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)

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Target

SARS-CoV-2 S protein

Mechanism

SARS-CoV-2 S protein inhibitors(Coronavirus spike glycoprotein inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19

Inactive Indication-

Originator Organization

Stemirna Therapeutics Co., Ltd.Startup

Active Organization

Stemirna Therapeutics Co., Ltd.Startup

Inactive Organization

Shanghai East Hospital

Drug Highest PhaseApproved

First Approval Date

LA (08 Dec 2022),

COVID-19

RegulationEmergency Use Authorization (LA)

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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:
To describe binding antibody profile at D01, D29 and D181 of each study group.
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.Startup

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.Startup

ChiCTR2100047917 / RecruitingPhase 1IIT

Comprehensive evaluations of dynamic changes in the immune system of healthy volunteers with sequential vaccination of inactivated Novel Coronavirus Pneumonia vaccine (Vero cells) followed by Novel Coronavirus Pneumonia mRNA vaccine (DF104B1)

Start Date21 Jun 2021

Sponsor / Collaborator

Shanghai East Hospital

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

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

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

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65

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

31 Dec 2024·Human Vaccines & Immunotherapeutics

No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial

Article

Author: Miller, Jacqueline ; Naficy, Abdi ; Seifert, Harry ; Mwakingwe-Omari, Agnes ; Hastie, Andrew ; Leav, Brett ; Anteyi, Kate ; Kuxhausen, Adrienne

The objective of the study was to assess the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV). This was a phase 3, randomized, open-label study. Eligible adults aged ≥ 18 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and QIV 2 weeks apart (Seq group) or concomitantly (Coad group). Primary objectives were non-inferiority of haemagglutinin inhibition (HI) and anti-Spike protein antibody responses in the Coad compared to Seq group. 497/498 participants were randomized and vaccinated in the Seq/Coad groups, respectively. The adjusted geometric mean titer/concentration ratios (95% confidence intervals) (Seq/Coad) for HI antibodies were 1.02 (0.89-1.18) for A/H1N1, 0.93 (0.82-1.05) for A/H3N2, 1.00 (0.89-1.14] for B/Victoria, and 1.04 (0.93-1.17) for B/Yamagata; and 0.98 (0.84-1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. The most frequently reported adverse events in both groups were pain at the injection site and myalgia. The 2 groups were similar in terms of the overall frequency, intensity, and duration of adverse events. In conclusion, co-administration of mRNA-1273 booster vaccine with QIV in adults was immunologically non-inferior to sequential administration. Safety and reactogenicity profiles were similar in both groups (clinicaltrials.gov NCT05047770).

01 Oct 2024·Seizure: European Journal of Epilepsy

Status epilepticus as a complication of SARS-CoV-2 vaccination: Two case reports and systematic review with individual patients’ data analysis

Review

Author: Evangelista, Giacomo ; Quintieri, Paolo ; Liviello, Davide ; Sensi, Stefano L ; Cipollone, Sara ; Dasara, Michelangelo ; Tomassini, Valentina ; Dono, Fedele

INTRODUCTIONStatus Epilepticus (SE) stands as a prominent neurological emergency, showing a mortality rate of approximately 20%. Since February 2021, a worldwide vaccination campaign has been launched against the Coronavirus 19 disease (COVID-19) pandemic. Several possible vaccine-related adverse events have been identified, including neurological manifestations. SE is beginning to surface in literature as an emergent condition in COVID-19-vaccinated individuals, though defined reasons accounting for this correlation are still missing.METHODSWe report two cases of SE related to the SARS-CoV-2 vaccine. In addition, we performed a systematic search of the literature to identify the consistency of the association between the SARS-CoV-2 vaccine and the SE onset. The following databases were consulted: PubMed and Google Scholar.RESULTSTwo novel super-refractory status epilepticus (SRSE) cases associated with the BNT162b2 mRNA COVID-19 vaccine were identified. Both patients received the second dose of the vaccine about 14 days prior to SE onset. Patients showed a non-convulsive semiology and were treated with a combined anesthetic and immunomodulant therapy, leading to SE resolution in both cases. The literature review identified seven additional cases, primarily non-convulsive SE. Four patients received the Spikevax (ex-COVID-19 Moderna mRNA -1273 vaccine), 2 patients the BNT162b2 (Pfizer/Biotech), and 1 patient the ChAdOx1-s (AstraZeneca) vaccine. The first vaccine dose (5/7, 71.4%) emerged as the most frequently associated with SE onset, which manifested at an average of 4.5 days (± 3.4) following vaccination. Five patients presented RSE and required continuous intravenous anesthetic drug administration. Resolution of SE was achieved in all cases.CONCLUSIONSStatus Epilepticus is a rare complication associated with Sars-CoV-2 vaccines. Additional studies are needed to ascertain the potential association between Sars-CoV-2 vaccines and status epilepticus.

