tetano
Editor, Senior Moderator
Vaccine
. 2023 Mar 21;S0264-410X(23)00312-2.
doi: 10.1016/j.vaccine.2023.03.027. Online ahead of print.
Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant
Waranyoo Phoolcharoen[SUP] 1 [/SUP], Balamurugan Shanmugaraj[SUP] 2 [/SUP], Narach Khorattanakulchai[SUP] 3 [/SUP], Piyanate Sunyakumthorn[SUP] 4 [/SUP], Sathit Pichyangkul[SUP] 4 [/SUP], Pornnarin Taepavarapruk[SUP] 5 [/SUP], Wanlapa Praserthsee[SUP] 6 [/SUP], Suchinda Malaivijitnond[SUP] 7 [/SUP], Suwimon Manopwisedjaroen[SUP] 8 [/SUP], Arunee Thitithanyanont[SUP] 8 [/SUP], Kanjana Srisutthisamphan[SUP] 9 [/SUP], Anan Jongkaewwattana[SUP] 9 [/SUP], Mark Tomai[SUP] 10 [/SUP], Christopher B Fox[SUP] 11 [/SUP], Suthira Taychakhoonavudh[SUP] 12 [/SUP]
Affiliations
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; Neutralizing antibody; Nicotiana benthamiana; Plant-produced subunit vaccine; Receptor binding domain; SARS-CoV-2.
. 2023 Mar 21;S0264-410X(23)00312-2.
doi: 10.1016/j.vaccine.2023.03.027. Online ahead of print.
Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant
Waranyoo Phoolcharoen[SUP] 1 [/SUP], Balamurugan Shanmugaraj[SUP] 2 [/SUP], Narach Khorattanakulchai[SUP] 3 [/SUP], Piyanate Sunyakumthorn[SUP] 4 [/SUP], Sathit Pichyangkul[SUP] 4 [/SUP], Pornnarin Taepavarapruk[SUP] 5 [/SUP], Wanlapa Praserthsee[SUP] 6 [/SUP], Suchinda Malaivijitnond[SUP] 7 [/SUP], Suwimon Manopwisedjaroen[SUP] 8 [/SUP], Arunee Thitithanyanont[SUP] 8 [/SUP], Kanjana Srisutthisamphan[SUP] 9 [/SUP], Anan Jongkaewwattana[SUP] 9 [/SUP], Mark Tomai[SUP] 10 [/SUP], Christopher B Fox[SUP] 11 [/SUP], Suthira Taychakhoonavudh[SUP] 12 [/SUP]
Affiliations
- PMID: 36963999
- PMCID: PMC10027959
- DOI: 10.1016/j.vaccine.2023.03.027
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; Neutralizing antibody; Nicotiana benthamiana; Plant-produced subunit vaccine; Receptor binding domain; SARS-CoV-2.