ArticleVaccines2023
Toxicological Assessments of a Pandemic COVID-19 Vaccine-Demonstrating the Suitability of a Platform Approach for mRNA Vaccines.
Article in Vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 34 citations in OpenAlex.
- Toxicological evaluation of a synthetic QS-21 adjuvant in a tuberculosis vaccine candidate-Demonstrating safety and immunological equivalence to natural reference.Human vaccines & immunotherapeutics · 2026Article
- mRNA-based tuberculosis vaccines BNT164a1 and BNT164b1 are immunogenic, well tolerated and efficacious in rodent models.Nature immunology · 2026Article
- Comparative analysis of expression, immunogenicity, and safety profiles between linear and circular RNA vaccine platforms.Molecular therapy. Nucleic acids · 2026Article
- Preclinical evaluation of an mRNA vaccine developed from the first human isolate of bovine H5N1.Cell reports. Medicine · 2026Article
- Innovative design and comprehensive characterization of a valine-enhanced lipid nanoparticle-coated mRNA vaccine targeting the SARS-CoV-2 S-RBD antigen.Scientific reports · 2025Article
- Synergistic effect of nucleoside modification and ionizable lipid composition on translation and immune responses to mRNA vaccines.NPJ vaccines · 2025Article
- Article
- Preclinical toxicological assessment of an α-galactosylceramide-adjuvanted mRNA cancer vaccine in Wistar Han rats and domestic pigs.Molecular therapy. Methods & clinical development · 2025Article
- A Similar Nonclinical Safety Evaluation of Prev(e)nar 13 in a Multi-Dose Formulation Containing the Preservative 2-Phenoxyethanol.Vaccines · 2025Article
- Impact of administration routes and dose frequency on the toxicology of SARS-CoV-2 mRNA vaccines in mice model.Archives of toxicology · 2025Article
- Technological breakthroughs and advancements in the application of mRNA vaccines: a comprehensive exploration and future prospects.Frontiers in immunology · 2025Review
- Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data.Human vaccines & immunotherapeutics · 2024Review
- Favorable Nonclinical Safety Profile of RSVpreF Bivalent Vaccine in Rats and Rabbits.Vaccines · 2024Article
- Session 4: mRNA and Self-Amplifying RNA (saRNA): Opportunities for Disease Prevention and Therapy.Toxicologic pathology · 2024Article
- Preclinical immunogenicity and safety of hemagglutinin-encoding modRNA influenza vaccines.NPJ vaccines · 2024Article
- Toxicologic Pathology Forum: mRNA Vaccine Safety-Separating Fact From Fiction.Toxicologic pathology · 2024Article
- Lipid Nanoparticle (LNP) Delivery Carrier-Assisted Targeted Controlled Release mRNA Vaccines in Tumor Immunity.Vaccines · 2024Review
- Global research on RNA vaccines for COVID-19 from 2019 to 2023: a bibliometric analysis.Frontiers in immunology · 2024Article
- Review
- Editorial: Immunological aspects of vaccine safety.Frontiers in immunology · 2023Article
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 2 countries.
Funding
Abstract
The emergence of SARS-CoV-2 at the end of 2019 required the swift development of a vaccine to address the pandemic. Nonclinical GLP-compliant studies in Wistar Han rats were initiated to assess the local tolerance, systemic toxicity, and immune response to four mRNA vaccine candidates encoding immunogens derived from the spike (S) glycoprotein of SARS-CoV-2, encapsulated in lipid nanoparticles (LNPs). Vaccine candidates were administered intramuscularly once weekly for three doses at 30 and/or 100 µg followed by a 3-week recovery period. Clinical pathology findings included higher white blood cell counts and acute phase reactant concentrations, lower platelet and reticulocyte counts, and lower RBC parameters. Microscopically, there was increased cellularity (lymphocytes) in the lymph nodes and spleen, increased hematopoiesis in the bone marrow and spleen, acute inflammation and edema at the injection site, and minimal hepatocellular vacuolation. These findings were generally attributed to the anticipated immune and inflammatory responses to the vaccines, except for hepatocyte vacuolation, which was interpreted to reflect hepatocyte LNP lipid uptake, was similar between candidates and resolved or partially recovered at the end of the recovery phase. These studies demonstrated safety and tolerability in rats, supporting SARS-CoV-2 mRNA-LNP vaccine clinical development.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.