IRCT20230131057293N1已完成1 期
Phase I, Randomized, Double Blind, Placebo-controlled, Study of the Safety and Immunogenicity of mRNA-based COVID-19 Vaccine (COReNAPCIN) Produced by ReNAP Co. as Booster Dose in Healthy Population Aged 18-50 Years
ReNAP Company0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- •Provides written informed consent prior to initiation of any study procedures
- •Be able to understand the purpose and risks of the study and willing and able to comply with planned study procedures and be available for all study visits
- •Agrees to perform all study procedures, including the collection of venous blood per protocol
- •18 to 50 years of age, inclusive
- •Body Mass Index 18-35 kg/m2
- •Women of childbearing potential must agree to use a reliable method of contraception from the time of enrollment until sixty days after receiving the intervention and negative urine or serum pregnancy test within 24 hours prior to intervention administration
- •Male subjects of childbearing potential with a female partner of childbearing potential agree to use effective contraception from intervention through 60 days after
- •Male subjects agree to refrain from sperm donation from the time of intervention through 60 days after
- •In good health as determined by medical history and physical examination and the opinion of the principal investigator
- •Has received 3 doses of inactivated Sinopharm or COVIran Barekat vaccine and the time interval from receiving the last dose of vaccine to receiving clinical study intervention at least 90 days and maximum 18 months, vaccination history must be checked and approved through the vaccination record
- •Normal vital signs at the screening visit and at the time of intervention including: temperature less than 38.0 °C; pulse no greater than 100 beats per minute; systolic blood pressure 90 to 140 mmHg and diastolic blood pressure 60 to 90 mmHg; Oxygen saturation= 95%; respiration rate 12 to 20 BPM
- •Clinical screening laboratory evaluations (WBC, Hgb, PLTs, ALT, AST, BUN, Cr, ALP, T.Bili, Lipase, PT, PTT, TSH, T4, FBS, and CRP) are within acceptable normal reference ranges
- •Agree to refrain from donating blood or plasma during the study (outside of this study)
排除标准
- •Positive pregnancy test either at screening or just prior to intervention administration
- •Female subject who is breastfeeding or plans to breastfeed from the time of intervention through 60 days after
- •Has any medical disease or condition that, in the opinion of the principal investigator, precludes study participation
- •Presence of self-reported or medically documented significant medical (including respiratory, cardiovascular, neurological, autoimmune, Immunodeficiency, and kidney diseases...) or psychiatric condition
- •Has an acute illness within 2 weeks prior to injection, with or without fever [temperature =38.0°C], runny nose or eyes, shortness of breath, cough, weakness, and diarrhea, that in the opinion of the principal investigator, precludes study participation
- •Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies
- •Has participated in another investigational study involving any investigational product (study drug, biologic, or device) within 60 days, or 5 half-lives, whichever is longer, before intervention administration
- •Currently enrolled in or plans to participate in another clinical trial during the study period
- •Has previously participated in an investigational study involving lipid nanoparticles (LNPs)
- •Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any components of the study product, any previous licensed or investigational vaccines or medication, and to any food or cosmetics
- •History of using any medication that, in the opinion of the principal investigator or the study pharmacotherapist, may be associated with impaired immune responsiveness
- •Anticipating the need for immunosuppressive treatment within Within 6 months after study enrollment
- •Received immunoglobulins and/or any blood or blood products within the 4 months before intervention administration or the possible need to use at any time during the study
- •Has any blood dyscrasias or significant disorder of coagulation
- •Has any chronic liver disease, including fatty liver
- •Has a history of alcohol abuse or other recreational drug use within 6 months before intervention administration
- •Has a positive test result for drugs of abuse at screening
- •Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region)
- •Received or plans to receive a licensed, live vaccine within 4 weeks before or after intervention administration
- •Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after intervention administration
- •History of clinical or virological diagnosis of COVID-19 within 3 months before intervention administration
- •Positive SARS-CoV-2 or influenza PCR test from nasopharyngeal swab at the screening visit, with a maximum time interval of 48 hours between taking the test and intervention administration
- •History of receiving medication to prevent COVID-19 within 3 months before intervention administration
- •On current treatment with investigational agents for prophylaxis of COVID-19
- •Current use of any prescription or over-the-counter medications within 7 days prior to intervention administration, unless approved by the investigator or necessary to manage a chronic condition
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate i
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