A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India
This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca. This participant-blin...
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| Veröffentlicht in: | EClinicalMedicine 2021-12, Vol.42, p.101218-101218, Article 101218 |
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| creator | Kulkarni, Prasad S Padmapriyadarsini, Chandrasekaran Vekemans, Johan Bavdekar, Ashish Gupta, Madhu Kulkarni, Praveen Garg, B S Gogtay, Nithya J Tambe, Muralidhar Lalwani, Sanjay Singh, Kiranjit Munshi, Renuka Meshram, Sushant Selvavinayagam, T S Pandey, Krishna Bhimarasetty, Devi Madhavi Ramakrishnan, S R Bhamare, Chetanraj Dharmadhikari, Abhijeet Vadakkedath, Rajeev Bonhomme, Cyrille J Thakar, Madhuri Kurle, Swarali N Kelly, Elizabeth J Gautam, Manish Gupta, Nivedita Panda, Samiran Bhargava, Balram Shaligram, Umesh Kapse, Dhananjay Gunale, Bhagwat |
| description | This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca.
This participant-blind, observer-blind study randomised participants 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (ChAdOx1 nCoV-19) (immunogenicity/reactogenicity cohort) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort). The study participants were enrolled from 14 hospitals across India between August 25 and October 31, 2020. Two doses of study products were given 4 weeks apart. The primary objectives were to demonstrate non-inferiority of SII-ChAdOx1 nCoV-19 to AZD1222 in terms of geometric mean titre (GMT) ratio of anti-SARS-CoV-2 spike IgG antibodies 28 days after the second dose (defined as lower limit of 95% CI >0·67) and to determine the incidence of serious adverse events (SAEs) causally related to SII-ChAdOx1 nCoV-19. The anti-spike IgG response was assessed using a multiplexed electrochemiluminescence-based immunoassay. Safety follow-up continued until 6 months after first dose. Trial registration: CTRI/2020/08/027170.
1601 participants were enrolled: 401 to the immunogenicity/reactogenicity cohort and 1200 to the safety cohort. After two doses, seroconversion rates for anti-spike IgG antibodies were more than 98·0% in both the groups. SII-ChAdOx1 nCoV-19 was non-inferior to AZD1222 (GMT ratio 0·98; 95% CI 0·78–1·23). SAEs were reported in ≤ 2·0% participants across the three groups; none were causally related. A total of 34 SARS-CoV-2 infections were reported; of which 6 occurred more than 2 weeks after the second dose; none were severe.
SII-ChAdOx1 nCoV-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile. Pharmacovigilance should be maintained to detect any safety signals.
SIIPL funded the contract research organisation and laboratory costs, while the site costs were funded by the Indian Council of Medical Research. The study vaccines were supplied by SIIPL and AstraZeneca. |
| doi_str_mv | 10.1016/j.eclinm.2021.101218 |
| format | Article |
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This participant-blind, observer-blind study randomised participants 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (ChAdOx1 nCoV-19) (immunogenicity/reactogenicity cohort) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort). The study participants were enrolled from 14 hospitals across India between August 25 and October 31, 2020. Two doses of study products were given 4 weeks apart. The primary objectives were to demonstrate non-inferiority of SII-ChAdOx1 nCoV-19 to AZD1222 in terms of geometric mean titre (GMT) ratio of anti-SARS-CoV-2 spike IgG antibodies 28 days after the second dose (defined as lower limit of 95% CI >0·67) and to determine the incidence of serious adverse events (SAEs) causally related to SII-ChAdOx1 nCoV-19. The anti-spike IgG response was assessed using a multiplexed electrochemiluminescence-based immunoassay. Safety follow-up continued until 6 months after first dose. Trial registration: CTRI/2020/08/027170.
1601 participants were enrolled: 401 to the immunogenicity/reactogenicity cohort and 1200 to the safety cohort. After two doses, seroconversion rates for anti-spike IgG antibodies were more than 98·0% in both the groups. SII-ChAdOx1 nCoV-19 was non-inferior to AZD1222 (GMT ratio 0·98; 95% CI 0·78–1·23). SAEs were reported in ≤ 2·0% participants across the three groups; none were causally related. A total of 34 SARS-CoV-2 infections were reported; of which 6 occurred more than 2 weeks after the second dose; none were severe.
