GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies)(GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies))

概要

基本信息

药物类型

治疗性疫苗

别名

gp120 depleted HZ321 HIV-1、GP120-depleted HIV-1 vaccine、HIV vaccine

+ [5]

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

获得性免疫缺陷综合征HIV感染

原研机构

The Salk Institute for Biological Studies

在研机构-

非在研机构

Agouron Pharmaceuticals LLCImmune Response Biopharma, Inc.The Immune Response Corporation, Inc.

+ [1]

最高研发阶段终止申请上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

关联

11

项与 GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies) 相关的临床试验

NCT02291809 / Unknown status临床2期

REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study

The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.

开始日期2017-11-01

申办/合作机构

Immune Response Biopharma, Inc.

NCT00001445 / Completed临床1期IIT

Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 Infection

This is a single dose, phase I study to evaluate the safety/tolerance and the immunogenicity of HIV-1 Immunogen, gp120-depleted inactivated HIV-1 preparation in Incomplete Freund's Adjuvant (IFA), in children with HIV-1 infection. A total of 32 children with HIV-1 infection will be enrolled in the study. Arm A of the study will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who have no history of and do not require antiretroviral therapy. Antiretroviral treatment given for less than 7 weeks (up to 6 weeks and 6 days) prior to entry will be considered as "no history" of treatment (treatment naive). Arm B will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who are on or have received antiretroviral treatment for more than 7 weeks. In order to assess the age-associated impact on the immune response rate, we plan to continue to attempt to enroll infants younger than 24 months of age. Children in each arm will receive 10 units of HIV-1 Immunogen intramuscularly at 0, 3, 6, 9, and 12 months.
Antiretroviral treatment will commence once patients meet the criteria for an initiation of the treatment as defined in the protocol. All antiretroviral agents that are currently approved by FDA for clinical indications in HIV-1-infected children (pediatric labeling) are permitted in the protocol. If the child has been receiving a single agent other than ddI, or has been on investigational antiretroviral agents, his/her antiretroviral therapy will have to be changed to an optimal combination regimen of the approved agents at least 6 weeks prior to the enrollment.

开始日期1995-08-01

申办/合作机构

National Cancer Institute

NCT00002359 / Completed临床3期

A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Regardless of Concomitant HIV Therapies

To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.

开始日期-

申办/合作机构

The Immune Response Corporation, Inc.

100 项与 GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies) 相关的临床结果

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100 项与 GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies) 相关的转化医学

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100 项与 GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies) 相关的专利（医药）

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22

项与 GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies) 相关的文献（医药）

2016-07-02·Expert opinion on biological therapy3区 · 医学

HIV-1 Immunogen: an overview of almost 30 years of clinical testing of a candidate therapeutic vaccine

3区 · 医学

Review

作者: Graziani, Gina M ; Angel, Jonathan B

INTRODUCTION:

Although current antiretroviral therapy (ART) has transformed HIV infection into a chronic, manageable disease, ART does not cure HIV infection. Furthermore, the majority of the world's infected individuals live in resource-limited countries in which access to ART is limited. Thus, the development of an effective therapeutic HIV vaccine would be an invaluable treatment alternative.

AREAS COVERED:

Developed by the late Dr. Jonas Salk, HIV-1 Immunogen (Remune®) is a candidate therapeutic vaccine that has been studied in thousands of HIV-infected individuals in more than a dozen clinical trials during almost three decades. This Drug Evaluation, which summarizes the results of these trials that have shown the vaccine to be safe and immunogenic, also discusses the contradictory and controversial conclusions drawn from the phases 2, 2/3 and 3 trials that assessed the clinical efficacy of this vaccine.

EXPERT OPINION:

Given the lack of unequivocal clinical benefits of HIV-1 Immunogen despite almost 30 years of extensive testing, it does not appear, in our view, that this vaccine is a clinically effective immunotherapy. However, inclusion of this vaccine in the newly proposed 'Kick/Shock and Kill' strategy for HIV eradication, or use as a prophylactic vaccine, could be considered for future trials.

2015-10-01·Journal of acquired immune deficiency syndromes (1999)3区 · 医学

The Effect of Therapeutic HIV Vaccination With ALVAC-HIV With or Without Remune on the Size of the Viral Reservoir (A CTN 173 Substudy)

3区 · 医学

Article

作者: Tremblay, Cecile L. ; Graziani, Gina M. ; Angel, Jonathan B. ; Routy, Jean-Pierre

OBJECTIVES:

To assess whether therapeutic vaccination with ALVAC-HIV ± Remune affects viral reservoir size in antiretroviral therapy-treated individuals.

METHODS:

Participants in CTN 173, a multicentre, randomized, 3-arm, placebo-controlled, double-blind study, were vaccinated with ALVAC-HIV ± Remune (groups 1 and 2, respectively) or with placebos (group 3) over 20 weeks and assessed for changes in the size of their viral reservoirs from weeks 0 to 24.

RESULTS:

Sixteen participants completed the viral reservoir substudy. The median sizes (interquartile range) of the viral reservoir at baseline (week 0) were 0.07 (0.03-0.37), 0.04 (0.02-0.33), and 0.13 (0.06-0.99) infectious units per million peripheral blood mononuclear cells for groups 1, 2, and 3, respectively; these baseline viral reservoir sizes were not significantly different (P = 0.37). By week 24, the median sizes of the viral reservoirs were 0.04 (0.01-2.16), 0.04 (0.01-0.34), and 0.12 (0.01-0.44) infectious units per million peripheral blood mononuclear cells for groups 1, 2, and 3 respectively; these week 24 viral reservoir sizes were not significantly different (P = 0.91). Furthermore, there were no statistically significant differences between baseline and week 24 reservoir sizes for any of the 3 groups (P = 0.88, P = 1.00, and P = 0.44, respectively).

