A Single-center,Open-label，Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Safety indexes of adverse reactions
研究概览
简要总结
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.
This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .
详细描述
This is a single-center,open-label，dose-escalating phase I clinical trial in healthy 18 to 60 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.One hundred and eight subjects will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of experimental vaccine or placebo on Days 1 in the deltoid muscle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 60 years.
- •Able to understand the content of informed consent and willing to sign the informed consent
- •Able and willing to complete all the secluded study process during the whole 6 months study follow-up period.
- •Negative in HIV diagnostic test.
- •Negative in serum antibodies (IgG and IgM) screening of COVID-
- •Normal in lung CT images (no imaging features of COVID-19
- •Axillary temperature ≤37.0°C.
- •The BMI index is 18.5-30.
- •Negative in Nasopharyngeal swabs / sputum and anal swabs through RT-PCR
- •Laboratory tests such as hematological examination and clinical biochemistry examination are in the normal range or without meaning judged by clinical doctor.
- •General good health as established by medical history and physical examination.
排除标准
- •Family history of seizure, epilepsy, brain or mental disease
- •Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
- •Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
- •Any acute fever disease or infections.
- •History of SARS
- •Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
- •Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
- •Hereditary angioneurotic edema or acquired angioneurotic edema
- •Urticaria in last one year
- •No spleen or functional spleen.
- •Platelet disorder or other bleeding disorder may cause injection contraindication
- •Faint at the sight of needles.
- •Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months.
- •Prior administration of blood products in last 4 months
- •Prior administration of other research medicines in last 1 month
- •Prior administration of attenuated vaccine in last 1 month
- •Prior administration of inactivated vaccine in last 14 days
- •Current anti-tuberculosis prophylaxis or therapy
- •According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.
结局指标
主要结局
Safety indexes of adverse reactions
时间窗: 0-7 days post-vaccination
Occurrence of adverse reactions post-vaccination
次要结局
- Immunogencity indexes of GMT(ELISA)(day14,28，month 3,6 post-vaccination)
- Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method)(day14,28，month 6 post-vaccination)
- Immunogencity indexes of GMC(Ad5 vector)(day、14,28，month3,6 post-vaccination)
- Safety indexes of adverse events(0-28 days post-vaccination)
- Safety indexes of lab measures(pre-vaccination, day 7 post-vaccination)
- Immunogencity indexes of GMT(pseudoviral neutralization test method)(day14,28，month 6 post-vaccination)
- Immunogencity indexes of GMI(ELISA)(day14,28，month 3,6 post-vaccination)
- Immunogencity indexes of cellular immune(day 14, 28,month 6 post-vaccination)
- Safety indexes of SAE(0-28 days, within 6 mouths post-vaccination)
- Immunogencity indexes of seropositivity rates(ELISA)(day14,28，month 3,6 post-vaccination)
- Immunogencity indexes of GMI(pseudoviral neutralization test method)(day14,28，month 6 post-vaccination)
- Immunogencity indexes of GMI(Ad5 vector)(day、14,28，month3,6 post-vaccination)