Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac-Combi", a Combined Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%.
The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.
详细描述
The study will include volunteers of both sexes, aged 18-55 years inclusive. The study will involve 268 (will receive the vaccine or placebo) healthy volunteers.
At the first stage, it is planned:
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study the safety of component 1 - 40 volunteers and 4 spares *
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study the safety of prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half and full dose - 40 volunteers and 4 spares * At the second phase, it is planned to study the safety and immunogenicity of the vaccine as part of a placebo-controlled randomized trial - 188 people, of whom 138 will receive the vaccine, and 50 will make up the control group of observation - they will be given a placebo. Data from 20 volunteers from the first phase who received the drug in selected dose will be included in the analysis of safety and immunogenicity of the second phase.
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Volunteers are replaced by spares before the introduction of the drug, if the volunteer took the drug, then the replacement is not performed.
Any volunteer who received a dose of the vaccine will be considered as included in the study, the data available on it will be used in assessing the safety and tolerability of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
This clinical trial is designed as a double blind randomized placebo-controlled study
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Volunteer participation in any other study over the past 90 days;
- •Any vaccination in the last 30 days;
- •Acute infectious and non-infectious diseases, exacerbations of chronic diseases within 4 weeks prior to screening;
- •subject has received treatment with steroids for the last 10 days;
- •subject has received immunoglobulins or other blood products over the last 3 months;
- •subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start of the study;
- •Pregnancy or lactation;
- •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.);
- •Diabetes mellitus or other forms of impaired glucose tolerance;
- •presence of a concomitant illness in decompensation stage which might affect the course of the study (CNS organic lesion, decompensated cardiovascular diseases, any manifestations of kidney or acute liver failure, oncological diseases, diabetes mellitus);
- •subject has a a history of neoplasms (ICD codes C00-D09);
- •blood donation (at least 450 ml of blood or plasma) by subject in less than 2 months prior to the start of the study;
- •Reception of narcotic and psychostimulating drugs at present or in the anamnesis;
- •subject has a history of the consumption of more than 5 units alcohol per week, alcohol intake within 48 hours before the injection of the test drug;
- •subject smokes more than 10 cigarettes a day;
- •subject has a planned hospitalization and / or surgery during the period of participation in the study, as well as 4 weeks before the estimated date of vaccination.
- •subject has any condition that, according to the researcher's doctor, may be a contraindication to participation in the study.
研究组 & 干预措施
phase 1, component 1
component 1 of vaccine
干预措施: BVRS-GamVac-Combi (Drug)
phase 1, half dose
prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half dose
干预措施: BVRS-GamVac-Combi (Drug)
phase 1, full dose
prime-boost vaccination with component 1 and component 2 with an interval of 21 days in full dose
干预措施: BVRS-GamVac-Combi (Drug)
phase 2, selected dose
prime-boost vaccination with component 1 and component 2 with an interval of 21 days in selected dose
干预措施: BVRS-GamVac-Combi (Drug)
phase 2, placebo
vaccination with placebo with an interval of 21 days
干预措施: placebo (Other)
结局指标
主要结局
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
Number of Participants With Serious Adverse Events
时间窗: through the whole study, an average of 180 days
Determination of Number of Participants With Serious Adverse Events
Number of Participants with Solicited Local and Systemic Adverse Events
时间窗: through the whole study, an average of 180 days
Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA)
时间窗: Time Frame for group 1 phase 1: at days 0, 7, 14, 21, 28, 42, 56 and 90. Time Frame for group 2 phase 1 and phase 2: at days 0, 7, 14, 21, 28, 35, 42, 56 and 90
Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)
次要结局
- Assessment of antigen-specific cell-mediated immune response(at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2))
- Neutralizing antibody levels(at days 0, 14 and 28 from the start of vaccination compared to baseline values)