Trial reportNature medicine2021
Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19.
Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04450004 (A Randomized, Partially-Blinded, Dose-Ranging Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID 19 Vaccine in Adults 18-55 Years of Age), which is not on this map. Cited by 202 papers, 7 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.
A Randomized, Partially-Blinded, Dose-Ranging Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID 19 Vaccine in Adults 18-55 Years of Age
Who cites it
202 citing papers in PubMed, 7 syntheses or guidelines pooled it, 308 citations in OpenAlex.
- Tobacco-Based Vaccines, Hopes, and Concerns: A Systematic Review.Molecular biotechnology · 2023Pooled it
- Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022Pooled it
- Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis.BMC medicine · 2022Pooled it
- Immunologic response, Efficacy, and Safety of Vaccines against COVID-19 Infection in Healthy and immunosuppressed Children and Adolescents Aged 2 - 21 years old: A Systematic Review and Meta-analysis.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2022Pooled it
- A systematic review on mucocutaneous presentations after COVID-19 vaccination and expert recommendations about vaccination of important immune-mediated dermatologic disorders.Dermatologic therapy · 2022Pooled it
- Immunogenicity and Safety of the COVID-19 Vaccines Compared With Control in Healthy Adults: A Qualitative and Systematic Review.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2022Pooled it
- Headache onset after vaccination against SARS-CoV-2: a systematic literature review and meta-analysis.The journal of headache and pain · 2022Pooled it
- Comparable safety and non-inferior immunogenicity of the SARS-CoV-2 mRNA vaccine candidate PTX-COVID19-B and BNT162b2 in a phase 2 randomized, observer-blinded study.Scientific reports · 2024Trial
- Durability and cross-reactivity of immune responses induced by a plant-based virus-like particle vaccine for COVID-19.Nature communications · 2022Trial
- Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine.The New England journal of medicine · 2022Trial
- Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study.The Lancet. Infectious diseases · 2022Trial
- A randomized, double-blind, placebo-controlled, dose-escalating phase I trial to evaluate safety and immunogenicity of a plant-produced, bivalent, recombinant norovirus-like particle vaccine.Frontiers in immunology · 2022Trial
- Tonoplast-Localized ABCC Transporters Enhance Heterologous Production of the Antidiabetic Montbretin A and Its Analogues in Nicotiana benthamiana.Plant biotechnology journal · 2026Article
- Plant-based production and characterization of monoclonal antibodies targeting extracellular enveloped proteins of the Mpox Virus.Biotechnology reports (Amsterdam, Netherlands) · 2026Article
- Review
- Bacteriophage P22 Virus-Like Particles as Nanoscale Protein Scaffolds for Plant Synthetic Biology.Plant biotechnology journal · 2026Article
- Polyphenol oxidase depletion in Nicotiana benthamiana enhances recombinant protein purification and preserves native protein integrity.The New phytologist · 2026Article
- Plant-Based Production of Human Major Histocompatibility Complex Class II Molecules.Plant biotechnology journal · 2026Article
- Rational design of an optimized ferritin nanoparticle vaccine targeting both SARS-CoV-2 and MERS-CoV.Journal of nanobiotechnology · 2026Article
- A decoy virus strategy using plant-produced SARS-CoV-2 virus-like-particles to inhibit infection and lung injury.Journal of translational medicine · 2026Article
142 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
19 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Several severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are being deployed, but the global need greatly exceeds the supply, and different formulations might be required for specific populations. Here we report Day 42 interim safety and immunogenicity data from an observer-blinded, dose escalation, randomized controlled study of a virus-like particle vaccine candidate produced in plants that displays the SARS-CoV-2 spike glycoprotein (CoVLP: NCT04450004 ). The co-primary outcomes were the short-term tolerability/safety and immunogenicity of CoVLP formulations assessed by neutralizing antibody (NAb) and cellular responses. Secondary outcomes in this ongoing study include safety and immunogenicity assessments up to 12 months after vaccination. Adults (18-55 years, n = 180) were randomized at two sites in Quebec, Canada, to receive two intramuscular doses of CoVLP (3.75 μg, 7.5 μg, and 15 μg) 21 d apart, alone or adjuvanted with AS03 or CpG1018. All formulations were well tolerated, and adverse events after vaccination were generally mild to moderate, transient and highest in the adjuvanted groups. There was no CoVLP dose effect on serum NAbs, but titers increased significantly with both adjuvants. After the second dose, NAbs in the CoVLP + AS03 groups were more than tenfold higher than titers in Coronavirus 2019 convalescent sera. Both spike protein-specific interferon-γ and interleukin-4 cellular responses were also induced. This pre-specified interim analysis supports further evaluation of the CoVLP vaccine candidate.
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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.