Delving into the Latest Updates on ChulaCov19 mRNA vaccine(Chulalongkorn University) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, mRNA vaccine

Synonyms

CUCov19 mRNA vaccine, Chula-Covid19, ChulaCov19 vaccine

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19

Inactive Indication-

Originator Organization

University of Chulalongkorn

Active Organization

University of Chulalongkorn

King Chulalongkorn Memorial Hospital

Inactive Organization

Chulalongkorn University Book Center

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants. Group 1 will enrol adults aged 18-55 years (inclusive); Group 2 will enroll elderly adults (elderly) aged 56-75 years (inclusive).
Phase 2 of this study will be a single centre, the proposed design will be observer-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of ChulaCov19 vaccine in healthy adults (18-75 years of age inclusive).

Start Date03 May 2021

Sponsor / Collaborator

University of Chulalongkorn

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100 Clinical Results associated with ChulaCov19 mRNA vaccine(Chulalongkorn University)

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100 Translational Medicine associated with ChulaCov19 mRNA vaccine(Chulalongkorn University)

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100 Patents (Medical) associated with ChulaCov19 mRNA vaccine(Chulalongkorn University)

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11

Literatures (Medical) associated with ChulaCov19 mRNA vaccine(Chulalongkorn University)

28 Aug 2024·mSphere

Lipid nanoparticle-encapsulated DNA vaccine confers protection against swine and human-origin H1N1 influenza viruses

Article

Author: Weaver, Eric A. ; Vu, Hiep L. X. ; Nguyen, The N. ; Sillman, Sarah ; Petro-Turnquist, Erika ; Lai, Danh C.

ABSTRACTIn 2009, a novel swine-origin H1N1 virus emerged, causing a pandemic. The virus, known as H1N1pdm09, quickly displaced the circulating H1 lineage and became the dominant seasonal influenza A virus subtype infecting humans. Human-to-swine spillovers of the H1N1pdm09 have occurred frequently, and each occurrence has led to sustained transmission of the human-origin H1N1pdm09 within swine populations. In the present study, we developed a lipid nanoparticle-based DNA vaccine (LNP-DNA) containing the hemagglutinin gene of a swine-origin H1N1pdm09. In pigs, this LNP-DNA vaccine induced a robust antibody response after a single intramuscular immunization and protected the pigs against challenge infection with the homologous swine-origin H1N1pdm09 virus. In a mouse model, the LNP-DNA vaccine induced antibody and T-cell responses and protected mice against lethal challenge with a mouse-adapted human-origin H1N1pdm09 virus. These findings demonstrate the potential of the LNP-DNA vaccine to protect against both swine- and human-origin H1N1pdm09 viruses.IMPORTANCESwine influenza A virus (IAV) is widespread and causes significant economic losses to the swine industry. Moreover, bidirectional transmission of IAV between swine and humans commonly occurs. Once introduced into the swine population, human-origin IAV often reassorts with endemic swine IAV, resulting in reassortant viruses. Thus, it is imperative to develop a vaccine that is not only effective against IAV strains endemic in swine but also capable of preventing the spillover of human-origin IAV. In this study, we developed a lipid nanoparticle-encapsulated DNA plasmid vaccine (LNP-DNA) that demonstrates efficacy against both swine- and human-origin H1N1 viruses. The LNP-DNA vaccines are non-infectious and non-viable, meeting the criteria to serve as a vaccine platform for rapidly updating vaccines. Collectively, this LNP-DNA vaccine approach holds great potential for alleviating the impact of IAV on the swine industry and preventing the emergence of reassortant IAV strains.

01 Jan 2024·Methods in Molecular Biology

Evaluation of the Acute Anaphylactoid Reactogenicity of Nanoparticle-Containing Medicines and Vaccines Using the Porcine CARPA Model

Article

Author: Szebeni, Janos

A small fraction, up to 10%, of people treated intravenously with state-of-the-art nanoparticulate drugs or diagnostic agents develop an acute infusion reaction which can be severe or even lethal. Activation of the complement (C) system can play a causal, or contributing role in these atypical, "pseudoallergic" reactions, hence their name, C activation-related pseudoallergy (CARPA). Intravenous (i.v.) administration of the human reaction-triggering (very small) dose of a test sample in pigs triggers a symptom tetrad (characteristic hemodynamic, hematological, skin, and laboratory changes) that correspond to the major human symptoms. Quantitating these changes provides a highly sensitive and reproducible method for assessing the risk of CARPA, enabling the implementation of appropriate preventive measures. Accordingly, the porcine CARPA model has been increasingly used for the safety evaluation of therapeutic and diagnostic nanomedicines and, recently, mRNA-lipid nanoparticle vaccines. This chapter provides details of the experimental procedure followed upon using the model.

01 Jan 2024·RNA Vaccines

A Basic Method for Formulating mRNA-Lipid Nanoparticle Vaccines in the Lab

Article

Author: Mellett, Mark ; Frei, Julia ; Pascolo, Steve ; Jarzebska, Natalia T ; Kündig, Thomas M ; Reichmuth, Andreas M

During recent years, RNA therapeutics have begun to make a substantial impact in the clinic, with the approval of the siRNA-based therapeutic Patisiran in 2018, and of the two mRNA SARS-CoV-2 vaccines, BNT162b2 and mRNA-1273 in 2021. A key to the success of these therapeutics lies in the lipid-based delivery system. The therapeutic RNAs are encapsulated in lipid nanoparticles (LNPs), which protect against enzymatic degradation and efficiently deliver the RNA across the cell membrane into the cytosol. Thereby, the method used for LNP synthesis and its lipid composition are crucial aspects that decide the efficacy of the LNP-RNA hetero system. Here we provide a detailed guide for the simple preparation of LNP-encapsulated mRNA vaccines.

100 Deals associated with ChulaCov19 mRNA vaccine(Chulalongkorn University)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	TH	University of Chulalongkorn	03 May 2021
COVID-19	Phase 2	TH	Chulalongkorn University Book Center	03 May 2021
COVID-19	Phase 2	TH	King Chulalongkorn Memorial Hospital	03 May 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04566276 (Pubmed) Manual	Phase 2	COVID-19	150	ChulaCov19 50 µg	(jxgxnrzcph) = most adverse events were mild to moderate and temporary. rbnxqjbqvn (xpmndfxkxf )	Positive	29 Jan 2024
				placebo