VRC-HIVADV014-00-VP(VRC-HIVADV014-00-VP) - 药物靶点：HIV-1 gag x HIV-1 pol_专利_临床

概要

基本信息

药物类型

重组载体疫苗、预防性疫苗

别名

AD5HIV-ENVA、HIV adenovector serotype Ad5 vaccine、multiclade recombinant HIV-1 adenoviral vector vaccine

+ [4]

靶点

HIV-1 gag x HIV-1 pol

作用方式

抑制剂

作用机制

HIV-1 gag抑制剂(HIV-1病毒gag蛋白抑制剂)、HIV-1 pol抑制剂(人类免疫缺陷病毒1型蛋白酶抑制剂)

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

GenVec, Inc.

在研机构-

非在研机构

National Institute of Allergy & Infectious Diseases

Vaccine Research Center

权益机构-

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

23

项与 VRC-HIVADV014-00-VP 相关的临床试验

NCT01479296

/ Completed临床1期IIT

A Phase 1b Randomized Double-Blind Clinical Trial to Examine Whether Polytopic Administration of VRC rAd5 Gag-pol/Env A/B/C Vaccine Enhances HIV-Specific Cellular Immune Responses in Humans

The purpose of this study is to evaluate the immune response to the Vaccine Research Center (VRC) rAd5 HIV vaccine when the vaccine components are administered in three different ways, in healthy, HIV-uninfected adults.

开始日期2011-12-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT01386489

/ Completed临床1期IIT

VRC 016: A Phase 1b Open-Label, Randomized Clinical Trial to Evaluate Early Innate and Adaptive Immune Responses to the Investigational HIV-1 Vaccines: VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP in Ad5 Seronegative Healthy Adults

Background:
The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection.
Purpose:
The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines.
Eligibility:
Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements.
Design:
Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests.
The study will have two groups:
One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months.
The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months.
All participants will be asked to provide blood and body fluid samples for testing during the study.
Payment for participation will be provided....

开始日期2011-06-17

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT00955006

/ Completed临床1期IIT

A Phase 1b Clinical Trial to Evaluate Mucosal Immune Responses to a DNA Plasmid Vaccine Prime Followed by an HIV-1 Adenoviral Vector Boost in Healthy Adenovirus Type 5 Seronegative HIV-1-uninfected Adults

The purpose of the study is to determine the safety of mucosal immune responses to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

开始日期2011-05-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与 VRC-HIVADV014-00-VP 相关的临床结果

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100 项与 VRC-HIVADV014-00-VP 相关的转化医学

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100 项与 VRC-HIVADV014-00-VP 相关的专利（医药）

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5

项与 VRC-HIVADV014-00-VP 相关的文献（医药）

2015-03-01·The lancet. HIV1区 · 医学

Effect of therapeutic intensification followed by HIV DNA prime and rAd5 boost vaccination on HIV-specific immunity and HIV reservoir (EraMune 02): a multicentre randomised clinical trial

1区 · 医学

Article

作者: Timothy J Wilkin ; Robert L Murphy ; Lambert Assoumou ; Richard A Koup ; Dominique Costagliola ; Christine Katlama ; Chad J Achenbach ; Vincent Calvez ; Steven G Deeks ; Sidonie Lambert-Niclot ; Joseph P Casazza ; Baiba Berzins ; Brigitte Autran

BACKGROUND:

Achievement of a cure for HIV infection might need reactivation of latent virus and improvement of HIV-specific immunity. As an initial step, in this trial we assessed the effect of antiretroviral therapy intensification and immune modulation with a DNA prime and recombinant adenovirus 5 (rAd5) boost vaccine.

METHODS:

In this multicentre, randomised, open-label, non-comparative, phase 2 clinical trial, we enrolled eligible adults 18-70 years of age with chronic HIV-1 infection on suppressive antiretroviral therapy with current CD4 count of at least 350 cells per μL and HIV DNA between 10 and 1000 copies per 10(6) peripheral blood mononuclear cells. After an 8 week lead-in of antiretroviral intensification therapy (standard dose raltegravir and dose-adjusted maraviroc based on baseline antiretroviral therapy), patients were randomly assigned (1:1) to receive antiretroviral therapy intensification alone or intensification plus injections of HIV DNA prime vaccine (4 mg VRC-HIVDNA016-00-VP) at weeks 8, 12, and 16, followed by HIV rAd5 boost vaccine (10(10) particle units of VRC-HIVADV014-00-VP) at week 32. Randomisation was computer generated in permuted blocks of six and was stratified by study site. The primary endpoint was a 0·5 log10 or greater decrease in HIV DNA in peripheral blood mononuclear cells at week 56. This study is registered with ClinicalTrials.gov, number NCT00976404.

