Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context
Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adu...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Yu-Zhou Gui [verfasserIn] Xue-Ning Li [verfasserIn] Jing-Xin Li [verfasserIn] Ming-Yun Shen [verfasserIn] Mei-Wei Zhang [verfasserIn] Ye Cao [verfasserIn] Hong-Rong Xu [verfasserIn] Hui Li [verfasserIn] Jie Cheng [verfasserIn] Liang Pan [verfasserIn] Ying-Lei Yi [verfasserIn] Li-Yu Liang [verfasserIn] Cheng-Yin Yu [verfasserIn] Gang-Yi Liu [verfasserIn] Chen Yu [verfasserIn] Bi-Jie Hu [verfasserIn] Feng-Cai Zhu [verfasserIn] Fei Liang [verfasserIn] Haifa Shen [verfasserIn] Jing-Ying Jia [verfasserIn] Hang-Wen Li [verfasserIn] Jian Zhou [verfasserIn] Jia Fan [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2023 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: EBioMedicine - Elsevier, 2015, 91(2023), Seite 104586- |
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| Übergeordnetes Werk: |
volume:91 ; year:2023 ; pages:104586- |
| Links: |
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| DOI / URN: |
10.1016/j.ebiom.2023.104586 |
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| Katalog-ID: |
DOAJ089959965 |
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| 100 | 0 | |a Yu-Zhou Gui |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context |
| 264 | 1 | |c 2023 | |
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| 520 | |a Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai. | ||
| 650 | 4 | |a SARS-CoV-2 | |
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| 700 | 0 | |a Ming-Yun Shen |e verfasserin |4 aut | |
| 700 | 0 | |a Mei-Wei Zhang |e verfasserin |4 aut | |
| 700 | 0 | |a Ye Cao |e verfasserin |4 aut | |
| 700 | 0 | |a Hong-Rong Xu |e verfasserin |4 aut | |
| 700 | 0 | |a Hui Li |e verfasserin |4 aut | |
| 700 | 0 | |a Jie Cheng |e verfasserin |4 aut | |
| 700 | 0 | |a Liang Pan |e verfasserin |4 aut | |
| 700 | 0 | |a Ying-Lei Yi |e verfasserin |4 aut | |
| 700 | 0 | |a Li-Yu Liang |e verfasserin |4 aut | |
| 700 | 0 | |a Cheng-Yin Yu |e verfasserin |4 aut | |
| 700 | 0 | |a Gang-Yi Liu |e verfasserin |4 aut | |
| 700 | 0 | |a Chen Yu |e verfasserin |4 aut | |
| 700 | 0 | |a Bi-Jie Hu |e verfasserin |4 aut | |
| 700 | 0 | |a Feng-Cai Zhu |e verfasserin |4 aut | |
| 700 | 0 | |a Fei Liang |e verfasserin |4 aut | |
| 700 | 0 | |a Haifa Shen |e verfasserin |4 aut | |
| 700 | 0 | |a Jing-Ying Jia |e verfasserin |4 aut | |
| 700 | 0 | |a Hang-Wen Li |e verfasserin |4 aut | |
| 700 | 0 | |a Jian Zhou |e verfasserin |4 aut | |
| 700 | 0 | |a Jia Fan |e verfasserin |4 aut | |
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10.1016/j.ebiom.2023.104586 doi (DE-627)DOAJ089959965 (DE-599)DOAJ8a8a7fea066c4164a25277ccaada978c DE-627 ger DE-627 rakwb eng R5-920 Yu-Zhou Gui verfasserin aut Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai. SARS-CoV-2 Heterologous boosting mRNA vaccine Clinical trial Medicine R Medicine (General) Xue-Ning Li verfasserin aut Jing-Xin Li verfasserin aut Ming-Yun Shen verfasserin aut Mei-Wei Zhang verfasserin aut Ye Cao verfasserin aut Hong-Rong Xu verfasserin aut Hui Li verfasserin aut Jie Cheng verfasserin aut Liang Pan verfasserin aut Ying-Lei Yi verfasserin aut Li-Yu Liang verfasserin aut Cheng-Yin Yu verfasserin aut Gang-Yi Liu verfasserin aut Chen Yu verfasserin aut Bi-Jie Hu verfasserin aut Feng-Cai Zhu verfasserin aut Fei Liang verfasserin aut Haifa Shen verfasserin aut Jing-Ying Jia verfasserin aut Hang-Wen Li verfasserin aut Jian Zhou verfasserin aut Jia Fan verfasserin aut In EBioMedicine Elsevier, 2015 91(2023), Seite 104586- (DE-627)802540074 (DE-600)2799017-5 23523964 nnns volume:91 year:2023 pages:104586- https://doi.org/10.1016/j.ebiom.2023.104586 kostenfrei https://doaj.org/article/8a8a7fea066c4164a25277ccaada978c kostenfrei http://www.sciencedirect.com/science/article/pii/S2352396423001512 kostenfrei https://doaj.org/toc/2352-3964 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 91 2023 104586- |