SII-ChAdOx1 nCoV-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile. Pharmacovigilance should be maintained to detect any safety signals.
SIIPL funded the contract research organisation and laboratory costs, while the site costs were funded by the Indian Council of Medical Research. The study vaccines were supplied by SIIPL and AstraZeneca.</description><identifier>ISSN: 2589-5370</identifier><identifier>EISSN: 2589-5370</identifier><identifier>DOI: 10.1016/j.eclinm.2021.101218</identifier><identifier>PMID: 34870133</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>AZD1222 ; COVID-19 ; Immunogenicity ; Research Paper ; Safety ; SII-ChAdOx1 nCoV-19</subject><ispartof>EClinicalMedicine, 2021-12, Vol.42, p.101218-101218, Article 101218</ispartof><rights>2021 The Authors</rights><rights>2021 The Authors.</rights><rights>2021 The Authors 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c463t-96e4cc5a9dd39d5a08b5500d69ac22c843902d527b973a577174ca623ea09a3</citedby><cites>FETCH-LOGICAL-c463t-96e4cc5a9dd39d5a08b5500d69ac22c843902d527b973a577174ca623ea09a3</cites><orcidid>0000-0002-2848-3089</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/PMC8629682/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8629682/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34870133$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kulkarni, Prasad S</creatorcontrib><creatorcontrib>Padmapriyadarsini, Chandrasekaran</creatorcontrib><creatorcontrib>Vekemans, Johan</creatorcontrib><creatorcontrib>Bavdekar, Ashish</creatorcontrib><creatorcontrib>Gupta, Madhu</creatorcontrib><creatorcontrib>Kulkarni, Praveen</creatorcontrib><creatorcontrib>Garg, B S</creatorcontrib><creatorcontrib>Gogtay, Nithya J</creatorcontrib><creatorcontrib>Tambe, Muralidhar</creatorcontrib><creatorcontrib>Lalwani, Sanjay</creatorcontrib><creatorcontrib>Singh, Kiranjit</creatorcontrib><creatorcontrib>Munshi, Renuka</creatorcontrib><creatorcontrib>Meshram, Sushant</creatorcontrib><creatorcontrib>Selvavinayagam, T S</creatorcontrib><creatorcontrib>Pandey, Krishna</creatorcontrib><creatorcontrib>Bhimarasetty, Devi Madhavi</creatorcontrib><creatorcontrib>Ramakrishnan, S R</creatorcontrib><creatorcontrib>Bhamare, Chetanraj</creatorcontrib><creatorcontrib>Dharmadhikari, Abhijeet</creatorcontrib><creatorcontrib>Vadakkedath, Rajeev</creatorcontrib><creatorcontrib>Bonhomme, Cyrille J</creatorcontrib><creatorcontrib>Thakar, Madhuri</creatorcontrib><creatorcontrib>Kurle, Swarali N</creatorcontrib><creatorcontrib>Kelly, Elizabeth J</creatorcontrib><creatorcontrib>Gautam, Manish</creatorcontrib><creatorcontrib>Gupta, Nivedita</creatorcontrib><creatorcontrib>Panda, Samiran</creatorcontrib><creatorcontrib>Bhargava, Balram</creatorcontrib><creatorcontrib>Shaligram, Umesh</creatorcontrib><creatorcontrib>Kapse, Dhananjay</creatorcontrib><creatorcontrib>Gunale, Bhagwat</creatorcontrib><creatorcontrib>COVISHIELD Study Group</creatorcontrib><title>A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India</title><title>EClinicalMedicine</title><addtitle>EClinicalMedicine</addtitle><description>This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca.
This participant-blind, observer-blind study randomised participants 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (ChAdOx1 nCoV-19) (immunogenicity/reactogenicity cohort) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort). The study participants were enrolled from 14 hospitals across India between August 25 and October 31, 2020. Two doses of study products were given 4 weeks apart. The primary objectives were to demonstrate non-inferiority of SII-ChAdOx1 nCoV-19 to AZD1222 in terms of geometric mean titre (GMT) ratio of anti-SARS-CoV-2 spike IgG antibodies 28 days after the second dose (defined as lower limit of 95% CI >0·67) and to determine the incidence of serious adverse events (SAEs) causally related to SII-ChAdOx1 nCoV-19. The anti-spike IgG response was assessed using a multiplexed electrochemiluminescence-based immunoassay. Safety follow-up continued until 6 months after first dose. Trial registration: CTRI/2020/08/027170.
