A Phase Ib Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The seroconversion rates (SCRs) of each group 30 days after three-dose regimen
研究概览
简要总结
The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV with high D antigen content. 20 infants aged 2 months (60~90 days) were administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.
详细描述
The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV with high D antigen content. 20 infants aged 2 months (60~90 days) were administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.
The antigen contents of type I, type II and type III polioviruses in the high-dose Sabin IPV were 22 DU, 65 DU and 65 DU. All vaccines were in liquid form, 0.5 ml per dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Days 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer aged 18~45 years with/without prior vaccination of poliovirus and without any contraindication for vaccination;
- •Healthy volunteer aged 4 years with/without prior vaccination of poliovirus but without booster vaccination and any contraindication for vaccination;
- •Healthy volunteer aged 2 months (60~90 days) without prior vaccination of poliovirus and any contraindication for vaccination;
- •Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- •Complying with the requirement of the study protocol;
- •Axillary temperature ≤ 37.0 °C;
排除标准
- •Women aged 18~45 years with positive urine pregnancy test, pregnant or lactating women, or women with pregnancy plans within 3 months;
- •Preterm or low birth weight infants;
- •Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- •History of polio;
- •Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- •History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- •Autoimmune disease or immunodeficiency/immunosuppressive;
- •Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder), or significant bruising or coagulopathy;
- •Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;
- •Mother of the participant has HIV infection;
- •Acute illness or acute exacerbation of chronic disease within the past 7 days;
- •Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C);
- •Receipt of any subunit or inactivated vaccine within the past 7 day;
- •Receipt of any live attenuated vaccine within the past 14 days;
- •Receipt of any blood product within the past 3 months;
- •Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
结局指标
主要结局
The seroconversion rates (SCRs) of each group 30 days after three-dose regimen
时间窗: 28~42 days
Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
The geometric mean titer (GMT) of each group 30 days after three-dose regimen
时间窗: 28~42 days
GMT of each group 28\~42 days after three-dose regimen
The geometric mean fold increase (GMI) of each group 30 days after three-dose regimen
时间窗: 28~42 days
The GMI is the increase of post-immune GMT from pre-immune GMT
次要结局
- The incidences of adverse events (AEs) of each group occurred within 30 days after each injection(30 days)
- The incidences of adverse reactions of each group occurred within 30 days after each injection(30 days)