Immunogenicity and safety of Biological E's CORBEVAX™ vaccine compared to COVISHIELD™ (ChAdOx1 nCoV-19) vaccine studied in a phase-3, single blind, multicentre, randomized clinical trial
Optimum formulation of Biological-E's protein subunit CORBEVAX™ vaccine was selected in phase-1 and -2 studies and found to be safe and immunogenic in healthy adult population. This is a phase-3 prospective, single-blinded, randomized, active controlled study conducted at 18 sites across India...
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| Veröffentlicht in: | Human vaccines & immunotherapeutics 2023-12, Vol.19 (1), p.2203632-2203632 |
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| creator | Thuluva, Subhash Paradkar, Vikram Gunneri, SubbaReddy Yerroju, Vijay Mogulla, Rammohan Suneetha, Pothakamuri Venkata Turaga, Kishore Kyasani, Mahesh Manoharan, Senthil Kumar Adabala, Srikanth Sri Javvadi, Aditya Medigeshi, Guruprasad Singh, Janmejay Shaman, Heena Binayke, Akshay Zaheer, Aymaan Awasthi, Amit Singh, Chandramani Rao A, Venkateshwar Basu, Indranil Kumar, Khobragade Akash Ashok Pandey, Anil Kumar |
| description | Optimum formulation of Biological-E's protein subunit CORBEVAX™ vaccine was selected in phase-1 and -2 studies and found to be safe and immunogenic in healthy adult population. This is a phase-3 prospective, single-blinded, randomized, active controlled study conducted at 18 sites across India in 18-80 year-old subjects. This study has two groups; (i) immunogenicity-group, participants randomized either to CORBEVAX™ (n = 319) or COVISHIELD™ arms (n = 320). (ii) Safety-group containing single CORBEVAX™ arm (n = 1500) and randomization is not applicable. Healthy adults without a history of COVID-19 vaccination or SARS-CoV-2 infection were enrolled into immunogenicity arm and subjects seronegative to SARS-CoV-2 infection were enrolled into the safety arm. The safety profile of CORBEVAX™ vaccine was comparable to the comparator vaccine COVISHIELD™. Majority of reported AEs were mild in nature in both arms. The CORBEVAX™ to COVISHIELD™ GMT-ratios at day-42 time-point were 1·15 and 1·56 and the lower limit of the 95% confidence interval for the GMT-ratios was determined as 1·02 and 1·27 against Ancestral and Delta strains of SARS-COV-2 respectively. Both COVISHIELD™ and CORBEVAX™ vaccines showed comparable seroconversion post-vaccination against anti-RBD-IgG response. The subjects in CORBEVAX™ cohort also exhibited higher interferon-gamma secreting PBMC's post-stimulation with SARS-COV-2 RBD-peptides than subjects in COVISHIELD™ cohort. |
| doi_str_mv | 10.1080/21645515.2023.2203632 |
| format | Article |
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This is a phase-3 prospective, single-blinded, randomized, active controlled study conducted at 18 sites across India in 18-80 year-old subjects. This study has two groups; (i) immunogenicity-group, participants randomized either to CORBEVAX™ (n = 319) or COVISHIELD™ arms (n = 320). (ii) Safety-group containing single CORBEVAX™ arm (n = 1500) and randomization is not applicable. Healthy adults without a history of COVID-19 vaccination or SARS-CoV-2 infection were enrolled into immunogenicity arm and subjects seronegative to SARS-CoV-2 infection were enrolled into the safety arm. The safety profile of CORBEVAX™ vaccine was comparable to the comparator vaccine COVISHIELD™. Majority of reported AEs were mild in nature in both arms. The CORBEVAX™ to COVISHIELD™ GMT-ratios at day-42 time-point were 1·15 and 1·56 and the lower limit of the 95% confidence interval for the GMT-ratios was determined as 1·02 and 1·27 against Ancestral and Delta strains of SARS-COV-2 respectively. Both COVISHIELD™ and CORBEVAX™ vaccines showed comparable seroconversion post-vaccination against anti-RBD-IgG response. The subjects in CORBEVAX™ cohort also exhibited higher interferon-gamma secreting PBMC's post-stimulation with SARS-COV-2 RBD-peptides than subjects in COVISHIELD™ cohort.</description><identifier>ISSN: 2164-5515</identifier><identifier>EISSN: 2164-554X</identifier><identifier>DOI: 10.1080/21645515.2023.2203632</identifier><identifier>PMID: 37113012</identifier><language>eng</language><publisher>United States: Taylor & Francis</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Neutralizing ; Antibodies, Viral ; ChAdOx1 nCoV-19 ; Coronavirus ; Covid-19 ; COVID-19 - prevention & control ; COVID-19 Vaccines - adverse effects ; Double-Blind Method ; Humans ; Immunogenicity, Vaccine ; Leukocytes, Mononuclear ; Middle Aged ; Prospective Studies ; protein subunit ; receptor binding domain ; SARS-CoV-2 ; Single-Blind Method ; spike protein ; vaccine ; Vaccines ; Young Adult</subject><ispartof>Human vaccines & immunotherapeutics, 2023-12, Vol.19 (1), p.2203632-2203632</ispartof><rights>2023 The Author(s). Published with license by Taylor & Francis Group, LLC. 2023</rights><rights>2023 The Author(s). Published with license by Taylor & Francis Group, LLC. 2023 The Author(s)</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c535t-2d51ade079245f687d2f5055c0b1fc0d0e31ccb6c046ffc9654cd771f98c2f7a3</citedby><cites>FETCH-LOGICAL-c535t-2d51ade079245f687d2f5055c0b1fc0d0e31ccb6c046ffc9654cd771f98c2f7a3</cites><orcidid>0000-0002-9099-420X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10294721/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10294721/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,27479,27901,27902,53766,53768,59116,59117</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37113012$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thuluva, Subhash</creatorcontrib><creatorcontrib>Paradkar, Vikram</creatorcontrib><creatorcontrib>Gunneri, SubbaReddy</creatorcontrib><creatorcontrib>Yerroju, Vijay</creatorcontrib><creatorcontrib>Mogulla, Rammohan</creatorcontrib><creatorcontrib>Suneetha, Pothakamuri Venkata</creatorcontrib><creatorcontrib>Turaga, Kishore</creatorcontrib><creatorcontrib>Kyasani, Mahesh</creatorcontrib><creatorcontrib>Manoharan, Senthil Kumar</creatorcontrib><creatorcontrib>Adabala, Srikanth</creatorcontrib><creatorcontrib>Sri Javvadi, Aditya</creatorcontrib><creatorcontrib>Medigeshi, Guruprasad</creatorcontrib><creatorcontrib>Singh, Janmejay</creatorcontrib><creatorcontrib>Shaman, Heena</creatorcontrib><creatorcontrib>Binayke, Akshay</creatorcontrib><creatorcontrib>Zaheer, Aymaan</creatorcontrib><creatorcontrib>Awasthi, Amit</creatorcontrib><creatorcontrib>Singh, Chandramani</creatorcontrib><creatorcontrib>Rao A, Venkateshwar</creatorcontrib><creatorcontrib>Basu, Indranil</creatorcontrib><creatorcontrib>Kumar, Khobragade Akash