Immunogenicity and protective efficacy of SARS-CoV-2 recombinant S-protein vaccine S-268019-b in cynomolgus monkeys
•A novel SARS-CoV-2 recombinant spike (S)-protein vaccine S-268019-b was developed.•S-268019-b induced antibodies against S-protein and its receptor binding domain.•Neutralizing antibody was induced against SARS-CoV-2 and pseudovirus variants.•S-268019-b demonstrated protective efficacy against SARS...
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| Veröffentlicht in: | Vaccine 2022-07, Vol.40 (31), p.4231-4241 |
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| container_title | Vaccine |
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| creator | Hashimoto, Masayuki Nagata, Noriyo Homma, Tomoyuki Maeda, Hiroki Dohi, Keiji Seki, Naomi M. Yoshihara, Ken Iwata-Yoshikawa, Naoko Shiwa-Sudo, Nozomi Sakai, Yusuke Shirakura, Masayuki Kishida, Noriko Arita, Tomoko Suzuki, Yasushi Watanabe, Shinji Asanuma, Hideki Sonoyama, Takuhiro Suzuki, Tadaki Omoto, Shinya Hasegawa, Hideki |
| description | •A novel SARS-CoV-2 recombinant spike (S)-protein vaccine S-268019-b was developed.•S-268019-b induced antibodies against S-protein and its receptor binding domain.•Neutralizing antibody was induced against SARS-CoV-2 and pseudovirus variants.•S-268019-b demonstrated protective efficacy against SARS-CoV-2 challenge.•S-268019-b was safe for use in cynomolgus macaques.
The vaccine S-268019-b is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S)-protein vaccine consisting of full-length recombinant SARS-CoV-2 S-protein (S-910823) as antigen, mixed with the squalene-based adjuvant A-910823. The current study evaluated the immunogenicity of S-268019-b using various doses of S-910823 and its vaccine efficacy against SARS-CoV-2 challenge in cynomolgus monkeys. The different doses of S-910823 combined with A-910823 were intramuscularly administered twice at a 3-week interval. Two weeks after the second dosing, dose-dependent humoral immune responses were observed with neutralizing antibody titers being comparable to that of human convalescent plasma. Pseudoviruses harboring S proteins from Beta and Gamma SARS-CoV-2 variants displayed approximately 3- to 4-fold reduced sensitivity to neutralizing antibodies induced after two vaccine doses compared with that against ancestral viruses, whereas neutralizing antibody titers were reduced >14-fold against the Omicron variant. Cellular immunity was also induced with a relative Th1 polarized response. No adverse clinical signs or weight loss associated with the vaccine were observed, suggesting safety of the vaccine in cynomolgus monkeys. Immunization with 10 µg of S-910823 with A-910823 demonstrated protective efficacy against SARS-CoV-2 challenge according to genomic and subgenomic viral RNA transcript levels in nasopharyngeal, throat, and rectal swab specimens. Pathological analysis revealed no detectable vaccine-dependent enhancement of disease in the lungs of challenged vaccinated monkeys. The current findings provide fundamental information regarding vaccine doses for human trials and support the development of S-268019-b as a safe and effective vaccine for controlling the current pandemic, as well as general protection against SARS-CoV-2 moving forward. |
| doi_str_mv | 10.1016/j.vaccine.2022.05.081 |
| format | Article |
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The vaccine S-268019-b is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S)-protein vaccine consisting of full-length recombinant SARS-CoV-2 S-protein (S-910823) as antigen, mixed with the squalene-based adjuvant A-910823. The current study evaluated the immunogenicity of S-268019-b using various doses of S-910823 and its vaccine efficacy against SARS-CoV-2 challenge in cynomolgus monkeys. The different doses of S-910823 combined with A-910823 were intramuscularly administered twice at a 3-week interval. Two weeks after the second dosing, dose-dependent humoral immune responses were observed with neutralizing antibody titers being comparable to that of human convalescent plasma. Pseudoviruses harboring S proteins from Beta and Gamma SARS-CoV-2 variants displayed approximately 3- to 4-fold reduced sensitivity to