Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the waning of vaccine-elicited neutralizing antibodies suggests that additional coronavirus disease 2019 (COVID-19) vaccine doses may be needed for individuals who initially received CoronaVac. We evaluated th...

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Published in:	Nature medicine Vol. 28; no. 2; pp. 401 - 409
Main Authors:	Li, Jingxin, Hou, Lihua, Guo, Xiling, Jin, Pengfei, Wu, Shipo, Zhu, Jiahong, Pan, Hongxing, Wang, Xue, Song, Zhizhou, Wan, Jingxuan, Cui, Lunbiao, Li, Junqiang, Chen, Yin, Wang, Xuewen, Jin, Lairun, Liu, Jingxian, Shi, Fengjuan, Xu, Xiaoyu, Zhu, Tao, Chen, Wei, Zhu, Fengcai
Format:	Journal Article
Language:	English
Published:	New York Nature Publishing Group US 01.02.2022 Nature Publishing Group
Subjects:	631/250/2152/2153/1291 631/250/590/1883 692/308/2779/109/1943 Adenoviridae - immunology Adenoviruses Adolescent Adult Adults Antibodies Antibodies, Neutralizing - blood Antibodies, Viral - blood Biomedical and Life Sciences Biomedicine Cancer Research China Coronaviruses COVID-19 COVID-19 - immunology COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects COVID-19 Vaccines - immunology Female Homology Humans Immunization Immunization, Secondary Immunogenicity Immunogenicity, Vaccine - immunology Immunoglobulin G - blood Infectious Diseases Injection Site Reaction - pathology Male Metabolic Diseases Middle Aged Molecular Medicine Neurosciences Neutralizing SARS-CoV-2 - immunology Severe acute respiratory syndrome coronavirus 2 Side effects T-Lymphocytes - immunology Vaccination Vaccines Vaccines, Inactivated - immunology Viral diseases Young Adult China
ISSN:	1078-8956, 1546-170X, 1546-170X
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Abstract	The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the waning of vaccine-elicited neutralizing antibodies suggests that additional coronavirus disease 2019 (COVID-19) vaccine doses may be needed for individuals who initially received CoronaVac. We evaluated the safety and immunogenicity of the recombinant adenovirus type 5 (AD5)-vectored COVID-19 vaccine Convidecia as a heterologous booster versus those of CoronaVac as homologous booster in adults previously vaccinated with CoronaVac in an ongoing, randomized, observer-blinded, parallel-controlled phase 4 trial ( NCT04892459 ). Adults who had received two doses of CoronaVac in the past 3–6 months were vaccinated with Convidecia ( n = 96) or CoronaVac ( n = 102). Adults who had received one dose of CoronaVac in the past 1–3 months were also vaccinated with Convidecia ( n = 51) or CoronaVac ( n = 50). The co-primary endpoints were the occurrence of adverse reactions within 28 d after vaccination and geometric mean titers (GMTs) of neutralizing antibodies against live wild-type SARS-CoV-2 virus at 14 d after booster vaccination. Adverse reactions after vaccination were significantly more frequent in Convidecia recipients but were generally mild to moderate in all treatment groups. Heterologous boosting with Convidecia elicited significantly increased GMTs of neutralizing antibody against SARS-CoV-2 than homologous boosting with CoronaVac in participants who had previously received one or two doses of CoronaVac. These data suggest that heterologous boosting with Convidecia following initial vaccination with CoronaVac is safe and more immunogenic than homologous boosting. Heterologous vaccination with Convidecia, a recombinant adenovirus type 5-vectored COVID-19 vaccine, after one or two doses of CoronaVac, an inactivated SARS-CoV-2 vaccine, is more reactogenic but elicits significantly higher levels of neutralizing antibodies than homologous vaccination.