1601 participants were enrolled: 401 to the immunogenicity/reactogenicity cohort and 1200 to the safety cohort. After two doses, seroconversion rates for anti-spike IgG antibodies were more than 98·0% in both the groups. SII-ChAdOx1 nCoV-19 was non-inferior to AZD1222 (GMT ratio 0·98; 95% CI 0·78–1·23). SAEs were reported in ≤ 2·0% participants across the three groups; none were causally related. A total of 34 SARS-CoV-2 infections were reported; of which 6 occurred more than 2 weeks after the second dose; none were severe.
SII-ChAdOx1 nCoV-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile. Pharmacovigilance should be maintained to detect any safety signals.
SIIPL funded the contract research organisation and laboratory costs, while the site costs were funded by the Indian Council of Medical Research. The study vaccines were supplied by SIIPL and AstraZeneca.</description><subject>AZD1222</subject><subject>COVID-19</subject><subject>Immunogenicity</subject><subject>Research Paper</subject><subject>Safety</subject><subject>SII-ChAdOx1 nCoV-19</subject><issn>2589-5370</issn><issn>2589-5370</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9UdtqGzEQXUpLE9L8QSl6TCHr6LI3vRSMezME_JCSVzGWxrHMruRKWlN_Vv-wWpyk6Uuf5sxozhnNnKJ4z-iMUdbc7Gaoe-uGGaecTSXOulfFOa87Wdaipa9f4LPiMsYdpZTTqpMNfVuciaprKRPivPg9J_stRCT8RlyTPYRktd2DS-U665tr4tcRwwHDUx7AGT_YiBlr71LwfY-GxDSaI0meQIwYI0lbJBE2mI4kE4gdhtH5B3RZPZf8htwtl-ViOzerX4y4hb8vmSRXi9X98vOEDqC1dfiRWEfAjH2KE1o6Y-Fd8WYDfcTLx3hR3H398mPxvbxdfVsu5relrhqRStlgpXUN0hghTQ20W9c1paaRoDnXXSUk5abm7Vq2Auq2ZW2loeECgUoQF8Wnk-p-XA9oNOZNoVf7YAcIR-XBqn9fnN2qB39QXcNl0_EscPUoEPzPEWNS-Wga-x4c-jEq3tBWUFqzKrdWp1YdfIwBN89jGFWT3WqnTnaryW51sjvTPrz84jPpydy_O2A-08FiUFFbdBqNDaiTMt7-f8IfpdS9bw</recordid><startdate>20211201</startdate><enddate>20211201</enddate><creator>Kulkarni, Prasad S</creator><creator>Padmapriyadarsini, Chandrasekaran</creator><creator>Vekemans, Johan</creator><creator>Bavdekar, Ashish</creator><creator>Gupta, Madhu</creator><creator>Kulkarni, Praveen</creator><creator>Garg, B S</creator><creator>Gogtay, Nithya J</creator><creator>Tambe, Muralidhar</creator><creator>Lalwani, Sanjay</creator><creator>Singh, Kiranjit</creator><creator>Munshi, Renuka</creator><creator>Meshram, Sushant</creator><creator>Selvavinayagam, T S</creator><creator>Pandey, Krishna</creator><creator>Bhimarasetty, Devi Madhavi</creator><creator>Ramakrishnan, S R</creator><creator>Bhamare, Chetanraj</creator><creator>Dharmadhikari, Abhijeet</creator><creator>Vadakkedath, Rajeev</creator><creator>Bonhomme, Cyrille J</creator><creator>Thakar, Madhuri</creator><creator>Kurle, Swarali N</creator><creator>Kelly, Elizabeth J</creator><creator>Gautam, Manish</creator><creator>Gupta, Nivedita</creator><creator>Panda, Samiran</creator><creator>Bhargava, Balram</creator><creator>Shaligram, Umesh</creator><creator>Kapse, Dhananjay</creator><creator>Gunale, Bhagwat</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-2848-3089</orcidid></search><sort><creationdate>20211201</creationdate><title>A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India</title><author>Kulkarni, Prasad S ; Padmapriyadarsini, Chandrasekaran ; Vekemans, Johan ; Bavdekar, Ashish ; Gupta, Madhu ; Kulkarni, Praveen ; Garg, B S ; Gogtay, Nithya J ; Tambe, Muralidhar ; Lalwani, Sanjay ; Singh, Kiranjit ; Munshi, Renuka ; Meshram, Sushant ; Selvavinayagam, T S ; Pandey, Krishna ; Bhimarasetty, Devi Madhavi ; Ramakrishnan, S R ; Bhamare, Chetanraj ; Dharmadhikari, Abhijeet ; Vadakkedath, Rajeev ; Bonhomme, Cyrille J ; Thakar, Madhuri ; Kurle, Swarali N ; Kelly, Elizabeth J ; Gautam, Manish ; Gupta, Nivedita ; Panda, Samiran ; Bhargava, Balram ; Shaligram, Umesh ; Kapse, Dhananjay ; Gunale, Bhagwat</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c463t-96e4cc5a9dd39d5a08b5500d69ac22c843902d527b973a577174ca623ea09a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>AZD1222</topic><topic>COVID-19</topic><topic>Immunogenicity</topic><topic>Research Paper</topic><topic>Safety</topic><topic>SII-ChAdOx1 nCoV-19</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kulkarni, Prasad S</creatorcontrib><creatorcontrib>Padmapriyadarsini, Chandrasekaran</creatorcontrib><creatorcontrib>Vekemans, Johan</creatorcontrib><creatorcontrib>Bavdekar, Ashish</creatorcontrib><creatorcontrib>Gupta, Madhu</creatorcontrib><creatorcontrib>Kulkarni, Praveen</creatorcontrib><creatorcontrib>Garg, B S</creatorcontrib><creatorcontrib>Gogtay, Nithya J</creatorcontrib><creatorcontrib>Tambe, Muralidhar</creatorcontrib><creatorcontrib>Lalwani, Sanjay</creatorcontrib><creatorcontrib>Singh, Kiranjit</creatorcontrib><creatorcontrib>Munshi, Renuka</creatorcontrib><creatorcontrib>Meshram, Sushant</creatorcontrib><creatorcontrib>Selvavinayagam, T S</creatorcontrib><creatorcontrib>Pandey, Krishna</creatorcontrib><creatorcontrib>Bhimarasetty, Devi Madhavi</creatorcontrib><creatorcontrib>Ramakrishnan, S R</creatorcontrib><creatorcontrib>Bhamare, Chetanraj</creatorcontrib><creatorcontrib>Dharmadhikari, Abhijeet</creatorcontrib><creatorcontrib>Vadakkedath, Rajeev</creatorcontrib><creatorcontrib>Bonhomme, Cyrille J</creatorcontrib><creatorcontrib>Thakar, Madhuri</creatorcontrib><creatorcontrib>Kurle, Swarali N</creatorcontrib><creatorcontrib>Kelly, Elizabeth J</creatorcontrib><creatorcontrib>Gautam, Manish</creatorcontrib><creatorcontrib>Gupta, Nivedita</creatorcontrib><creatorcontrib>Panda, Samiran</creatorcontrib><creatorcontrib>Bhargava, Balram</creatorcontrib><creatorcontrib>Shaligram, Umesh</creatorcontrib><creatorcontrib>Kapse, Dhananjay</creatorcontrib><creatorcontrib>Gunale, Bhagwat</creatorcontrib><creatorcontrib>COVISHIELD Study Group</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>EClinicalMedicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kulkarni, Prasad S</au><au>Padmapriyadarsini, Chandrasekaran</au><au>Vekemans, Johan</au><au>Bavdekar, Ashish</au><au>Gupta, Madhu</au><au>Kulkarni, Praveen</au><au>Garg, B S</au><au>Gogtay, Nithya J</au><au>Tambe, Muralidhar</au><au>Lalwani, Sanjay</au><au>Singh, Kiranjit</au><au>Munshi, Renuka</au><au>Meshram, Sushant</au><au>Selvavinayagam, T S</au><au>Pandey, Krishna</au><au>Bhimarasetty, Devi Madhavi</au><au>Ramakrishnan, S R</au><au>Bhamare, Chetanraj</au><au>Dharmadhikari, Abhijeet</au><au>Vadakkedath, Rajeev</au><au>Bonhomme, Cyrille J</au><au>Thakar, Madhuri</au><au>Kurle, Swarali N</au><au>Kelly, Elizabeth J</au><au>Gautam, Manish</au><au>Gupta, Nivedita</au><au>Panda, Samiran</au><au>Bhargava, Balram</au><au>Shaligram, Umesh</au><au>Kapse, Dhananjay</au><au>Gunale, Bhagwat</au><aucorp>COVISHIELD Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India</atitle><jtitle>EClinicalMedicine</jtitle><addtitle>EClinicalMedicine</addtitle><date>2021-12-01</date><risdate>2021</risdate><volume>42</volume><spage>101218</spage><epage>101218</epage><pages>101218-101218</pages><artnum>101218</artnum><issn>2589-5370</issn><eissn>2589-5370</eissn><abstract>This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca.
