ISRCTN82411169进行中（未招募）1 期
A phase I/II randomized, two parts, dose-finding study to evaluate the safety, tolerability and immunogenicity of an inactivated, adjuvanted SARS-CoV-2 virus vaccine candidate (VLA2001), against COVID-19 in healthy subjects
Valneva (Austria)0 个研究点目标入组 150 人开始时间: 2020年12月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subject is 18 to 55 years of age
- •2. Subject who has a smart phone and is willing and able to install and use an eDiary
- •3. Subject has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures
- •4. Subject is generally healthy as determined by the Investigator
- •5. Subject has a Body Mass Index (BMI) of 18.0-30.0 kg/m²
- •6. If the subject is of childbearing potential:
- •6.1. Subject has practiced an adequate method of contraception during the 30 days before screening (Visit 0)
- •6.2. Subject has a negative serum or urine pregnancy test at screening (Visit 0) or Visit 1, respectively
- •6.3. Subject agrees to employ adequate birth control measures up to Day 106 (Visit 5)
排除标准
- •1. Clinically significant infection or other acute illness, including fever =38°C within 24 hours prior to the planned study vaccination
- •2. History of laboratory-confirmed SARS-CoV-2 infection
- •3. Subject had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening (Visit 0)
- •4. Subject has participated in a clinical study involving an investigational SARS-CoV-2 vaccine
- •5. Subject has an acute or recent infection not due to SARS-CoV-2
- •6. Subject has a history of SARS-CoV-1 or MERS infection (self-reported)
- •7. Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- •8. Subject has received any vaccine within 30 days prior Visit 1 other than the study intervention, with the exception of the seasonal influenza vaccination
- •9. Subject has abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator
- •10. Subjects with either medical history of or present acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation or completion of the study, based on Investigator’s clinical judgement
- •11. Subjects with underlying diseases with a high risk of developing severe COVID-19 symptoms if infected
- •12. Subject has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the subject may be enrolled. A history of hematologic malignancy is a permanent exclusion. Subjects with a history of skin cancer must not be vaccinated at the previous tumor site
- •13. Subject has a known or suspected defect of the immune system, such as subjects with congenital or acquired immune deficiency
- •14. Subject received immuno-suppressive therapy within 4 weeks prior to Visit 1 or receipt of immunosuppressive therapy is expected during the study.
- •15. Subject has a history of any vaccine related contraindicating event
- •16. Subject presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws
- •17. Subject is pregnant, has plans to become pregnant up to Day 106 of the study or lactating at the time of enrolment
- •18. Subject has donated blood, blood fractions or plasma within 4 weeks prior to Visit 1 or received blood-derived products (e.g. plasma) within 12 weeks prior to Visit 1 in this study or plans to donate blood or use blood products during the study
- •19. Subject with clinically significant bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following IM injections or venipuncture
- •20. Subject has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating
- •21. Subject has a known or suspected problem with alcohol or drug abuse as determined by the Investigator
- •22. Subject has any condition that, in the opinion of the Inves
研究者
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