Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children : Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial
Copyright © 2022 Xia, Duan, Zhang, Zeng, Zhao, Zhang, Xie, Li, Peng, Zhang, Yang, Chen, Gao, You, Wang, Wang, Shi, Wang, Yang, Li, Huang, Wang, Lu, Yang, Guo, Zhou, Wan, Wu, Wang, Huang, Du, Nian, Deng, Yuan, Shen, Guo, Liu and Yang..
Safe and effective vaccines against SARS-CoV-2 for children are urgently needed. Here we aimed to assess the safety and immunogenicity of an inactivated COVID-19 vaccine candidate, WIBP-CorV, in participants aged 3-17 years. A randomized, double-blind, placebo-controlled, phase 1/2 clinical trial was conducted in Henan Province, China, in healthy children aged 3-17 years. 240 participants in phase 1 trial and 576 participants in phase 2 trial were randomly assigned to vaccine or control with an age de-escalation in three cohorts (3-5, 6-12 and 13-17 years) and dose-escalation in three groups (2.5, 5.0 and 10.0μg/dose), and received 3 intramuscular injections at day 0, 28, and 56. WIBP-CorV showed a promising safety profile with approximately 17% adverse reactions within 30 days after injection and no grade 3 or worse adverse events. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting. The geometric mean titers of neutralizing antibody ranged from 102.2 to 1065.5 in vaccinated participants at 28 days after the third vaccination, and maintained at a range of 14.3 to 218.2 at day 180 after the third vaccination. WIBP-CorV elicited significantly higher titers of neutralizing antibody in the cohort aged 3-5 years than the other two cohorts. There were no detectable antibody responses in all alum-only groups. Taken together, our data demonstrate that WIBP-CorV is safe and well tolerated at all tested doses in participants aged 3-17 years, and elicited robust humoral responses against SARS-CoV-2 lasted for at least 6 months after the third vaccination. This study is ongoing and is registered with www.chictr.org.cn, ChiCTR2000031809.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
Frontiers in immunology - 13(2022) vom: 01., Seite 898151 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Xia, Shengli [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 12.07.2022 Date Revised 16.07.2022 published: Electronic-eCollection Citation Status MEDLINE |
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| doi: |
10.3389/fimmu.2022.898151 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 245 | 1 | 0 | |a Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children |b Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial |
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| 520 | |a Copyright © 2022 Xia, Duan, Zhang, Zeng, Zhao, Zhang, Xie, Li, Peng, Zhang, Yang, Chen, Gao, You, Wang, Wang, Shi, Wang, Yang, Li, Huang, Wang, Lu, Yang, Guo, Zhou, Wan, Wu, Wang, Huang, Du, Nian, Deng, Yuan, Shen, Guo, Liu and Yang. | ||
| 520 | |a Safe and effective vaccines against SARS-CoV-2 for children are urgently needed. Here we aimed to assess the safety and immunogenicity of an inactivated COVID-19 vaccine candidate, WIBP-CorV, in participants aged 3-17 years. A randomized, double-blind, placebo-controlled, phase 1/2 clinical trial was conducted in Henan Province, China, in healthy children aged 3-17 years. 240 participants in phase 1 trial and 576 participants in phase 2 trial were randomly assigned to vaccine or control with an age de-escalation in three cohorts (3-5, 6-12 and 13-17 years) and dose-escalation in three groups (2.5, 5.0 and 10.0μg/dose), and received 3 intramuscular injections at day 0, 28, and 56. WIBP-CorV showed a promising safety profile with approximately 17% adverse reactions within 30 days after injection and no grade 3 or worse adverse events. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting. The geometric mean titers of neutralizing antibody ranged from 102.2 to 1065.5 in vaccinated participants at 28 days after the third vaccination, and maintained at a range of 14.3 to 218.2 at day 180 after the third vaccination. WIBP-CorV elicited significantly higher titers of neutralizing antibody in the cohort aged 3-5 years than the other two cohorts. There were no detectable antibody responses in all alum-only groups. Taken together, our data demonstrate that WIBP-CorV is safe and well tolerated at all tested doses in participants aged 3-17 years, and elicited robust humoral responses against SARS-CoV-2 lasted for at least 6 months after the third vaccination. This study is ongoing and is registered with www.chictr.org.cn, ChiCTR2000031809 | ||
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| 700 | 1 | |a Xie, Zhiqiang |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Xinguo |e verfasserin |4 aut | |
| 700 | 1 | |a Peng, Cheng |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Yunkai |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Xiaoxiao |e verfasserin |4 aut | |
| 700 | 1 | |a You, Wangyang |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Xuewei |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Zejun |e verfasserin |4 aut | |
| 700 | 1 | |a Shi, Zhengli |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Yanxia |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Xuqin |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Qingliang |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Lili |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Qian |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Jia |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Yongli |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, Jing |e verfasserin |4 aut | |
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| 700 | 1 | |a Wu, Cong |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Wenhui |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Shihe |e verfasserin |4 aut | |
| 700 | 1 | |a Du, Jianhui |e verfasserin |4 aut | |
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| 700 | 1 | |a Shen, Shuo |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, Wanshen |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Jia |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Xiaoming |e verfasserin |4 aut | |
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