FINDINGS:

Between Nov 29, 2010, and Oct 28, 2011, we enrolled 28 eligible patients from three academic HIV clinics in the USA. After the 8 week lead-in of antiretroviral intensification therapy, 14 patients were randomly assigned to continue antiretroviral therapy intensification alone and 14 to intensification plus vaccine. Enrolled participants had median CD4 count of 636 cells per μL, median HIV DNA 170 copies per 10(6) peripheral blood mononuclear cells, and duration of antiretroviral therapy of 13 years. The median amount of HIV DNA did not change significantly between baseline and week 56 in the antiretroviral therapy intensification plus vaccine group. One participant in the antiretroviral therapy intensification alone group reached the primary endpoint, with 0·55 log10 decrease in HIV DNA in peripheral blood mononuclear cells. Both treatments were well tolerated. No severe or systemic reactions to vaccination occurred, and five serious adverse events were recorded during the study, most of which resolved spontaneously or were judged unrelated to study treatments.

INTERPRETATION:

Antiretroviral therapy intensification followed by DNA prime and rAd5 boost vaccine did not significantly increase HIV expression or reduce the latent HIV reservoir. A multifaceted approach that includes stronger activators of HIV expression and novel immune modulators will probably be needed to reduce the latent HIV reservoir and allow for long-term control in patients off antiretroviral therapy.

FUNDING:

Objectif Recherche Vaccin SIDA (ORVACS).

2010-01-01·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials

作者: Tomillero, A. ; Moral, M.A.

[¹¹C]RAC; (18)F-Fluoromisonidazole; 89-12; 9-[¹⁸F]Fluoropropyl-(+)-dihydrotetrabenazine; Adalimumab, Adecatumumab, ADMVA, ADXS-11-001, Aflibercept, Agatolimod sodium, AGS-004, Alglucosidase alfa, Aliskiren fumarate, Alvocidib hydrochloride, AMG-108, AMG-853, Apixaban, Aripiprazole, Armodafinil, Atazanavir sulfate, Atomoxetine hydrochloride; Bevacizumab, BioMatrix Flex drug eluting stent, Biphasic insulin aspart, Bortezomib, Bosentan; Caspofungin acetate, Cediranib, Cetuximab, ChimeriVax-Dengue, Choriogonadotropin alfa, Cinacalcet hydrochloride, Cizolirtine citrate, Clofarabine, Cocaine conjugate vaccine, CX-717; Darbepoetin alfa, Dasatinib, Decitabine, Denosumab, Desvenlafaxine succinate, Dexamethasone sodium phosphate, Dienogest, Diphencyprone, Doripenem, DTaP-HepB-IPV, Dutasteride; E-7010, Ecallantide, Ecstasy, Eicosapentaenoic acid/docosahexaenoic acid, Emtricitabine, Enfuvirtide, Erlotinib hydrochloride, Eszopiclone, Etonogestrel/ethinyl estradiol, Etoricoxib, Everolimus, Everolimus-eluting coronary stent EVT-201, Ezetimibe, Ezetimibe/simvastatin; Ferumoxytol, Fesoterodine fumavate, Figitumumab, Filgrastim, Fingolimod hydrochloride, Fluticasone furoate, Fluval P, Fluzone, Fondaparinux sodium, Fulvestrant, Fungichromin; Gamma-hydroxybutyrate sodium, Gefitinib, GHB-01L1, GLY-230, GSK-1349572; Hib-MenCY-TT, Hib-TT, HPV-6/11/16/18, Hydrocodone bitartrate; IC-51, Icatibant acetate, Imatinib mesylate, Immunoglobulin intravenous (human), Indetanib, Influenza A (H1N1) 2009 Monovalent Vaccine, Inhalable human insulin, Insulin glargine, Insulin glulisine, Interferon-beta, Ispinesib mesylate, Ixabepilone; Laromustine, Latanoprost/timolol maleate, L-Citrulline, Lenalidomide, Lexatumumab, Linezolid, Lopinavir/ritonavir, Lutropin alfa; Mapatumumab, MDX-066, MDX-1388, Mepolizumab, Methoxy polyethylene glycol-epoetin-beta, Metreleptin, Micafungin sodium, Mometasone furoate/oxymetazoline hydrochloride, Mx-dnG1, Mycophenolic acid sodium salt; Nabiximols, Natalizumab, Nemonoxacin, Norelgestromin/ethinyl estradiol; Oblimersen sodium, Ocriplasmin, Olmesartan medoxomil, Omacetaxine mepesuccinate; Paclitaxel-eluting stent, Pagoclone, Paliperidone, Panitumumab, Pazopanib hydrochloride, PCV7, Pegaptanib octasodium, Peginterferon alfa-2a, Peginterferon alfa-2b/ ribavirin, Pegvisomant, Pemetrexed disodium, Perifosine, Pimecrolimus, Pitavastatin calcium, Plerixafor hydrochloride, Plitidepsin, Posaconazole, Pregabalin, Progesterone capriate; Raltegravir potassium, Ramucirumab, Ranelic acid distrontium salt, Rasburicase, Recombinant Bet V1, Recombinant human insulin, rhFSH, Rolofylline, Romidepsin, Romiplostim, Rosuvastatin calcium; Sapacitabine, Sevelamer carbonate, Sinecatechins, Sirolimus-eluting stent, Sitagliptin phosphate monohydrate, SN-29244, Sorafenib, Sugammadex sodium, Sunitinib malate; Tadalafil, Tafenoquine, Talnetant, Tanezumab, Tapentadol hydrochloride, Tasocitinib citrate, Technosphere/Insulin, Telcagepant, Tenofovir disoproxil fumarate, Teriparatide, Ticagrelor, Tigecycline, Tiotropium bromide, Tipifarnib, Tocilizumab, TS-041; Ulipristal acetate, Urtoxazumab, Ustekinumab; Vandetanib, Varenicline tartrate, Vicriviroc, Voriconazole, Vorinostat, VRC-HIVADV014-00-VP, VRC-HIVDNA016-00-VP; Zoledronic acid monohydrate.

