Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of adverse reactions following vaccination
研究概览
简要总结
The purpose of this trial is to determine whether the new inactivated polio vaccine that is based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy adults.
详细描述
The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI).
- The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first in human).
- The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy immunized adults.
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
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 49, inclusive at the time of enrolment
- •in good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the investigator
- •Must have received polio vaccinations with OPV according to the Polish National Immunization Program as a child based on vaccination cards or information given by subjects during interview with investigator
- •Preferred: number (and date) of polio vaccinations known
- •Willingness and ability to adhere to the study regimen
- •Having a signed informed consent form
排除标准
- •IPV or OPV booster dose after the age of 12 years
- •Positive for HIV, Hepatitis B or Hepatitis C
- •Known or suspected allergy against any of the vaccine components
- •History of unusual or severe reactions to any previous vaccination
- •Known or suspected disease or use of medication that may influence the immune system
- •Known or suspected immune deficiency
- •Systemic treatment with corticosteroids within one month before screening
- •Administration of plasma (including immunoglobulins) or blood products three months prior to the study
- •Blood donation within one month before screening
- •Any vaccination within three months before screening and during the study until the last visit
- •History of any neurological disorder including epilepsy or febrile seizures
- •Evidence of excessive alcohol use or drug use
- •Any infectious disease at the time of screening and/or inclusion
- •Participation in another clinical trial within three months before screening
- •Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
- •Bleeding disorders or the usage of anticoagulants
研究组 & 干预措施
Sabin-IPV
Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 20, 32, and 64 D-antigen units respectively of Sabin-1,-2 and -3 per dose
干预措施: Sabin-IPV (Drug)
Adjuvanted Sabin-IPV
Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, and 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose, adjuvanted with 0.5 mg aluminium hydroxide
干预措施: Adjuvanted Sabin-IPV (Drug)
IPV
Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 40, 8, and 32 D-antigen units respectively of Mahoney, MEF-1 and Saukett poliovirus per dose
干预措施: IPV (Drug)
结局指标
主要结局
Number of adverse reactions following vaccination
时间窗: 4 days or until adverse reactions have resolved
次要结局
- Level of virus neutralizing titers in serum(28 days)
研究者
Pauline Verdijk
Clinical Research Scientist
National Institute for Public Health and the Environment (RIVM)