Frontiers in Immunology (Jun 2022)

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

  • Shengli Xia,
  • Kai Duan,
  • Yuntao Zhang,
  • Xiaoqing Zeng,
  • Dongyang Zhao,
  • Huajun Zhang,
  • Zhiqiang Xie,
  • Xinguo Li,
  • Cheng Peng,
  • Wei Zhang,
  • Yunkai Yang,
  • Wei Chen,
  • Xiaoxiao Gao,
  • Wangyang You,
  • Xuewei Wang,
  • Zejun Wang,
  • Zhengli Shi,
  • Yanxia Wang,
  • Xuqin Yang,
  • Qingliang Li,
  • Lili Huang,
  • Qian Wang,
  • Jia Lu,
  • Yongli Yang,
  • Jing Guo,
  • Wei Zhou,
  • Xin Wan,
  • Cong Wu,
  • Wenhui Wang,
  • Shihe Huang,
  • Jianhui Du,
  • Xuanxuan Nian,
  • Tao Deng,
  • Zhiming Yuan,
  • Shuo Shen,
  • Wanshen Guo,
  • Jia Liu,
  • Xiaoming Yang,
  • Xiaoming Yang

DOI
https://doi.org/10.3389/fimmu.2022.898151
Journal volume & issue
Vol. 13

Abstract

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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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