2010-01-01·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials

作者: Moral, M A ; Tomillero, A

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil fumarate, Tocilizumab, Tositumomab/iodine (I131) tositumomab, Trabectedin, TransVax™ hepatitis C vaccine; Ustekinumab; V-260, Valspodar, Varenicline tartrate, VCL-IPT1, Vildagliptin, VRC-HIVADV014-00-VP, VRC-HIVDNA009-00-VP, VRC-HIVDNA016-00-VP; Yttrium 90 (90Y) ibritumomab tiuxetan, Yttrium Y90 Epratuzumab; Zibotentan, Zotarolimus-eluting stent.

100 项与 VRC-HIVADV014-00-VP 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	美国	National Institute of Allergy & Infectious Diseases	2005-09-01
HIV感染	临床2期	巴西	National Institute of Allergy & Infectious Diseases	2005-09-01
HIV感染	临床2期	海地	National Institute of Allergy & Infectious Diseases	2005-09-01
HIV感染	临床2期	牙买加	National Institute of Allergy & Infectious Diseases	2005-09-01
HIV感染	临床2期	南非	National Institute of Allergy & Infectious Diseases	2005-09-01

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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


NCT00865566 (CTgov)	临床2期	HIV感染	2,504	recombinant DNA plasmid vaccine+DNA plasmid vaccine+Recombinant adenoviral serotype 5 (rAD5) vector vaccine (Vaccine)	窪壓觸壓夢鏇窪繭築鑰 = 簾壓憲齋糧鑰蓋餘願餘鬱鹽鹹鬱糧鏇壓壓獵築 (壓鏇襯淵選觸積網衊壓, 襯壓窪選餘襯襯廠窪鏇 ~ 觸繭積網繭窪鏇醖繭醖) 更多	-	2019-02-27
				placebo (Placebo)	窪壓觸壓夢鏇窪繭築鑰 = 遞艱觸夢築築壓淵齋窪鬱鹽鹹鬱糧鏇壓壓獵築 (壓鏇襯淵選觸積網衊壓, 築襯網蓋獵蓋觸鏇築餘 ~ 鏇積鹽獵膚觸鑰壓糧齋) 更多
NCT00976404 (Pubmed \| Lancet HIV) 人工标引	临床2期	HIV感染	28	raltegravir+maraviroc+VRC-HIVDNA016-00-VP	窪窪襯築積獵憲齋鹹艱(壓積鑰壓顧簾衊壓艱鏇) = One participant in the antiretroviral therapy intensification alone group reached the primary endpoint, with 0·55 log10 decrease in HIV DNA in peripheral blood mononuclear cells. 願憲遞築鏇壓鹹襯鹹淵 (簾蓋鹹艱衊醖選顧餘窪 )	不佳	2015-03-01
				raltegravir+maraviroc
NCT00976404 (EraMune02, CTgov)	临床2期	HIV感染	28	maraviroc+raltegravir (Maraviroc + Raltegravir Intensification)	衊鬱構憲積憲糧選選齋(憲淵鑰製鑰顧憲壓憲構) = 網鹽製鏇製衊齋糧顧鏇鏇窪願顧鬱餘網願夢構 (獵艱顧餘廠構糧鬱襯鑰, 艱齋顧構願簾壓繭衊鏇 ~ 簾築淵積顧鹽繭築窪簾) 更多	-	2014-09-12
				DNA + HIV-rAd5 vaccine+maraviroc+raltegravir (Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine)	衊鬱構憲積憲糧選選齋(憲淵鑰製鑰顧憲壓憲構) = 蓋壓願餘齋選壓鏇壓餘鏇窪願顧鬱餘網願夢構 (獵艱顧餘廠構糧鬱襯鑰, 遞獵蓋廠蓋蓋網餘膚築 ~ 壓築鑰醖餘顧艱廠蓋壓) 更多
NCT00083330 (Pubmed \| J Infect Dis)	临床1期	HIV感染	-	Vaccine at dose level 10^9 particle units	鏇醖膚壓鹹膚積襯構糧(鬱餘構壓遞繭糧鬱壓鹽) = 壓築鑰築積憲壓蓋餘廠糧蓋遞網築糧膚淵餘鏇 (淵構選顧膚鏇築觸鹹鏇 )	-	2006-12-15
				Vaccine at dose level 10^10 particle units	鏇醖膚壓鹹膚積襯構糧(鬱餘構壓遞繭糧鬱壓鹽) = 鹽顧衊鏇築憲廠構淵鬱糧蓋遞網築糧膚淵餘鏇 (淵構選顧膚鏇築觸鹹鏇 )