NCT04437875已完成1 期
An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac Lyo" Lyophilizate for the Preparation of a Solution for Intramuscular Injection With the Participation of Healthy Volunteers
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- The changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days
研究概览
简要总结
the purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular administration, at various times after vaccination in healthy adult volunteers.
详细描述
An open two stage non-randomized Phase 1 study with the participation of healthy volunteers. This clinical trial is an open study of safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, with the participation of healthy volunteers.
Study objectives
- A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using single dose of each component (Stage 1).
- A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2).
Study Design Stage 1 the First group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 1 in a full therapeutic dose.
the Second group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 2 in the full therapeutic dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •males and females within the age range from 18 to 60 years;
- •written informed consent;
- •subject body mass index (BMI): 18.5 ≤ BMI ≤ 30;
- •negative PCR test results for SARS-CoV-2 (during the screening);
- •no history of COVID-2019 disease;
- •no contacts of volunteers with patients with COVID-2019 for at least 14 days;
- •negative test results for IgM and IgG antibodies to SARS-CoV-2;
- •subject agrees to use effective contraceptive methods during the entire period of participation in the study;
- •absence of acute infectious diseases at the time of vaccine administration and 14 days before vaccination;
- •negative pregnancy test of blood or urine (for women of childbearing age);
- •subject has negative tests for HIV, hepatitis B and С, syphilis or confirmed medical history;
- •subject has a negative result of the urine test for residual narcotic drugs;
- •negative test for alcohol in exhaled air;
- •the absence of malignant diseases of any nature and localization;
- •in medical history and based on the screening results, subject has no diseases or pathologies of the gastrointestinal system, liver, kidneys, cardiovascular system and blood, CNS, musculoskeletal system, urogenital, immune and endocrine systems that from the point of view of the researcher and/or of the organizer of the study, may affect the safety of the volunteer and the evaluation of the study results (clinical, instrumental and laboratory tests did not reveal diseases or clinically significant deviations)
排除标准
- •volunteer involvement in another study over the last 90 days;
- •any vaccination over the last 30 days;
- •history of COVID-2019 disease;
- •positive PCR test results for SARS-CoV-2 (during the screening);
- •positive test results for IgM and IgG antibodies to SARS-CoV-2;
- •health staff in contact with people with COVID-2019;
- •respiratory symptoms in the last 14 days;
- •the administration of immunoglobulins or other blood products in the last 3 months;
- •regular current or past use of narcotic drugs;
- •subject has received immunosuppressive and/or immunomodulating agents within 6 months before the start of the study;
- •pregnancy or breast feeding;
- •exacerbation of allergic diseases at the time of vaccination;
- •subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 100 beats per minute;
- •a burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, a history of serum sickness, hypersensitivity or allergic reactions to the introduction of any vaccines in history, known allergic reactions to vaccine components, etc.);
- •a history of autoimmune diseases in the volunteer's medical history and in relatives' medical history of the 1-2 degree of kinship;
- •subject smokes more than 10 cigarettes per day;
- •alcohol intake exceeding the low-risk level: no more than 20 grams of pure alcohol per day, no more than 5 days a week, alcohol intake within 48 hours before the administration of the drug;
- •planned hospitalization and/or surgery during the period of participation in the study, as well as 4 weeks before the expected date of the administration of the drug;
- •the presence of an associated disease that may affect the assessment of the results of the study;
- •any conditions that, according to the researcher's doctor, may be a contraindication to the participation in the study.
结局指标
主要结局
The changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days
时间窗: at days 0, 14, 21, 28, 42
Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Number of Participants With Adverse Events
时间窗: through the whole study, an average of 180 days
Determination of Number of Participants With Adverse Events
次要结局
- The changing of virus neutralizing antibody titer(at days 0, 14, 28, 42)
- The changing of antigen-specific cellular immunity level(at days 0, 14, 28)
研究者
研究点 (2)
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