neutralizing antibodies induced after two vaccine doses compared with that against ancestral viruses, whereas neutralizing antibody titers were reduced >14-fold against the Omicron variant. Cellular immunity was also induced with a relative Th1 polarized response. No adverse clinical signs or weight loss associated with the vaccine were observed, suggesting safety of the vaccine in cynomolgus monkeys. Immunization with 10 µg of S-910823 with A-910823 demonstrated protective efficacy against SARS-CoV-2 challenge according to genomic and subgenomic viral RNA transcript levels in nasopharyngeal, throat, and rectal swab specimens. Pathological analysis revealed no detectable vaccine-dependent enhancement of disease in the lungs of challenged vaccinated monkeys. The current findings provide fundamental information regarding vaccine doses for human trials and support the development of S-268019-b as a safe and effective vaccine for controlling the current pandemic, as well as general protection against SARS-CoV-2 moving forward.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2022.05.081</identifier><identifier>PMID: 35691872</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>adjuvants ; Animals ; Antibodies ; Antibodies, Neutralizing ; Antibodies, Viral ; Antigens ; Cell-mediated immunity ; Chromatography ; Clinical trials ; Coronavirus disease 2019 ; Coronaviruses ; COVID-19 ; COVID-19 - prevention & control ; COVID-19 - therapy ; COVID-19 Serotherapy ; COVID-19 vaccines ; Cynomolgus monkeys ; Dosage ; dose response ; Enzymes ; genomics ; humans ; Immune response (humoral) ; Immunization ; Immunization, Passive ; Immunogenicity ; Immunogenicity, Vaccine ; Laboratories ; Lung diseases ; Lymphocytes T ; Macaca fascicularis ; messenger RNA ; Monkeys ; Neutralizing ; pandemic ; Pandemics ; Proteins ; Pseudoviridae ; Recombinant protein vaccine ; S-268019-b ; SARS-CoV-2 ; Severe acute respiratory syndrome coronavirus 2 ; Spike Glycoprotein, Coronavirus ; Squalene ; throat ; Vaccine efficacy ; Vaccines ; Viral diseases ; Viral Vaccines ; Viruses ; Weight loss</subject><ispartof>Vaccine, 2022-07, Vol.40 (31), p.4231-4241</ispartof><rights>2022 The Authors</rights><rights>Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><rights>2022. The Authors</rights><rights>2022 The Authors 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c495t-f377111e1ec590a07055053ebeb819f3d3479e43a65ebf59e40a3c86196527983</citedby><cites>FETCH-LOGICAL-c495t-f377111e1ec590a07055053ebeb819f3d3479e43a65ebf59e40a3c86196527983</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0264410X22007186$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35691872$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hashimoto, Masayuki</creatorcontrib><creatorcontrib>Nagata, Noriyo</creatorcontrib><creatorcontrib>Homma, Tomoyuki</creatorcontrib><creatorcontrib>Maeda, Hiroki</creatorcontrib><creatorcontrib>Dohi, Keiji</creatorcontrib><creatorcontrib>Seki, Naomi M.</creatorcontrib><creatorcontrib>Yoshihara, Ken</creatorcontrib><creatorcontrib>Iwata-Yoshikawa, Naoko</creatorcontrib><creatorcontrib>Shiwa-Sudo, Nozomi</creatorcontrib><creatorcontrib>Sakai, Yusuke</creatorcontrib><creatorcontrib>Shirakura, Masayuki</creatorcontrib><creatorcontrib>Kishida, Noriko</creatorcontrib><creatorcontrib>Arita, Tomoko</creatorcontrib><creatorcontrib>Suzuki, Yasushi</creatorcontrib><creatorcontrib>Watanabe, Shinji</creatorcontrib><creatorcontrib>Asanuma, Hideki</creatorcontrib><creatorcontrib>Sonoyama, Takuhiro</creatorcontrib><creatorcontrib>Suzuki, Tadaki</creatorcontrib><creatorcontrib>Omoto, Shinya</creatorcontrib><creatorcontrib>Hasegawa, Hideki</creatorcontrib><title>Immunogenicity and protective efficacy of SARS-CoV-2 recombinant S-protein vaccine S-268019-b in cynomolgus monkeys</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>•A novel SARS-CoV-2 recombinant spike (S)-protein vaccine S-268019-b was developed.•S-268019-b induced antibodies against S-protein and its receptor binding domain.•Neutralizing antibody was induced against SARS-CoV-2 and pseudovirus variants.•S-268019-b demonstrated protective efficacy against SARS-CoV-2 challenge.•S-268019-b was safe for use in cynomolgus macaques.
