red fluorescent proteins were used to demonstrate the impact of spatial separation on DNA delivery to increase the number of transfected cells and avoid interference through visible expression patterns. To investigate the impact of plasmid interference on immunogenicity, a disease target was investigated where issues with multi-valent vaccines had been previously described. DNA-based Hantaan and Puumala virus vaccines were delivered separately or as a combination and the effect of multi-valence was determined by appropriate assays. While a negative impact was observed for both antigenic vaccines when delivered together, these effects were mitigated when the vaccine was delivered using the multi-head device. We also demonstrate how the multi-head device facilitates higher dose delivery to the skin resulting in improved immune responses. This new multi-head platform device is an efficient, tolerable and non-invasive method to deliver multiple plasmid DNA constructs simultaneously allowing the tailoring of delivery sites for combination vaccines. Additionally, this device would allow the delivery of multi-plasmid vaccine formulations without risk of impacted immune responses through interference. Such a low-cost, easy to use device platform for the delivery of multi-agent DNA vaccines would have direct applications by the military and healthcare sectors for mass vaccination purposes.

2014-10-03·Human Vaccines & Immunotherapeutics3区 · 医学

A multi-head intradermal electroporation device allows for tailored and increased dose DNA vaccine delivery to the skin

3区 · 医学

Article

作者: Mendoza, Janess M ; McCoy, Jay R ; Schmaljohn, Connie S ; Spik, Kristin W ; Broderick, Kate E ; Sardesai, Niranjan Y ; Gomez, Alan F ; Badger, Catherine

The identification of an effective and tolerable delivery method is a necessity for the success of DNA vaccines in the clinic. This manuscript describes the development and validation of a multi-headed intradermal electroporation device which would be applicable for delivering multiple DNA vaccine plasmids simultaneously but spatially separated. Reporter gene plasmids expressing green and red fluorescent proteins were used to demonstrate the impact of spatial separation on DNA delivery to increase the number of transfected cells and avoid interference through visible expression patterns. To investigate the impact of plasmid interference on immunogenicity, a disease target was investigated where issues with multi-valent vaccines had been previously described. DNA-based Hantaan and Puumala virus vaccines were delivered separately or as a combination and the effect of multi-valence was determined by appropriate assays. While a negative impact was observed for both antigenic vaccines when delivered together, these effects were mitigated when the vaccine was delivered using the multi-head device. We also demonstrate how the multi-head device facilitates higher dose delivery to the skin resulting in improved immune responses. This new multi-head platform device is an efficient, tolerable and non-invasive method to deliver multiple plasmid DNA constructs simultaneously allowing the tailoring of delivery sites for combination vaccines. Additionally, this device would allow the delivery of multi-plasmid vaccine formulations without risk of impacted immune responses through interference. Such a low-cost, easy to use device platform for the delivery of multi-agent DNA vaccines would have direct applications by the military and healthcare sectors for mass vaccination purposes.

100 项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 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
病毒性出血热	临床2期	-	Ichor Medical Systems, Inc.	-
病毒性出血热	临床2期	-	United States Army Medical Research and Materiel Command	-
肾综合征出血热	药物发现	美国	Ichor Medical Systems, Inc.	2012-01-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02116205 (CTgov)	临床2期	肾综合征出血热	130	Placebo+HTNV/PUUV DNA vaccine (Vaccine + Placebo at 1.0 mg)	糧遞遞鬱壓築鹹壓網鬱(鑰築夢廠鏇餘齋夢構範) = 顧壓鑰鏇廠鑰遞窪遞衊鬱餘鏇夢夢範範壓積鬱 (顧醖觸鬱願鹽廠糧淵網, 齋憲製範鑰窪膚廠醖獵 ~ 網糧築簾觸鬱淵獵獵選) 更多	-	2020-12-01
				TriGrid Delivery System (TDS)+HTNV/PUUV DNA vaccine (Vaccine at 1.0 mg)	糧遞遞鬱壓築鹹壓網鬱(鑰築夢廠鏇餘齋夢構範) = 壓遞繭壓醖積築衊網廠鬱餘鏇夢夢範範壓積鬱 (顧醖觸鬱願鹽廠糧淵網, 鑰夢繭廠製觸鹹選衊壓 ~ 醖築餘壓醖蓋齋憲網選) 更多