PepGNP-SARSCoV2(Emergex Vaccines Holding)(PepGNP-SARSCoV2(Emergex Vaccines Holding)) - 药物靶点：SARS-CoV-2 antigen_在研适应症：新型冠状病毒感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名-

靶点

SARS-CoV-2 antigen

作用方式

抑制剂

作用机制

新冠病毒抗原抑制剂

治疗领域

感染呼吸系统疾病

在研适应症

新型冠状病毒感染

非在研适应症-

原研机构

Gylden Pharma Ltd.

在研机构

Gylden Pharma Ltd.

非在研机构-

权益机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 PepGNP-SARSCoV2(Emergex Vaccines Holding) 相关的临床试验

NCT05633446

/ Not yet recruiting临床1/2期

A Phase I-II, Blinded, Randomized, Placebo-controlled Study of a T Cell Priming Next-generation Vaccine Against Coronavirus Disease in Healthy Adults

The study aims to investigate the safety and immunogenicity of one dose vs two doses of a T-cell priming next-generation vaccine against Coronavirus disease.

开始日期2025-09-01

申办/合作机构

Gylden Pharma Ltd.

NCT05113862

/ Completed临床1期

A Phase-I, Double-blind, Randomized, Vehicle-controlled, Dose-finding, Safety Study of a Synthetic Nanoparticle-based, T Cell Priming Peptide Vaccine Against SARS-CoV-2 in Healthy Adults in Switzerland

This trial is Stage 2 of a 2-part adaptive trial. The study aims to investigate the safety of 2 doses of a T-cell priming specific cocktail of Coronaviruses peptides mounted on a gold nanoparticle.
Note: Stage 1 of the 2-part adaptive trial, testing a specifically selected mix of Dengue virus peptides, commenced Aug 2021. This is now in follow up (NCT04935801).

开始日期2022-01-10

申办/合作机构

Gylden Pharma Ltd.

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100 项与 PepGNP-SARSCoV2(Emergex Vaccines Holding) 相关的临床结果

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100 项与 PepGNP-SARSCoV2(Emergex Vaccines Holding) 相关的转化医学

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100 项与 PepGNP-SARSCoV2(Emergex Vaccines Holding) 相关的专利（医药）

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1

项与 PepGNP-SARSCoV2(Emergex Vaccines Holding) 相关的文献（医药）

BMC Infectious Diseases

A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland

Article

作者: Schaufelberger, Sylvain ; Warpelin-Decrausaz, Loane ; Genton, Blaise ; Audran, Régine ; Hajjami, Hélène Maby-El ; Spertini, François ; Faivre, Vincent ; Faouzi, Mohamed ; Hartley, Mary-Anne ; Sene, Loredana ; Besson, Juliette ; Miauton, Alix ; Karlen, Maxime

AbstractBackgroundNew vaccines with broader protection against SARS-CoV-2 are needed to reduce the risk of immune escape and provide broad and long-lasting cellular immunity. The objectives of the naNO-COVID trial were to evaluate the safety and immunogenicity of a CD8 + T cell, gold nanoparticle-based, peptide COVID-19 vaccine.MethodsA randomized, double-blind, vehicle-controlled, phase 1 trial in healthy adults to receive PepGNP-Covid19 or Vehicle-GNP, followed over 180 days, using a dose-escalation strategy.ResultsTwenty participants received PepGNP-Covid19 (low dose [LD] or high dose [HD], n = 10 each) and six Vehicle-GNP (LD or HD, n = 3 each).Vaccinations were safe. No serious adverse events were reported. Most of the adverse events were mild, two adverse events of special interest related to the product (fever and fatigue). Reactogenicity was similar overall between vaccine, comparator, and doses.Virus-specific humoral responses in LD PepGNP-Covid19 and Vehicle-GNP groups coincided with SARS-CoV-2 infections. PepGNP-Covid19 vaccination induced the modulation of Covid19-specific CD137 + CD69 + CD8 + , and an increase at day 35 particularly in central and effector memory T cells in LD group, and in late effector memory cells in HD group.ConclusionsThe favourable safety profile and cellular responses observed support further development of PepGNP-Covid19.Trial registrationClinicalTrials.gov, NCT05113862, approved 09.11.2021.

100 项与 PepGNP-SARSCoV2(Emergex Vaccines Holding) 相关的药物交易

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