AbstractList	The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the waning of vaccine-elicited neutralizing antibodies suggests that additional coronavirus disease 2019 (COVID-19) vaccine doses may be needed for individuals who initially received CoronaVac. We evaluated the safety and immunogenicity of the recombinant adenovirus type 5 (AD5)-vectored COVID-19 vaccine Convidecia as a heterologous booster versus those of CoronaVac as homologous booster in adults previously vaccinated with CoronaVac in an ongoing, randomized, observer-blinded, parallel-controlled phase 4 trial (NCT04892459). Adults who had received two doses of CoronaVac in the past 3–6 months were vaccinated with Convidecia (n = 96) or CoronaVac (n = 102). Adults who had received one dose of CoronaVac in the past 1–3 months were also vaccinated with Convidecia (n = 51) or CoronaVac (n = 50). The co-primary endpoints were the occurrence of adverse reactions within 28 d after vaccination and geometric mean titers (GMTs) of neutralizing antibodies against live wild-type SARS-CoV-2 virus at 14 d after booster vaccination. Adverse reactions after vaccination were significantly more frequent in Convidecia recipients but were generally mild to moderate in all treatment groups. Heterologous boosting with Convidecia elicited significantly increased GMTs of neutralizing antibody against SARS-CoV-2 than homologous boosting with CoronaVac in participants who had previously received one or two doses of CoronaVac. These data suggest that heterologous boosting with Convidecia following initial vaccination with CoronaVac is safe and more immunogenic than homologous boosting. Heterologous vaccination with Convidecia, a recombinant adenovirus type 5-vectored COVID-19 vaccine, after one or two doses of CoronaVac, an inactivated SARS-CoV-2 vaccine, is more reactogenic but elicits significantly higher levels of neutralizing antibodies than homologous vaccination. The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the waning of vaccine-elicited neutralizing antibodies suggests that additional coronavirus disease 2019 (COVID-19) vaccine doses may be needed for individuals who initially received CoronaVac. We evaluated the safety and immunogenicity of the recombinant adenovirus type 5 (AD5)-vectored COVID-19 vaccine Convidecia as a heterologous booster versus those of CoronaVac as homologous booster in adults previously vaccinated with CoronaVac in an ongoing, randomized, observer-blinded, parallel-controlled phase 4 trial ( NCT04892459 ). Adults who had received two doses of CoronaVac in the past 3-6 months were vaccinated with Convidecia (n = 96) or CoronaVac (n = 102). Adults who had received one dose of CoronaVac in the past 1-3 months were also vaccinated with Convidecia (n = 51) or CoronaVac (n = 50). The co-primary endpoints were the occurrence of adverse reactions within 28 d after vaccination and geometric mean titers (GMTs) of neutralizing antibodies against live wild-type SARS-CoV-2 virus at 14 d after booster vaccination. Adverse reactions after vaccination were significantly more frequent in Convidecia recipients but were generally mild to moderate in all treatment groups. Heterologous boosting with Convidecia elicited significantly increased GMTs of neutralizing antibody against SARS-CoV-2 than homologous boosting with CoronaVac in participants who had previously received one or two doses of CoronaVac. These data suggest that heterologous boosting with Convidecia following initial vaccination with CoronaVac is safe and more immunogenic than homologous boosting.The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the waning of vaccine-elicited neutralizing antibodies suggests that additional coronavirus disease 2019 (COVID-19) vaccine doses may be needed for individuals who initially received CoronaVac. We evaluated the safety and immunogenicity of the recombinant adenovirus type 5 (AD5)-vectored COVID-19 vaccine Convidecia as a heterologous booster versus those of CoronaVac as homologous booster in adults previously vaccinated with CoronaVac in an ongoing, randomized, observer-blinded, parallel-controlled phase 4 trial ( NCT04892459 ). Adults who had received two doses of CoronaVac in the past 3-6 months were vaccinated with Convidecia (n = 96) or CoronaVac (n = 102). Adults who had received one dose of CoronaVac in the past 1-3 months were also vaccinated with Convidecia (n = 51) or CoronaVac (n = 50). The co-primary endpoints were the occurrence of adverse reactions within 28 d after vaccination and geometric mean titers (GMTs) of neutralizing antibodies against live wild-type SARS-CoV-2 virus at 14 d after booster vaccination. Adverse reactions after vaccination were significantly more frequent in Convidecia recipients but were generally mild to moderate in all treatment groups. Heterologous boosting with Convidecia elicited significantly increased GMTs of neutralizing antibody against SARS-CoV-2 than homologous boosting with CoronaVac in participants who had previously received one or two doses of CoronaVac. These data suggest that heterologous boosting with Convidecia following initial vaccination with CoronaVac is safe and more immunogenic than homologous