01 Mar 2024·Clinical Microbiology and Infection

Intradermal delivery of the third dose of the mRNA-1273 SARS-CoV-2 vaccine: safety and immunogenicity of a fractional booster dose

Article

Author: Jochems, Simon P ; Rosendaal, Frits R ; Roukens, Anna H E ; Kuijer, Marjan ; Roestenberg, Meta ; Kikkert, Marjolein ; Visser, Leo G ; de Gruyter, Heidi L M ; Lamers, Olivia A C ; Prins, Manon L M ; Hartog, Gerco den ; Feltkamp, Mariet C W ; Janse, Jacqueline J ; Huisman, Wesley ; van Binnendijk, Rob S ; Prins, Corine ; Myeni, Sebenzile K ; Koopman, Jan Pieter R ; Roozen, Geert V T ; Pothast, Cilia R ; Heemskerk, Mirjam H M

OBJECTIVESThe aim of this study was to assess the safety and immunogenicity of a dose-sparing fractional intradermal (ID) booster strategy with the mRNA-1273 COVID-19 vaccine.METHODSCOVID-19 naive adults aged 18-30 years were recruited from a previous study on primary vaccination regimens that compared 20 μg ID vaccinations with 100 μg intramuscular (IM) vaccinations with mRNA-1273 as the primary vaccination series. Participants previously immunized with ID regimens were randomly assigned (1:1) to receive a fractional ID booster dose (20 μg) or the standard-of-care intramuscular (IM) booster dose (50 μg) of the mRNA-1273 vaccine, 6 months after completing their primary series (ID-ID and ID-IM group, respectively). Participants that had received a full dose IM regimen as the primary series, received the IM standard-of-care booster dose (IM-IM group). In addition, COVID-19 naive individuals aged 18-40 years who had received an IM mRNA vaccine as the primary series were recruited from the general population to receive a fractional ID booster dose (IM-ID group). Immunogenicity was assessed using IgG anti-spike antibody responses and neutralizing capacity against SARS-CoV-2. Cellular immune responses were measured in a sub-group. Safety and tolerability were monitored.RESULTSIn January 2022, 129 participants were included in the study. Fractional ID boosting was safe and well tolerated, with fewer systemic adverse events compared with IM boosting. At day 28 post-booster, anti-spike S1 IgG geometric mean concentrations were 9106 (95% CI, 7150-11 597) binding antibody units (BAU)/mL in the IM-IM group and 4357 (3003-6322) BAU/mL; 6629 (4913-8946) BAU/mL; and 5264 (4032-6873) BAU/mL in the ID-IM, ID-ID, and IM-ID groups, respectively.DISCUSSIONIntradermal boosting provides robust immune responses and is a viable dose-sparing strategy for mRNA COVID-19 vaccines. The favourable side-effect profile supports its potential to reduce vaccine hesitancy. Fractional dosing strategies should be considered early in the clinical development of future mRNA vaccines to enhance vaccine availability and pandemic preparedness.

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

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R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Preclinical	CN	Stemirna Therapeutics Co., Ltd.Startup	29 Nov 2021
COVID-19	Preclinical	CN	Shanghai East Hospital	29 Nov 2021

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Clinical Result

Indication

Phase

Evaluation

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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	cbxvaqyzkk(savrfpxjrj) = nugjzvxlzz jtrksgjqsk (ppeqgqvxsg ) View more	Positive	01 Oct 2023
				Anti-CD20 therapy	cbxvaqyzkk(savrfpxjrj) = cadqkshesg jtrksgjqsk (ppeqgqvxsg )
ESMO2021	Not Applicable	Neoplasms	-	COVID-19 mRNA vaccines (Patients without cancer)	izzmgkygtd(dxpflyqspl) = zigcjtisil efzdwuwmmb (fvdiftfhte )	-	16 Sep 2021
				COVID-19 mRNA vaccines (Patients with cancer)	izzmgkygtd(dxpflyqspl) = obnfeqrvah efzdwuwmmb (fvdiftfhte )