Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial
•COVID-19 vaccine booster doses are needed to elicit protective immune response.•MVC-COV1901, a protein subunit vaccine, was given and compared as a booster dose.•Heterologous boosting elicited the strongest immunogenic response.•Protein subunit vaccines elicited less adverse events than other platf...
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| Veröffentlicht in: | Vaccine 2023-05, Vol.41 (23), p.3497-3505 |
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| creator | Estephan, Lila Lin, Ying-Chin Lin, Yi-Tsung Chen, Yen-Hsu Pan, Sung-Ching Hsieh, Szu-Min Torkehagen, Paal Fure Weng, Yi-Jen Cheng, Hao-Yuan Estrada, Josue Antonio Waits, Alexander Chen, Charles Lien, Chia En |
| description | •COVID-19 vaccine booster doses are needed to elicit protective immune response.•MVC-COV1901, a protein subunit vaccine, was given and compared as a booster dose.•Heterologous boosting elicited the strongest immunogenic response.•Protein subunit vaccines elicited less adverse events than other platforms.
To report the safety and immunogenicity profile of a protein subunit vaccine (MVC-COV1901) compared to AZD1222 and mRNA-1273 when given as a third (booster) dose to individuals who have completed different primary vaccine regimens.
Individuals were classified according to their primary vaccine regimens, including two-dose MVC-COV1901, AZD1222, or mRNA-1273. A third dose of either half-dose MVC-COV1901, full-dose MVC-COV1901, standard-dose AZD1222, half-dose mRNA-1273 was administered in a 1:1:1:1 treatment ratio to individuals with an interval range of 84–365 days after the second dose. Endpoints included safety, humoral immunogenicity, and cell-mediated immune response on trial days 15 and 29. Exploratory endpoint included testing against variants of concern (Omicron).
Overall, 803 participants were randomized and boosted − 201 received half-dose MVC-COV1901, 196 received full-dose MVC-COV1901, 203 received AZD1222, and 203 received half-dose mRNA-1273. Reactogenicity was mild to moderate, and less in the MVC-COV1901 booster group. Heterologous boosting provided the best immunogenic response. Boosting with mRNA-1273 in MVC-COV1901 primed individuals induced the highest antibody titers, even against Omicron, and cell-mediated immune response.
Overall, MVC-COV1901 as a booster showed the best safety profiles. MVC-COV1901 as a primary series, with either homologous or heterologous booster, elicited the highest immunogenic response.
ClinicalTrials.gov registration NCT05197153 |
| doi_str_mv | 10.1016/j.vaccine.2023.04.029 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10090360</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0264410X23004218</els_id><sourcerecordid>2805027387</sourcerecordid><originalsourceid>FETCH-LOGICAL-c529t-f6d395a115e590ad8986548defa0c44ac22a3bbc5b1816c0bde8865c913826673</originalsourceid><addsrcrecordid>eNqNUsuO0zAUjRCIKQOfALLEhkUT_IhTh82oKk9pYKQpVIiN5dg3ravELnZSNPwiP4Wr6QyPDayu7HvuOfdxsuwxwQXBpHq-LfZKa-ugoJiyApcFpvWdbELEjOWUE3E3m2BalXlJ8OeT7EGMW4wxZ6S-n52wGRZY0HqS_ViqFoYrpJxBtu9H59fgrLbpy7do43vf-bUfI9pDiClsYIBw89d4H9MTGR8BfbPDBs2_vCSU0inqLz_Mc0JnbIp8QO9Xi3xxsSI1Jmg5v1zmC7_KKTpOEJF1SJmxG-ILNHfINxFC0subzjoDJrGlnM01uKQ2RbuNSnoUhdS07-13MGgIVnUPs3ut6iI8OsbT7NPrVx8Xb_PzizfvFvPzXHNaD3lbGVZzRQgHXmNlRC0qXgoDrcK6LJWmVLGm0bwhglQaNwZEQuiaMEGrasZOs7Nr3t3Y9GAObQXVyV2wvQpX0isr_8w4u5Frv5cE4xqzCieGZ0eG4L-OEAfZ26ih65SDtFhJBSvTWWec_QcU84Rk4tDX07-gWz8Gl1aRUITTskxjJhS_RungYwzQ3jZOsDxYS27l8TDyYC2JS5msleqe_D71bdWNl36tBdLu9xaCjNqC02BsAD1I4-0_JH4COK3h-w</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2815244548</pqid></control><display><type>article</type><title>Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Estephan, Lila ; Lin, Ying-Chin ; Lin, Yi-Tsung ; Chen, Yen-Hsu ; Pan, Sung-Ching ; Hsieh, Szu-Min ; Torkehagen, Paal Fure ; Weng, Yi-Jen ; Cheng, Hao-Yuan ; Estrada, Josue Antonio ; Waits, Alexander ; Chen, Charles ; Lien, Chia En</creator><creatorcontrib>Estephan, Lila ; Lin, Ying-Chin ; Lin, Yi-Tsung ; Chen, Yen-Hsu ; Pan, Sung-Ching ; Hsieh, Szu-Min ; Torkehagen, Paal Fure ; Weng, Yi-Jen ; Cheng, Hao-Yuan ; Estrada, Josue Antonio ; Waits, Alexander ; Chen, Charles ; Lien, Chia En</creatorcontrib><description>•COVID-19 vaccine booster doses are needed to elicit protective immune response.•MVC-COV1901, a protein subunit vaccine, was given and compared as a booster dose.•Heterologous boosting elicited the strongest immunogenic response.•Protein subunit vaccines elicited less adverse events than other platforms.
To report the safety and immunogenicity profile of a protein subunit vaccine (MVC-COV1901) compared to AZD1222 and mRNA-1273 when given as a third (booster) dose to individuals who have completed different primary vaccine regimens.
Individuals were classified according to their primary vaccine regimens, including two-dose MVC-COV1901, AZD1222, or mRNA-1273. A third dose of either half-dose MVC-COV1901, full-dose MVC-COV1901, standard-dose AZD1222, half-dose mRNA-1273 was administered in a 1:1:1:1 treatment ratio to individuals with an interval range of 84–365 days after the second dose. Endpoints included safety, humoral immunogenicity, and cell-mediated immune response on trial days 15 and 29. Exploratory endpoint included testing against variants of concern (Omicron).
Overall, 803 participants were randomized and boosted − 201 received half-dose MVC-COV1901, 196 received full-dose MVC-COV1901, 203 received AZD1222, and 203 received half-dose mRNA-1273. Reactogenicity was mild to moderate, and less in the MVC-COV1901 booster group. Heterologous boosting provided the best immunogenic response. Boosting with mRNA-1273 in MVC-COV1901 primed individuals induced the highest antibody titers, even against Omicron, and cell-mediated immune response.
Overall, MVC-COV1901 as a booster showed the best safety profiles. MVC-COV1901 as a primary series, with either homologous or heterologous booster, elicited the highest immunogenic response.
ClinicalTrials.gov registration NCT05197153</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2023.04.029</identifier><identifier>PMID: 37080829</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>2019-nCoV Vaccine mRNA-1273 ; Adult ; Antibodies ; Antibodies, Neutralizing ; Antibodies, Viral ; Antigens ; Booster ; cell-mediated immunity ; ChAdOx1 nCoV-19 ; Coronaviruses ; COVID-19 ; COVID-19 - prevention & control ; COVID-19 vaccines ; COVID-19 Vaccines - adverse effects ; Developing countries ; Enzymes ; Epidemics ; FDA approval ; Homology ; Humans ; Immune response ; Immune response (cell-mediated) ; Immune response (humoral) ; Immune system ; Immunogenicity ; Immunogenicity, Vaccine ; Immunoglobulins ; Immunology ; Infections ; Laboratories ; LDCs ; mRNA ; MVC-COV1901 ; Omicron strain ; protein subunits ; Safety ; SARS-CoV-2 ; SARS-CoV-2 vaccine ; Schedules ; Severe acute respiratory syndrome coronavirus 2 ; Subunit vaccine ; subunit vaccines ; Tumor necrosis factor-TNF ; Vaccines</subject><ispartof>Vaccine, 2023-05, Vol.41 (23), p.3497-3505</ispartof><rights>2023 The Authors</rights><rights>Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><rights>2023. The Authors</rights><rights>2023 The Authors. Published by Elsevier Ltd. 