boosting. The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the waning of vaccine-elicited neutralizing antibodies suggests that additional coronavirus disease 2019 (COVID-19) vaccine doses may be needed for individuals who initially received CoronaVac. We evaluated the safety and immunogenicity of the recombinant adenovirus type 5 (AD5)-vectored COVID-19 vaccine Convidecia as a heterologous booster versus those of CoronaVac as homologous booster in adults previously vaccinated with CoronaVac in an ongoing, randomized, observer-blinded, parallel-controlled phase 4 trial ( NCT04892459 ). Adults who had received two doses of CoronaVac in the past 3-6 months were vaccinated with Convidecia (n = 96) or CoronaVac (n = 102). Adults who had received one dose of CoronaVac in the past 1-3 months were also vaccinated with Convidecia (n = 51) or CoronaVac (n = 50). The co-primary endpoints were the occurrence of adverse reactions within 28 d after vaccination and geometric mean titers (GMTs) of neutralizing antibodies against live wild-type SARS-CoV-2 virus at 14 d after booster vaccination. Adverse reactions after vaccination were significantly more frequent in Convidecia recipients but were generally mild to moderate in all treatment groups. Heterologous boosting with Convidecia elicited significantly increased GMTs of neutralizing antibody against SARS-CoV-2 than homologous boosting with CoronaVac in participants who had previously received one or two doses of CoronaVac. These data suggest that heterologous boosting with Convidecia following initial vaccination with CoronaVac is safe and more immunogenic than homologous boosting. The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the waning of vaccine-elicited neutralizing antibodies suggests that additional coronavirus disease 2019 (COVID-19) vaccine doses may be needed for individuals who initially received CoronaVac. We evaluated the safety and immunogenicity of the recombinant adenovirus type 5 (AD5)-vectored COVID-19 vaccine Convidecia as a heterologous booster versus those of CoronaVac as homologous booster in adults previously vaccinated with CoronaVac in an ongoing, randomized, observer-blinded, parallel-controlled phase 4 trial ( NCT04892459 ). Adults who had received two doses of CoronaVac in the past 3–6 months were vaccinated with Convidecia ( n = 96) or CoronaVac ( n = 102). Adults who had received one dose of CoronaVac in the past 1–3 months were also vaccinated with Convidecia ( n = 51) or CoronaVac ( n = 50). The co-primary endpoints were the occurrence of adverse reactions within 28 d after vaccination and geometric mean titers (GMTs) of neutralizing antibodies against live wild-type SARS-CoV-2 virus at 14 d after booster vaccination. Adverse reactions after vaccination were significantly more frequent in Convidecia recipients but were generally mild to moderate in all treatment groups. Heterologous boosting with Convidecia elicited significantly increased GMTs of neutralizing antibody against SARS-CoV-2 than homologous boosting with CoronaVac in participants who had previously received one or two doses of CoronaVac. These data suggest that heterologous boosting with Convidecia following initial vaccination with CoronaVac is safe and more immunogenic than homologous boosting. The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and the waning of vaccine-elicited neutralizing antibodies suggests that additional coronavirus disease 2019 (COVID-19) vaccine doses may be needed for individuals who initially received CoronaVac. We evaluated the safety and immunogenicity of the recombinant adenovirus type 5 (AD5)-vectored COVID-19 vaccine Convidecia as a heterologous booster versus those of CoronaVac as homologous booster in adults previously vaccinated with CoronaVac in an ongoing, randomized, observer-blinded, parallel-controlled phase 4 trial ( NCT04892459 ). Adults who had received two doses of CoronaVac in the past 3–6 months were vaccinated with Convidecia ( n = 96) or CoronaVac ( n = 102). Adults who had received one dose of CoronaVac in the past 1–3 months were also vaccinated with Convidecia ( n = 51) or CoronaVac ( n = 50). The co-primary endpoints were the occurrence of adverse reactions within 28 d after vaccination and geometric mean titers (GMTs) of neutralizing antibodies against live wild-type SARS-CoV-2 virus at 14 d after booster vaccination. Adverse reactions after vaccination were significantly more frequent in Convidecia recipients but were generally mild to moderate in all treatment groups. Heterologous boosting with Convidecia elicited significantly increased GMTs of neutralizing antibody against SARS-CoV-2 than homologous boosting with CoronaVac in participants who had previously received one or two doses of CoronaVac. These data suggest that heterologous boosting with Convidecia following initial vaccination with CoronaVac is safe and more immunogenic than homologous boosting. Heterologous vaccination with Convidecia, a recombinant adenovirus type 5-vectored COVID-19 vaccine, after one or two doses of CoronaVac, an inactivated SARS-CoV-2 vaccine, is more reactogenic but elicits significantly higher levels of neutralizing antibodies than homologous vaccination.
