Immunogenicity and safety of a SARS-CoV-2 mRNA vaccine (SYS6006) in healthy Chinese participants : A randomized, observer-blinded, placebo-controlled phase 2 clinical trial
Copyright © 2024 Elsevier Ltd. All rights reserved..
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine enables quick upgrade of antigen sequence to combat emerging new variants. In an observer-blinded, randomized, placebo-controlled phase 2 trial, immunologically naïve 300 adults and 150 older participants were enrolled and randomized (1:1:1) to receive two doses of 20 µg or 30 µg of a SARS-CoV-2 mRNA vaccine (SYS6006) or placebo. Adverse events (AEs) were recorded through 30 days after the second dose. Live virus neutralizing antibody (Nab), S1 protein-specific binding antibody (S1-IgG) and cellular immunity were tested. Results showed that robust wild-type Nab response was elicited with geometric mean titers of 91.3 and 84.9 in the adults, and 74.0 and 115.9 in the elders, 14 days following the second dose (Day 35) in the 20-µg and 30-µg groups, respectively. All seroconverted for wild-type Nab except two participants. Nab against Omicron BA.5 was mild. Robust wild-type S1-IgG response was induced with geometric mean concentrations of 2751.0 and 3142.2 BAU/mL in adults, and 2474.1 and 2993.5 BAU/mL in elders at Day 35 in the 20-µg and 30-µg groups, respectively. S1-IgG against Omicron BA.2 was induced. Cellular immunity was elicited, particularly in enzyme-linked immunospot assay. The most frequent AEs were injection-site pain and fever. Most reported AEs were grade 1 or grade 2. The AE incidences were similar following the first dose and second dose. No vaccination-associated serious AE was reported. In conclusion, two-dose vaccination with SYS6006 demonstrated good safety, tolerability and immunogenicity in immunologically naïve healthy participants aged 18 years or more.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:42 |
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| Enthalten in: |
Vaccine - 42(2024), 7 vom: 07. März, Seite 1561-1570 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Jin, Fei [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 18.03.2024 Date Revised 18.03.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.vaccine.2024.01.098 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Immunogenicity and safety of a SARS-CoV-2 mRNA vaccine (SYS6006) in healthy Chinese participants |b A randomized, observer-blinded, placebo-controlled phase 2 clinical trial |
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| 520 | |a Copyright © 2024 Elsevier Ltd. All rights reserved. | ||
| 520 | |a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine enables quick upgrade of antigen sequence to combat emerging new variants. In an observer-blinded, randomized, placebo-controlled phase 2 trial, immunologically naïve 300 adults and 150 older participants were enrolled and randomized (1:1:1) to receive two doses of 20 µg or 30 µg of a SARS-CoV-2 mRNA vaccine (SYS6006) or placebo. Adverse events (AEs) were recorded through 30 days after the second dose. Live virus neutralizing antibody (Nab), S1 protein-specific binding antibody (S1-IgG) and cellular immunity were tested. Results showed that robust wild-type Nab response was elicited with geometric mean titers of 91.3 and 84.9 in the adults, and 74.0 and 115.9 in the elders, 14 days following the second dose (Day 35) in the 20-µg and 30-µg groups, respectively. All seroconverted for wild-type Nab except two participants. Nab against Omicron BA.5 was mild. Robust wild-type S1-IgG response was induced with geometric mean concentrations of 2751.0 and 3142.2 BAU/mL in adults, and 2474.1 and 2993.5 BAU/mL in elders at Day 35 in the 20-µg and 30-µg groups, respectively. S1-IgG against Omicron BA.2 was induced. Cellular immunity was elicited, particularly in enzyme-linked immunospot assay. The most frequent AEs were injection-site pain and fever. Most reported AEs were grade 1 or grade 2. The AE incidences were similar following the first dose and second dose. No vaccination-associated serious AE was reported. In conclusion, two-dose vaccination with SYS6006 demonstrated good safety, tolerability and immunogenicity in immunologically naïve healthy participants aged 18 years or more | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Phase 2 clinical trial | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a Safety | |
| 650 | 4 | |a mRNA vaccine | |
| 650 | 7 | |a SYS6006 COVID-19 vaccine |2 NLM | |
| 650 | 7 | |a COVID-19 Vaccines |2 NLM | |
| 650 | 7 | |a mRNA Vaccines |2 NLM | |
| 650 | 7 | |a Immunoglobulin G |2 NLM | |
| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 650 | 7 | |a Antibodies, Neutralizing |2 NLM | |
| 700 | 1 | |a Qiu, Yuanzheng |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Zhiwei |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Yuan-Hui |e verfasserin |4 aut | |
| 700 | 1 | |a Cai, Chengye |e verfasserin |4 aut | |
| 700 | 1 | |a Fu, Liangcai |e verfasserin |4 aut | |
| 700 | 1 | |a Jiao, Wenbin |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Huixian |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Ming |e verfasserin |4 aut | |
| 700 | 1 | |a Su, Chang |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Jun-Heng |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Chao-Chao |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Qing |e verfasserin |4 aut | |
| 700 | 1 | |a Ni, Shaonan |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Maosheng |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, Lixian |e verfasserin |4 aut | |
| 700 | 1 | |a Ji, Li |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Hanyu |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Yuliang |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Chunlei |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Xiang |e verfasserin |4 aut | |
| 700 | 1 | |a Su, Yu-Wen |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Qi |e verfasserin |4 aut | |
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