Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults
AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1...
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2304974 |
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| author | Prasad S. Kulkarni Chandrasekaran Padmapriyadarsini Johan Vekemans Ashish Bavdekar Madhu Gupta Praveen Kulkarni B.S. Garg Nithya J. Gogtay Muralidhar Tambe Sanjay Lalwani Kiranjit Singh Renuka Munshi Sushant Meshram T.S. Selvavinayagam Krishna Pandey Devi Madhavi Bhimarasetty S.R. Ramakrishnan Chetanraj Bhamare Abhijeet Dharmadhikari Chandrashekhar Budhawant Cyrille J. Bonhomme Madhuri Thakar Swarali N. Kurle Elizabeth J. Kelly Manish Gautam Nivedita Gupta Samiran Panda Balram Bhargava Cyrus S. Poonawalla Umesh Shaligram Dhananjay Kapse Bhagwat Gunale |
| author_facet | Prasad S. Kulkarni Chandrasekaran Padmapriyadarsini Johan Vekemans Ashish Bavdekar Madhu Gupta Praveen Kulkarni B.S. Garg Nithya J. Gogtay Muralidhar Tambe Sanjay Lalwani Kiranjit Singh Renuka Munshi Sushant Meshram T.S. Selvavinayagam Krishna Pandey Devi Madhavi Bhimarasetty S.R. Ramakrishnan Chetanraj Bhamare Abhijeet Dharmadhikari Chandrashekhar Budhawant Cyrille J. Bonhomme Madhuri Thakar Swarali N. Kurle Elizabeth J. Kelly Manish Gautam Nivedita Gupta Samiran Panda Balram Bhargava Cyrus S. Poonawalla Umesh Shaligram Dhananjay Kapse Bhagwat Gunale |
| author_sort | Prasad S. Kulkarni |
| collection | DOAJ |
| description | AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41–0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44–1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated. |
| format | Article |
| id | doaj-art-8b89a3e8f8ac470894c80a7c06493aa6 |
| institution | OA Journals |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-8b89a3e8f8ac470894c80a7c06493aa62025-08-20T02:16:44ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2304974Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adultsPrasad S. Kulkarni0Chandrasekaran Padmapriyadarsini1Johan Vekemans2Ashish Bavdekar3Madhu Gupta4Praveen Kulkarni5B.S. Garg6Nithya J. Gogtay7Muralidhar Tambe8Sanjay Lalwani9Kiranjit Singh10Renuka Munshi11Sushant Meshram12T.S. Selvavinayagam13Krishna Pandey14Devi Madhavi Bhimarasetty15S.R. Ramakrishnan16Chetanraj Bhamare17Abhijeet Dharmadhikari18Chandrashekhar Budhawant19Cyrille J. Bonhomme20Madhuri Thakar21Swarali N. Kurle22Elizabeth J. Kelly23Manish Gautam24Nivedita Gupta25Samiran Panda26Balram Bhargava27Cyrus S. Poonawalla28Umesh Shaligram29Dhananjay Kapse30Bhagwat Gunale31Serum Institute of India Pvt Ltd, Pune, IndiaIndian Council of Medical Research, Delhi, IndiaFormerly of: Clinical Development, Infection, Late-stage Development, Respiratory and Immunology (R&I), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, SwedenKEM Hospital Research Centre, Pune, IndiaDepartment of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education & Research, Chandigarh, IndiaDepartment of Community Medicine, JSS Academy of Higher Education and Research, Mysore, IndiaDepartment of Community Medicine and Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Wardha, IndiaDepartment of Clinical Pharmacology, Seth G S Medical College & KEM Hospital, Mumbai, IndiaDepartment of Community Medicine, B J Government Medical College and Sassoon General Hospitals, Pune, IndiaDepartment of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, IndiaJehangir Clinical Development Centre Pvt Ltd, Pune, IndiaDepartment of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai, IndiaDepartment of Pulmonary Medicine, Government Medical College, Nagpur, IndiaDirectorate of Public Health and Preventive Medicine, Chennai, IndiaRajendra Memorial Research Institute of Medical Sciences, Patna, IndiaDepartment of Community Medicine, Andhra Medical College, Visakhapatnam, IndiaDepartment of Clinical Research, Sri Ramchandra Institute of Higher Education and Research, Chennai, IndiaSerum Institute of India Pvt Ltd, Pune, IndiaSerum Institute of India Pvt Ltd, Pune, IndiaBiostatistics, PPD India Pvt Ltd, Mumbai, IndiaLaboratory Services, Vaccines Sciences Lab, Clinical Research, PPD, Part of Thermo Fisher Scientific, Richmond, VA, USAIndian Council of Medical Research, Delhi, IndiaIndian Council of Medical Research, Delhi, IndiaFormerly of: Translational Medicine, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USASerum Institute of India Pvt Ltd, Pune, IndiaIndian Council of Medical Research, Delhi, IndiaIndian Council of Medical Research, Delhi, IndiaIndian Council of Medical Research, Delhi, IndiaSerum Institute of India Pvt Ltd, Pune, IndiaSerum Institute of India Pvt Ltd, Pune, IndiaSerum Institute of India Pvt Ltd, Pune, IndiaSerum Institute of India Pvt Ltd, Pune, IndiaAZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41–0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44–1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.https://www.tandfonline.com/doi/10.1080/21645515.2024.2304974SARS-CoV-2COVID-19 vaccineSII-ChAdOx1 nCoV-19AZD1222 (ChAdOx1 nCoV-19)safetyimmunogenicity |
| spellingShingle | Prasad S. Kulkarni Chandrasekaran Padmapriyadarsini Johan Vekemans Ashish Bavdekar Madhu Gupta Praveen Kulkarni B.S. Garg Nithya J. Gogtay Muralidhar Tambe Sanjay Lalwani Kiranjit Singh Renuka Munshi Sushant Meshram T.S. Selvavinayagam Krishna Pandey Devi Madhavi Bhimarasetty S.R. Ramakrishnan Chetanraj Bhamare Abhijeet Dharmadhikari Chandrashekhar Budhawant Cyrille J. Bonhomme Madhuri Thakar Swarali N. Kurle Elizabeth J. Kelly Manish Gautam Nivedita Gupta Samiran Panda Balram Bhargava Cyrus S. Poonawalla Umesh Shaligram Dhananjay Kapse Bhagwat Gunale Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults Human Vaccines & Immunotherapeutics SARS-CoV-2 COVID-19 vaccine SII-ChAdOx1 nCoV-19 AZD1222 (ChAdOx1 nCoV-19) safety immunogenicity |
| title | Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults |
| title_full | Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults |
| title_fullStr | Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults |
| title_full_unstemmed | Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults |
| title_short | Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults |
| title_sort | seropersistence of sii chadox1 ncov 19 covid 19 vaccine 6 month follow up of a randomized controlled observer blind phase 2 3 immuno bridging study in indian adults |
| topic | SARS-CoV-2 COVID-19 vaccine SII-ChAdOx1 nCoV-19 AZD1222 (ChAdOx1 nCoV-19) safety immunogenicity |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2304974 |
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