JPRN-jRCT2071210067已完成1 期
A phase 1 study of self-amplifying mRNA vaccine VLPCOV-01Randomized, placebo-controlled, parallel group, first-in-human study (FIH Study)(COVID-19)
Sato Nobuaki0 个研究点目标入组 45 人开始时间: 2021年9月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
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
- 年龄范围
- >= 20age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •1. Healthy Japanese male and female subjects who are 20 to 65 years of age.
- •2. Participants who understand and agree to comply with the study procedures and provide written informed consent.
- •3. Participants whose BMI is 18-35 kg/m^2.
- •4. Participants whose body temperature is below 37.5 degree Celsius at screening.
- •5. Participants who have negative PCR test results SARS-CoV-2 at screening.
- •6. Participants who is willing and able to keep diary by himself/herself.
排除标准
- •1. Female participants who are confirmed or suspected pregnant, planned to be pregnant within 90 days of the last vaccination, or lactating.
- •2. Participants who are judged inappropriate in their health condition by Principal investigator or Sub-investigator.
- •3. Participants who have known history of COVID-19.
- •4. Participants who have history of COVID-19 vaccination, including investigational vaccine (exclusion placebo).
- •5. Participants who have history of significant diseases of cardiac, vascular system (including thrombosis), blood, respiratory, hepatic, renal, GI, psychiatric diseases or disorders.
- •6. Participants who have history of allergy such as systemic skin rash.
- •7. Participants who have history of convulsion (including febrile convulsions), Guillain-Barre syndrome, acute disseminated encephalomyelitis.
- •8. Participants who were diagnosed immune system disorder.
- •9. Participants who are receiving or scheduling any medicine and/or therapy that could interfere with immunogenicity assessment of test medications.
- •10. Participants who have history of anaphylaxis caused by food or medicines.
- •11. Participants who have history or risk of allergy or anaphylaxis caused by any components of study medications.
- •12. Participants who received any investigational product or vaccine 28 days prior to screening of this study, or who are planning to join any other investigation study during this study.
- •13. Participants who are bleeding tendency and considered a contraindication to intramuscular injection by Principal investigator or Sub-investigator.
- •14. Participants who received investigational product or medicine that contains lipid nano particle.
研究者
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