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Vaccine . Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant

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  • Vaccine . Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant


    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 1 , Balamurugan Shanmugaraj 2 , Narach Khorattanakulchai 3 , Piyanate Sunyakumthorn 4 , Sathit Pichyangkul 4 , Pornnarin Taepavarapruk 5 , Wanlapa Praserthsee 6 , Suchinda Malaivijitnond 7 , Suwimon Manopwisedjaroen 8 , Arunee Thitithanyanont 8 , Kanjana Srisutthisamphan 9 , Anan Jongkaewwattana 9 , Mark Tomai 10 , Christopher B Fox 11 , Suthira Taychakhoonavudh 12



    AffiliationsFree PMC article

    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.

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