Delving into the Latest Updates on Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine

Synonyms

Cytomegalovirus glycoprotein vaccine, GSK Biologicals' recombinant CMV gB vaccine

+ [1]

Target

CMV gB

Action

antagonists

Mechanism

CMV gB antagonists(CMV gB antagonists)

Therapeutic Areas

Infectious Diseases

Active Indication

Cytomegalovirus Infections

Inactive Indication-

Originator Organization

GSK Plc

Active Organization

GSK Plc

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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A Phase 1/2, First-Time-in Human (FTiH), Randomized, Observer-blind, Placebo-controlled, Dose Escalation Study to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Cytomegalovirus (CMV) Vaccine Comprising Recombinant Protein and Adjuvant When Administered Intramuscularly in Healthy Adults

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the candidate CMV recombinant protein subunit (CMVsu) vaccine consisting of a combination of glycoproteins B (gB) and pentamer antigens adjuvanted, regardless of baseline CMV sero-status. This FTiH study will be conducted in healthy adults 18 to 50 years of age, in which the 4 dose levels of the vaccine will be administered in a step-wise dose escalation manner, based upon safety adjudication.

Start Date14 Oct 2021

Sponsor / Collaborator

GSK Plc

NCT01357915

/ CompletedNot Applicable

A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults

The purpose of this study is to evaluate the persistence of the vaccine induced immune responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3 doses of GSK Biologicals' candidate CMV vaccine according to a 0-1-6 month schedule during the primary study 108890 (NCT00435396) (vaccine group). The immune response to CMV infection in naturally infected subjects who participated in the screening visit of the primary study 108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value (seropositive reference group). In addition, this study will continue to assess the occurrence of CMV infections as well as the continued development and validation of read-outs in the CMV project.
The primary vaccination phase and Year 2 follow-up were posted as a separate protocol posting (NCT00435396).

Start Date24 Jun 2011

Sponsor / Collaborator

GSK Plc

NCT00435396

/ CompletedPhase 1

A Phase I, Open-label, Vaccination Study to Evaluate the Safety and Immunogenicity of the GSK Biologicals Recombinant CMV gB Sub-unit Vaccine GSK1492903A in CMV-seronegative Healthy Male Adult Subjects

This will be the first time in humans (FTIH) study with the GSK Bio recombinant gB antigen to evaluate safety and immunogenicity of this CMV candidate vaccine with a proprietary GSK adjuvant system. The vaccine will be administered to young male healthy subjects at 0, 1 and 6 months. The trial will assess the safety and immunogenicity of the candidate CMV vaccine. An additional secondary objective of this trial is to identify and validate a test which will be able to differentiate between previous CMV infection and CMV vaccination. Subjects will be followed for a total of 2 years.

Start Date22 Feb 2007

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc)

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21

Literatures (Medical) associated with Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc)

01 Sep 2023·Epidemics

Optimizing age specific strategies of vaccination for prevention of cytomegalovirus infection in the US using agent-based simulation

Article

Author: Chen, Yao-Hsuan ; Wang, Dawei ; Ventresca, Mario

BACKGROUNDThere is an urgent need to develop a cytomegalovirus (CMV) vaccine as it remains the leading cause of birth defects in the United States. While several CMV vaccine candidates are currently in late-stage clinical trials, the most effective vaccination program remains an open research question.METHODSTo take into account the critical uncertainties when evaluating the vaccine impact on both vertical (congenital) and horizontal CMV transmissions, we developed a CMV agent-based model representative of the US population and contact network structures.RESULTSWe evaluated 648 vaccination scenarios under various assumptions of vaccination age, vaccine efficacy, protection duration, and vaccination coverage. The optimal age of vaccination under all scenarios is shown to be during early childhood. However, a relatively modest benefit was also seen with vaccination of females of reproduction age (around age of 25) assuming near universal coverage and long vaccine-mediated protection.CONCLUSIONSThis study highlights the important need for a pediatric vaccination program in mitigating CMV in the United States. Our model is poised to investigate further location-based vaccine effectiveness questions in future planning of both clinical trials as well as eventual program implementation.

