Immunogenicity, safety and consistency of seven lots of an inactivated COVID-19 vaccine in healthy children and adolescents: a randomized, double-blind, controlled, phase IV clinical trial
BackgroundCoronaVac has been authorized worldwide for preventing coronavirus disease 2019. Information on the safety, immunogenicity and consistency of different lots and workshops of CoronaVac is presented here.MethodsIn this randomized, double-blind, phase IV clinical trial in healthy children and...
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Frontiers Media S.A.
2024-01-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2023.1320352/full |
| _version_ | 1827390343293698048 |
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| author | Weijun Hu Xiaoyu Liu Xi Lu Dan Zhang Shuo Liu Xianjin Gu Dan Liu Jianwen Sun Tiantian Zhou Xinge Li Yongjun Gao Yanwei Zhao Guoliang Cui Shaobai Zhang |
| author_facet | Weijun Hu Xiaoyu Liu Xi Lu Dan Zhang Shuo Liu Xianjin Gu Dan Liu Jianwen Sun Tiantian Zhou Xinge Li Yongjun Gao Yanwei Zhao Guoliang Cui Shaobai Zhang |
| author_sort | Weijun Hu |
| collection | DOAJ |
| description | BackgroundCoronaVac has been authorized worldwide for preventing coronavirus disease 2019. Information on the safety, immunogenicity and consistency of different lots and workshops of CoronaVac is presented here.MethodsIn this randomized, double-blind, phase IV clinical trial in healthy children and adolescents aged 3-17 years, we aimed to assess the lot-to-lot and workshop-to-workshop consistency, as well as immunogenicity and safety of seven lots of commercial-scale CoronaVac from three workshops. Eligible participants were enrolled into three age cohorts (3-5, 6-11 and 12-17 years). Within each cohort, participants were randomly assigned to seven groups to receive two doses of CoronaVac, with four weeks apart. Serum samples were collected before the first dose and 28 days after the second dose for neutralizing antibody testing. The primary objective was to evaluate the consistency of immune response among different lots within workshop 2 or 3, as well as among different workshops. The primary endpoint was geometric mean titer (GMT) of neutralizing antibody at 28 days after full-course vaccination.ResultsBetween July 27th and November 19th, 2021, a total of 2,520 eligible participants were enrolled. Results showed that 95% confidence intervals (CIs) of GMT ratios for all comparative groups among different lots or workshops were within the equivalence criteria of [0.67, 1.5]. The GMT and seroconversion rate for all participants were 126.42 (95%CI: 121.82, 131.19) and 99.86% (95%CI: 99.59%, 99.97%) at 28 days after two-dose vaccination. The incidences of adverse reactions were similar among seven lots, and most adverse reactions were mild in Grade 1, with no serious adverse event.ConclusionCoronaVac is well-tolerated and can elicit a good immune response among children and adolescents. Lot-to-lot consistency results indicate stable manufacturing of commercial-scale CoronaVac. |
| first_indexed | 2024-03-08T16:51:14Z |
| format | Article |
| id | doaj.art-9b95c89cc5d340e28e6285f47cd53fc6 |
| institution | Directory Open Access Journal |
| issn | 1664-3224 |
| language | English |
| last_indexed | 2024-03-08T16:51:14Z |
| publishDate | 2024-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Immunology |
| spelling | doaj.art-9b95c89cc5d340e28e6285f47cd53fc62024-01-05T04:35:38ZengFrontiers Media S.A.Frontiers in Immunology1664-32242024-01-011410.3389/fimmu.2023.13203521320352Immunogenicity, safety and consistency of seven lots of an inactivated COVID-19 vaccine in healthy children and adolescents: a randomized, double-blind, controlled, phase IV clinical trialWeijun Hu0Xiaoyu Liu1Xi Lu2Dan Zhang3Shuo Liu4Xianjin Gu5Dan Liu6Jianwen Sun7Tiantian Zhou8Xinge Li9Yongjun Gao10Yanwei Zhao11Guoliang Cui12Shaobai Zhang13Institute of Immunization Program, Shaanxi Provincial Center for Disease Control and Prevention, Xi’an, ChinaInstitute of Immunization Program, Shaanxi Provincial Center for Disease Control and Prevention, Xi’an, ChinaMedical Affairs Department, Sinovac Biotech Co., Ltd., Beijing, ChinaInstitute of Immunization Program, Shaanxi Provincial Center for Disease Control and Prevention, Xi’an, ChinaClinical Research and Development Center, Sinovac Biotech Co., Ltd., Beijing, ChinaDepartment of Immunization Program, Yanliang District Center for Disease Control and Prevention, Xi’an, ChinaDepartment of Immunization Program, Yanliang District Center for Disease Control and Prevention, Xi’an, ChinaMedical Affairs Department, Sinovac Life Sciences Co., Ltd., Beijing, ChinaInstitute of Immunization Program, Shaanxi Provincial Center for Disease Control and Prevention, Xi’an, ChinaClinical Research and Development Center, Sinovac Biotech Co., Ltd., Beijing, ChinaMedical Affairs Department, Sinovac Biotech Co., Ltd., Beijing, ChinaMedical Affairs Department, Sinovac Life Sciences Co., Ltd., Beijing, ChinaQuality Assurance Department, Sinovac Life Sciences Co., Ltd., Beijing, ChinaInstitute of Immunization Program, Shaanxi Provincial Center for Disease Control and Prevention, Xi’an, ChinaBackgroundCoronaVac has been authorized worldwide for preventing coronavirus disease 2019. Information on the safety, immunogenicity and consistency of different lots and workshops of CoronaVac is presented here.MethodsIn this randomized, double-blind, phase IV clinical trial in healthy children and adolescents aged 3-17 years, we aimed to assess the lot-to-lot and workshop-to-workshop consistency, as well as immunogenicity and safety of seven lots of commercial-scale CoronaVac from three workshops. Eligible participants were enrolled into three age cohorts (3-5, 6-11 and 12-17 years). Within each cohort, participants were randomly assigned to seven groups to receive two doses of CoronaVac, with four weeks apart. Serum samples were collected before the first dose and 28 days after the second dose for neutralizing antibody testing. The primary objective was to evaluate the consistency of immune response among different lots within workshop 2 or 3, as well as among different workshops. The primary endpoint was geometric mean titer (GMT) of neutralizing antibody at 28 days after full-course vaccination.ResultsBetween July 27th and November 19th, 2021, a total of 2,520 eligible participants were enrolled. Results showed that 95% confidence intervals (CIs) of GMT ratios for all comparative groups among different lots or workshops were within the equivalence criteria of [0.67, 1.5]. The GMT and seroconversion rate for all participants were 126.42 (95%CI: 121.82, 131.19) and 99.86% (95%CI: 99.59%, 99.97%) at 28 days after two-dose vaccination. The incidences of adverse reactions were similar among seven lots, and most adverse reactions were mild in Grade 1, with no serious adverse event.ConclusionCoronaVac is well-tolerated and can elicit a good immune response among children and adolescents. Lot-to-lot consistency results indicate stable manufacturing of commercial-scale CoronaVac.https://www.frontiersin.org/articles/10.3389/fimmu.2023.1320352/fullCoronaVaclot-to-lot consistencyimmunogenicitysafetychildren and adolescents |
| spellingShingle | Weijun Hu Xiaoyu Liu Xi Lu Dan Zhang Shuo Liu Xianjin Gu Dan Liu Jianwen Sun Tiantian Zhou Xinge Li Yongjun Gao Yanwei Zhao Guoliang Cui Shaobai Zhang Immunogenicity, safety and consistency of seven lots of an inactivated COVID-19 vaccine in healthy children and adolescents: a randomized, double-blind, controlled, phase IV clinical trial Frontiers in Immunology CoronaVac lot-to-lot consistency immunogenicity safety children and adolescents |
| title | Immunogenicity, safety and consistency of seven lots of an inactivated COVID-19 vaccine in healthy children and adolescents: a randomized, double-blind, controlled, phase IV clinical trial |
| title_full | Immunogenicity, safety and consistency of seven lots of an inactivated COVID-19 vaccine in healthy children and adolescents: a randomized, double-blind, controlled, phase IV clinical trial |
| title_fullStr | Immunogenicity, safety and consistency of seven lots of an inactivated COVID-19 vaccine in healthy children and adolescents: a randomized, double-blind, controlled, phase IV clinical trial |
| title_full_unstemmed | Immunogenicity, safety and consistency of seven lots of an inactivated COVID-19 vaccine in healthy children and adolescents: a randomized, double-blind, controlled, phase IV clinical trial |
| title_short | Immunogenicity, safety and consistency of seven lots of an inactivated COVID-19 vaccine in healthy children and adolescents: a randomized, double-blind, controlled, phase IV clinical trial |
| title_sort | immunogenicity safety and consistency of seven lots of an inactivated covid 19 vaccine in healthy children and adolescents a randomized double blind controlled phase iv clinical trial |
| topic | CoronaVac lot-to-lot consistency immunogenicity safety children and adolescents |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2023.1320352/full |
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