IRCT20201202049567N1招募中1 期
A double-blinded, randomized, placebo-controlled Phase I Clinical trial to evaluate the safety and immunogenicity of COVID-19 inactivated vaccine (Shif-Pharmed) in a healthy population
Shifa Pharmed Industrial Co.0 个研究点目标入组 56 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 years 至 50 years（—）
- 性别
- All
入选标准
- •Aged 18 to 50 years
- •Healthy general condition according to medical history and initial medical examinations
- •Willing and able to cooperate throughout the study period according to the study protocol
- •Being able to fully understand the study processes and understand the explanations of the facilitators correctly
- •Being able to understand the contents of the informed consent form and sign it before entering the study
- •Allowing researchers access to medical records, test results if hospitalized due to suspicion, or approval of COVID-19
- •A negative pregnancy test at screening or vaccination (women only)
- •Using effective methods of contraception during the study (male and female)
- •Volunteers who agree not to donate blood, blood products, or bone marrow from the start of the vaccine until three months after receiving the last dose
排除标准
- •Confirmed, suspected, or asymptomatic COVID-19 detected by PCR at baseline.
- •COVID-19 positive antibody
- •History of SARS-CoV-2 infection
- •History of contact with a person with SARS-CoV-2 infection (positive PCR test) during the last 14 days
- •People in the home quarantine period due to Covid (suspicion of exposure or suspicious symptoms)
- •Fever (axillary temperature greater than 37 ° C) Dry cough, extreme tiredness, nasal congestion, runny nose, sore throat, muscle aches, diarrhea, dyspnea, and shortness of breath during the 14 days prior to vaccination
- •Abnormality in biochemistry, blood and urine laboratory tests
- •History of severe allergy or allergic reactions to Inactivated vaccine components
- •Personal or family history of seizure, epilepsy, encephalopathy or mental disorders
- •Congenital malformations
- •History of neurologic disorders or seizure or Guillain-Barre syndrome (excluding childhood febrile seizure)
- •Growth disorders
- •Any Genetic disorder
- •History or signs of malnutrition
- •Hepatorenal diseases
- •Uncontrolled hypertension
- •Diabetes complications
- •Any malignancy
- •Acute diseases or an exacerbation of a chronic disease in the last 7 days
- •Known case of immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases
- •Thyroid disease or history of thyroidectomy
- •Splenectomy or history of any organ removal
- •History of coagulopathy
- •Receiving Anti-TB treatment
- •Positive HBSAg
- •Positive HIV test
- •Positive HCV antibody
- •Receiving immunomodulators or immunosuppressors at least 14 days in the past 3 months
- •Receiving live vaccine in one month or other vaccines in 14 days before inoculation
- •History of drug or alcohol abuse
- •Receiving immunoglobulins or blood products in 3 months before inoculation
- •Receiving any other investigational drug in 6 months before inoculation
- •Planning to receive any vaccination in on month after inoculation
- •History of severe mental disorders affecting the participation in the study
- •Pregnant or lactating women or those who intend to become pregnant during the study period
- •Having a high-risk job of being exposed to the SARS-CoV-2 virus or having a high risk of exposure according to the investigator evaluation
- •Any other condition that makes a person inappropriate for participation based on the investigator opinion
研究者
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