Ashok</creatorcontrib><creatorcontrib>Pandey, Anil Kumar</creatorcontrib><title>Immunogenicity and safety of Biological E's CORBEVAX™ vaccine compared to COVISHIELD™ (ChAdOx1 nCoV-19) vaccine studied in a phase-3, single blind, multicentre, randomized clinical trial</title><title>Human vaccines & immunotherapeutics</title><addtitle>Hum Vaccin Immunother</addtitle><description>Optimum formulation of Biological-E's protein subunit CORBEVAX™ vaccine was selected in phase-1 and -2 studies and found to be safe and immunogenic in healthy adult population. 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Both COVISHIELD™ and CORBEVAX™ vaccines showed comparable seroconversion post-vaccination against anti-RBD-IgG response. The subjects in CORBEVAX™ cohort also exhibited higher interferon-gamma secreting PBMC's post-stimulation with SARS-COV-2 RBD-peptides than subjects in COVISHIELD™ cohort.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Neutralizing</subject><subject>Antibodies, Viral</subject><subject>ChAdOx1 nCoV-19</subject><subject>Coronavirus</subject><subject>Covid-19</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>Double-Blind Method</subject><subject>Humans</subject><subject>Immunogenicity, Vaccine</subject><subject>Leukocytes, Mononuclear</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>protein subunit</subject><subject>receptor binding domain</subject><subject>SARS-CoV-2</subject><subject>Single-Blind Method</subject><subject>spike protein</subject><subject>vaccine</subject><subject>Vaccines</subject><subject>Young Adult</subject><issn>2164-5515</issn><issn>2164-554X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>0YH</sourceid><sourceid>EIF</sourceid><sourceid>DOA</sourceid><recordid>eNp9UstuEzEUHSEQrUo_AeQdRcoE2zOexwrSaaCRIkXiEXVnOX4krjx2sGdKw5ov4UP4GL4E59GIbvDG1r3nnHuv70mSlwgOEazgW4yKnBBEhhjibIgxzIoMP0lOt_GUkPzm6fGNyElyHsItjKeEOC-K58lJViKUQYRPk9-Ttu2tW0qrue42gFkBAlMyPp0Cl9oZt9ScGTB-HUAz-3Q5no9u_vz8Be4Y59pKwF27Zl4K0LmYn08-X0_G06st4qJZjcTsHgHbuHmK6jdHTuh6oSNFW8DAesWCTLMBCNoujQQLo60YgLY3nebSdl4OgI9tuVb_iBwe07uGOq-ZeZE8U8wEeX64z5KvH8Zfmut0Ovs4aUbTlJOMdCkWBDEhYVnjnKiiKgVWBBLC4QIpDgWUGeJ8UXCYF0rxuiA5F2WJVF1xrEqWnSWTva5w7JauvW6Z31DHNN0FnF9S5mO_RtL4yzVb1CJnqMrLuK6S40oRnuO6Knitota7vda6X7RS7GZk5pHo44zVK7p0dxRBXOclRlHh4qDg3bdeho62OnBpDLPS9YHiajspJqiOULKHcu9C8FId6yBIt16iD16iWy_Rg5ci79W_TR5ZD86JgPd7gLbK-ZZ9d94I2rGNcV7FfXEdaPb_Gn8By2_aJg</recordid><startdate>20231231</startdate><enddate>20231231</enddate><creator>Thuluva, Subhash</creator><creator>Paradkar, Vikram</creator><creator>Gunneri, SubbaReddy</creator><creator>Yerroju, Vijay</creator><creator>Mogulla, Rammohan</creator><creator>Suneetha, Pothakamuri Venkata</creator><creator>Turaga, Kishore</creator><creator>Kyasani, Mahesh</creator><creator>Manoharan, Senthil Kumar</creator><creator>Adabala, Srikanth</creator><creator>Sri Javvadi, Aditya</creator><creator>Medigeshi, Guruprasad</creator><creator>Singh, Janmejay</creator><creator>Shaman, Heena</creator><creator>Binayke, Akshay</creator><creator>Zaheer, Aymaan</creator><creator>Awasthi, Amit</creator><creator>Singh, Chandramani</creator><creator>Rao A, Venkateshwar</creator><creator>Basu, Indranil</creator><creator>Kumar, Khobragade Akash Ashok</creator><creator>Pandey, Anil Kumar</creator><general>Taylor & Francis</general><general>Taylor & Francis