Abstract
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.
Keywords: COVID-19; SARS-CoV-2; children; clinical trial; immunogenicity; inactivated vaccine; safety.
【저자키워드】 COVID-19, SARS-CoV-2, immunogenicity, clinical trial, Safety, children, Inactivated vaccine, 【초록키워드】 neutralizing antibody, Vaccine, COVID-19 vaccine, vaccination, immunogenicity, Phase 2, Antibody Response, adverse events, Adverse reactions, China, Randomized, Cohort, Humoral response, Inactivated vaccine, Fever, Mild, age, Placebo, placebo-controlled, safety profile, phase 2 trial, inactivated, Escalation, dose, Adverse reaction, alum, Safe, double-blind, Intramuscular injection, followed by, grade 3, Phase 1, geometric mean, Effective vaccines, geometric mean titers, three groups, Registered, cohorts, injection, participant, phase 1 trial, healthy children, geometric mean titer, injection site pain, Randomly, dose-escalation, robust, tested, detectable, conducted, significantly higher, effective vaccine, assigned, groups, elicited, ranged, three group, 【제목키워드】 Safety, phase, Controlled, Interim,