SWIM816 / China CDC, Tongji University, Stemirna Therap - LARVOL DELTA

Broad-spectrum Delta-BA.2 tandem-fused heterodimer mRNA vaccine delivered by lipopolyplex. (PubMed, PLoS Pathog) - "Here, based on a similar dimeric RBD design as our previous ZF2001 vaccine, we developed a novel broad-spectrum COVID-19 mRNA vaccine, SWIM516, with chimeric Delta-BA.2 RBD dimer delivered by lipopolyplex (LPP)...When challenged with Delta or Omicron live virus, vaccinated hACE2 transgenic mice and rhesus macaques were both protected, displaying significantly reduced viral loads and markedly relieved pathological damages. We believe the SWIM516 vaccine qualifies as a candidate for the next-generation broad-spectrum COVID-19 vaccine."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

An inoculation site-retained mRNA vaccine induces robust immune responses against SARS-CoV-2 variants. (PubMed, J Control Release) - "More importantly, the vaccine demonstrated a benign safety profile in non-human primates, with limited side effects after repeated treatment with high dosages of LPP/mRNA. Taken together, the inoculation site-retained vaccine formulation serves as a promising vehicle for mRNA vaccines and therapeutic agents."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, immunogenicity, and efficacy of a modified COVID-19 mRNA vaccine, SW-BIC-213, in healthy people aged 18 years and above: a phase 3 double-blinded, randomized, parallel controlled clinical trial in Lao PDR (Laos). (PubMed, EClinicalMedicine) - P3 | "A heterologous booster with the COVID-19 mRNA vaccine SW-BIC-213 manifests a favorable safety profile and proves highly immunogenic and efficacious in preventing symptomatic COVID-19 in individuals who have previously received two doses of inactivated vaccine. Shanghai Strategic Emerging Industries Development Special Fund, Biomedical Technology Support Special Project of Shanghai "Science and Technology Innovation Action Plan", Shanghai Municipal Science and Technology Commission."

Clinical • Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Soybean Oil-Derived Lipids for Efficient Mrna Delivery. (PubMed, Adv Mater) - "The rapid progress in the development of COVID-19 mRNA vaccines during the initial year of the pandemic has highlighted the significance of lipid nanoparticles in therapeutic delivery...Furthermore, we observed organ-specific targeting capabilities in certain formulations, and we demonstrated their outstanding performance in delivering Cre mRNA for gene editing. These results showcase the potential of soybean oil-derived lipids in mRNA delivery, offering utility across a broad spectrum of bioapplications."

Journal • Infectious Disease • Novel Coronavirus Disease • Oncology

mRNA vaccine in cancer therapy: Current advance and future outlook. (PubMed, Clin Transl Med) - "In the past 2 years, SARS-CoV-2 mRNA vaccines have contributed tremendously against SARS-CoV2, which has prompted the arrival of the mRNA vaccine research boom, especially in the research of cancer vaccines. Compared with conventional cancer vaccines, mRNA vaccines have significant advantages, including efficient production of protective immune responses, relatively low side effects and lower cost of acquisition. In this review, we elaborated on the development of cancer vaccines and mRNA cancer vaccines, as well as the potential biological mechanisms of mRNA cancer vaccines and the latest progress in various tumour treatments, and discussed the challenges and future directions for the field."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

A Phase II/III Study to Evaluate the Immunogenicity and Safety and Efficacy of SWIM816 Vaccines for SARS-CoV-2 (clinicaltrials.gov) - P2/3 | N=800 | Not yet recruiting | Sponsor: Stemirna Therapeutics

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trial. (PubMed, EBioMedicine) - "SW-BIC-213, a core-shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults."

Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

The Dose- and Time-Dependent Effectiveness and Safety Associated with COVID-19 Vaccination During Pregnancy: A Systematic Review and Meta-analysis. (PubMed, Int J Infect Dis) - "Our findings affirm that the effectiveness varies for different types of vaccines and is significantly and positively correlated with time in the pregnant population. COVID-19 vaccines have also been deemed safe for pregnant women. Thus, we developed a comprehensive understanding of the role of vaccines in pregnant women."

Journal • Retrospective data • Review • Fatigue • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Obstetrics • Postpartum Hemorrhage • Small for Gestational Age

A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above (clinicaltrials.gov) - P1/2 | N=480 | Completed | Sponsor: Stemirna Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above (clinicaltrials.gov) - P1/2 | N=640 | Active, not recruiting | Sponsor: Stemirna Therapeutics | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2022 ➔ Aug 2022

Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Single-cell transcriptome atlas reveals protective characteristics of COVID-19 mRNA vaccine. (PubMed, J Med Virol) - "Cell-cell interaction in the lung compartment was also altered by vaccination. These data collectively unravel the mechanisms by which the SW0123 protects against lung damage caused by SARS-CoV-2 infection."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Rational development of a combined mRNA vaccine against COVID-19 and influenza. (PubMed, NPJ Vaccines) - "Then, ARIAV was combined with our COVID-19 mRNA vaccine ARCoV, which encodes the receptor-binding domain (RBD) of the SARS-CoV-2 S protein, to formulate the final combined vaccine, AR-CoV/IAV. More importantly, AR-CoV/IAV immunization protected mice from coinfection with IAV and the SARS-CoV-2 Alpha and Delta variants. Our results highlight the potential of the LNP-mRNA vaccine platform in preventing COVID-19 and influenza, as well as other respiratory diseases."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above (clinicaltrials.gov) - P1/2 | N=640 | Recruiting | Sponsor: Stemirna Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

A Phase I/II Clinical Trial in Healthy People Aged 18 Years and Above (clinicaltrials.gov) - P1/2; N=640; Not yet recruiting; Sponsor: Stemirna Therapeutics

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Study of Ameliorating Effect of COVID-19 mRNA Vaccine in Individuals Immunized With Inactivated Vaccine (clinicaltrials.gov) - P=N/A; N=112; Not yet recruiting; Sponsor: Qihan Li

Clinical • New trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases