To Compare the Reactogenicity and Immunogenicity of Recommended COVID-19 Vaccines in Young Adolescents and Children in Hong Kong
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,018
- 试验地点
- 1
- 主要终点
- Neutralizing antibody response
研究概览
简要总结
Objectives To assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in healthy children and adults as well as pediatric patients receiving the COVID-19 vaccines-BNT162b2, CoronaVac-chosen by the Hong Kong Government; to compare the reactogenicity and immunogenicity across the vaccines used for these children and adults.
Hypothesis to be tested The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines in children are non-inferior to those in adults.
Design and subjects A single-site, comparative nonrandomised clinical trial for 450 healthy individuals or patients under 18 years old and one or both healthy parents and unrelated adults to receive one of COVID-19 vaccines by intramuscular injection (and intradermal injection)
Instruments Mobile app for subjects to record adverse effects, enzyme-linked immunosorbent assay, plaque reduction neutralization assay, luciferase immunoprecipitation system assay and flow cytometry.
Interventions BNT162b2 and CoronaVac, by intramuscular or intradermal route
Main outcome measures Types and frequencies of adverse effects within 7 days, and changes and peaks of antibody levels and antigen-specific memory T cell responses for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent from the parents or a legally acceptable representative for an underage participant
- •biological parents of students enrolled in the trial or unrelated healthy adults
- •ability to adhere to the follow-up schedules
- •willingness to report reactogenicity daily for 7 days post dose 1, 2 and 3 (and 4) proactively
- •willingness to receive that vaccine available for that particular recruitment period (as student-parent pair, if applicable)
- •good past health, including pre-existing clinically stable disease, such as paediatric or immune disorders
- •prior COVID-19 (for COVID-19 survivor subgroup)
排除标准
- •reported pregnancy or breastfeeding
结局指标
主要结局
Neutralizing antibody response
时间窗: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Geometric mean levels and geometric mean fold rise of SARS-CoV2 neutralizing antibodies as determined by plaque reduction neutralization assay and surrogate assays
T cell response
时间窗: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Geometric mean percentage of CD4 and CD8 T cells specific to SARS-CoV2 S (and N and M) protein
Adverse reactions
时间窗: 7 days post-doses 1, 2 and 3 (and 4)
Percentage of occurrence, types, duration and severity of adverse reactions occurring within 7 days
Binding antibody response
时间窗: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Geometric mean levels of SARS-CoV2 S and S-RBD-specific binding antibody and related markers as determined by Enzyme-linked Immunosorbent Assay
次要结局
- Vaccine breakthrough(Throughout the study period, until 36 months post-dose 3/4)
- Binding anti-N antibody response(1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4))
- Adverse events(Throughout the study period, until 36 months post-dose 3/4)