HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.)(HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.))

概要

基本信息

药物类型

DNA疫苗、预防性疫苗

别名

HIV DNA vaccine

+ [2]

靶点-

作用机制

免疫刺激剂

治疗领域

免疫系统疾病感染泌尿生殖系统疾病

在研适应症-

非在研适应症

HIV感染

原研机构

Pharmexa-Epimmune, Inc.

在研机构-

非在研机构

VaxOnco, Inc.Epimmune, Inc.Pharmexa-Epimmune, Inc.

最高研发阶段终止临床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

4

项与 HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.) 相关的临床试验

NCT00532974 / Unknown status临床1期

A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)

The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.

开始日期2006-10-01

申办/合作机构

Epimmune, Inc.

[+2]

NCT00141024 / Completed临床1期IIT

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Protein Vaccine EP-1043 and the DNA Vaccine EP HIV-1090 Given Alone or in Combination in Healthy, HIV-1-Uninfected Adult Participants

The purpose of the study is to determine the safety of and immune response to the investigational HIV vaccine, EP HIV-1090, in HIV uninfected adults.

开始日期2006-01-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT00052182 / Completed临床1期IIT

A Single Center Phase I Safety and Immunogenicity Study of Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) for Immunotherapy of HIV-1 Infected Individuals Receiving Highly Active Antiretroviral Therapy (HAART)

HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost the immune system's responses against many HIV-1 proteins. The main purposes of this study are to test the safety of this HIV vaccine (EP HIV-1090) and to test whether the vaccine can stimulate immune system responses in people who have HIV-1 infection.

开始日期2002-10-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与 HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.) 相关的临床结果

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100 项与 HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.) 相关的转化医学

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100 项与 HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.) 相关的专利（医药）

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5

项与 HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.) 相关的文献（医药）

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

In silicodesign of a DNA-based HIV-1 multi-epitope vaccine for Chinese populations

3区 · 医学

Article

作者: Yusen Zhou ; Hong Yu ; Shihui Sun ; Jingjing Guo ; Yi Yang ; Xia Jin ; Yan Guo ; Zhihua Kou ; Guangyu Zhao ; Weilai Sun ; Jungfeng Li ; Shibo Jiang ; Lanying Du

The development of an HIV-1 vaccine that is capable of inducing effective and broadly cross-reactive humoral and cellular immune responses remains a challenging task because of the extensive diversity of HIV-1, the difference of virus subtypes (clades) in different geographical regions, and the polymorphism of human leukocyte antigens (HLA). We performed an in silico design of 3 DNA vaccines, designated pJW4303-MEG1, pJW4303-MEG2 and pJW4303-MEG3, encoding multi-epitopes that are highly conserved within the HIV-1 subtypes most prevalent in China and can be recognized through HLA alleles dominant in China. The pJW4303-MEG1-encoded protein consisted of one Th epitope in Env, and one, 2, and 6 epitopes in Pol, Env, and Gag proteins, respectively, with a GGGS linker sequence between epitopes. The pJW4303-MEG2-encoded protein contained similar epitopes in a different order, but with the same linker as pJW4303-MEG1. The pJW4303-MEG3-encoded protein contained the same epitopes in the same order as that of pJW4303-MEG2, but with a different linker sequence (AAY). To evaluate immunogenicity, mice were immunized intramuscularly with these DNA vaccines. Both pJW4303-MEG1 and pJW4303-MEG2 vaccines induced equally potent humoral and cellular immune responses in the vaccinated mice, while pJW4303-MEG3 did not induce immune responses. These results indicate that both epitope and linker sequences are important in designing effective epitope-based vaccines against HIV-1 and other viruses.

2008-06-01·Clinical and Vaccine Immunology

Clinical Phase 1 Testing of the Safety and Immunogenicity of an Epitope-Based DNA Vaccine in Human Immunodeficiency Virus Type 1-Infected Subjects Receiving Highly Active Antiretroviral Therapy

Article

作者: MaWhinney, Samantha ; Newman, Mark J. ; Forster, Jeri E. ; Scott, Jim ; Livingston, Brian D. ; Schooley, Robert T. ; Wilson, Cara C. ; Benson, Constance A.

