PACTR202210848418417尚未招募2 期
A Phase IIb, Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial to Evaluate the Immunogenicity and Safety of the AdCLD-CoV19-1 in Healthy Adults Aged 19 Years Old and Above
Cellid0 个研究点目标入组 200 人开始时间: 2022年9月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy individual aged 19 years and above at consentconsent.
- •2.Individual willing to provide written informed consent to participate study voluntarily.
- •3.Individuals who can be followed up during the study period and can comply with the study requirements.
- •4.Individual who agrees not to donate blood during the study participation
- •5.Females of childbearing potential with negative serum or urinary pregnancy test on the day of screening.
- •6.Females of childbearing potential who are using an effective birth control method* for at least 4 weeks before the screening and during the study participation.
排除标准
- •1.Prior SARS-CoV-2 infection confirmed by a rapid antibody kit at screening.
- •2. History of receiving any vaccine (licensed or investigational) for SARS-CoV-2.
- •3. History of SARS-CoV-1 or MERS vaccination and treatment.
- •4.Individual determined to be clinically significantly abnormal by the screening outcome based on medical history, physical examination, laboratory evaluations (negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and Human Immunodeficiency Virus (HIV) antibody), electrocardiogram (ECG) and Chest X-ray, and the clinical judgment of the investigator.
- •5. Individual who has received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the study vaccine.
- •6. Febrile illness (tympanic temperature = 38°C) or acute illness with any clinically significant,, respiratory symptoms (e.g., sore throat, cough, sputum) within 3 days prior to the study vaccination.
- •7. Known history or allergy to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome).
- •8. Individual with major congenital abnormalities, which in the opinion of investigator may affect the participant’s participation in the study.
- •9. Chronic use of systemic steroids (>10 mg/day prednisone equivalent for periods exceeding 14 days), cytotoxic or other immunosuppressive drugs within the past 6 weeks.
- •10. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental to the safety of the participant and interfere with the assessment of the study objectives.
- •11. Individual with hereditary or idiopathic angioneurotic edema
- •12. Individual concomitantly enrolled or scheduled to be enrolled in another trial.
研究者
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