Delving into the Latest Updates on GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

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

+ [5]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication-

Inactive Indication

Acquired Immunodeficiency SyndromeHIV Infections

Originator Organization

The Salk Institute for Biological Studies

Active Organization-

Inactive Organization

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

+ [1]

Drug Highest PhaseDiscontinuedNDA/BLA

First Approval Date-

Regulation-

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.

Start Date01 Nov 2017

Sponsor / Collaborator

Immune Response Biopharma, Inc.

NCT02366026 / Unknown statusPhase 3

REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study

The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+ & CD8+ T cell counts along with increased HIV immunity.

Start Date01 Jun 2017

Sponsor / Collaborator

Immune Response Biopharma, Inc.

NCT00005758 / CompletedPhase 3IIT

A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Effect of Immunization With an HIV Immunogen on the Time to Virologic Relapse in Individuals Receiving Potent, Suppressive Antiretroviral Therapies

The purpose of this study is to look at the effects of the HIV vaccine Remune on viral load (level of HIV in the blood) and on the way the immune system responds to HIV. This study will also try to see if the effects of the vaccine are different in patients entering the study with a viral load below 50 copies/ml compared to those who have a viral load from 50 to 500 copies/ml. (This study is currently being redesigned and the purpose may be revised.) Treatment with anti-HIV drugs does not always keep HIV viral load undetectable (so low that it cannot be measured). This study originally added an HIV vaccine called Remune to treat patients. Remune was thought to reduce viral load and improve immune responses. However, new information suggests that Remune may not be as effective as was first believed. The study has been changed to follow people already in the study and to let people enroll only if they participate in the substudy. The substudy will look at the effect of another HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about the safety of these vaccines in HIV-positive patients will be gathered.

Start Date-

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies)

Login to view more data

100 Translational Medicine associated with GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies)

Login to view more data

100 Patents (Medical) associated with GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies)

Login to view more data

22

Literatures (Medical) associated with GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies)

02 Jul 2016·Expert opinion on biological therapyQ3 · MEDICINE

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

Q3 · MEDICINE

Review

Author: 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.

01 Oct 2015·Journal of acquired immune deficiency syndromes (1999)Q3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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.

27 Mar 2011·AIDS (London, England)Q2 · MEDICINE

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

Q2 · MEDICINE

Article

Author: Kovacs, Colin ; Smaill, Fiona ; Gurunathan, Sanjay ; Tremblay, Cecile ; Angel, Jonathan B. ; Bernard, Nicole ; Sekaly, Rafick-Pierre ; Routy, Jean-Pierre ; Singer, Joel ; 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 Deals associated with GP120-depleted HIV-1 vaccine(The Salk Institute for Biological Studies)

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	NDA/BLA	-	The Salk Institute for Biological Studies	-
Acquired Immunodeficiency Syndrome	Phase 2	US	Immune Response Biopharma, Inc.	01 Nov 2017

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


STIR-2102 (IAS2006)	Not Applicable	HIV Infections	54	Remune	mupaglopaa(pgwbsgrior) = iusezdcxgm gszbazdeoh (etzdnnptyo ) View more	-	01 Jan 2006
				IFA	mupaglopaa(pgwbsgrior) = fpdmqllxgf gszbazdeoh (etzdnnptyo ) View more
IAS2002	Not Applicable	-	243	inactivated HIV-1 immunogen (Immunogen (Remune))	xmdnfuzvuh(vxqvahyqyn): RR = 0.63 (95% CI, 0.41 - 0.97), P-Value = 0.034	Positive	01 Jan 2002
				Placebo
P2101B (IAS2002)	Not Applicable	-	223	Remune monotherapy	tssdzeglml(ceiruumvew) = nxaekodyjs rqtstxlojs (whdbikejym ) View more	Positive	01 Jan 2002
IAS2001	Not Applicable	HIV Infections	-	REMUNE	ffcgffunym(lsinznkqhm) = rrgwdoeszn donpqlthmf (mbjketwnle ) View more	-	01 Jan 2001
				IFA	ffcgffunym(lsinznkqhm) = magoffjkvr donpqlthmf (mbjketwnle ) View more
P2101B (IAS2001)	Not Applicable	HIV Infections	297	Remune	pdiashnomu(bxopezojmt) = tolerable injection site reactions as a common adverse event nhtulcnrjx (ltujjduqlk )	-	01 Jan 2001