ABSTRACTA DNA vaccine encoding sequence-conserved human immunodeficiency virus type 1 (HIV-1)-derived cytotoxic T-lymphocyte (CTL) epitopes from multiple HIV-1 gene products (designated EP HIV-1090) was evaluated in a placebo-controlled, dose escalation phase 1 clinical trial of HIV-1-infected subjects receiving potent combination antiretroviral therapy. Patients received four intramuscular immunizations with EP HIV-1090 over a 4-month period at one of four doses (0.5, 1.0, 2.0, or 4.0 mg) or received a placebo. The vaccine was determined to be safe and well tolerated at all doses tested. CTL responses were measured from cryopreserved peripheral blood mononuclear cells using gamma interferon enzyme-linked immunospot assays, with and without in vitro peptide stimulation (IVS). Responses to one or more vaccine epitopes were detected throughout the course of vaccination in 37.5% (12/32) and 47% (15/32) of vaccine recipients measured without and with IVS, respectively, indicating possible vaccine-induced priming of epitope-specific T cells. However, differences in rates of response to HIV-1 epitopes between vaccine and placebo recipients did not achieve statistical significance. The HIV-1 epitope-specific CTL responses measured in the peripheral blood after vaccination were often low level and short-lived, and therefore, alternative immunization schedules, routes of delivery, or vaccine formulations may be required to increase vaccine potency.

2003-11-15·The Journal of Immunology2区 · 医学

Development of a DNA Vaccine Designed to Induce Cytotoxic T Lymphocyte Responses to Multiple Conserved Epitopes in HIV-1

2区 · 医学

Article

作者: Sette, Alessandro ; MaWhinney, Samantha ; Crimi, Claire ; Newman, Mark J. ; McKinney, Denise ; Southwood, Scott ; Chesnut, Robert ; Anders, Michelle ; Wilson, Cara C. ; Livingston, Brian D. ; Forster, Jeri

AbstractEpitope-based vaccines designed to induce CTL responses specific for HIV-1 are being developed as a means for addressing vaccine potency and viral heterogeneity. We identified a set of 21 HLA-A2, HLA-A3, and HLA-B7 restricted supertype epitopes from conserved regions of HIV-1 to develop such a vaccine. Based on peptide-binding studies and phenotypic frequencies of HLA-A2, HLA-A3, and HLA-B7 allelic variants, these epitopes are predicted to be immunogenic in greater than 85% of individuals. Immunological recognition of all but one of the vaccine candidate epitopes was demonstrated by IFN-γ ELISPOT assays in PBMC from HIV-1-infected subjects. The HLA supertypes of the subjects was a very strong predictor of epitope-specific responses, but some subjects responded to epitopes outside of the predicted HLA type. A DNA plasmid vaccine, EP HIV-1090, was designed to express the 21 CTL epitopes as a single Ag and tested for immunogenicity using HLA transgenic mice. Immunization of HLA transgenic mice with this vaccine was sufficient to induce CTL responses to multiple HIV-1 epitopes, comparable in magnitude to those induced by immunization with peptides. The CTL induced by the vaccine recognized target cells pulsed with peptide or cells transfected with HIV-1 env or gag genes. There was no indication of immunodominance, as the vaccine induced CTL responses specific for multiple epitopes in individual mice. These data indicate that the EP HIV-1090 DNA vaccine may be suitable for inducing relevant HIV-1-specific CTL responses in humans.

100 项与 HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.) 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
HIV感染	临床2期	-	VaxOnco, Inc.	-
HIV感染	临床2期	-	VaxOnco, Inc.	-

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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


IAS2004	N/A	HIV感染	-	epitope-based DNA vaccine (EP HIV-1090)	鏇範醖憲積襯範鬱鑰願(築顧壓壓構選醖選繭獵) = 鬱製襯鹹鹹網顧製衊襯齋廠窪鬱憲憲鏇範鑰衊 (壓遞膚憲衊遞遞醖構範 )	-	2004-01-01