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c529t-f6d395a115e590ad8986548defa0c44ac22a3bbc5b1816c0bde8865c913826673</citedby><cites>FETCH-LOGICAL-c529t-f6d395a115e590ad8986548defa0c44ac22a3bbc5b1816c0bde8865c913826673</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0264410X23004218$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37080829$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Estephan, Lila</creatorcontrib><creatorcontrib>Lin, Ying-Chin</creatorcontrib><creatorcontrib>Lin, Yi-Tsung</creatorcontrib><creatorcontrib>Chen, Yen-Hsu</creatorcontrib><creatorcontrib>Pan, Sung-Ching</creatorcontrib><creatorcontrib>Hsieh, Szu-Min</creatorcontrib><creatorcontrib>Torkehagen, Paal Fure</creatorcontrib><creatorcontrib>Weng, Yi-Jen</creatorcontrib><creatorcontrib>Cheng, Hao-Yuan</creatorcontrib><creatorcontrib>Estrada, Josue Antonio</creatorcontrib><creatorcontrib>Waits, Alexander</creatorcontrib><creatorcontrib>Chen, Charles</creatorcontrib><creatorcontrib>Lien, Chia En</creatorcontrib><title>Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>•COVID-19 vaccine booster doses are needed to elicit protective immune response.•MVC-COV1901, a protein subunit vaccine, was given and compared as a booster dose.•Heterologous boosting elicited the strongest immunogenic response.•Protein subunit vaccines elicited less adverse events than other platforms.
To report the safety and immunogenicity profile of a protein subunit vaccine (MVC-COV1901) compared to AZD1222 and mRNA-1273 when given as a third (booster) dose to individuals who have completed different primary vaccine regimens.
Individuals were classified according to their primary vaccine regimens, including two-dose MVC-COV1901, AZD1222, or mRNA-1273. A third dose of either half-dose MVC-COV1901, full-dose MVC-COV1901, standard-dose AZD1222, half-dose mRNA-1273 was administered in a 1:1:1:1 treatment ratio to individuals with an interval range of 84–365 days after the second dose. Endpoints included safety, humoral immunogenicity, and cell-mediated immune response on trial days 15 and 29. Exploratory endpoint included testing against variants of concern (Omicron).
Overall, 803 participants were randomized and boosted − 201 received half-dose MVC-COV1901, 196 received full-dose MVC-COV1901, 203 received AZD1222, and 203 received half-dose mRNA-1273. Reactogenicity was mild to moderate, and less in the MVC-COV1901 booster group. Heterologous boosting provided the best immunogenic response. Boosting with mRNA-1273 in MVC-COV1901 primed individuals induced the highest antibody titers, even against Omicron, and cell-mediated immune response.
Overall, MVC-COV1901 as a booster showed the best safety profiles. MVC-COV1901 as a primary series, with either homologous or heterologous booster, elicited the highest immunogenic response.
ClinicalTrials.gov registration NCT05197153</description><subject>2019-nCoV Vaccine mRNA-1273</subject><subject>Adult</subject><subject>Antibodies</subject><subject>Antibodies, Neutralizing</subject><subject>Antibodies, Viral</subject><subject>Antigens</subject><subject>Booster</subject><subject>cell-mediated immunity</subject><subject>ChAdOx1 nCoV-19</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>Developing countries</subject><subject>Enzymes</subject><subject>Epidemics</subject><subject>FDA approval</subject><subject>Homology</subject><subject>Humans</subject><subject>Immune response</subject><subject>Immune response (cell-mediated)</subject><subject>Immune response (humoral)</subject><subject>Immune system</subject><subject>Immunogenicity</subject><subject>Immunogenicity, Vaccine</subject><subject>Immunoglobulins</subject><subject>Immunology</subject><subject>Infections</subject><subject>Laboratories</subject><subject>LDCs</subject><subject>mRNA</subject><subject>MVC-COV1901</subject><subject>Omicron strain</subject><subject>protein subunits</subject><subject>Safety</subject><subject>SARS-CoV-2</subject><subject>SARS-CoV-2 vaccine</subject><subject>Schedules</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Subunit vaccine</subject><subject>subunit vaccines</subject><subject>Tumor necrosis