The vaccine S-268019-b is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S)-protein vaccine consisting of full-length recombinant SARS-CoV-2 S-protein (S-910823) as antigen, mixed with the squalene-based adjuvant A-910823. The current study evaluated the immunogenicity of S-268019-b using various doses of S-910823 and its vaccine efficacy against SARS-CoV-2 challenge in cynomolgus monkeys. The different doses of S-910823 combined with A-910823 were intramuscularly administered twice at a 3-week interval. Two weeks after the second dosing, dose-dependent humoral immune responses were observed with neutralizing antibody titers being comparable to that of human convalescent plasma. Pseudoviruses harboring S proteins from Beta and Gamma SARS-CoV-2 variants displayed approximately 3- to 4-fold reduced sensitivity to neutralizing antibodies induced after two vaccine doses compared with that against ancestral viruses, whereas neutralizing antibody titers were reduced >14-fold against the Omicron variant. Cellular immunity was also induced with a relative Th1 polarized response. No adverse clinical signs or weight loss associated with the vaccine were observed, suggesting safety of the vaccine in cynomolgus monkeys. Immunization with 10 µg of S-910823 with A-910823 demonstrated protective efficacy against SARS-CoV-2 challenge according to genomic and subgenomic viral RNA transcript levels in nasopharyngeal, throat, and rectal swab specimens. Pathological analysis revealed no detectable vaccine-dependent enhancement of disease in the lungs of challenged vaccinated monkeys. The current findings provide fundamental information regarding vaccine doses for human trials and support the development of S-268019-b as a safe and effective vaccine for controlling the current pandemic, as well as general protection against SARS-CoV-2 moving forward.</description><subject>adjuvants</subject><subject>Animals</subject><subject>Antibodies</subject><subject>Antibodies, Neutralizing</subject><subject>Antibodies, Viral</subject><subject>Antigens</subject><subject>Cell-mediated immunity</subject><subject>Chromatography</subject><subject>Clinical trials</subject><subject>Coronavirus disease 2019</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 - therapy</subject><subject>COVID-19 Serotherapy</subject><subject>COVID-19 vaccines</subject><subject>Cynomolgus monkeys</subject><subject>Dosage</subject><subject>dose response</subject><subject>Enzymes</subject><subject>genomics</subject><subject>humans</subject><subject>Immune response (humoral)</subject><subject>Immunization</subject><subject>Immunization, Passive</subject><subject>Immunogenicity</subject><subject>Immunogenicity, Vaccine</subject><subject>Laboratories</subject><subject>Lung diseases</subject><subject>Lymphocytes T</subject><subject>Macaca fascicularis</subject><subject>messenger RNA</subject><subject>Monkeys</subject><subject>Neutralizing</subject><subject>pandemic</subject><subject>Pandemics</subject><subject>Proteins</subject><subject>Pseudoviridae</subject><subject>Recombinant protein vaccine</subject><subject>S-268019-b</subject><subject>SARS-CoV-2</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Spike