Preclinical evaluation of a plant-derived SARS-CoV-2 subunit vaccine: Protective efficacy, immunogenicity, safety, and toxicity
Vaccine·
- DOI
- 10.1016/j.vaccine.2022.05.087
- PMID
- 35697573
- PMCID
- PMC9167921
- OpenAlex
- W4282031643
- Study type
- Journal article
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
The study presents preclinical evidence for a plant-based vaccine platform that demonstrated protective immunity and acceptable safety in animal models, suggesting potential applicability for COVID-19 vaccine development.
Structured evidence summary
Research question
This study evaluated the protective efficacy, safety, and toxicity of a plant-derived protein subunit vaccine (Baiya SARS-CoV-2 Vax 1) in preclinical models.
Study design
A preclinical study evaluated a two-dose vaccine regimen (administered on Days 0 and 21) across K18-hACE2 mice, cynomolgus monkeys, and Wistar rats, assessing protective efficacy, safety pharmacology, and toxicology.
Population and setting
Experimental animal models including K18-hACE2 mice (for challenge and protective efficacy assessment), cynomolgus monkeys (for safety pharmacology), and Wistar rats (for toxicology evaluation) were used.
Main findings
In K18-hACE2 mice, two vaccine doses reduced SARS-CoV-2 viral loads in lungs and brains and protected against viral challenge. In monkeys, safety pharmacology testing of the central nervous, cardiovascular, and respiratory systems revealed no safety concerns. In rats, toxicology assessment showed no vaccine-related pathological changes, with healthy outcomes and clinical tolerance even at the highest tested concentration.
Public-health relevance
The study presents preclinical evidence for a plant-based vaccine platform that demonstrated protective immunity and acceptable safety in animal models, suggesting potential applicability for COVID-19 vaccine development.
Important limitations
This summary is limited to the supplied single-article abstract and metadata; the original full text is required for decision-grade interpretation. The study reports preclinical animal data only, without human clinical trial evidence, and specific details on population demographics or study setting are not available in the abstract.
GIDS interpretation
This article describes preclinical vaccine research and is catalogued under vaccination, SARS, and COVID-19 topics. No surveillance signal connection is established or inferred from this evidence alone.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 10 auditable classifier relationships to diseases, places, topics, and study design.