IRCT20210620051639N1招募中1 期
A randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the safety and immunogenicity of three dose regimens of COVID-19 RBD protein recombinant vaccine (AmitisGen; 80µg and 120µg) in a healthy population
Bagheiat-allah University of Medical Sciences0 个研究点目标入组 70 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
- 70
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
- •Age between 18 and 50 years old
- •Healthy in terms of past medical history, physical examination, and laboratory data-
- •Body mass index: 17-35 kg/m2
- •Willingness to participate in the study and complete follow-up
- •Ability to comprehend study methodology
- •Ability to comprehend and sign informed consent-
- •Provision of consent to access medical documents in case of contracting COVID-19
- •For women: negative pregnancy screening
- •Acceptance of contraception use from 21 days before randomization until six months after receiving the last vaccine dose
- •Acceptance of not receiving blood product or bone marrow from randomization until three months after receiving last vaccine dose
排除标准
- •Positive COVID-19 PCR test
- •Positive antibodies against SARS-CoV-2 (IgG, IgM)
- •History of infection with SARS-CoV-2 documented with RT-PCR test
- •Close contact with COVID-19 infected individual in the past 14 days
- •Isolation due to signs and symptoms that are suspicious of COVID-19
- •Fever (axillary temperature > 37° C), dry cough, fatigue, nasal congestion, rhinorrhea, sore throat, myalgia, diarrhea, dyspnea in the past 14 days
- •Laboratory abnormalities in biochemistry profile, blood, and urine (including urea, creatinine, fasting blood sugar, Na, K, aspartate transaminase, alanine transaminase, alkaline phosphatase, total bilirubin, hemoglobin, leukocyte count, neutrophil count, lymphocyte count, platelet count, urine protein, urine glucose, blood cells in urine)
- •History of severe allergic reactions or allergy to vaccine components (latex)
- •Experience to severe allergic or allergic reactions to components of the recombinant RBD protein vaccine (latex sensitivity)
- •Personal or family history of seizure, epilepsy, encephalopathy, psychiatric disorder
- •Congenital malformations
- •-History of neurologic diseases or seizure (except for febrile seizure at childhood)
- •Growth disorders
- •Genetic disorders
- •Malnutrition
- •Renal or liver abnormalities
- •Uncontrolled hypertension (>140/90 mmHg)
- •Heart failure with NYHA class =2
- •Recent exacerbations of cardiovascular disease include cardiovascular intervention, the addition of new cardiovascular drugs to control symptoms, or unstable angina.
- •Chronic obstructive lung disease with GOLD score =2-
- •Diabetic complications
- •BMI > 35 kg/m2
- •History of malignancy in the past five years
- •Exacerbation of chronic diseases in the past 7 days
- •Immunodeficiency, lymphoma, leukemia, autoimmune diseases
- •Thyroid disease or history of thyroidectomy without proper control
- •Splenectomy or history of resection of solid organs
- •Coagulation abnormalities
- •Anti-tuberculosis treatment
- •Positive HBSAg
- •Positive HIV Ab
- •Positive HCV Ab
- •Receiving immunosuppressive therapy for 14 consecutive days in the past 3 months or need for such therapy in the following 6 months
- •Receiving any off-label or investigational therapy for COVID-19
- •Receiving flu vaccine in the past 14 days or other vaccines in the past 4 weeks
- •History of drug or alcohol abuse in the prior year
- •Receiving immunoglobulin or blood products in the prior 3 months
- •Receiving investigational drugs in the past 45 days
- •Planning to receive other vaccines in the next month
- •Severe psychiatric disorders interfering with participation in the trial
- •Women with positive beta-HCG, pregnancy, or during breastfeeding, or plan to become pregnant during the study
- •High risk occupation for COVID-19 exposure (health care workers) or with decision of investigators
- •First degree family members of the trial personnel
- •Any other reason that the investigators document making volunteers ineligible
研究者
相似试验
招募中
2 期
CAPRISA 012CHIV/AIDSPACTR202112683307570CAPRISA990
进行中（未招募）
1 期
A randomized, double-blind, placebo-controlled, parallel group study to determine the efficacy, the duration of action, and safety of latanoprost in patients with Menière’s diseaseEUCTR2013-002261-18-SESynphora AB
招募中
1 期
Phase 1 clinical trial of an inactivated COVID-19 vaccine (Shifa-Pharmed) in healthy individualsIRCT20201202049567N1Shifa Pharmed Industrial Co.56
进行中（未招募）
1 期
Study of the possibility to increase remnant insulin production in patients with type 1 diabetes using the glucagon-like peptide 1 mimicking drug liraglutideEUCTR2014-005174-11-SEppsala University Hospital50
尚未招募
不适用
A randomized, double-blind, placebo-controlled, placebo-controlled trial for Jiawei Zhichan Decoction for the treatment of sleep disorders in Parkinson's diseaseParkinson's DiseaseITMCTR2000003654Shanghai Municipal Hospital of Traditional Chinese Medicine