CONCLUSIONS:

Despite evidence that ALVAC-HIV ± Remune was associated with a trend toward a delay in viral rebound and a smaller decrease in CD4 T-cell counts following antiretroviral therapy interruption, ALVAC-HIV ± Remune did not influence the size of the viral reservoir.

2011-03-27·AIDS (London, England)2区 · 医学

A randomized controlled trial of HIV therapeutic vaccination using ALVAC with or without Remune

2区 · 医学

Article

作者: Kovacs, Colin ; Smaill, Fiona ; Gurunathan, Sanjay ; Tremblay, Cecile ; Angel, Jonathan B. ; Bernard, Nicole ; Singer, Joel ; Sekaly, Rafick-Pierre ; Routy, Jean-Pierre ; Woods, Ryan ; Ayers, Dieter

OBJECTIVES:

Therapeutic HIV vaccination during the time of virologic suppression may delay or blunt viral load rebound after interruption of antiretroviral therapy (ART). The use of ALVAC, to enhance cytotoxic T-lymphocyte responses, with Remune, which provides CD4 T-cell help, may induce anti-HIV responses capable of controlling viral replication.

METHODS:

CTN173 was a randomized, placebo-controlled double-blind study in which effectively treated HIV-infected individuals (viral load <50 copies/ml for more than 2 years) with CD4 nadir more than 250 cells/μl and current CD4 cell counts more than 500 cells/μl were randomized to receive: ALVAC with Remune, ALVAC alone or matching placebos over 20 weeks. At week 24, participants interrupted ART with intensive clinical, virologic and immunologic monitoring to week 48.

RESULTS:

Baseline characteristics of the 52 randomized participants were balanced between arms. Forty-eight participants who received all vaccinations interrupted ART at week 24. Median time to viral load more than 50 copies/ml tended to be greater in the two vaccine arms (24.5, 23.0 vs. 13.5 days in the placebo arm, P = 0.097 for combined vaccine groups vs. placebo), but subsequent viral load set-point was not different between groups. Significantly fewer participants in the two vaccine arms restarted ART or met CD4 criteria to do so (P = 0.024).

CONCLUSION:

Although ALVAC with or without Remune did not lower the viral load set-point, it tended to delay viral load rebound and was associated with a greater time to meet preset criteria to restart ART. Further investigations of those individuals who derived benefit from vaccination could provide important insights into HIV therapeutic vaccine development.

100 项与 GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies) 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	申请上市	-	The Salk Institute for Biological Studies	-
获得性免疫缺陷综合征	临床2期	美国	Immune Response Biopharma, Inc.	2017-11-01

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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


STIR-2102 (IAS2006)	N/A	HIV感染	54	Remune	願繭範膚餘網選艱網積(廠鹹觸選鏇繭範製蓋獵) = 鏇獵醖鹹襯構窪構積鹽遞淵顧製鹹鏇鬱網餘鑰 (顧觸構製積顧夢鹹淵鏇 ) 更多	-	2006-01-01
				IFA	願繭範膚餘網選艱網積(廠鹹觸選鏇繭範製蓋獵) = 窪網襯願蓋餘夢鏇蓋憲遞淵顧製鹹鏇鬱網餘鑰 (顧觸構製積顧夢鹹淵鏇 ) 更多
IAS2002	N/A	-	243	inactivated HIV-1 immunogen (Immunogen (Remune))	膚餘鑰願顧膚願範構範(蓋憲鏇衊醖鬱壓觸願觸): RR = 0.63 (95% CI, 0.41 ~ 0.97), P-Value = 0.034	积极	2002-01-01
				Placebo
P2101B (IAS2002)	N/A	-	223	Remune monotherapy	艱夢艱觸鑰襯遞製積艱(淵蓋餘鬱醖範鏇蓋夢遞) = 夢構艱艱願範範遞壓築製鬱膚觸廠餘獵構蓋繭 (餘繭築鹹襯艱網蓋積鏇 ) 更多	积极	2002-01-01
P2101B (IAS2001)	N/A	HIV感染	297	Remune	糧窪願憲鬱醖鏇憲範衊(襯襯選觸糧廠範艱製餘) = tolerable injection site reactions as a common adverse event 蓋醖觸壓鑰糧鬱鑰憲構 (築願鏇鹹願餘鏇鹽鏇衊 )	-	2001-01-01
IAS2001	N/A	HIV感染	-	REMUNE	糧糧衊齋製鑰獵襯餘艱(膚鹽蓋蓋獵選餘顧選廠) = 網鏇廠餘積壓鬱衊簾鑰願齋積壓繭蓋襯壓網遞 (願製鏇觸觸鬱艱衊遞壓 ) 更多	-	2001-01-01
				IFA	糧糧衊齋製鑰獵襯餘艱(膚鹽蓋蓋獵選餘顧選廠) = 糧壓醖鹹醖鏇壓壓夢鹽願齋積壓繭蓋襯壓網遞 (願製鏇觸觸鬱艱衊遞壓 ) 更多