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 HIV-1 vaccine、HIV vaccine、REMUNE

+ [5]

靶点-

作用方式

刺激剂

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.免疫反应公司

+ [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-

登录后查看时间轴

关联

12

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

NCT00005001

/ Completed临床2期

A Pilot, Phase II, Double-Blind Study to Assess the Virologic Effect of Remune Versus Incomplete Freund's Adjuvant (IFA) in Patients Who Are Infected With Human Immunodeficiency Virus Type I (HIV-1), Have a Plasma HIV-1 RNA Level Less Than 50 Copies/Ml, Are Receiving Highly Active Antiretroviral Therapy (HAART), and Who Subsequently Discontinue Their HAART Regimen

The purpose of this study is to see if giving HIV-positive patients an HIV vaccine plus anti-HIV drugs can help lower HIV levels in the blood (viral load).

开始日期-

申办/合作机构

Agouron Pharmaceuticals LLC

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

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

登录后查看更多信息

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

登录后查看更多信息

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

登录后查看更多信息

36

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

2021-01-01·Journal of healthcare, science and the humanities

The (Contrasted) Ethics of Covid-19 and HIV: Will the Favor be Returned?

Article

作者: Hodge, David Augustin ; Abdul-Mutakabbir, Jacinda C ; Campbell, Hope E

With 118,000 cases in 114 countries and 4291 global mortalities, the World Health Organization (WHO) declared COVID-19 a pandemic on March 11, 2020. The origins were believed to be from Wuhan, China, and SARS CoV-2, a coronavirus, was quickly identified as the causative organism. Researchers at the National Institute of Health Vaccine Research Center identified the spike protein as the critical portion of the virus that allows for attachment to human cells. In just 66 days after identifying the genetic sequence, the first COVID-19 vaccine candidate began the enrollment of human subjects into a Phase I clinical trial. This accelerated effort was due to a collective and collaborative global response. Currently, one COVID-19 vaccine has been approved and two others have received an emergency use authorization (EUA) from the United States Food and Drug Administration (FDA). Thus, there has been a clear comparison of the COVID-19 response efforts and that which was utilized in addressing the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic. For over four decades, the HIV/AIDS epidemic has been historically defined by a disproportionate number of infections and related mortalities amongst racially and ethnically minoritized individuals, including those that identify as homosexual. While novel drug therapies have been developed for the treatment of HIV/AIDS; there have been key components employed amid the global health response to COVID-19, that have been absent from the management of the HIV/AIDS epidemic. Majorly, the development and availability of vaccine against HIV/AIDS. Many of the ideas and initiatives that have resulted in a positive COVID-19 response and the eventual successful vaccination development; have been those learned from the trial and error of mitigating increasing global rates of HIV/AIDS infections. Hence, the question remains as to whether the lessons and approaches learned during the COVID-19 pandemic, namely vaccination development, will be applied to managing the HIV/AIDS epidemic. Herein, we aim to compare the HIV/AIDS epidemic and COVID-19 pandemic, by describing how the fight against HIV/AIDs equipped global scientific leaders with effective strategies to overcome future public health crises (COVID-19), discuss the ethical considerations associated with the differences in the global health responses to the HIV/ AIDS epidemic versus the COVID-19 pandemic, and finally, identify lessons learned from the COVID-19 pandemic that can be applied to the quest for an HIV/AIDS vaccine..

2020-12-22·Journal of Virology2区 · 医学

Enhancement of HIV-1 Env-Specific CD8 T Cell Responses Using Interferon-Stimulated Gene 15 as an Immune Adjuvant

2区 · 医学

Article

作者: Falqui, Michela ; Sorzano, Carlos Óscar S. ; Perdiguero, Beatriz ; Gómez, Carmen Elena ; Esteban, Mariano ; García-Arriaza, Juan ; Guerra, Susana ; Marín, María Q. ; Bécares, Martina

Our study described the potential role of ISG15 as an immunomodulatory molecule in the optimization of HIV/AIDS vaccine candidates. Using a DNA prime–MVA boost immunization protocol, our results indicated an increase in the potency and the quality of the HIV-1 Env-specific CD8 T cell response. These results highlight the adjuvant potency of ISG15 to elicit improved viral antigen presentation to the immune system, resulting in an enhanced HIV-1 vaccine immune response. The DNA-ISG15 vector could find applicability in the vaccine field in combination with other nucleic acid-based vector vaccines.

2020-01-01·China CDC Weekly4区 · 医学

China CDC’s HIV/AIDS Vaccine Efforts, from Basic Research to Clinical Studies

4区 · 医学

Article

作者: Wang, Shuhui ; Liu, Ying ; Li, Dan ; Wu, Yingqi ; Wu, Hao ; Xu, Jing ; Hao, Yanling ; Zhang, Tong ; Ren, Li ; Shao, Yiming ; Li, Taisheng ; Wu, Lihua

100 项与 GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies) 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
获得性免疫缺陷综合征	申请上市	美国	Immune Response Biopharma, Inc.	2017-11-01
HIV感染	申请上市	-	The Salk Institute for Biological Studies	-
HIV感染	申请上市	-	The Salk Institute for Biological Studies	-

登录后查看更多信息

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


STIR-2102 (IAS2006)	N/A	HIV感染	54	Remune	選築鹹鑰鑰醖艱廠鬱築(鏇觸憲齋積襯遞構構衊) = 蓋築廠遞願構觸鏇夢衊膚夢網艱顧餘選衊糧觸 (簾憲壓選艱獵壓鑰壓鏇 ) 更多	-	2006-01-01
				IFA	選築鹹鑰鑰醖艱廠鬱築(鏇觸憲齋積襯遞構構衊) = 選構簾餘鹹遞鹹構網繭膚夢網艱顧餘選衊糧觸 (簾憲壓選艱獵壓鑰壓鏇 ) 更多
IAS2002	N/A	-	243	inactivated HIV-1 immunogen (Immunogen (Remune))	(觸壓餘獵獵築遞壓窪蓋): 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	繭製網願衊衊窪築築窪(鑰鑰簾鬱網繭襯夢糧簾) = 膚獵鏇壓齋鏇糧窪顧顧觸積範憲夢選壓齋壓淵 (網顧築願衊糧膚鬱網積 ) 更多	积极	2002-01-01
P2101B (IAS2001)	N/A	HIV感染	297	Remune	(選繭鹹糧範範鏇鏇壓簾) = tolerable injection site reactions as a common adverse event 顧鏇遞簾淵衊夢廠範鹹 (築醖鹹壓願構觸選壓鬱 )	-	2001-01-01
IAS2001	N/A	HIV感染	-	REMUNE	襯網廠憲餘醖築製構餘(窪衊艱窪餘鬱衊蓋餘壓) = 鏇鑰鹽鹽糧襯簾艱鏇蓋窪廠願願糧簾鏇獵衊顧 (積廠網遞鏇選壓願衊醖 ) 更多	-	2001-01-01
				IFA	襯網廠憲餘醖築製構餘(窪衊艱窪餘鬱衊蓋餘壓) = 醖範膚鏇選構襯遞觸淵窪廠願願糧簾鏇獵衊顧 (積廠網遞鏇選壓願衊醖 ) 更多