Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant
Issued Date
2023-04-24
Resource Type
ISSN
0264410X
eISSN
18732518
Scopus ID
2-s2.0-85151419515
Pubmed ID
36963999
Journal Title
Vaccine
Volume
41
Issue
17
Start Page
2781
End Page
2792
Rights Holder(s)
SCOPUS
Bibliographic Citation
Vaccine Vol.41 No.17 (2023) , 2781-2792
Suggested Citation
Phoolcharoen W., Shanmugaraj B., Khorattanakulchai N., Sunyakumthorn P., Pichyangkul S., Taepavarapruk P., Praserthsee W., Malaivijitnond S., Manopwisedjaroen S., Thitithanyanont A., Srisutthisamphan K., Jongkaewwattana A., Tomai M., Fox C.B., Taychakhoonavudh S. Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant. Vaccine Vol.41 No.17 (2023) , 2781-2792. 2792. doi:10.1016/j.vaccine.2023.03.027 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/81361
Title
Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant
Other Contributor(s)
Abstract
Cost-effective, and accessible vaccines are needed for mass immunization to control the ongoing coronavirus disease 2019 (COVID-19), especially in low- and middle-income countries (LMIC). A plant-based vaccine is an attractive technology platform since the recombinant proteins can be easily produced at large scale and low cost. For the recombinant subunit-based vaccines, effective adjuvants are crucial to enhance the magnitude and breadth of immune responses elicited by the vaccine. In this study, we report a preclinical evaluation of the immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052 (TLR7/8 agonist)-Alum adjuvant. This vaccine formulation, named Baiya SARS-CoV-2 Vax 2, induced significant levels of RBD-specific IgG and neutralizing antibody responses in mice. A viral challenge study using humanized K18-hACE2 mice has shown that animals vaccinated with two doses of Baiya SARS-CoV-2 Vax 2 established immune protection against SARS-CoV-2. A study in nonhuman primates (cynomolgus monkeys) indicated that immunization with two doses of Baiya SARS-CoV-2 Vax 2 was safe, well tolerated, and induced neutralizing antibodies against the prototype virus and other viral variants (Alpha, Beta, Gamma, Delta, and Omicron subvariants). The toxicity of Baiya SARS-CoV-2 Vax 2 was further investigated in Jcl:SD rats, which demonstrated that a single dose and repeated doses of Baiya SARS-CoV-2 Vax 2 were well tolerated and no mortality or unanticipated findings were observed. Overall, these preclinical findings support further clinical development of Baiya SARS-CoV-2 Vax 2.