NCT04540419已完成3 期
Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group Study Evaluating Efficacy, Reactogenicity and Safety of Recombinant Vaccine Ad5-nCoV Against Novel Coronavirus Infection in Adult Volunteers
NPO Petrovax14 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2020年9月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 14
- 主要终点
- Superiority of the vaccine Ad5-nCoV to placebo by the level of seroconversion
研究概览
简要总结
This study is a phase III clinical trial to evaluate efficacy, reactogenicity and safety of the vaccine Ad5-nCoV compared with placebo in volunteers at the age from 18 to 85 years，with the randomized, double-blind design
详细描述
A total of 500 healthy adult volunteers at the age from 18 to 85 years will be randomized into two treatment (vaccination) groups in ratio 3:1 by double-blind design.
Volunteers in group 1 (n=375) will be administered a single dose of the vaccine Ad5-nCoV (5E10vp).
Volunteers in group 2 (n=125): will be administered a single dose of placebo. Vaccine Ad5-nCoV or placebo will be administered intramuscularly into the deltoid muscle of the arm at a single dose of 0.5 mL (1 prefilled syringe).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of signed and dated Informed Consent of volunteer for participation in this study.
- •Men and women at the age of 18-85 years.
- •Bodyweight index 18.5-30.0 kg/m
- •The negative result of the test, performed by using PCR, for the presence of SARS-CoV-2 RNA at the stage of screening.
- •Negative result for anti-SARS-CoV-2 IgM and IgG antibodies at the stage of screening.
- •No history of the diagnosis COVID-
- •Absence of close contacts with individuals, suspicious for infection SARS-CoV-2, or individuals, in whom the diagnosis COVID-19 was confirmed in laboratory within the last 14 days.
- •Absence of signs of respiratory infection within the last 14 days.
- •Negative results of human immunodeficiency virus (HIV), syphilis, hepatitis B and hepatitis C tests.
- •According to historical data and results of screening examination, a volunteer has no diseases and/or conditions, which in view of Investigator, may influence the safety of volunteer participation and evaluation of study results.
- •Volunteer consent for using safe contraceptive methods through all the study.
排除标准
- •Positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain).
- •Axillary body temperature ≥37.1 °C at the time of screening/randomization.
- •Systolic blood pressure more than 139 mm Hg or less than 100 mm Hg and/or diastolic blood pressure more than 90 mm Hg or less than 60 mm Hg.
- •Clinical significant abnormal laboratory and/or instrumental parameters at screening examination.
- •Acute infectious diseases less than 4 weeks ahead of conduction of screening procedures.
- •Acute and acute course of chronic diseases of GIT, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems.
- •History of blood and hematopoietic organ diseases.
- •History of diabetes mellitus.
- •History of epilepsy, epileptic syndrome, seizures.
- •History of congenital and acquired immunodeficiency, HIV-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases.
- •History malignancies.
- •Using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [GCS] or using specified preparations less than 4 weeks ahead of the screening.
- •Using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening.
- •Using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization.
- •Blood donation or loss (≥450 mL of blood or plasma) less than 3 months ahead of the screening.
- •Vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study.
- •Anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses.
- •Major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening.
- •Carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study.
- •Pregnancy or breast-feeding period.
- •Participation in another clinical study within 3 months ahead of the screening.
- •Psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of Study Protocol.
- •Volunteers, who are Clinical Site staff.
- •Other reasons, not allowing the volunteer to take part in this study in view of the study physician.
结局指标
主要结局
Superiority of the vaccine Ad5-nCoV to placebo by the level of seroconversion
时间窗: Day 28 after vaccination
Proportion of subjects with four-fold and higher increment of anti-receptor-binding domain antibodies \[receptor-binding domain, RBD\] of S-protein SARS-CoV-2).
次要结局
- Immunogenicity of the vaccine Ad5-nCoV compared with placebo (titer of SARS-CoV-2 antibodies)(Day 14, 28 and after 6 months after vaccination.)
- Frequency of death due to COVID-19.(Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination))
- Immunogenicity of the vaccine Ad5-nCoV compared with placebo (rise of SARS-CoV-2 antibodies)(Day 14, 28 and after 6 months after vaccination.)
- Immunogenicity of the vaccine Ad5-nCoV compared with placebo (T-cell response)(Day 14, 28 and after 6 months after vaccination.)
- Frequency of cases with severe course of COVID-19(Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination))
- To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (blood pressure)(Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography(Day -7-1 (Screening), Day 2)
- Frequency of confirmed cases of COVID-19, requiring hospitalization(Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination))
- Reactogenicity of the vaccine Ad5-nCoV compared with placebo(Day 0 (day of vaccination), Day 2, Day 7)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (heart rate)(Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hemoglobin)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram(Day -7-1 (Screening), Day 2, Day 28)
- Immunogenicity of the vaccine Ad5-nCoV compared with placebo (level of seroconversion)(Day 14, 28 and after 6 months after vaccination.)
- Frequency of confirmed COVID-19(Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination))
- Frequency and character of adverse events and serious adverse events.(Day 0 - Month 6)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (respiratory rate)(Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of physical examination(Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry (enzymes)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hematocrit)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocyte sedimentation rate)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram (fibrinogen)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography (Heart rate)(Day -7-1 (Screening), Day 2)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocytes)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (pH)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (protein)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (relative density)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of determination of immunoglobulin E serum concentrations.(Day -7-1 (Screening), Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (glucose)(Day -7-1 (Screening), Day 2, Day 28)
- To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry(Day -7-1 (Screening), Day 2, Day 28)
研究者
研究点 (14)
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