Delving into the Latest Updates on COVID-19-mRNA Vaccine(Stemirna Therapeutics) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, mRNA vaccine

Synonyms

COVID-19 messenger ribonucleic acid(mRNA) vaccine from Stemirna Therapeutics, COVID-19-mRNA Vaccine(Stemirna Therapeutics), SARS-Cov-2 mRNA vaccine immunization(Stemirna Therapeutics)

+ [4]

Target

SARS-CoV-2 S protein

Action

inhibitors

Mechanism

SARS-CoV-2 S protein inhibitors(SARS-CoV-2 S protein inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19

Inactive Indication-

Originator Organization

Stemirna Therapeutics Co., Ltd.

Active Organization

Stemirna Therapeutics Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Laos (08 Dec 2022),

COVID-19

RegulationEmergency Use Authorization (Laos)

Login to view timeline

A Randomized, Single-blind, Parallel Controlled Trial to Evaluate the Immunogenicity ,Safety,Efficacy of A Heterologous Booster Dose With SW-BIC-213, in Previously Vaccinated Subjects Against COVID-19 With Two Inactivated COVID-19 Vaccine Doses Compared to a Booster Dose With Pfizer of Sinopharmin Adults

Primary#Objectives #Immunogenicity:To demonstrate the non-inferiority of binding antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with mRNA COVID-19 vaccine(Pfizer) 14 days post dose.
Secondary#Immunogenicity:
1. To describe binding antibody profile at D01, D29 and D181 of each study group.
2. To describe the neutralizing antibody profile at D15, D29 and D181 of each study intervention group.
Secondary#Safety:
To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with two Sinopharm doses.
Exploratory#Cell-mediated immunity:
To describe the cellular immune response profile at D01, D08, D15, in a subset of 30 participants for each study group.
Exploratory#Efficacy:
To describe theoccurrence ofvirologically-confirmedCOVID-19 like illness and serologicallyconfirmed SARS-CoV-2 infection.

Start Date19 Oct 2022

Sponsor / Collaborator

Stemirna Therapeutics Co., Ltd.

NCT05580159

/ RecruitingPhase 3

A Multi-national, Randomized, Observer-blinded, Parallel Controlled Trial to Evaluate the Immunogenicity and Safety of New Generation COVID-19 mRNA Booster Vaccination Against Emerging Variants of Concern (VOC)

Primary：Objectives ：SafetyTo describe the safetyprofile of all participants in each group up to 6months post-dose.Immunogenicity：To demonstrate the superiorityof neutralizing antibodyresponse in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine28 days post dose. Secondary:Immunogenicity
To describe binding antibodyprofile at D01,D08, D15, D29,D91 and D181 of eachstudy group.
To describe the neutralizing antibody profile atD08,D15,D91 and D181of 600 participants for each studyintervention group. Exploratory:Cell-mediated immunity To describe the cellular immuneresponse profile at D01, D08, D15and D29, in a subset of 30 participants for each study group.
Efficacy:To describe the occurrence of virologically-confirmed COVID-19 like illness and serologically confirmed SARS-CoV-2 infection.

Start Date01 Oct 2022

Sponsor / Collaborator

Stemirna Therapeutics Co., Ltd.

NCT05144139

/ CompletedPhase 1/2

A Phase I/II Clinical Trial to Evaluate the Safety, Immunogenicity and Immune Persistence of COVID-19 mRNA Vaccine in Healthy People Aged 18 Years and Above.

This clinical trial is a phase I/II clinical trial to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18 years and above.

Start Date03 Dec 2021

Sponsor / Collaborator

Stemirna Therapeutics Co., Ltd.

100 Clinical Results associated with COVID-19-mRNA Vaccine(Stemirna Therapeutics)

Login to view more data

100 Translational Medicine associated with COVID-19-mRNA Vaccine(Stemirna Therapeutics)

Login to view more data

100 Patents (Medical) associated with COVID-19-mRNA Vaccine(Stemirna Therapeutics)

Login to view more data

31

Literatures (Medical) associated with COVID-19-mRNA Vaccine(Stemirna Therapeutics)

01 Apr 2025·Infection

Syncopes, paresis and loss of vision after COVID-19 mRNA-based vaccination and SARS-CoV-2 infection

Article

Author: Vehreschild, Maria J G T ; Schüttfort, Gundolf ; Weirauch, Tobias

AbstractmRNA-based vaccines played a key role in fighting the global COVID-19 pandemic by saving millions of lives. In rare cases, however, the BNT162b2 vaccine has been associated with severe adverse reactions e.g. myocarditis (OE ratio 2.78; 95% CI 2.61; 2.95) [Faksova in Vaccine 42(9):2200-2211, 2024, https://doi.org/10.1016/j.vaccine.2024.01.100, Schwab in Clin Res Cardiol 112(3):431-440, 2022, https://doi.org/10.1007/s00392-022-02129-5]. Here, we describe the case of a 38-year-old man who developed a wide variety of long-term symptoms (fatigue, dizziness, palpitations with recurrent syncopes, paresthesia, paresis and fasciculations) following his first mRNA-based BNT162b2 COVID-19 vaccination. 143 days after vaccination, a subsequent COVID-19 infection was associated with exacerbation of paresis and a temporary loss of vision. After ruling out other causes and due to the immediate temporal association, an adverse reaction to vaccination appears likely. The fact that these symptoms worsened after a subsequent acute COVID 19 infection hints at the possibility of a common underlying pathophysiology. This case combines two clinical phenomena that have emerged during the COVID 19 pandemic, side effects associated with novel vaccines and Post-COVID Syndrome.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Allergy to PEG (polyethylene glycol) – sensitivity of basophil activation test with COVID-19 mRNA-vaccine BNT162B2