factor-TNF</subject><subject>Vaccines</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNUsuO0zAUjRCIKQOfALLEhkUT_IhTh82oKk9pYKQpVIiN5dg3ravELnZSNPwiP4Wr6QyPDayu7HvuOfdxsuwxwQXBpHq-LfZKa-ugoJiyApcFpvWdbELEjOWUE3E3m2BalXlJ8OeT7EGMW4wxZ6S-n52wGRZY0HqS_ViqFoYrpJxBtu9H59fgrLbpy7do43vf-bUfI9pDiClsYIBw89d4H9MTGR8BfbPDBs2_vCSU0inqLz_Mc0JnbIp8QO9Xi3xxsSI1Jmg5v1zmC7_KKTpOEJF1SJmxG-ILNHfINxFC0subzjoDJrGlnM01uKQ2RbuNSnoUhdS07-13MGgIVnUPs3ut6iI8OsbT7NPrVx8Xb_PzizfvFvPzXHNaD3lbGVZzRQgHXmNlRC0qXgoDrcK6LJWmVLGm0bwhglQaNwZEQuiaMEGrasZOs7Nr3t3Y9GAObQXVyV2wvQpX0isr_8w4u5Frv5cE4xqzCieGZ0eG4L-OEAfZ26ih65SDtFhJBSvTWWec_QcU84Rk4tDX07-gWz8Gl1aRUITTskxjJhS_RungYwzQ3jZOsDxYS27l8TDyYC2JS5msleqe_D71bdWNl36tBdLu9xaCjNqC02BsAD1I4-0_JH4COK3h-w</recordid><startdate>20230526</startdate><enddate>20230526</enddate><creator>Estephan, Lila</creator><creator>Lin, Ying-Chin</creator><creator>Lin, Yi-Tsung</creator><creator>Chen, Yen-Hsu</creator><creator>Pan, Sung-Ching</creator><creator>Hsieh, Szu-Min</creator><creator>Torkehagen, Paal Fure</creator><creator>Weng, Yi-Jen</creator><creator>Cheng, Hao-Yuan</creator><creator>Estrada, Josue Antonio</creator><creator>Waits, Alexander</creator><creator>Chen, Charles</creator><creator>Lien, Chia En</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><general>The Authors. 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prevention & control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - adverse effects</topic><topic>Developing countries</topic><topic>Enzymes</topic><topic>Epidemics</topic><topic>FDA approval</topic><topic>Homology</topic><topic>Humans</topic><topic>Immune response</topic><topic>Immune response (cell-mediated)</topic><topic>Immune response (humoral)</topic><topic>Immune system</topic><topic>Immunogenicity</topic><topic>Immunogenicity, Vaccine</topic><topic>Immunoglobulins</topic><topic>Immunology</topic><topic>Infections</topic><topic>Laboratories</topic><topic>LDCs</topic><topic>mRNA</topic><topic>MVC-COV1901</topic><topic>Omicron strain</topic><topic>protein subunits</topic><topic>Safety</topic><topic>SARS-CoV-2</topic><topic>SARS-CoV-2 vaccine</topic><topic>Schedules</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Subunit vaccine</topic><topic>subunit vaccines</topic><topic>Tumor necrosis factor-TNF</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Estephan, Lila</creatorcontrib><creatorcontrib>Lin, Ying-Chin</creatorcontrib><creatorcontrib>Lin, Yi-Tsung</creatorcontrib><creatorcontrib>Chen, Yen-Hsu</creatorcontrib><creatorcontrib>Pan, Sung-Ching</creatorcontrib><creatorcontrib>Hsieh, Szu-Min</creatorcontrib><creatorcontrib>Torkehagen, Paal Fure</creatorcontrib><creatorcontrib>Weng, Yi-Jen</creatorcontrib><creatorcontrib>Cheng, Hao-Yuan</creatorcontrib><creatorcontrib>Estrada, Josue Antonio</creatorcontrib><creatorcontrib>Waits, Alexander</creatorcontrib><creatorcontrib>Chen, Charles</creatorcontrib><creatorcontrib>Lien, Chia En</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>AGRICOLA</collection><collection>AGRICOLA - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Estephan, Lila</au><au>Lin, Ying-Chin</au><au>Lin, Yi-Tsung</au><au>Chen, Yen-Hsu</au><au>Pan, Sung-Ching</au><au>Hsieh, Szu-Min</au><au>Torkehagen, Paal Fure</au><au>Weng, Yi-Jen</au><au>Cheng, Hao-Yuan</au><au>Estrada, Josue Antonio</au><au>Waits, Alexander</au><au>Chen, Charles</au><au>Lien, Chia En</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2023-05-26</date><risdate>2023</risdate><volume>41</volume><issue>23</issue><spage>3497</spage><epage>3505</epage><pages>3497-3505</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>•COVID-19 vaccine booster doses are needed to elicit protective immune response.•MVC-COV1901, a protein subunit vaccine, was given and compared as a booster dose.•Heterologous boosting elicited the strongest immunogenic response.•Protein subunit vaccines elicited less adverse events than other platforms.
