Preclinical evaluation of immunogenicity,efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant |
| |
| Institution: | 1. Center of Excellence in Plant-produced Pharmaceuticals, Chulalongkorn University, Bangkok 10330, Thailand;2. Department of Pharmacognosy and Pharmaceutical Botany, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10330, Thailand;3. Baiya Phytopharm Co., Ltd, Bangkok 10330, Thailand;4. US Armed Forces Research Institute of Medical Sciences, Bangkok 10400, Thailand;5. Center for Animal Research and Department of Physiology, Faculty of Medical Science, Naresuan University, Pitsanulok 65000, Thailand;6. Center for Animal Research, Naresuan University, Pitsanulok 65000, Thailand;7. National Primate Research Center of Thailand-Chulalongkorn University, Saraburi 18110, Thailand;8. Department of Microbiology, Faculty of Science, Mahidol University, Bangkok 10400, Thailand;9. Virology and Cell Technology Laboratory, National Center for Genetic Engineering and Biotechnology (BIOTEC), National Science and Technology Development Agency, Pathumthani, Thailand;10. 3M Healthcare, 3M Center, Bldg 270-4N-04, St. Paul, MN 55144-1000, USA;11. Access to Advanced Health Institute (AAHI), 1616 Eastlake Ave E, Ste 400, Seattle, WA 98102, USA;12. Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10330, Thailand |
| |
| 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. |
| |
| Keywords: | COVID-19 SARS-CoV-2 Plant-produced subunit vaccine Receptor binding domain Neutralizing antibody |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