| spelling |
10.1016/j.ebiom.2023.104586 doi (DE-627)DOAJ089959965 (DE-599)DOAJ8a8a7fea066c4164a25277ccaada978c DE-627 ger DE-627 rakwb eng R5-920 Yu-Zhou Gui verfasserin aut Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai. SARS-CoV-2 Heterologous boosting mRNA vaccine Clinical trial Medicine R Medicine (General) Xue-Ning Li verfasserin aut Jing-Xin Li verfasserin aut Ming-Yun Shen verfasserin aut Mei-Wei Zhang verfasserin aut Ye Cao verfasserin aut Hong-Rong Xu verfasserin aut Hui Li verfasserin aut Jie Cheng verfasserin aut Liang Pan verfasserin aut Ying-Lei Yi verfasserin aut Li-Yu Liang verfasserin aut Cheng-Yin Yu verfasserin aut Gang-Yi Liu verfasserin aut Chen Yu verfasserin aut Bi-Jie Hu verfasserin aut Feng-Cai Zhu verfasserin aut Fei Liang verfasserin aut Haifa Shen verfasserin aut Jing-Ying Jia verfasserin aut Hang-Wen Li verfasserin aut Jian Zhou verfasserin aut Jia Fan verfasserin aut In EBioMedicine Elsevier, 2015 91(2023), Seite 104586- (DE-627)802540074 (DE-600)2799017-5 23523964 nnns volume:91 year:2023 pages:104586- https://doi.org/10.1016/j.ebiom.2023.104586 kostenfrei https://doaj.org/article/8a8a7fea066c4164a25277ccaada978c kostenfrei http://www.sciencedirect.com/science/article/pii/S2352396423001512 kostenfrei https://doaj.org/toc/2352-3964 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 91 2023 104586- |
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10.1016/j.ebiom.2023.104586 doi (DE-627)DOAJ089959965 (DE-599)DOAJ8a8a7fea066c4164a25277ccaada978c DE-627 ger DE-627 rakwb eng R5-920 Yu-Zhou Gui verfasserin aut Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai. SARS-CoV-2 Heterologous boosting mRNA vaccine Clinical trial Medicine R Medicine (General) Xue-Ning Li verfasserin aut Jing-Xin Li verfasserin aut Ming-Yun Shen verfasserin aut Mei-Wei Zhang verfasserin aut Ye Cao verfasserin aut Hong-Rong Xu verfasserin aut Hui Li verfasserin aut Jie Cheng verfasserin aut Liang Pan verfasserin aut Ying-Lei Yi verfasserin aut Li-Yu Liang verfasserin aut Cheng-Yin Yu verfasserin aut Gang-Yi Liu verfasserin aut Chen Yu verfasserin aut Bi-Jie Hu verfasserin aut Feng-Cai Zhu verfasserin aut Fei Liang verfasserin aut Haifa Shen verfasserin aut Jing-Ying Jia verfasserin aut Hang-Wen Li verfasserin aut Jian Zhou verfasserin aut Jia Fan verfasserin aut In EBioMedicine Elsevier, 2015 91(2023), Seite 104586- (DE-627)802540074 (DE-600)2799017-5 23523964 nnns volume:91 year:2023 pages:104586- https://doi.org/10.1016/j.ebiom.2023.104586 kostenfrei https://doaj.org/article/8a8a7fea066c4164a25277ccaada978c kostenfrei http://www.sciencedirect.com/science/article/pii/S2352396423001512 kostenfrei https://doaj.org/toc/2352-3964 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 91 2023 104586- |
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10.1016/j.ebiom.2023.104586 doi (DE-627)DOAJ089959965 (DE-599)DOAJ8a8a7fea066c4164a25277ccaada978c DE-627 ger DE-627 rakwb eng R5-920 Yu-Zhou Gui verfasserin aut Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai. SARS-CoV-2 Heterologous boosting mRNA vaccine Clinical trial Medicine R Medicine (General) Xue-Ning Li verfasserin aut Jing-Xin Li verfasserin aut Ming-Yun Shen verfasserin aut Mei-Wei Zhang verfasserin aut Ye Cao verfasserin aut Hong-Rong Xu verfasserin aut Hui Li verfasserin aut Jie Cheng verfasserin aut Liang Pan verfasserin aut Ying-Lei Yi verfasserin aut Li-Yu Liang verfasserin aut Cheng-Yin Yu verfasserin aut Gang-Yi Liu verfasserin aut Chen Yu verfasserin aut Bi-Jie Hu verfasserin aut Feng-Cai Zhu verfasserin aut Fei Liang verfasserin aut Haifa Shen verfasserin aut Jing-Ying Jia verfasserin aut Hang-Wen Li verfasserin aut Jian Zhou verfasserin aut Jia Fan verfasserin aut In EBioMedicine Elsevier, 2015 91(2023), Seite 104586- (DE-627)802540074 (DE-600)2799017-5 23523964 nnns volume:91 year:2023 pages:104586- https://doi.org/10.1016/j.ebiom.2023.104586 kostenfrei https://doaj.org/article/8a8a7fea066c4164a25277ccaada978c kostenfrei http://www.sciencedirect.com/science/article/pii/S2352396423001512 kostenfrei https://doaj.org/toc/2352-3964 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 91 2023 104586- |