To report the safety and immunogenicity profile of a protein subunit vaccine (MVC-COV1901) compared to AZD1222 and mRNA-1273 when given as a third (booster) dose to individuals who have completed different primary vaccine regimens.
Individuals were classified according to their primary vaccine regimens, including two-dose MVC-COV1901, AZD1222, or mRNA-1273. A third dose of either half-dose MVC-COV1901, full-dose MVC-COV1901, standard-dose AZD1222, half-dose mRNA-1273 was administered in a 1:1:1:1 treatment ratio to individuals with an interval range of 84–365 days after the second dose. Endpoints included safety, humoral immunogenicity, and cell-mediated immune response on trial days 15 and 29. Exploratory endpoint included testing against variants of concern (Omicron).
Overall, 803 participants were randomized and boosted − 201 received half-dose MVC-COV1901, 196 received full-dose MVC-COV1901, 203 received AZD1222, and 203 received half-dose mRNA-1273. Reactogenicity was mild to moderate, and less in the MVC-COV1901 booster group. Heterologous boosting provided the best immunogenic response. Boosting with mRNA-1273 in MVC-COV1901 primed individuals induced the highest antibody titers, even against Omicron, and cell-mediated immune response.
Overall, MVC-COV1901 as a booster showed the best safety profiles. MVC-COV1901 as a primary series, with either homologous or heterologous booster, elicited the highest immunogenic response.
ClinicalTrials.gov registration NCT05197153</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>37080829</pmid><doi>10.1016/j.vaccine.2023.04.029</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2023-05, Vol.41 (23), p.3497-3505 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10090360 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | 2019-nCoV Vaccine mRNA-1273 Adult Antibodies Antibodies, Neutralizing Antibodies, Viral Antigens Booster cell-mediated immunity ChAdOx1 nCoV-19 Coronaviruses COVID-19 COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects Developing countries Enzymes Epidemics FDA approval Homology Humans Immune response Immune response (cell-mediated) Immune response (humoral) Immune system Immunogenicity Immunogenicity, Vaccine Immunoglobulins Immunology Infections Laboratories LDCs mRNA MVC-COV1901 Omicron strain protein subunits Safety SARS-CoV-2 SARS-CoV-2 vaccine Schedules Severe acute respiratory syndrome coronavirus 2 Subunit vaccine subunit vaccines Tumor necrosis factor-TNF Vaccines |
| title | Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-29T05%3A43%3A33IST&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=Safety%20and%20immunogenicity%20of%20homologous%20versus%20heterologous%20booster%20dose%20with%20AZD1222,%20mRNA-1273,%20or%20MVC-COV1901%20SARS-CoV-2%20vaccines%20in%20adults:%20An%20observer-blinded,%20multi-center,%20phase%202%20randomized%20trial&rft.jtitle=Vaccine&rft.au=Estephan,%20Lila&rft.date=2023-05-26&rft.volume=41&rft.issue=23&rft.spage=3497&rft.epage=3505&rft.pages=3497-3505&rft.issn=0264-410X&rft.eissn=1873-2518&rft_id=info:doi/10.1016/j.vaccine.2023.04.029&rft_dat=%3Cproquest_pubme%3E2805027387%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=2815244548&rft_id=info:pmid/37080829&rft_els_id=S0264410X23004218&rfr_iscdi=true |