Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine in SARS-СoV-2 Infection Prophylactic Treatment
试验速览
- 阶段
- 3 期
- 入组人数
- 33,758
- 试验地点
- 23
- 主要终点
- percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose
研究概览
简要总结
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
详细描述
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
The trial will include 40,000 volunteers aged 18+. After screening, they will be randomized (3:1) into two groups - a reference group of 10,000 volunteers receiving placebo and a study group of 30,000 volunteers receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection.
The trial subjects will be randomized into five age strata: 18-30, 31-40, 41-50, 51-60, and 60+ years.
The PCR test for SARS-CoV-2 RNA detection at the visit is performed during screening and before the second administration of the vaccine/placebo
Each subject will participate in the trial for 180±14 days after the first dose of the study drug/placebo and will have one screening visit and five on-site visits to the study physician during the said period. The study drug/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 0 and day 21±2). Subsequent observation visits 3, 4, and 5 will be made on days14±2, 28±2, 35±2,42±2, and 180±14 respectively. During the observation visits, vital signs will be assessed in all trial subjects and changes in the subjects' condition and wellbeing compared to the previous visit will be recorded. Observation visits may be remote, through the telemedicine consultation (TMC).
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)
入排标准
- 年龄范围
- 18 Years 至 111 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent of a subject to participate in the trial
- •Males and females aged ≥18 y.o.;
- •Negative HIV, hepatitis, and syphilis test results
- •Negative anti-SARS CoV2 IgM and IgG antibodies test carried out with the enzyme immunoassay method
- •Negative COVID-2019 PCR test result at the screening visit
- •No COVID-2019 in the past medical history
- •No contact with COVID-2019 diseased persons within at least 14 days before the enrollment (according to trial subjects)
- •Consent to use effective contraception methods during the trial
- •Negative urine pregnancy test at the screening visit (for child-bearing age women)
- •Negative drugs or psychostimulants urine test at the screening visit
- •Negative alcohol test at the screening visit
- •No evident vaccine-induced reactions or complications after receiving immunobiological products in the past medical history
- •No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.
排除标准
- •Any vaccination/immunization within 30 days before the enrollment;
- •Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
- •Immunosuppressors therapy finished within 3 months before the enrollment
- •Pregnancy or breast-feeding
- •Acute coronary syndrome or stroke suffered less than one year before the enrollment
- •Tuberculosis, chronic systemic infections
- •Drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day
- •Neoplasms in the past medical history (ICD codes C00-D09)
- •Donated blood or plasma (450+ ml) within 2 months before the enrollment
- •History of splenectomy;
- •Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past medical history within 6 months before the enrollment
- •Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C
- •Anorexia, protein deficiency of any origin
- •Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration
- •Alcohol or drug addiction in the past medical history
- •Participation in any other interventional clinical trial
- •Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
- •Study center staff or other employees directly involved in the trial, or their families.
- •If a subject has any contraindications to vaccination based on the Guidelines on Detection, Investigation and Prevention, of Vaccination-induced Side Reactions (approved by the Ministry of Healthcare of Russia on Apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.
结局指标
主要结局
percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose
时间窗: through the whole study, an average of 180 days
Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
次要结局
- Changing of of virus neutralizing antibody titer(the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose)
- Incidence of adverse events in trial subjects(through the whole study, an average of 180 days)
- Severity of adverse events in trial subjects(through the whole study, an average of 180 days)
- the severity of the clinical course of COVID-19(through the whole study, an average of 180 days)
- Changing of antibody levels against the SARS-CoV-2 glycoprotein S(day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose)
- Changing of antigen-specific cellular immunity level(the drug administration day before injecting the first dose of the study drug/placebo and 28±2 days after the first dose)
- estimation of the proportion of study subjects with antibodies to the N-protein of the virus SARS-CoV-2(day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose)