Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial
Antibody persistence and safety up to 12 months of heterologous orally administered adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in individuals who were primed with two-dose inactivated SARS-CoV-2 vaccine (CoronaVac) previously, has not been reported yet. This randomized, open-label, s...
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Taylor & Francis Group
2023-12-01
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| Series: | Emerging Microbes and Infections |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/22221751.2022.2155251 |
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| author | Lairun Jin Rong Tang Shipo Wu Xiling Guo Haitao Huang Lihua Hou Xiaoqin Chen Tao Zhu Jinbo Gou Jin Zhong Hongxing Pan Lunbiao Cui Yin Chen Xin Xia Jialu Feng Xue Wang Qi Zhao XiaoYu Xu Zhuopei Li Xiaoyin Zhang Wei Chen Jingxin Li Fengcai Zhu |
| author_facet | Lairun Jin Rong Tang Shipo Wu Xiling Guo Haitao Huang Lihua Hou Xiaoqin Chen Tao Zhu Jinbo Gou Jin Zhong Hongxing Pan Lunbiao Cui Yin Chen Xin Xia Jialu Feng Xue Wang Qi Zhao XiaoYu Xu Zhuopei Li Xiaoyin Zhang Wei Chen Jingxin Li Fengcai Zhu |
| author_sort | Lairun Jin |
| collection | DOAJ |
| description | Antibody persistence and safety up to 12 months of heterologous orally administered adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in individuals who were primed with two-dose inactivated SARS-CoV-2 vaccine (CoronaVac) previously, has not been reported yet. This randomized, open-label, single-centre trial included Chinese adults who have received two-dose CoronaVac randomized to low-dose or high-dose aerosolised Ad5-nCoV group, or CoronaVac group. In this report, we mainly evaluated the geometric mean titres (GMTs) of neutralizing antibodies (NAbs) against live wild-type SARS-CoV-2 virus and omicron BA.4/5 pseudovirus at 12 months after the booster dose and the incidence of serious adverse events (SAEs) till month 12. Of 419 participants, all were included in the safety analysis and 120 (28.64%) were included in the immunogenicity analysis. Serum NAb GMT against live wild-type SARS-CoV-2 was 204.36 (95% CI 152.91, 273.14) in the low-dose group and 171.38 (95% CI 121.27, 242.19) in the high-dose group at month 12, significantly higher than the GMT in the CoronaVac group (8.00 [95% CI 4.22, 15.17], p < 0.0001). Serum NAb GMT against omicron BA.4/5 pseudovirus was 40.97 (95% CI 30.15, 55.67) in the low-dose group and 35.08 (95% CI 26.31, 46.77) in the high-dose group at month 12, whereas the GMT in the CoronaVac group was below the lower limit of detection. No vaccine-related SAEs were observed. Orally administered aerosolised Ad5-nCoV following two-dose CoronaVac priming has a good safety profile and is persistently more immunogenic than three-dose CoronaVac within 12 months after the booster dose.Trial registration: ClinicalTrials.gov identifier: NCT05043259.. |
| format | Article |
| id | doaj-art-952e19af7a5242b6bd29e417ed9ab9af |
| institution | Kabale University |
| issn | 2222-1751 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Emerging Microbes and Infections |
| spelling | doaj-art-952e19af7a5242b6bd29e417ed9ab9af2025-08-20T03:52:56ZengTaylor & Francis GroupEmerging Microbes and Infections2222-17512023-12-0112110.1080/22221751.2022.2155251Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trialLairun Jin0Rong Tang1Shipo Wu2Xiling Guo3Haitao Huang4Lihua Hou5Xiaoqin Chen6Tao Zhu7Jinbo Gou8Jin Zhong9Hongxing Pan10Lunbiao Cui11Yin Chen12Xin Xia13Jialu Feng14Xue Wang15Qi Zhao16XiaoYu Xu17Zhuopei Li18Xiaoyin Zhang19Wei Chen20Jingxin Li21Fengcai Zhu22School of Public Health, Southeast University, Nanjing, People’s Republic of ChinaNational Health Commission (NHC) Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, People’s Republic of ChinaBeijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, People’s Republic of ChinaNational Health Commission (NHC) Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, People’s Republic of ChinaCansino Biologics Inc., Tianjin, People’s Republic of ChinaBeijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, People’s Republic of ChinaDonghai County Center for Disease Control and Prevention, Lianyungang, Jiangsu, People’s Republic of ChinaCansino Biologics Inc., Tianjin, People’s Republic of ChinaCansino Biologics