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10.1016/j.ebiom.2023.104586 doi (DE-627)DOAJ089959965 (DE-599)DOAJ8a8a7fea066c4164a25277ccaada978c DE-627 ger DE-627 rakwb eng R5-920 Yu-Zhou Gui verfasserin aut Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai. SARS-CoV-2 Heterologous boosting mRNA vaccine Clinical trial Medicine R Medicine (General) Xue-Ning Li verfasserin aut Jing-Xin Li verfasserin aut Ming-Yun Shen verfasserin aut Mei-Wei Zhang verfasserin aut Ye Cao verfasserin aut Hong-Rong Xu verfasserin aut Hui Li verfasserin aut Jie Cheng verfasserin aut Liang Pan verfasserin aut Ying-Lei Yi verfasserin aut Li-Yu Liang verfasserin aut Cheng-Yin Yu verfasserin aut Gang-Yi Liu verfasserin aut Chen Yu verfasserin aut Bi-Jie Hu verfasserin aut Feng-Cai Zhu verfasserin aut Fei Liang verfasserin aut Haifa Shen verfasserin aut Jing-Ying Jia verfasserin aut Hang-Wen Li verfasserin aut Jian Zhou verfasserin aut Jia Fan verfasserin aut In EBioMedicine Elsevier, 2015 91(2023), Seite 104586- (DE-627)802540074 (DE-600)2799017-5 23523964 nnns volume:91 year:2023 pages:104586- https://doi.org/10.1016/j.ebiom.2023.104586 kostenfrei https://doaj.org/article/8a8a7fea066c4164a25277ccaada978c kostenfrei http://www.sciencedirect.com/science/article/pii/S2352396423001512 kostenfrei https://doaj.org/toc/2352-3964 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 91 2023 104586- |
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Yu-Zhou Gui @@aut@@ Xue-Ning Li @@aut@@ Jing-Xin Li @@aut@@ Ming-Yun Shen @@aut@@ Mei-Wei Zhang @@aut@@ Ye Cao @@aut@@ Hong-Rong Xu @@aut@@ Hui Li @@aut@@ Jie Cheng @@aut@@ Liang Pan @@aut@@ Ying-Lei Yi @@aut@@ Li-Yu Liang @@aut@@ Cheng-Yin Yu @@aut@@ Gang-Yi Liu @@aut@@ Chen Yu @@aut@@ Bi-Jie Hu @@aut@@ Feng-Cai Zhu @@aut@@ Fei Liang @@aut@@ Haifa Shen @@aut@@ Jing-Ying Jia @@aut@@ Hang-Wen Li @@aut@@ Jian Zhou @@aut@@ Jia Fan @@aut@@ |
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Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. 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Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context |
| abstract |
Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai. |
| abstractGer |
Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai. |
| abstract_unstemmed |
Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai. |
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| title_short |
Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context |
| url |
https://doi.org/10.1016/j.ebiom.2023.104586 https://doaj.org/article/8a8a7fea066c4164a25277ccaada978c http://www.sciencedirect.com/science/article/pii/S2352396423001512 https://doaj.org/toc/2352-3964 |
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true |
| author2 |
Xue-Ning Li Jing-Xin Li Ming-Yun Shen Mei-Wei Zhang Ye Cao Hong-Rong Xu Hui Li Jie Cheng Liang Pan Ying-Lei Yi Li-Yu Liang Cheng-Yin Yu Gang-Yi Liu Chen Yu Bi-Jie Hu Feng-Cai Zhu Fei Liang Haifa Shen Jing-Ying Jia Hang-Wen Li Jian Zhou Jia Fan |
| author2Str |
Xue-Ning Li Jing-Xin Li Ming-Yun Shen Mei-Wei Zhang Ye Cao Hong-Rong Xu Hui Li Jie Cheng Liang Pan Ying-Lei Yi Li-Yu Liang Cheng-Yin Yu Gang-Yi Liu Chen Yu Bi-Jie Hu Feng-Cai Zhu Fei Liang Haifa Shen Jing-Ying Jia Hang-Wen Li Jian Zhou Jia Fan |
| ppnlink |
802540074 |
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R - General Medicine |
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c |
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true |
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false |
| doi_str |
10.1016/j.ebiom.2023.104586 |
| callnumber-a |
R5-920 |
| up_date |
2024-07-04T01:21:59.752Z |
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1803609565830316032 |
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| score |
7.397874 |