Systems Biology of Vaccination for EV71 Vaccine in Chinese Healthy Children Aged From 2 to 5 Years Old
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
研究概览
简要总结
Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1 and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the candidate vaccine for the phase 3 clinical trial.
This clinical trial is a supplementary phase 2 trial, which is designed to study the gene expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5 years old use a systems biology approach combined with microarray analysis，RT-PCR and neutralizing antibody testing for PBMC and serum collected form the studied children population, to predict immunogenicity, and explore mechanistic insights about the EV71 vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects aged from 2 to 5 years old as established by medical history and clinical examination
- •The pre-vaccination neutralizing antibody against EV71 <1:8 which is determined by ELISA
- •The subjects' guardians are able to understand and sign the informed consent
- •Had never received the vaccine against EV71
- •Subjects who can and will comply with the requirements of the protocol
- •Subjects with temperature <37.1°C on axillary setting
排除标准
- •Subject who has a medical history of HFMD
- •<= 37 weeks gestation
- •Subjects with a birth weight <2.5 kg
- •Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- •Family history of seizures or progressive neurological disease
- •Family history of congenital or hereditary immunodeficiency
- •Severe malnutrition or dysgenopathy
- •Major congenital defects or serious chronic illness, including perinatal brain damage
- •Autoimmune disease
- •Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- •Any acute infections in last 7 days
- •Any prior administration of immunodepressant or corticosteroids in last 6month
- •Any prior administration of blood products in last 3 month
- •Any prior administration of other research medicines in last 1month
- •Any prior administration of attenuated live vaccine in last 28 days
- •Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal vaccine
- •Under the anti - TB prevention or therapy
- •Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
研究组 & 干预措施
320U /0.5ml in children (from 2 to 5 years old)
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 48 children aged 2-5 years old on day 0,28
干预措施: 320U /0.5ml (Biological)
0/0.5ml placebo in children (from 2 to 5 years old)
0/0.5ml placebo in 24 children aged 2-5 years old on day 0, 28
干预措施: 0/0.5ml placebo (Biological)
结局指标
主要结局
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
时间窗: 6 months after first dose
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at month 6 in children aged 2-5 years
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
时间窗: Frame: 3 days after first dose
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 3 in children aged 2-5 years
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
时间窗: 7 days after first dose
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 7 in children aged 2-5 years
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
时间窗: 28 days after first dose
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 28 in children aged 2-5 years
Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
时间窗: 28 days after second dose
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 56 in children aged 2-5 years
次要结局
- GMT, seroconversion rate of anti-EV71 antibodies in serum after first vaccination(28 days after the first vaccination)
- GMT, seroconversion rate of anti-EV71 antibodies in serum after second vaccination(28 days after second vaccination)
- the safety of EV71 vaccine in healthy children aged 2-5 years(28 days after the second dose)
- the safety of EV71 vaccine in healthy children aged 2-5 years(28 days after the first dose)