Glycoprotein, Coronavirus</subject><subject>Squalene</subject><subject>throat</subject><subject>Vaccine efficacy</subject><subject>Vaccines</subject><subject>Viral diseases</subject><subject>Viral Vaccines</subject><subject>Viruses</subject><subject>Weight loss</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkUtv1DAUhS0EokPhJ4AssWGT1I_YiTegasSjUiWkDiB2luPcDB4Se7CTkfLvcZmhKmy6snX93eN77kHoJSUlJVRe7MqDsdZ5KBlhrCSiJA19hFa0qXnBBG0eoxVhsioqSr6foWcp7QghglP1FJ1xIVUG2Qqlq3GcfdiCd9ZNCza-w_sYJrCTOwCGvnfW2AWHHm8ubzbFOnwrGI5gw9g6b_yEN8Uf3nl8GihXmGwIVUWLc9UuPoxh2M4Jj8H_hCU9R096MyR4cTrP0dcP77-sPxXXnz9erS-vC1spMRU9r2tKKVCwQhFDaiJENgAttA1VPe94VSuouJEC2l7kKzHcNpIqKVitGn6O3h5193M7QmfBT9EMeh_daOKig3H63xfvfuhtOGhFZd1wlgXenARi-DVDmvTokoVhMB7CnDSracO4Elxl9PV_6C7M0Wd7mslaKk4k55kSR8rGkFKE_m4YSvRtrHqnT1vUt7FqInSONfe9uu_krutvjhl4dwQg7_PgIOpkHXgLnctZTboL7oEvfgP0ULXU</recordid><startdate>20220729</startdate><enddate>20220729</enddate><creator>Hashimoto, Masayuki</creator><creator>Nagata, Noriyo</creator><creator>Homma, Tomoyuki</creator><creator>Maeda, Hiroki</creator><creator>Dohi, Keiji</creator><creator>Seki, Naomi M.</creator><creator>Yoshihara, Ken</creator><creator>Iwata-Yoshikawa, Naoko</creator><creator>Shiwa-Sudo, Nozomi</creator><creator>Sakai, Yusuke</creator><creator>Shirakura, Masayuki</creator><creator>Kishida, Noriko</creator><creator>Arita, Tomoko</creator><creator>Suzuki, Yasushi</creator><creator>Watanabe, Shinji</creator><creator>Asanuma, Hideki</creator><creator>Sonoyama, Takuhiro</creator><creator>Suzuki, Tadaki</creator><creator>Omoto, Shinya</creator><creator>Hasegawa, Hideki</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><general>The Authors. 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Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>AGRICOLA</collection><collection>AGRICOLA - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hashimoto, Masayuki</au><au>Nagata, Noriyo</au><au>Homma, Tomoyuki</au><au>Maeda, Hiroki</au><au>Dohi, Keiji</au><au>Seki, Naomi M.</au><au>Yoshihara, Ken</au><au>Iwata-Yoshikawa, Naoko</au><au>Shiwa-Sudo, Nozomi</au><au>Sakai, Yusuke</au><au>Shirakura, Masayuki</au><au>Kishida, Noriko</au><au>Arita, Tomoko</au><au>Suzuki, Yasushi</au><au>Watanabe, Shinji</au><au>Asanuma, Hideki</au><au>Sonoyama, Takuhiro</au><au>Suzuki, Tadaki</au><au>Omoto, Shinya</au><au>Hasegawa, Hideki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and protective efficacy of SARS-CoV-2 recombinant S-protein vaccine S-268019-b in cynomolgus monkeys</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2022-07-29</date><risdate>2022</risdate><volume>40</volume><issue>31</issue><spage>4231</spage><epage>4241</epage><pages>4231-4241</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>•A novel SARS-CoV-2 recombinant spike (S)-protein vaccine S-268019-b was developed.•S-268019-b induced antibodies against S-protein and its receptor binding domain.•Neutralizing antibody was induced against SARS-CoV-2 and pseudovirus variants.•S-268019-b demonstrated protective efficacy against SARS-CoV-2 challenge.•S-268019-b was safe for use in cynomolgus macaques.