Group</general><scope>0YH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-9099-420X</orcidid></search><sort><creationdate>20231231</creationdate><title>Immunogenicity and safety of Biological E's CORBEVAX™ vaccine compared to COVISHIELD™ (ChAdOx1 nCoV-19) vaccine studied in a phase-3, single blind, multicentre, randomized clinical trial</title><author>Thuluva, Subhash ; Paradkar, Vikram ; Gunneri, SubbaReddy ; Yerroju, Vijay ; Mogulla, Rammohan ; Suneetha, Pothakamuri Venkata ; Turaga, Kishore ; Kyasani, Mahesh ; Manoharan, Senthil Kumar ; Adabala, Srikanth ; Sri Javvadi, Aditya ; Medigeshi, Guruprasad ; Singh, Janmejay ; Shaman, Heena ; Binayke, Akshay ; Zaheer, Aymaan ; Awasthi, Amit ; Singh, Chandramani ; Rao A, Venkateshwar ; Basu, Indranil ; Kumar, Khobragade Akash Ashok ; Pandey, Anil Kumar</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c535t-2d51ade079245f687d2f5055c0b1fc0d0e31ccb6c046ffc9654cd771f98c2f7a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Neutralizing</topic><topic>Antibodies, Viral</topic><topic>ChAdOx1 nCoV-19</topic><topic>Coronavirus</topic><topic>Covid-19</topic><topic>COVID-19 - prevention & control</topic><topic>COVID-19 Vaccines - adverse effects</topic><topic>Double-Blind Method</topic><topic>Humans</topic><topic>Immunogenicity, Vaccine</topic><topic>Leukocytes, Mononuclear</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>protein subunit</topic><topic>receptor binding domain</topic><topic>SARS-CoV-2</topic><topic>Single-Blind Method</topic><topic>spike protein</topic><topic>vaccine</topic><topic>Vaccines</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Thuluva, Subhash</creatorcontrib><creatorcontrib>Paradkar, Vikram</creatorcontrib><creatorcontrib>Gunneri, SubbaReddy</creatorcontrib><creatorcontrib>Yerroju, Vijay</creatorcontrib><creatorcontrib>Mogulla, Rammohan</creatorcontrib><creatorcontrib>Suneetha, Pothakamuri Venkata</creatorcontrib><creatorcontrib>Turaga, Kishore</creatorcontrib><creatorcontrib>Kyasani, Mahesh</creatorcontrib><creatorcontrib>Manoharan, Senthil Kumar</creatorcontrib><creatorcontrib>Adabala, Srikanth</creatorcontrib><creatorcontrib>Sri Javvadi, Aditya</creatorcontrib><creatorcontrib>Medigeshi, Guruprasad</creatorcontrib><creatorcontrib>Singh, Janmejay</creatorcontrib><creatorcontrib>Shaman, Heena</creatorcontrib><creatorcontrib>Binayke, Akshay</creatorcontrib><creatorcontrib>Zaheer, Aymaan</creatorcontrib><creatorcontrib>Awasthi, Amit</creatorcontrib><creatorcontrib>Singh, Chandramani</creatorcontrib><creatorcontrib>Rao A, Venkateshwar</creatorcontrib><creatorcontrib>Basu, Indranil</creatorcontrib><creatorcontrib>Kumar, Khobragade Akash Ashok</creatorcontrib><creatorcontrib>Pandey, Anil Kumar</creatorcontrib><collection>Taylor & Francis Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Human vaccines & immunotherapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Thuluva, Subhash</au><au>Paradkar, Vikram</au><au>Gunneri, SubbaReddy</au><au>Yerroju, Vijay</au><au>Mogulla, Rammohan</au><au>Suneetha, Pothakamuri Venkata</au><au>Turaga, Kishore</au><au>Kyasani, Mahesh</au><au>Manoharan, Senthil Kumar</au><au>Adabala, Srikanth</au><au>Sri Javvadi, Aditya</au><au>Medigeshi, Guruprasad</au><au>Singh, Janmejay</au><au>Shaman, Heena</au><au>Binayke, Akshay</au><au>Zaheer, Aymaan</au><au>Awasthi, Amit</au><au>Singh, Chandramani</au><au>Rao