Author	Song, Zhizhou Shi, Fengjuan Cui, Lunbiao Wang, Xuewen Jin, Lairun Xu, Xiaoyu Pan, Hongxing Zhu, Jiahong Chen, Wei Li, Jingxin Jin, Pengfei Wang, Xue Liu, Jingxian Zhu, Tao Chen, Yin Guo, Xiling Li, Junqiang Zhu, Fengcai Wu, Shipo Wan, Jingxuan Hou, Lihua
Author_xml	– sequence: 1 givenname: Jingxin surname: Li fullname: Li, Jingxin organization: NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Institute of Global Health and Emergency Pharmacy, China Pharmaceutical University – sequence: 2 givenname: Lihua orcidid: 0000-0001-7366-8974 surname: Hou fullname: Hou, Lihua organization: Institute of Biotechnology, Academy of Military Medical Sciences – sequence: 3 givenname: Xiling surname: Guo fullname: Guo, Xiling organization: NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention – sequence: 4 givenname: Pengfei surname: Jin fullname: Jin, Pengfei organization: NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention – sequence: 5 givenname: Shipo orcidid: 0000-0001-8083-247X surname: Wu fullname: Wu, Shipo organization: Institute of Biotechnology, Academy of Military Medical Sciences – sequence: 6 givenname: Jiahong surname: Zhu fullname: Zhu, Jiahong organization: Lianshui County Center for Disease Control and Prevention – sequence: 7 givenname: Hongxing surname: Pan fullname: Pan, Hongxing organization: NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention – sequence: 8 givenname: Xue surname: Wang fullname: Wang, Xue organization: CanSino Biologics Inc – sequence: 9 givenname: Zhizhou surname: Song fullname: Song, Zhizhou organization: Lianshui County Center for Disease Control and Prevention – sequence: 10 givenname: Jingxuan surname: Wan fullname: Wan, Jingxuan organization: CanSino Biologics Inc – sequence: 11 givenname: Lunbiao surname: Cui fullname: Cui, Lunbiao organization: NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention – sequence: 12 givenname: Junqiang surname: Li fullname: Li, Junqiang organization: CanSino Biologics Inc – sequence: 13 givenname: Yin surname: Chen fullname: Chen, Yin organization: NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention – sequence: 14 givenname: Xuewen surname: Wang fullname: Wang, Xuewen organization: Canming Medical Technology Co., Ltd – sequence: 15 givenname: Lairun surname: Jin fullname: Jin, Lairun organization: Department of Public Health, Southeast University – sequence: 16 givenname: Jingxian surname: Liu fullname: Liu, Jingxian organization: NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention – sequence: 17 givenname: Fengjuan surname: Shi fullname: Shi, Fengjuan organization: NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention – sequence: 18 givenname: Xiaoyu surname: Xu fullname: Xu, Xiaoyu organization: Vazyme Biotech Co., Ltd – sequence: 19 givenname: Tao surname: Zhu fullname: Zhu, Tao organization: CanSino Biologics Inc – sequence: 20 givenname: Wei orcidid: 0000-0001-5805-2469 surname: Chen fullname: Chen, Wei email: cw0226@foxmail.com organization: Institute of Biotechnology, Academy of Military Medical Sciences – sequence: 21 givenname: Fengcai orcidid: 0000-0002-1644-0006 surname: Zhu fullname: Zhu, Fengcai email: jszfc@vip.sina.com organization: NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Institute of Global Health and Emergency Pharmacy, China Pharmaceutical University, Center for Global Health, Nanjing Medical University
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/35087233$$D View this record in MEDLINE/PubMed
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SubjectTerms	631/250/2152/2153/1291 631/250/590/1883 692/308/2779/109/1943 Adenoviridae - immunology Adenoviruses Adolescent Adult Adults Antibodies Antibodies, Neutralizing - blood Antibodies, Viral - blood Biomedical and Life Sciences Biomedicine Cancer Research China Coronaviruses COVID-19 COVID-19 - immunology COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects COVID-19 Vaccines - immunology Female Homology Humans Immunization Immunization, Secondary Immunogenicity Immunogenicity, Vaccine - immunology Immunoglobulin G - blood Infectious Diseases Injection Site Reaction - pathology Male Metabolic Diseases Middle Aged Molecular Medicine Neurosciences Neutralizing SARS-CoV-2 - immunology Severe acute respiratory syndrome coronavirus 2 Side effects T-Lymphocytes - immunology Vaccination Vaccines Vaccines, Inactivated - immunology Viral diseases Young Adult
Title	Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial
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