Safety and immunogenicity of a modified Omicron-adapted inactivated vaccine in healthy adults: a randomized, double-blind, active-controlled Phase III clinical trial
Background Updated vaccine strategies are needed to protect against new SARS-CoV-2 variants with increased immune escape. Here, information on the safety and immunogenicity of an inactivated Omicron-adapted vaccine is presented, as compared with CoronaVac. Methods A randomized, double-blind, active-...
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Published in | Frontiers in immunology Vol. 14; p. 1241153 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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18.09.2023
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Abstract | Background
Updated vaccine strategies are needed to protect against new SARS-CoV-2 variants with increased immune escape. Here, information on the safety and immunogenicity of an inactivated Omicron-adapted vaccine is presented, as compared with CoronaVac.
Methods
A randomized, double-blind, active-controlled, phase III clinical trial was conducted to compare a modified Omicron-adapted vaccine (Omicron vaccine) with the authorized prototype vaccine (CoronaVac®) as a booster dose. Healthy adults aged ≥18 years, who have previously received 2 or 3 doses of CoronaVac (2C or 3C cohort) at least 6 months before, were enrolled to get a booster dose of Omicron vaccine or CoronaVac in a ratio of 2:1 (2C/3C+1O/1C). Back-up serums after two initial doses of CoronaVac (2C+0) for adults aged 26-45 years were collected from a previous study. Immunogenicity and safety data at 28 days after vaccination were collected and analyzed. One of the primary objectives was to evaluate the superiority of immunogenicity of Omicron vaccine booster against Omicron BA.1, compared with CoronaVac booster against BA.1. Another objective was to evaluate the non-inferiority of immunogenicity of Omicron vaccine booster against BA.1, compared with two initial doses of CoronaVac against ancestral strain.
Results
Between June 1
st
and July 21
st
, 2022, a total of 1,500 healthy adults were enrolled. Results show that all pre-specified superiority criteria for BA.1 neutralizing antibody were met. Specifically, within the 3C cohort (3C+1O vs. 3C+1C), the geometric mean titers’ (GMT) ratio and 95% confidence interval (CI) was 1.64 (1.42, 1.89), with the lower 95%CI ≥1; a GMT ratio of 1.84 (1.57, 2.16) was observed for 2C+1O versus 3C+1C. For seroconversion rate, the lower 95%CIs of differences between immuno-comparative groups (2/3C+1O vs. 3C+1C) were all above the superiority criterion 0%. However, the non-inferiority criterion of the lower 95%CI of GMT ratio ≥2/3 was unfulfilled for 2C/3C+1O against BA.1 versus 2C+0 against ancestral strain. Safety profiles were similar between groups, with no safety concerns identified.
Conclusion
The Omicron-adapted vaccine was well-tolerated and could elicit superior immune responses as compared with CoronaVac against Omicron, while it appeared inferior to CoronaVac against ancestral strain.
Clinical trial registration
https://classic.clinicaltrials.gov/ct2/show/NCT05381350?term=NCT05381350&draw=2&rank=1
, identifier NCT05381350. |
---|---|
AbstractList | Background
Updated vaccine strategies are needed to protect against new SARS-CoV-2 variants with increased immune escape. Here, information on the safety and immunogenicity of an inactivated Omicron-adapted vaccine is presented, as compared with CoronaVac.
Methods
A randomized, double-blind, active-controlled, phase III clinical trial was conducted to compare a modified Omicron-adapted vaccine (Omicron vaccine) with the authorized prototype vaccine (CoronaVac®) as a booster dose. Healthy adults aged ≥18 years, who have previously received 2 or 3 doses of CoronaVac (2C or 3C cohort) at least 6 months before, were enrolled to get a booster dose of Omicron vaccine or CoronaVac in a ratio of 2:1 (2C/3C+1O/1C). Back-up serums after two initial doses of CoronaVac (2C+0) for adults aged 26-45 years were collected from a previous study. Immunogenicity and safety data at 28 days after vaccination were collected and analyzed. One of the primary objectives was to evaluate the superiority of immunogenicity of Omicron vaccine booster against Omicron BA.1, compared with CoronaVac booster against BA.1. Another objective was to evaluate the non-inferiority of immunogenicity of Omicron vaccine booster against BA.1, compared with two initial doses of CoronaVac against ancestral strain.