A, Venkateshwar</au><au>Basu, Indranil</au><au>Kumar, Khobragade Akash Ashok</au><au>Pandey, Anil Kumar</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and safety of Biological E's CORBEVAX™ vaccine compared to COVISHIELD™ (ChAdOx1 nCoV-19) vaccine studied in a phase-3, single blind, multicentre, randomized clinical trial</atitle><jtitle>Human vaccines & immunotherapeutics</jtitle><addtitle>Hum Vaccin Immunother</addtitle><date>2023-12-31</date><risdate>2023</risdate><volume>19</volume><issue>1</issue><spage>2203632</spage><epage>2203632</epage><pages>2203632-2203632</pages><issn>2164-5515</issn><eissn>2164-554X</eissn><abstract>Optimum formulation of Biological-E's protein subunit CORBEVAX™ vaccine was selected in phase-1 and -2 studies and found to be safe and immunogenic in healthy adult population. This is a phase-3 prospective, single-blinded, randomized, active controlled study conducted at 18 sites across India in 18-80 year-old subjects. This study has two groups; (i) immunogenicity-group, participants randomized either to CORBEVAX™ (n = 319) or COVISHIELD™ arms (n = 320). (ii) Safety-group containing single CORBEVAX™ arm (n = 1500) and randomization is not applicable. Healthy adults without a history of COVID-19 vaccination or SARS-CoV-2 infection were enrolled into immunogenicity arm and subjects seronegative to SARS-CoV-2 infection were enrolled into the safety arm. The safety profile of CORBEVAX™ vaccine was comparable to the comparator vaccine COVISHIELD™. Majority of reported AEs were mild in nature in both arms. The CORBEVAX™ to COVISHIELD™ GMT-ratios at day-42 time-point were 1·15 and 1·56 and the lower limit of the 95% confidence interval for the GMT-ratios was determined as 1·02 and 1·27 against Ancestral and Delta strains of SARS-COV-2 respectively. Both COVISHIELD™ and CORBEVAX™ vaccines showed comparable seroconversion post-vaccination against anti-RBD-IgG response. The subjects in CORBEVAX™ cohort also exhibited higher interferon-gamma secreting PBMC's post-stimulation with SARS-COV-2 RBD-peptides than subjects in COVISHIELD™ cohort.</abstract><cop>United States</cop><pub>Taylor & Francis</pub><pmid>37113012</pmid><doi>10.1080/21645515.2023.2203632</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0002-9099-420X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2164-5515 |
| ispartof | Human vaccines & immunotherapeutics, 2023-12, Vol.19 (1), p.2203632-2203632 |
| issn | 2164-5515 2164-554X |
| language | eng |
| recordid | cdi_pubmed_primary_37113012 |
| source | Taylor & Francis Open Access; MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Adolescent Adult Aged Aged, 80 and over Antibodies, Neutralizing Antibodies, Viral ChAdOx1 nCoV-19 Coronavirus Covid-19 COVID-19 - prevention & control COVID-19 Vaccines - adverse effects Double-Blind Method Humans Immunogenicity, Vaccine Leukocytes, Mononuclear Middle Aged Prospective Studies protein subunit receptor binding domain SARS-CoV-2 Single-Blind Method spike protein vaccine Vaccines Young Adult |
| title | Immunogenicity and safety of Biological E's CORBEVAX™ vaccine compared to COVISHIELD™ (ChAdOx1 nCoV-19) vaccine studied in a phase-3, single blind, multicentre, randomized clinical trial |
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