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 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
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| Enthalten in: |
Human vaccines & immunotherapeutics - 19(2023), 1 vom: 31. Dez., Seite 2203632 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Thuluva, Subhash [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 28.06.2023 Date Revised 01.07.2023 published: Print-Electronic CTRI: CTRI/2021/08/036074 Citation Status MEDLINE |
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| doi: |
10.1080/21645515.2023.2203632 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM356165876 |
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| 100 | 1 | |a Thuluva, Subhash |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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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| 500 | |a Date Completed 28.06.2023 | ||
| 500 | |a Date Revised 01.07.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CTRI: CTRI/2021/08/036074 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
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| 700 | 1 | |a Turaga, Kishore |e verfasserin |4 aut | |
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| 700 | 1 | |a Manoharan, Senthil Kumar |e verfasserin |4 aut | |
| 700 | 1 | |a Adabala, Srikanth |e verfasserin |4 aut | |
| 700 | 1 | |a Sri Javvadi, Aditya |e verfasserin |4 aut | |
| 700 | 1 | |a Medigeshi, Guruprasad |e verfasserin |4 aut | |
| 700 | 1 | |a Singh, Janmejay |e verfasserin |4 aut | |
| 700 | 1 | |a Shaman, Heena |e verfasserin |4 aut | |
| 700 | 1 | |a Binayke, Akshay |e verfasserin |4 aut | |
| 700 | 1 | |a Zaheer, Aymaan |e verfasserin |4 aut | |
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| 700 | 1 | |a Singh, Chandramani |e verfasserin |4 aut | |
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| 700 | 1 | |a Basu, Indranil |e verfasserin |4 aut | |
| 700 | 1 | |a Kumar, Khobragade Akash Ashok |e verfasserin |4 aut | |
| 700 | 1 | |a Pandey, Anil Kumar |e verfasserin |4 aut | |
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