JPRN-jRCT2071200084已完成1 期
A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-019 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
Kuriyama Kenji0 个研究点目标入组 200 人开始时间: 2021年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
2 doses of TAK-019 (SARS-CoV-2 rS 5 mcg with Matrix-M1 adjuvant 50 mcg dose), administered 21 days apart demonstrated good tolerability and acceptable safety profile, and induced significant and persistent anti-SARS-CoV-2 immune responses in Japanese population aged 20 years and older.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent.
- •2. Participants who understand and are willing to comply with trial procedures and are available for the duration of follow-up.
排除标准
- •1. Participants who received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial.
- •2. Participants who have close contact of anyone known to have COVID-19 within 30 days prior to the trial vaccination.
- •3. Participants who were tested positive for SARS-CoV-2 prior to the trial or before the trial vaccination.
- •4. Participants who are on current treatment with other investigational agents for prophylaxis of COVID-19.
- •5. Participants who have traveled outside of Japan in the 30 days prior to the trial participation.
- •6. Participants with a clinically significant active infection (as assessed by the Investigator) or oral temperature >= 38 degree Celsius within 3 days of the intended date of vaccination.
- •7. Participants with known hypersensitivity or allergy to any of the investigational vaccine components.
- •8. Participants with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial.
- •9. Participants with known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
- •10. Abnormalities of splenic or thymic function.
- •11. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •12. Participants with any serious chronic or progressive disease (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- •13. Participants with body mass index (BMI) greater than or equal to 30 kg/m^2 (BMI= weight in kg/ height in meters^2).
- •14. Participants participating in any clinical trial with another investigational product within 30 days prior to the trial vaccination or intend to participate in another clinical trial at any time during the conduct of this trial.
- •15. Participants who received or plan to receive any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to trial dose administration.
- •16. Participants with acute or chronic clinically significant disease including pulmonary, cardiovascular, hepatic or renal abnormality evaluated by physical examination.
- •17. Participants involved in the trial conduct or their first degree relatives.
- •18. Participants who have history or infection of hepatitis B, hepatitis C, and human immunodeficiency virus infection.
- •19. Female participants who are pregnant or breastfeeding.
研究者
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