Results
Between June 1
st
and July 21
st
, 2022, a total of 1,500 healthy adults were enrolled. Results show that all pre-specified superiority criteria for BA.1 neutralizing antibody were met. Specifically, within the 3C cohort (3C+1O vs. 3C+1C), the geometric mean titers’ (GMT) ratio and 95% confidence interval (CI) was 1.64 (1.42, 1.89), with the lower 95%CI ≥1; a GMT ratio of 1.84 (1.57, 2.16) was observed for 2C+1O versus 3C+1C. For seroconversion rate, the lower 95%CIs of differences between immuno-comparative groups (2/3C+1O vs. 3C+1C) were all above the superiority criterion 0%. However, the non-inferiority criterion of the lower 95%CI of GMT ratio ≥2/3 was unfulfilled for 2C/3C+1O against BA.1 versus 2C+0 against ancestral strain. Safety profiles were similar between groups, with no safety concerns identified.
Conclusion
The Omicron-adapted vaccine was well-tolerated and could elicit superior immune responses as compared with CoronaVac against Omicron, while it appeared inferior to CoronaVac against ancestral strain.
Clinical trial registration
https://classic.clinicaltrials.gov/ct2/show/NCT05381350?term=NCT05381350&draw=2&rank=1
, identifier NCT05381350. BackgroundUpdated vaccine strategies are needed to protect against new SARS-CoV-2 variants with increased immune escape. Here, information on the safety and immunogenicity of an inactivated Omicron-adapted vaccine is presented, as compared with CoronaVac.MethodsA randomized, double-blind, active-controlled, phase III clinical trial was conducted to compare a modified Omicron-adapted vaccine (Omicron vaccine) with the authorized prototype vaccine (CoronaVac®) as a booster dose. Healthy adults aged ≥18 years, who have previously received 2 or 3 doses of CoronaVac (2C or 3C cohort) at least 6 months before, were enrolled to get a booster dose of Omicron vaccine or CoronaVac in a ratio of 2:1 (2C/3C+1O/1C). Back-up serums after two initial doses of CoronaVac (2C+0) for adults aged 26-45 years were collected from a previous study. Immunogenicity and safety data at 28 days after vaccination were collected and analyzed. One of the primary objectives was to evaluate the superiority of immunogenicity of Omicron vaccine booster against Omicron BA.1, compared with CoronaVac booster against BA.1. Another objective was to evaluate the non-inferiority of immunogenicity of Omicron vaccine booster against BA.1, compared with two initial doses of CoronaVac against ancestral strain.ResultsBetween June 1st and July 21st, 2022, a total of 1,500 healthy adults were enrolled. Results show that all pre-specified superiority criteria for BA.1 neutralizing antibody were met. Specifically, within the 3C cohort (3C+1O vs. 3C+1C), the geometric mean titers’ (GMT) ratio and 95% confidence interval (CI) was 1.64 (1.42, 1.89), with the lower 95%CI ≥1; a GMT ratio of 1.84 (1.57, 2.16) was observed for 2C+1O versus 3C+1C. For seroconversion rate, the lower 95%CIs of differences between immuno-comparative groups (2/3C+1O vs. 3C+1C) were all above the superiority criterion 0%. However, the non-inferiority criterion of the lower 95%CI of GMT ratio ≥2/3 was unfulfilled for 2C/3C+1O against BA.1 versus 2C+0 against ancestral strain. Safety profiles were similar between groups, with no safety concerns identified.ConclusionThe Omicron-adapted vaccine was well-tolerated and could elicit superior immune responses as compared with CoronaVac against Omicron, while it appeared inferior to CoronaVac against ancestral strain.Clinical trial registrationhttps://classic.clinicaltrials.gov/ct2/show/NCT05381350?term=NCT05381350&draw=2&rank=1, identifier NCT05381350. |
