IRCT20210206050259N2已完成2 期
Phase 2 trial of safety and immunogenicity of 10 micro gram inactivated SARS-CoV-2 vaccine (FAKHRAVAC), two doses two weeks apart in adults aged 18-70 years: a randomized, double-blind, placebo-controlled, clinical trial
Organization of Defensive Innovation and Research0 个研究点目标入组 500 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
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 70 years（—）
- 性别
- All
入选标准
- •Age 18 to 70 years
- •Body mass index between 18 and 35 kg per square meter
- •No current or previous COVID-19 disease
- •No pregnancy
- •Using safe methods of contraception
- •Signing the informed consent form
- •Having Iranian citizenship
- •Participants should be able to read and understand informed consent, preferably having an education at a diploma or higher level.
- •Temperatures less than or equal to 37.2 ° C, sublingual, measured by a digital thermometer
- •Negative IgG and IgM antibody titers against COVID-19 N antigen
- •Negative RT-PCR -test for SARS-CoV-2
- •IgG ELISA negative blood test against HIV
- •Heart rate between 60 and 100
- •Systolic blood pressure (between 90 and 140 mm Hg), Diastolic blood pressure (between 60 and 90 mm Hg)
- •Committing to observing the requested behavioral protocol to reduce the risk of COVID-19
- •Negative pregnancy test for ß-hCG on the day of screening and the day of vaccination
- •Clinical trial participants should refrain from donating blood or plasma from the first vaccination until three months after the last vaccination.
- •Participants should not enter any other trial while in this study
- •Expressing readiness to remain in the study for the entire study period
- •Use one of a safe methods of contraception in men and women up to 3 months after the last dose of the vaccine
排除标准
- •Current acute or chronic symptomatic illness that requires ongoing medical or surgical care
- •High-risk occupations regarding the risk of acquiring COVID-19, including medical staff, occupations with close contact with many clients
- •Serving in compulsory military service (soldiers) in the subdivisions of the Armed Forces
- •Breastfeeding
- •History of receiving any research vaccine during the 30 days before the day of screening
- •History of transfusion of any blood product or immunoglobulin within the three months before the screening day
- •History of long-term use of immunosuppressive drugs or systemic corticosteroids in the last four months leading up to screening day
- •History of allergic diseases such as angioedema or anaphylactic reactions
- •History of any allergy to drugs or vaccines
- •History of cancer or chemotherapy in the last 5 years
- •History of serious psychiatric illnesses
- •History of blood disorders (Blood Dyscrasias, coagulation, platelet deficiency or disorder, etc)
- •Having chronic obstructive pulmonary disease such as asthma and COPD, ischemic cardiovascular disease diagnosed and treated by a specialist
- •Uncontrolled blood pressure (systolic higher than 140 and diastolic higher than 90)
- •Uncontrolled diabetes (HbA1c higher than six or BS higher than 140) or diabetes treatment by insulin
- •History of chronic neurological diseases (including seizures and epilepsy)
- •Having thyroid disease or a history of thyroidectomy except for controlled hypothyroidism
- •Any history of drug/alcohol abuse (addiction) during the last 2 years
- •Any grade 2 or higher toxicity in the hematology or biochemistry test results performed at the time of screening
- •History of confirmed COVID-19
- •Acute or chronic hepatitis B and C
- •Receiving prophylactic drug against tuberculosis
- •History of syncope when seeing or giving blood
- •Having splenectomy for any reason
- •Any close contact with a definitively infected person with COVID-19 for a maximum of two weeks before the day of receiving the first dose
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