01 Jan 2023·Reviews in Medical Virology

Indirect effects of cytomegalovirus infection: Implications for vaccine development

Review

Author: Moseley, Philip ; Klenerman, Paul ; Kadambari, Seilesh

AbstractDevelopment of a cytomegalovirus (CMV) vaccine is a high priority due to its significant global impact—contributing to mortality in immunosuppressed individuals, neurodevelopmental delay in infected neonates and non‐genetic sensorineural hearing loss. The impact of CMV on the general population has been less well studied; however, a wide range of evidence indicates that CMV may increase the risk of atherosclerosis, cancer, immunosenescence, and progression of tuberculosis (TB) and human immunodeficiency virus. Due to the high seroprevalence of CMV worldwide, any modulation of risk by CMV is likely to have a significant impact on the epidemiology of these diseases. This review will evaluate how CMV may cause morbidity and mortality outside of the neonatal and immunosuppressed populations and consider the potential impact of a CMV vaccine on these outcomes.

01 Jun 2022·Molecular Therapy - Methods & Clinical DevelopmentQ2 · MEDICINE

Pre-clinical data supporting immunotherapy for HIV using CMV-HIV-specific CAR T cells with CMV vaccine

Q2 · MEDICINE

ArticleOA

Author: Holguin, Leo ; Browning, Diana L ; Blanchard, M Suzette ; Le Verche, Virginia ; Yazaki, Paul ; Scott, Tristan ; Forman, Stephen J ; Cardoso, Angelo A ; Burnett, John C ; Miller, Aaron ; Guan, Min ; Li, Shirley ; Lim, Laura ; Morris, Kevin V ; Li, Shasha ; Vyas, Vibhuti ; Han, Tianxu ; Urak, Ryan ; Wang, Xiuli ; Echavarria, Liliana ; Zaia, John A ; Chang, Wen-Chung

T cells engineered to express HIV-specific chimeric antigen receptors (CARs) represent a promising strategy to clear HIV-infected cells, but to date have not achieved clinical benefits. A likely hurdle is the limited T cell activation and persistence when HIV antigenemia is low, particularly during antiretroviral therapy (ART). To overcome this issue, we propose to use a cytomegalovirus (CMV) vaccine to stimulate CMV-specific T cells that express CARs directed against the HIV-1 envelope protein gp120. In this study, we use a GMP-compliant platform to engineer CMV-specific T cells to express a second-generation CAR derived from the N6 broadly neutralizing antibody, one of the broadest anti-gp120 neutralizing antibodies. These CMV-HIV CAR T cells exhibit dual effector functions upon in vitro stimulation through their endogenous CMV-specific T cell receptors or the introduced CARs. Using a humanized HIV mouse model, we show that CMV vaccination during ART accelerates CMV-HIV CAR T cell expansion in the peripheral blood and that higher numbers of CMV-HIV CAR T cells were associated with a better control of HIV viral load and fewer HIV antigen p24⁺ cells in the bone marrow upon ART interruption. Collectively, these data support the clinical development of CMV-HIV CAR T cells in combination with a CMV vaccine in HIV-infected individuals.

100 Deals associated with Cytomegalovirus glycoprotein vaccine(GlaxoSmithKline Plc)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cytomegalovirus Infections	Phase 2	United States	GSK Plc	14 Oct 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01357915 (CTgov)	Not Applicable	Cytomegalovirus Infections	47	Blood sampling+GSK149203A (GSK149203A S- Group)	bhssozppmi(vkzzgnxrxk) = kabznxjrln tlwkvoaxhg (gsfxosmgmw, pelubtoebn - vbnocmgdtx) View more	-	06 Oct 2017
				Blood sampling (GSK149203A S+ Group)	rroinewcdw(leyjmkmhsg) = aezpopibnf mopdbgqemn (vnxqoohaoy, udrlofycgh - kfdnpbimzk) View more