ACTRN12622001415796已完成1 期
A randomized, double-blind, active-controlled, phase I clinical study to evaluate the safety, tolerability, and immunogenicity of a COVID-19 mRNA vaccine (in002.5.1) in comparison with an approved mRNA booster vaccine for COVID-19 in population >= 18 years of age
Shenzhen Shenxin Biotechnology Co., Ltd.0 个研究点目标入组 56 人开始时间: 2022年11月7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
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 59 Years（—）
- 性别
- All
入选标准
- •1.Male or female, >=18 and <= 59 years of age.
- •2.Body mass index (BMI) > 18.5 and < 35.0 kg/m2 and body weight >= 50.0 kg for males and >= 45.0 kg for females.
- •3.Participants with Gilbert’s syndrome who have normal conjugated bilirubin and normal liver function tests (LFTs).
- •4.Participants must have previously received a mRNA vaccine (Moderna or Pfizer/BioNTech) COVID-19 vaccine.
- •5.Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test and they are not breastfeeding.
- •6.Sexually active non-sterile male subjects must be willing to use an acceptable contraceptive method throughout the study.
- •7.Female subjects of childbearing potential must be willing not to donate eggs from dosing until the EOS.
- •8.Male subjects must be willing not to donate sperm from dosing until the EOS.
- •9.Participants who provide signed informed consent to participate in the study and are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
排除标准
- •1.Any clinically significant abnormal finding at physical examination.
- •2.Subjects with any of the following laboratory abnormalities at Screening:
- •a. Alanine aminotransferase (ALT) > 1.5X upper limit of normal (ULN)
- •b.Aspartate aminotransferase (AST) > 1.5X ULN
- •c.Alkaline phosphatase > 1.5X ULN
- •d.Total Bilirubin > 2X ULN
- •e.Neutrophils < 1.5 x 109/µL or < 1.0 x 109/µL in African Americans or black subjects
- •3.Participants had close contact (without personal protective equipment [PPE]) as defined by the Centers for Disease Control and Prevention (CDC) in the past 14 days to someone diagnosed with SARS-CoV-2 infection or COVID-19 within 10 days of the close contact. Participants may be rescreened after 14 days provided that they remain asymptomatic.
- •4.Participant has tested positive for SARS-CoV-2 by an authorized/approved lateral flow/rapid antigen or polymerase chain reaction (PCR) test within 90 days of Screening.
- •5.Participant has received a COVID-19 vaccine within 90 days of the Screening Visit.
- •6.Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- •7.Participant has dosed in an interventional clinical study within 90 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.
- •8.Previous participation in other studies involving study intervention with lipid nanoparticles (LNPs).
- •9.Positive pregnancy test or lactating female subject.
- •10.Positive urine drug screen or alcohol breath test.
- •11.History of significant allergic reactions (e.g., anaphylactic reaction, hypersensitivity, angioedema) to any drug or vaccine, or any excipients in the formulation.
- •12.Clinically significant electrocardiogram (ECG) abnormalities or vital signs abnormalities (systolic blood pressure (BP) lower than 85 or over 150 mmHg, diastolic BP lower than 50 or over 90 mmHg, heart rate (HR) less than 40 or over 100 bpm, or respiratory rate (RR) less than 8 or over 22 bpm) at screening.
- •13.History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis, persistent myocardial viral infection (e.g., due to enterovirus or adenovirus), and celiac disease.
- •14.History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
- •15.History of a known or suspected respiratory system disorder including, but not limited to, cystic fibrosis, interstitial lung disease, reactive airway disease, emphysema, chronic bronchitis, pulmonary hypertension, chronic obstructive pulmonary disease (COPD), or asthma (participants with childhood asthma can be included in the study).
- •16.Presence of tattoos, scarring, skin discoloration, or any other skin disturbances at the injection site which, in the opinion of the Investigator, may inhibit the ability to effectively perform an injection site assess
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