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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| Veröffentlicht in: | Nature medicine 2022-02, Vol.28 (2), p.401-409 |
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| creator | 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 |
| description | 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. |
| doi_str_mv | 10.1038/s41591-021-01677-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8863573</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2631747844</sourcerecordid><originalsourceid>FETCH-LOGICAL-c540t-80d4fbe84c7e5c148d679c3eb5bcf02d1af989f7c8133443dca14575015334353</originalsourceid><addsrcrecordid>eNp9UctOwzAQtBCIlsIPcECROAfs2I4dDkhVeRSpUi9QcbMcx2lSpXax00r06zH0QblwsNa7Mzuz0gBwieANgpjfeoJohmKYhIdSxuL1EegiStIYMfh-HP6Q8ZhnNO2AM-9nEEIMaXYKOphCzhKMu6Aa6lY729ipXfqo_0BjMxhPokUTuoF11siJVNFKOx8GlZ3vmAeYVKo2sq2tuYtk5KQp7Lxe6yJaVNLriEStq2VzDk5K2Xh9sa098Pb0-DoYxqPx88ugP4oVJbCNOSxImWtOFNNUIcKLlGUK65zmqoRJgWSZ8axkiiOMCcGFkohQRiGioccU98D9RnexzOe6UNq0TjZi4eq5dJ_Cylr8RUxdialdCc5TTBkOAtdbAWc_ltq3YmaXzoSbRZJixAjjwbcHkg1LOeu90-XeAUHxnY7YpCNCOuInHbEOS1eHt-1XdnEEAt4QfIDMVLtf739kvwD_Ppy9</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2631747844</pqid></control><display><type>article</type><title>Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial</title><source>MEDLINE</source><source>Nature Journals Online</source><source>SpringerLink Journals - AutoHoldings</source><creator>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</creator><creatorcontrib>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</creatorcontrib><description>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.</description><identifier>ISSN: 1078-8956</identifier><identifier>EISSN: 1546-170X</identifier><identifier>DOI: 10.1038/s41591-021-01677-z</identifier><identifier>PMID: 35087233</identifier><language>eng</language><publisher>New York: Nature Publishing Group US</publisher><subject>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</subject><ispartof>Nature medicine, 2022-02, Vol.28 (2), p.401-409</ispartof><rights>The Author(s) 2022</rights><rights>2022. The Author(s).</rights><rights>The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c540t-80d4fbe84c7e5c148d679c3eb5bcf02d1af989f7c8133443dca14575015334353</citedby><cites>FETCH-LOGICAL-c540t-80d4fbe84c7e5c148d679c3eb5bcf02d1af989f7c8133443dca14575015334353</cites><orcidid>0000-0001-7366-8974 ; 0000-0001-5805-2469 ; 0000-0002-1644-0006 ; 0000-0001-8083-247X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/s41591-021-01677-z$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/s41591-021-01677-z$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35087233$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Li, Jingxin</creatorcontrib><creatorcontrib>Hou, Lihua</creatorcontrib><creatorcontrib>Guo, Xiling</creatorcontrib><creatorcontrib>Jin, Pengfei</creatorcontrib><creatorcontrib>Wu, Shipo</creatorcontrib><creatorcontrib>Zhu, Jiahong</creatorcontrib><creatorcontrib>Pan, Hongxing</creatorcontrib><creatorcontrib>Wang, Xue</creatorcontrib><creatorcontrib>Song, Zhizhou</creatorcontrib><creatorcontrib>Wan, Jingxuan</creatorcontrib><creatorcontrib>Cui, Lunbiao</creatorcontrib><creatorcontrib>Li, Junqiang</creatorcontrib><creatorcontrib>Chen, Yin</creatorcontrib><creatorcontrib>Wang, Xuewen</creatorcontrib><creatorcontrib>Jin, Lairun</creatorcontrib><creatorcontrib>Liu, Jingxian</creatorcontrib><creatorcontrib>Shi, Fengjuan</creatorcontrib><creatorcontrib>Xu, Xiaoyu</creatorcontrib><creatorcontrib>Zhu, Tao</creatorcontrib><creatorcontrib>Chen, Wei</creatorcontrib><creatorcontrib>Zhu, Fengcai</creatorcontrib><title>Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial</title><title>Nature medicine</title><addtitle>Nat Med</addtitle><addtitle>Nat Med</addtitle><description>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.