Trial reportWiener klinische Wochenschrift2021
Safety and immunogenicity of an mRNA-lipid nanoparticle vaccine candidate against SARS-CoV-2 : A phase 1 randomized clinical trial.
Trial report in Wiener klinische Wochenschrift, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 100 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
100 citing papers in PubMed, 6 syntheses or guidelines pooled it, 130 citations in OpenAlex.
- Immunogenicity and Protective Efficacy of Nucleic Acid-Based Vaccines Against COVID-19: A Systematic Review.Molecular biotechnology · 2024Pooled it
- Immunogenicity Characterization of COVID-19 Vaccines: A Systematic Review and Meta-analysis.Revista da Sociedade Brasileira de Medicina Tropical · 2023Pooled it
- Axes of social inequities in COVID-19 clinical trials: A systematic review.Frontiers in public health · 2023Pooled it
- Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis.BMC medicine · 2022Pooled it
- Adverse events following COVID-19 vaccination: A systematic review and meta-analysis.International immunopharmacology · 2022Pooled it
- Vaccines for COVID-19: A Systematic Review of Immunogenicity, Current Development, and Future Prospects.Frontiers in immunology · 2022Pooled it
- Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study.Human vaccines & immunotherapeutics · 2024Trial
- Trial
- A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults.Clinical and translational medicine · 2022Trial
- Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial.The Lancet. Infectious diseases · 2022Trial
- Distinct neutralization profile of spike variants by antibodies induced upon SARS-CoV-2 infection or vaccination.American journal of hematology · 2022Trial
- Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1-2, dose-ranging study.The Lancet. Infectious diseases · 2021Trial
- Genetic Code Expansion Enables Oriented, Site-Specific Conjugation of DARPins to Lipid Nanoparticles for Selective mRNA Delivery to CD8International journal of molecular sciences · 2026Article
- Bipolar CD4-targeted dual-DARPin-55/57 lipid nanoparticle enables efficient CRISPR/Cas-mediated HIV-1 DNA excision and reactivation blockade in latent CD4 T cell lines.Materials today. Bio · 2026Article
- A novel gene therapy platform for the treatment of type 2 diabetes and obesity.Molecular therapy. Nucleic acids · 2025Article
- Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025Review
- Strong immunogenicity and protection against SARS-CoV-2 in hamsters induced by heterologous boost vaccination with an MVA-based COVID-19 vaccine candidate.The Journal of general virology · 2025Article
- Health Technology Assessment of mRNA Vaccines: Clinical, Economic, and Public Health Implications.Vaccines · 2025Review
- The Nanocarrier Landscape─Evaluating Key Drug Delivery Vehicles and Their Capabilities: A Translational Perspective.ACS applied materials & interfaces · 2025Review
- Next-Generation Vaccine Platforms: Integrating Synthetic Biology, Nanotechnology, and Systems Immunology for Improved Immunogenicity.Vaccines · 2025Review
40 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe used the RNActive® technology platform (CureVac N.V., Tübingen, Germany) to prepare CVnCoV, a COVID-19 vaccine containing sequence-optimized mRNA coding for a stabilized form of SARS-CoV‑2 spike (S) protein encapsulated in lipid nanoparticles (LNP).
methodsThis is an interim analysis of a dosage escalation phase 1 study in healthy 18-60-year-old volunteers in Hannover, Munich and Tübingen, Germany, and Ghent, Belgium. After giving 2 intramuscular doses of CVnCoV or placebo 28 days apart we assessed solicited local and systemic adverse events (AE) for 7 days and unsolicited AEs for 28 days after each vaccination. Immunogenicity was measured as enzyme-linked immunosorbent assay (ELISA) IgG antibodies to SARS-CoV‑2 S‑protein and receptor binding domain (RBD), and SARS-CoV‑2 neutralizing titers (MN
resultsIn 245 volunteers who received 2 CVnCoV vaccinations (2 μg, n = 47, 4 μg, n = 48, 6 μg, n = 46, 8 μg, n = 44, 12 μg, n = 28) or placebo (n = 32) there were no vaccine-related serious AEs. Dosage-dependent increases in frequency and severity of solicited systemic AEs, and to a lesser extent local AEs, were mainly mild or moderate and transient in duration. Dosage-dependent increases in IgG antibodies to S‑protein and RBD and MN
conclusionIn this study 2 CVnCoV doses were safe, with acceptable reactogenicity and 12 μg dosages elicited levels of immune responses that overlapped those observed in convalescent sera.
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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.