Inc., Tianjin, People’s Republic of ChinaDonghai County Center for Disease Control and Prevention, Lianyungang, Jiangsu, People’s Republic of ChinaNational Health Commission (NHC) Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, People’s Republic of ChinaNational Health Commission (NHC) Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, People’s Republic of ChinaNational Health Commission (NHC) Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, People’s Republic of ChinaSchool of Public Health, Nanjing Medical University, Nanjing, People’s Republic of ChinaSchool of Public Health, Nanjing Medical University, Nanjing, People’s Republic of ChinaCansino Biologics Inc., Tianjin, People’s Republic of ChinaCansino Biologics Inc., Tianjin, People’s Republic of ChinaVazyme Biotech Co., Ltd, Nanjing, People’s Republic of ChinaSchool of Public Health, Nanjing Medical University, Nanjing, People’s Republic of ChinaSchool of Public Health, Southeast University, Nanjing, People’s Republic of ChinaBeijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, People’s Republic of ChinaNational Health Commission (NHC) Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, People’s Republic of ChinaSchool of Public Health, Southeast University, Nanjing, People’s Republic of ChinaAntibody persistence and safety up to 12 months of heterologous orally administered adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in individuals who were primed with two-dose inactivated SARS-CoV-2 vaccine (CoronaVac) previously, has not been reported yet. This randomized, open-label, single-centre trial included Chinese adults who have received two-dose CoronaVac randomized to low-dose or high-dose aerosolised Ad5-nCoV group, or CoronaVac group. In this report, we mainly evaluated the geometric mean titres (GMTs) of neutralizing antibodies (NAbs) against live wild-type SARS-CoV-2 virus and omicron BA.4/5 pseudovirus at 12 months after the booster dose and the incidence of serious adverse events (SAEs) till month 12. Of 419 participants, all were included in the safety analysis and 120 (28.64%) were included in the immunogenicity analysis. Serum NAb GMT against live wild-type SARS-CoV-2 was 204.36 (95% CI 152.91, 273.14) in the low-dose group and 171.38 (95% CI 121.27, 242.19) in the high-dose group at month 12, significantly higher than the GMT in the CoronaVac group (8.00 [95% CI 4.22, 15.17], p < 0.0001). Serum NAb GMT against omicron BA.4/5 pseudovirus was 40.97 (95% CI 30.15, 55.67) in the low-dose group and 35.08 (95% CI 26.31, 46.77) in the high-dose group at month 12, whereas the GMT in the CoronaVac group was below the lower limit of detection. No vaccine-related SAEs were observed. Orally administered aerosolised Ad5-nCoV following two-dose CoronaVac priming has a good safety profile and is persistently more immunogenic than three-dose CoronaVac within 12 months after the booster dose.Trial registration: ClinicalTrials.gov identifier: NCT05043259..https://www.tandfonline.com/doi/10.1080/22221751.2022.2155251COVID-19 vaccinesbooster doselong-term immunityheterologousorally administration |
| spellingShingle | Lairun Jin Rong Tang Shipo Wu Xiling Guo Haitao Huang Lihua Hou Xiaoqin Chen Tao Zhu Jinbo Gou Jin Zhong Hongxing Pan Lunbiao Cui Yin Chen Xin Xia Jialu Feng Xue Wang Qi Zhao XiaoYu Xu Zhuopei Li Xiaoyin Zhang Wei Chen Jingxin Li Fengcai Zhu Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial Emerging Microbes and Infections COVID-19 vaccines booster dose long-term immunity heterologous orally administration |
| title | Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial |
| title_full | Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial |
| title_fullStr | Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial |
| title_full_unstemmed | Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial |
| title_short | Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial |
| title_sort | antibody persistence and safety after heterologous boosting with orally aerosolised ad5 ncov in individuals primed with two dose coronavac previously 12 month analyses of a randomized controlled trial |
| topic | COVID-19 vaccines booster dose long-term immunity heterologous orally administration |
| url | https://www.tandfonline.com/doi/10.1080/22221751.2022.2155251 |
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