Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant
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...
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| Veröffentlicht in: | Vaccine 2023-04, Vol.41 (17), p.2781-2792 |
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| creator | Phoolcharoen, Waranyoo Shanmugaraj, Balamurugan Khorattanakulchai, Narach Sunyakumthorn, Piyanate Pichyangkul, Sathit Taepavarapruk, Pornnarin Praserthsee, Wanlapa Malaivijitnond, Suchinda Manopwisedjaroen, Suwimon Thitithanyanont, Arunee Srisutthisamphan, Kanjana Jongkaewwattana, Anan Tomai, Mark Fox, Christopher B. Taychakhoonavudh, Suthira |
| description | 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. |
| doi_str_mv | 10.1016/j.vaccine.2023.03.027 |
| format | Article |
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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.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2023.03.027</identifier><identifier>PMID: 36963999</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adjuvants ; Adjuvants, Immunologic ; Aluminum ; Aluminum Hydroxide ; Animal welfare ; Animals ; Antibodies ; Antibodies, Neutralizing ; Antibodies, Viral ; Clinical trials ; Coronaviruses ; COVID-19 ; COVID-19 - prevention & control ; COVID-19 vaccines ; Cytokines ; Disease control ; Effectiveness ; Immune response ; Immunization ; Immunogenicity ; Immunogenicity, Vaccine ; Immunoglobulin G ; Laboratory animals ; Macaca fascicularis ; Mice ; Monkeys & apes ; Neutralizing ; Neutralizing antibody ; Nicotiana benthamiana ; Pandemics ; Peptides ; Pharmacology ; Plant-produced subunit vaccine ; Proteins ; Rats ; Rats, Sprague-Dawley ; Receptor binding domain ; Safety ; SARS-CoV-2 ; Severe acute respiratory syndrome coronavirus 2 ; Spike Glycoprotein, Coronavirus - genetics ; TLR7 protein ; Toll-like receptors ; Toxicity ; Toxicology ; Vaccines ; Viral diseases</subject><ispartof>Vaccine, 2023-04, Vol.41 (17), p.2781-2792</ispartof><rights>2023 Elsevier Ltd</rights><rights>Copyright © 2023 Elsevier Ltd. All rights reserved.</rights><rights>2023. Elsevier Ltd</rights><rights>2023 Elsevier Ltd. All rights reserved. 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c496t-ae9fa3bbfc919629f0dd3d3b5daea68d0d3f5539cd3fc760831099693ed396753</citedby><cites>FETCH-LOGICAL-c496t-ae9fa3bbfc919629f0dd3d3b5daea68d0d3f5539cd3fc760831099693ed396753</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2801564420?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>230,314,780,784,885,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36963999$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Phoolcharoen, Waranyoo</creatorcontrib><creatorcontrib>Shanmugaraj, Balamurugan</creatorcontrib><creatorcontrib>Khorattanakulchai, Narach</creatorcontrib><creatorcontrib>Sunyakumthorn, Piyanate</creatorcontrib><creatorcontrib>Pichyangkul, Sathit</creatorcontrib><creatorcontrib>Taepavarapruk, Pornnarin</creatorcontrib><creatorcontrib>Praserthsee, Wanlapa</creatorcontrib><creatorcontrib>Malaivijitnond, Suchinda</creatorcontrib><creatorcontrib>Manopwisedjaroen, Suwimon</creatorcontrib><creatorcontrib>Thitithanyanont, Arunee</creatorcontrib><creatorcontrib>Srisutthisamphan, Kanjana</creatorcontrib><creatorcontrib>Jongkaewwattana, Anan</creatorcontrib><creatorcontrib>Tomai, Mark</creatorcontrib><creatorcontrib>Fox, Christopher B.</creatorcontrib><creatorcontrib>Taychakhoonavudh, Suthira</creatorcontrib><title>Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>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. 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apes</subject><subject>Neutralizing</subject><subject>Neutralizing antibody</subject><subject>Nicotiana benthamiana</subject><subject>Pandemics</subject><subject>Peptides</subject><subject>Pharmacology</subject><subject>Plant-produced subunit vaccine</subject><subject>Proteins</subject><subject>Rats</subject><subject>Rats, Sprague-Dawley</subject><subject>Receptor binding domain</subject><subject>Safety</subject><subject>SARS-CoV-2</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Spike Glycoprotein, Coronavirus - genetics</subject><subject>TLR7 protein</subject><subject>Toll-like receptors</subject><subject>Toxicity</subject><subject>Toxicology</subject><subject>Vaccines</subject><subject>Viral 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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.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>36963999</pmid><doi>10.1016/j.vaccine.2023.03.027</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2023-04, Vol.41 (17), p.2781-2792 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10027959 |
| source | MEDLINE; ScienceDirect Journals (5 years ago - present); ProQuest Central UK/Ireland |
| subjects | Adjuvants Adjuvants, Immunologic Aluminum Aluminum Hydroxide Animal welfare Animals Antibodies Antibodies, Neutralizing Antibodies, Viral Clinical trials Coronaviruses COVID-19 COVID-19 - prevention & control COVID-19 vaccines Cytokines Disease control Effectiveness Immune response Immunization Immunogenicity Immunogenicity, Vaccine Immunoglobulin G Laboratory animals Macaca fascicularis Mice Monkeys & apes Neutralizing Neutralizing antibody Nicotiana benthamiana Pandemics Peptides Pharmacology Plant-produced subunit vaccine Proteins Rats Rats, Sprague-Dawley Receptor binding domain Safety SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Spike Glycoprotein, Coronavirus - genetics TLR7 protein Toll-like receptors Toxicity Toxicology Vaccines Viral diseases |
| title | Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-05T16%3A31%3A17IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Preclinical%20evaluation%20of%20immunogenicity,%20efficacy%20and%20safety%20of%20a%20recombinant%20plant-based%20SARS-CoV-2%20RBD%20vaccine%20formulated%20with%203M-052-Alum%20adjuvant&rft.jtitle=Vaccine&rft.au=Phoolcharoen,%20Waranyoo&rft.date=2023-04-24&rft.volume=41&rft.issue=17&rft.spage=2781&rft.epage=2792&rft.pages=2781-2792&rft.issn=0264-410X&rft.eissn=1873-2518&rft_id=info:doi/10.1016/j.vaccine.2023.03.027&rft_dat=%3Cproquest_pubme%3E2801564420%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2801564420&rft_id=info:pmid/36963999&rft_els_id=S0264410X23003122&rfr_iscdi=true |