Cargando…

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

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 wa...

Descripción completa

Detalles Bibliográficos
Autores principales: Xia, Shengli, Duan, Kai, Zhang, Yuntao, Zeng, Xiaoqing, Zhao, Dongyang, Zhang, Huajun, Xie, Zhiqiang, Li, Xinguo, Peng, Cheng, Zhang, Wei, Yang, Yunkai, Chen, Wei, Gao, Xiaoxiao, You, Wangyang, Wang, Xuewei, Wang, Zejun, Shi, Zhengli, Wang, Yanxia, Yang, Xuqin, Li, Qingliang, Huang, Lili, Wang, Qian, Lu, Jia, Yang, Yongli, Guo, Jing, Zhou, Wei, Wan, Xin, Wu, Cong, Wang, Wenhui, Huang, Shihe, Du, Jianhui, Nian, Xuanxuan, Deng, Tao, Yuan, Zhiming, Shen, Shuo, Guo, Wanshen, Liu, Jia, Yang, Xiaoming
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9265248/
https://www.ncbi.nlm.nih.gov/pubmed/35812412
http://dx.doi.org/10.3389/fimmu.2022.898151
Descripción
Sumario: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.