This participant-blind, observer-blind study randomised participants 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (ChAdOx1 nCoV-19) (immunogenicity/reactogenicity cohort) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort). The study participants were enrolled from 14 hospitals across India between August 25 and October 31, 2020. Two doses of study products were given 4 weeks apart. The primary objectives were to demonstrate non-inferiority of SII-ChAdOx1 nCoV-19 to AZD1222 in terms of geometric mean titre (GMT) ratio of anti-SARS-CoV-2 spike IgG antibodies 28 days after the second dose (defined as lower limit of 95% CI >0·67) and to determine the incidence of serious adverse events (SAEs) causally related to SII-ChAdOx1 nCoV-19. The anti-spike IgG response was assessed using a multiplexed electrochemiluminescence-based immunoassay. Safety follow-up continued until 6 months after first dose. Trial registration: CTRI/2020/08/027170.
1601 participants were enrolled: 401 to the immunogenicity/reactogenicity cohort and 1200 to the safety cohort. After two doses, seroconversion rates for anti-spike IgG antibodies were more than 98·0% in both the groups. SII-ChAdOx1 nCoV-19 was non-inferior to AZD1222 (GMT ratio 0·98; 95% CI 0·78–1·23). SAEs were reported in ≤ 2·0% participants across the three groups; none were causally related. A total of 34 SARS-CoV-2 infections were reported; of which 6 occurred more than 2 weeks after the second dose; none were severe.
SII-ChAdOx1 nCoV-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile. Pharmacovigilance should be maintained to detect any safety signals.
SIIPL funded the contract research organisation and laboratory costs, while the site costs were funded by the Indian Council of Medical Research. The study vaccines were supplied by SIIPL and AstraZeneca.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>34870133</pmid><doi>10.1016/j.eclinm.2021.101218</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0002-2848-3089</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2589-5370 |
| ispartof | EClinicalMedicine, 2021-12, Vol.42, p.101218-101218, Article 101218 |
| issn | 2589-5370 2589-5370 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8629682 |
| source | PubMed Central; Directory of Open Access Journals; Alma/SFX Local Collection; EZB Electronic Journals Library |
| subjects | AZD1222 COVID-19 Immunogenicity Research Paper Safety SII-ChAdOx1 nCoV-19 |
| title | A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-20T15%3A22%3A27IST&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=A%20phase%202/3,%20participant-blind,%20observer-blind,%20randomised,%20controlled%20study%20to%20assess%20the%20safety%20and%20immunogenicity%20of%20SII-ChAdOx1%20nCoV-19%20(COVID-19%20vaccine)%20in%20adults%20in%20India&rft.jtitle=EClinicalMedicine&rft.au=Kulkarni,%20Prasad%20S&rft.aucorp=COVISHIELD%20Study%20Group&rft.date=2021-12-01&rft.volume=42&rft.spage=101218&rft.epage=101218&rft.pages=101218-101218&rft.artnum=101218&rft.issn=2589-5370&rft.eissn=2589-5370&rft_id=info:doi/10.1016/j.eclinm.2021.101218&rft_dat=%3Cproquest_pubme%3E2607300514%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=2607300514&rft_id=info:pmid/34870133&rft_els_id=S2589537021004995&rfr_iscdi=true |