The vaccine S-268019-b is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S)-protein vaccine consisting of full-length recombinant SARS-CoV-2 S-protein (S-910823) as antigen, mixed with the squalene-based adjuvant A-910823. The current study evaluated the immunogenicity of S-268019-b using various doses of S-910823 and its vaccine efficacy against SARS-CoV-2 challenge in cynomolgus monkeys. The different doses of S-910823 combined with A-910823 were intramuscularly administered twice at a 3-week interval. Two weeks after the second dosing, dose-dependent humoral immune responses were observed with neutralizing antibody titers being comparable to that of human convalescent plasma. Pseudoviruses harboring S proteins from Beta and Gamma SARS-CoV-2 variants displayed approximately 3- to 4-fold reduced sensitivity to neutralizing antibodies induced after two vaccine doses compared with that against ancestral viruses, whereas neutralizing antibody titers were reduced >14-fold against the Omicron variant. Cellular immunity was also induced with a relative Th1 polarized response. No adverse clinical signs or weight loss associated with the vaccine were observed, suggesting safety of the vaccine in cynomolgus monkeys. Immunization with 10 µg of S-910823 with A-910823 demonstrated protective efficacy against SARS-CoV-2 challenge according to genomic and subgenomic viral RNA transcript levels in nasopharyngeal, throat, and rectal swab specimens. Pathological analysis revealed no detectable vaccine-dependent enhancement of disease in the lungs of challenged vaccinated monkeys. The current findings provide fundamental information regarding vaccine doses for human trials and support the development of S-268019-b as a safe and effective vaccine for controlling the current pandemic, as well as general protection against SARS-CoV-2 moving forward.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>35691872</pmid><doi>10.1016/j.vaccine.2022.05.081</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2022-07, Vol.40 (31), p.4231-4241 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9167832 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | adjuvants Animals Antibodies Antibodies, Neutralizing Antibodies, Viral Antigens Cell-mediated immunity Chromatography Clinical trials Coronavirus disease 2019 Coronaviruses COVID-19 COVID-19 - prevention & control COVID-19 - therapy COVID-19 Serotherapy COVID-19 vaccines Cynomolgus monkeys Dosage dose response Enzymes genomics humans Immune response (humoral) Immunization Immunization, Passive Immunogenicity Immunogenicity, Vaccine Laboratories Lung diseases Lymphocytes T Macaca fascicularis messenger RNA Monkeys Neutralizing pandemic Pandemics Proteins Pseudoviridae Recombinant protein vaccine S-268019-b SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Spike Glycoprotein, Coronavirus Squalene throat Vaccine efficacy Vaccines Viral diseases Viral Vaccines Viruses Weight loss |
| title | Immunogenicity and protective efficacy of SARS-CoV-2 recombinant S-protein vaccine S-268019-b in cynomolgus monkeys |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-09T17%3A11%3A26IST&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=Immunogenicity%20and%20protective%20efficacy%20of%20SARS-CoV-2%20recombinant%20S-protein%20vaccine%20S-268019-b%20in%20cynomolgus%20monkeys&rft.jtitle=Vaccine&rft.au=Hashimoto,%20Masayuki&rft.date=2022-07-29&rft.volume=40&rft.issue=31&rft.spage=4231&rft.epage=4241&rft.pages=4231-4241&rft.issn=0264-410X&rft.eissn=1873-2518&rft_id=info:doi/10.1016/j.vaccine.2022.05.081&rft_dat=%3Cproquest_pubme%3E2676930633%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=2676930633&rft_id=info:pmid/35691872&rft_els_id=S0264410X22007186&rfr_iscdi=true |