Preclinical evaluation of a plant-derived SARS-CoV-2 subunit vaccine: Protective efficacy, immunogenicity, safety, and toxicity
3
Issued Date
2022-07-30
Resource Type
ISSN
0264410X
eISSN
18732518
Scopus ID
2-s2.0-85131788460
Pubmed ID
35697573
Journal Title
Vaccine
Volume
40
Issue
32
Start Page
4440
End Page
4452
Rights Holder(s)
SCOPUS
Bibliographic Citation
Vaccine Vol.40 No.32 (2022) , 4440-4452
Suggested Citation
Shanmugaraj B., Khorattanakulchai N., Panapitakkul C., Malla A., Im-erbsin R., Inthawong M., Sunyakumthorn P., Hunsawong T., Klungthong C., Reed M.C., Kemthong T., Suttisan N., Malaivijitnond S., Srimangkornkaew P., Klinkhamhom A., Manopwisedjaroen S., Thitithanyanont A., Taychakhoonavudh S., Phoolcharoen W. Preclinical evaluation of a plant-derived SARS-CoV-2 subunit vaccine: Protective efficacy, immunogenicity, safety, and toxicity. Vaccine Vol.40 No.32 (2022) , 4440-4452. 4452. doi:10.1016/j.vaccine.2022.05.087 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/83669
Title
Preclinical evaluation of a plant-derived SARS-CoV-2 subunit vaccine: Protective efficacy, immunogenicity, safety, and toxicity
Author(s)
Other Contributor(s)
Abstract
Coronavirus disease 2019 (COVID-19) is an acute respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The prevention of SARS-CoV-2 transmission has become a global priority. Previously, we showed that a protein subunit vaccine that was developed based on the fusion of the SARS-CoV-2 receptor-binding domain (RBD) to the Fc portion of human IgG1 (RBD-Fc), produced in Nicotiana benthamiana, and adjuvanted with alum, namely, Baiya SARS-CoV-2 Vax 1, induced potent immunological responses in both mice and cynomolgus monkeys. Hence, this study evaluated the protective efficacy, safety, and toxicity of Baiya SARS-CoV-2 Vax 1 in K18-hACE2 mice, monkeys and Wistar rats. Two doses of vaccine were administered three weeks apart on Days 0 and 21. The administration of the vaccine to K18-hACE2 mice reduced viral loads in the lungs and brains of the vaccinated animals and protected the mice against challenge with SARS-CoV-2. In monkeys, the results of safety pharmacology tests, general clinical observations, and a core battery of studies of three vital systems, namely, the central nervous, cardiovascular, and respiratory systems, did not reveal any safety concerns. The toxicology study of the vaccine in rats showed no vaccine-related pathological changes, and all the animals remained healthy under the conditions of this study. Furthermore, the vaccine did not cause any abnormal toxicity in rats and was clinically tolerated even at the highest tested concentration. In addition, general health status, body temperature, local toxicity at the administration site, hematology, and blood chemistry parameters were also monitored. Overall, this work presents the results of the first systematic study of the safety profile of a plant-derived vaccine, Baiya SARS-CoV-2 Vax 1; this approach can be considered a viable strategy for the development of vaccines against COVID-19.