</description><subject>631/250/2152/2153/1291</subject><subject>631/250/590/1883</subject><subject>692/308/2779/109/1943</subject><subject>Adenoviridae - immunology</subject><subject>Adenoviruses</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Adults</subject><subject>Antibodies</subject><subject>Antibodies, Neutralizing - blood</subject><subject>Antibodies, Viral - blood</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cancer Research</subject><subject>China</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 - immunology</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>COVID-19 Vaccines - immunology</subject><subject>Female</subject><subject>Homology</subject><subject>Humans</subject><subject>Immunization</subject><subject>Immunization, Secondary</subject><subject>Immunogenicity</subject><subject>Immunogenicity, Vaccine - immunology</subject><subject>Immunoglobulin G - blood</subject><subject>Infectious Diseases</subject><subject>Injection Site Reaction - pathology</subject><subject>Male</subject><subject>Metabolic Diseases</subject><subject>Middle Aged</subject><subject>Molecular Medicine</subject><subject>Neurosciences</subject><subject>Neutralizing</subject><subject>SARS-CoV-2 - immunology</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Side effects</subject><subject>T-Lymphocytes - immunology</subject><subject>Vaccination</subject><subject>Vaccines</subject><subject>Vaccines, Inactivated - immunology</subject><subject>Viral 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AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c540t-80d4fbe84c7e5c148d679c3eb5bcf02d1af989f7c8133443dca14575015334353</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>631/250/2152/2153/1291</topic><topic>631/250/590/1883</topic><topic>692/308/2779/109/1943</topic><topic>Adenoviridae - immunology</topic><topic>Adenoviruses</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Adults</topic><topic>Antibodies</topic><topic>Antibodies, Neutralizing - 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Lihua</au><au>Guo, Xiling</au><au>Jin, Pengfei</au><au>Wu, Shipo</au><au>Zhu, Jiahong</au><au>Pan, Hongxing</au><au>Wang, Xue</au><au>Song, Zhizhou</au><au>Wan, Jingxuan</au><au>Cui, Lunbiao</au><au>Li, Junqiang</au><au>Chen, Yin</au><au>Wang, Xuewen</au><au>Jin, Lairun</au><au>Liu, Jingxian</au><au>Shi, Fengjuan</au><au>Xu, Xiaoyu</au><au>Zhu, Tao</au><au>Chen, Wei</au><au>Zhu, Fengcai</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial</atitle><jtitle>Nature medicine</jtitle><stitle>Nat Med</stitle><addtitle>Nat Med</addtitle><date>2022-02-01</date><risdate>2022</risdate><volume>28</volume><issue>2</issue><spage>401</spage><epage>409</epage><pages>401-409</pages><issn>1078-8956</issn><eissn>1546-170X</eissn><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.</abstract><cop>New York</cop><pub>Nature Publishing Group US</pub><pmid>35087233</pmid><doi>10.1038/s41591-021-01677-z</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-7366-8974</orcidid><orcidid>https://orcid.org/0000-0001-5805-2469</orcidid><orcidid>https://orcid.org/0000-0002-1644-0006</orcidid><orcidid>https://orcid.org/0000-0001-8083-247X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1078-8956 |
| ispartof | Nature medicine, 2022-02, Vol.28 (2), p.401-409 |
| issn | 1078-8956 1546-170X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8863573 |
| source | MEDLINE; Nature Journals Online; SpringerLink Journals - AutoHoldings |
| 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 |
| title | Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-06T19%3A19%3A34IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Heterologous%20AD5-nCOV%20plus%20CoronaVac%20versus%20homologous%20CoronaVac%20vaccination:%20a%20randomized%20phase%204%20trial&rft.jtitle=Nature%20medicine&rft.au=Li,%20Jingxin&rft.date=2022-02-01&rft.volume=28&rft.issue=2&rft.spage=401&rft.epage=409&rft.pages=401-409&rft.issn=1078-8956&rft.eissn=1546-170X&rft_id=info:doi/10.1038/s41591-021-01677-z&rft_dat=%3Cproquest_pubme%3E2631747844%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2631747844&rft_id=info:pmid/35087233&rfr_iscdi=true |