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 HIV-1 vaccine, HIV vaccine, REMUNE

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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.immune response company

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Drug Highest PhaseDiscontinuedNDA/BLA

First Approval Date-

Regulation-

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A Randomized, Double-Blind, Adjuvant-Controlled, Multicenter Study to Compare the Virologic and Immunologic Effect of Highly Active Antiretroviral Therapy (HAART) Plus Remune Versus HAART Plus Incomplete Freund's Adjuvant (IFA) in Antiretroviral-Naive Patients Infected With Human Immunodeficiency Virus Type 1 (HIV-1)

The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.

Start Date-

Sponsor / Collaborator

Agouron Pharmaceuticals LLC

NCT02291809 / Unknown statusPhase 2

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.

Start Date01 Nov 2017

Sponsor / Collaborator

Immune Response Biopharma, Inc.

NCT00001445 / CompletedPhase 1IIT

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.

Start Date01 Aug 1995

Sponsor / Collaborator

National Cancer Institute

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

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

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

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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: Angel, Jonathan B ; Graziani, Gina M

INTRODUCTIONAlthough 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 COVEREDDeveloped 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 OPINIONGiven 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·JAIDS Journal of Acquired Immune Deficiency SyndromesQ3 · 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: Angel, Jonathan B. ; Tremblay, Cecile L. ; Graziani, Gina M. ; Routy, Jean-Pierre

OBJECTIVESTo assess whether therapeutic vaccination with ALVAC-HIV ± Remune affects viral reservoir size in antiretroviral therapy-treated individuals.METHODSParticipants 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.RESULTSSixteen 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).CONCLUSIONSDespite 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·AIDSQ2 · MEDICINE

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

Q2 · MEDICINE

Article

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

OBJECTIVESTherapeutic 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.METHODSCTN173 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.RESULTSBaseline 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).CONCLUSIONAlthough 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)

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R&D Status

10 top R&D records.

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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


STIR-2102 (IAS2006)	Not Applicable	HIV Infections	54	Remune	uuccpyvuio(ceytmtxapf) = ujyuicjpnr qasrgnpgkm (ghmhfeadtj ) View more	-	01 Jan 2006
				IFA	uuccpyvuio(ceytmtxapf) = pssgqrdosl qasrgnpgkm (ghmhfeadtj ) View more
IAS2002	Not Applicable	-	243	inactivated HIV-1 immunogen (Immunogen (Remune))	(tfptpcaqcx): 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	ifptxwkqpe(ahmdkvomus) = tmjcpllqtd lgewlgoggq (skrixsnxub ) View more	Positive	01 Jan 2002
P2101B (IAS2001)	Not Applicable	HIV Infections	297	Remune	(spjsmoxxfb) = tolerable injection site reactions as a common adverse event zpqlwbsuol (mpmootihms )	-	01 Jan 2001
IAS2001	Not Applicable	HIV Infections	-	REMUNE	jawkllwiej(yxkoixikcs) = wylyxhdsxg ohxxlotgdy (kfqbociztn ) View more	-	01 Jan 2001
				IFA	jawkllwiej(yxkoixikcs) = xvoggzxtza ohxxlotgdy (kfqbociztn ) View more