Author | Chu, Kai Wang, Kaiqin Hu, Jialei Liu, Yueyue Shu, Qun Qiao, Yaping Hu, Yaling Liu, Shuo Yang, Xuenan Pan, Hongxing |
AuthorAffiliation | 3 Clinical Research and Development Center, Sinovac Biotech Co., Ltd. , Beijing , China 1 Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention , Nanjing, Jiangsu , China 5 Center of Research and Development, Sinovac Life Sciences Co., Ltd. , Beijing , China 2 Division of Respiratory Virus Vaccines, Institute for Biological Product Control, National Institutes for Food and Drug Control , Beijing , China 4 Statistics and Decision Science, Beijing Key Tech Statistics Technology Co., Ltd. , Beijing , China |
AuthorAffiliation_xml | – name: 1 Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention , Nanjing, Jiangsu , China – name: 4 Statistics and Decision Science, Beijing Key Tech Statistics Technology Co., Ltd. , Beijing , China – name: 2 Division of Respiratory Virus Vaccines, Institute for Biological Product Control, National Institutes for Food and Drug Control , Beijing , China – name: 3 Clinical Research and Development Center, Sinovac Biotech Co., Ltd. , Beijing , China – name: 5 Center of Research and Development, Sinovac Life Sciences Co., Ltd. , Beijing , China |
Author_xml | – sequence: 1 givenname: Jialei surname: Hu fullname: Hu, Jialei – sequence: 2 givenname: Yueyue surname: Liu fullname: Liu, Yueyue – sequence: 3 givenname: Shuo surname: Liu fullname: Liu, Shuo – sequence: 4 givenname: Qun surname: Shu fullname: Shu, Qun – sequence: 5 givenname: Xuenan surname: Yang fullname: Yang, Xuenan – sequence: 6 givenname: Kai surname: Chu fullname: Chu, Kai – sequence: 7 givenname: Yaping surname: Qiao fullname: Qiao, Yaping – sequence: 8 givenname: Yaling surname: Hu fullname: Hu, Yaling – sequence: 9 givenname: Kaiqin surname: Wang fullname: Wang, Kaiqin – sequence: 10 givenname: Hongxing surname: Pan fullname: Pan, Hongxing |
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Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Reviewed by: Larry Ellingsworth, Novavax, Inc., United States; Elizabeth De Gaspari, Adolfo Lutz Institute, Brazil These authors have contributed equally to this work and share first authorship Edited by: Salman Sadullah Usmani, Albert Einstein College of Medicine, United States |
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References | B20 Reynolds (B29) 2022; 377 Chalkias (B16) 2022; 387 Wu (B21) 2021; 21 B24 Xia (B8) 2022; 7 B26 Adams (B11) 2022; 379 Gilboa (B30) 2022; 5 Jara (B7) 2021; 385 Bai (B2) 2022; 29 Peng (B31) 2022; 77 B12 B13 Zhang (B22) 2021; 21 Aguilar-Bretones (B28) 2023; 133 Wan (B33) 2022; 29 Mathieu (B3) 2020 Cele (B9) 2022; 602 Tanriover (B6) 2021; 398 McMenamin (B10) 2022; 22 B18 B19 Winokur (B15) 2023; 388 B4 B5 Zou (B17) 2023; 388 Zhu (B25) 2022; 18 Suryawanshi (B27) 2022; 607 Chalkias (B14) 2023 Han (B23) 2021; 21 Jung (B1) 2022; 96 Mok (B32) 2022; 27 |
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Snippet | Background
Updated vaccine strategies are needed to protect against new SARS-CoV-2 variants with increased immune escape. Here, information on the safety and... BackgroundUpdated vaccine strategies are needed to protect against new SARS-CoV-2 variants with increased immune escape. Here, information on the safety and... |
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Title | Safety and immunogenicity of a modified Omicron-adapted inactivated vaccine in healthy adults: a randomized, double-blind, active-controlled Phase III clinical trial |
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