A Randomized, Double-blind, Placebo-controlled, Phase 1 Clinical Trial to Investigate the Safety and Immunogenicity of High-dose IN-B001 After Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Frequency and severity of adverse events of IN-B001 (Safety of IN-B001)
研究概览
简要总结
This study aims to evaluate the safety and immunogenicity of high-dose IN-B001 after administration in healthy subjects
详细描述
Enterovirus 71(EV71) and coxsackievirus A16(CVA16) are major causes of Hand-foot-and-mouth disease (HFMD) occurring in pediatric population. Although EV71 vaccine has been licensed in China, vaccine for CVA16-associated HFMD is currently not available anywhere. The purpose of this phase I study is to evaluate the safety and immunogenicity of EV71/CVA16 bivalent vaccine in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult aged ≥19 to <50 years at the time of screening tests
- •Body mass index(BMI) of ≥18.0 kg/m2 to ≤27.0 kg/m2, with body weight of ≥55.0 kg to ≤90.0 kg for men and ≥50.0 kg to ≤90.0 kg for women at the time of screening tests
- •Determined by the investigator to be eligible for study participation based on the results of screening tests
- •Intact deltoid muscle that allows administration of the investigational product
- •Consent to use medically acceptable contraception throughout the study
- •Negative finding from a pregnancy test (urine hCG) at the time of the screening for women of childbearing potential
- •Voluntary decision and provision of written consent on participation in this study
排除标准
- •History of a hand-foot-mouth disease or history of a disease related with enterovirus(EV) infection within 3 months prior to the 1st IP administration
- •Medical history of an anaphylactic or similar acute reaction to IN-B001 or similar vaccine
- •Febrile disease or infectious disease within 2 weeks prior to the 1st IP administration
- •Whole blood donation within 2 months or apheresis within 1 month prior to the 1st IP administration
- •Vaccination with other prevention vaccine within 2 months prior to the 1st IP administration
- •Use of an immunomodulator or immunosuppressant within 3 months prior to the 1st IP administration
- •History of a Guillain Barre syndrome
- •Excessive caffeine intake or continuous alcohol consumption or incapable of abstention from alcohol during the study
- •Participation in other clinical trial within 6 months prior to the 1st IP administration
- •Pregnant or breastfeeding women
- •Clinically significant hepatic, renal, neurological, respiratory, endocrine, hematology and oncology, cardiovascular, urological or psychiatric disease or such history
- •Positive serological finding (type B hepatitis test, type C hepatitis test, human immunodeficiency virus(HIV) test)
- •History of drug abuse or positive finding from a urine screening test for an abusive drug
- •Use or of any prescription medication or oriental medicine within 2 weeks or any over-the-counter(OTC) medication, health functional food or vitamin within 1 week prior to the 1st IP administration or expected use of such products
- •Administration of a blood product or blood-derived agent within 3 months prior to the 1st IP administration
- •Determined by the investigator to be ineligible for study participation due to other reason including clinical laboratory findings
研究组 & 干预措施
IN-B001 EV71 A dose
Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval)
干预措施: IN-B001 EV71 A dose (Biological)
IN-B001 EV71 A dose
Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval)
干预措施: Placebo (Biological)
IN-B001 CVA16 B dose
Inactivated CVA16 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)
干预措施: IN-B001 CVA16 B dose (Biological)
IN-B001 CVA16 B dose
Inactivated CVA16 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)
干预措施: Placebo (Biological)
IN-B001 Bivalent C dose
Inactivated EV71/CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval)
干预措施: IN-B001 Bivalent C dose (Biological)
IN-B001 Bivalent C dose
Inactivated EV71/CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval)
干预措施: Placebo (Biological)
结局指标
主要结局
Frequency and severity of adverse events of IN-B001 (Safety of IN-B001)
时间窗: Week 0 to Week 32
Frequency and severity of adverse events up to 32 weeks post first dose
次要结局
- Immunogenicity of IN-B001: Anti-EV71 IgG titer(Week 0 to Week 32)
- Immunogenicity of IN-B001 : Anti-CVA16 IgG titer(Week 0 to Week 32)
- Immunogenicity of IN-B001 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers(Week 0 to Week 32)
- Immunogenicity of IN-B001 : GMT of CVA16 neutralizing antibody titers(Week 0 to Week 32)