Article

Author: Brockow, Knut ; Eberlein, Bernadette ; Darsow, Ulf ; Biedermann, Tilo ; Mathes, Sonja

Basophil activation test (BAT) with COVID-19 mRNA vaccine seems particularly suitable for detecting sensitization to polyethylene glycol (PEG) in patients with PEG allergy. It was the aim of this study to determine the cutoffs for BAT using BNT162B2 (Comirnaty®) in a larger group of PEG allergic patients and controls. 10 PEG allergic patients and 10 controls were studied. BAT was performed using anti-CCR3 for basophil identification and anti-CD63 to assess basophil activation. Incubations with BNT162B2 at four different concentrations were performed. Basophil activation was significantly higher in PEG allergic patients compared to controls at the higher concentrations used. ROC curves showed best results with a sensitivity of 60% and specificity of 100% with a cutoff of 5% CD63⁺ basophils at a concentration of 4.5 µg/ml. Controls showed no positive results. In our group of PEG allergic patients, a concentration of 4.5 µg/ml BNT162B2 with a cutoff of 5% CD63⁺ basophils was the most suitable condition for identifying patients with a sensitization to PEG. Allergological work-up of PEG allergic patients including BAT with PEGylated lipid nanoparticles might play a role in the future when these substances will be used for other vaccines and cancer immunotherapies.

01 May 2024·Clinical Microbiology and Infection

Immunogenicity and safety of concomitant bivalent COVID-19 and quadrivalent influenza vaccination: implications of immune imprinting and interference

Article

Author: Cheong, Hee Jin ; Kim, Woo Joo ; Kim, Jae Won ; Lee, June-Woo ; Song, Joon Young ; Park, Se-Jin ; Shin, So Youn ; Ju, Hea Jeon ; Kim, Hwa Jung ; Kim, Byoungguk ; Gwak, WonSeok ; Yang, Yun-Jung ; Yoon, Sun Kyung ; Choi, Min Joo ; Kim, Chulwoo ; Yu, Young Jun

OBJECTIVESConcomitant COVID-19 and influenza vaccination would be an efficient strategy. Although the co-administration of monovalent COVID-19 and influenza vaccinations showed acceptable immunogenicity, it remains unknown whether the bivalent COVID-19 vaccine could intensify immune interference. We aimed to evaluate the immunogenicity and safety of concomitant BA.5-based bivalent COVID-19 and influenza vaccination.METHODSAn open-label, nonrandomized clinical trial was conducted for 154 age-matched and sex-matched healthy adults between October 2022 and December 2022. Participants received either a concomitant bivalent COVID-19 mRNA booster and quadrivalent influenza vaccination (group C) or separate vaccinations (group S) at least 4 weeks apart. Solicited and unsolicited adverse events were reported up to 6 months postvaccination. Immunogenicity was evaluated by anti-spike (S) IgG electrochemiluminescence immunoassay, focus reduction neutralization test, and hemagglutination inhibition assay.RESULTSGroup C did not meet the noninferiority criteria for the seroconversion rates of anti-S IgG and neutralizing antibodies against the wild-type SARS-CoV-2 strain compared with group S (44.2% vs. 46.8%, difference of -2.6% [95% CI, -18 to 13.4]; 44.2% vs. 57.1%, difference of -13.0% [95% CI to -28.9 to 2.9]). However, group C showed a stronger postvaccination neutralizing antibody response against Omicron BA.5 (72.7% vs. 64.9%). Postvaccination geometric mean titers for SARS-CoV-2 and influenza strains were similar between groups, except for influenza B/Victoria. Most adverse events were mild and comparable between the study groups.DISCUSSIONConcomitant administration of bivalent COVID-19 mRNA and quadrivalent influenza vaccines showed tolerable safety profiles and sufficient immunogenicity, particularly attenuating immune imprinting induced by previous ancestral vaccine strains.

100 Deals associated with COVID-19-mRNA Vaccine(Stemirna Therapeutics)

Login to view more data

R&D Status

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
COVID-19	Laos	Stemirna Therapeutics Co., Ltd.	08 Dec 2022

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NevroVAX (ECTRIMS2023)	Not Applicable	Multiple Sclerosis anti-CD20 therapy \| sphingosine-1-phosphate receptor modulators (S1PM)	5,545	mRNA-COVID-19 vaccines (People with multiple sclerosis (pwMS))	nxxqztyvtn(qftwtdxdgj) = uqnzwwhfvt xmwoakrqzi (nygrlzvhve ) View more	Positive	01 Oct 2023
				Anti-CD20 therapy	nxxqztyvtn(qftwtdxdgj) = wzmezrcjzl xmwoakrqzi (nygrlzvhve )