Multicenter, Randomized, Blind, Placebo-controlled Clinical Study of III Phase on Assessment of Preventive Efficiency, Safety and Immunogenicity QazCovid-in®-Vaccine Against COVID-19 in Healthy Adult Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Frequency of confirmed cases of COVID-19
研究概览
简要总结
Multicenter, randomized, blind, placebo-controlled clinical study of III phases on the assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against COVID-19 in healthy adult volunteers
详细描述
The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher increase in antibody titers to SARS-CoV-2) on the 21st, 42nd day, 90th and 180th days after vaccination.
To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo.
Evaluate vaccine efficacy.
Evaluate the safety of vaccine versus placebo.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Availability of signed and dated informed consent of the volunteer to participate in the study.
- •Healthy male and female volunteers aged 18 and above. Ability and voluntary desire to independently keep records in the Self-Observation Diary, as well as to carry out all the repeated visits provided for in the study for control medical observation.
- •The voluntary desire of females to use methods of reliable contraception throughout the entire period of their participation in the study.
- •Negative results for IgM and IgG antibodies to SARS-CoV-
- •Absence of COVID-19 diagnosis in history. Absence in the last 14 days of close contact with persons suspected of being infected with SARS-CoV-2, or persons whose diagnosis of COVID-19 has been confirmed with laboratory.
排除标准
- •Aggravated allergic history, drug intolerance, including hypersensitivity to any of the components of the study drug, as well as a history of serious adverse events during vaccine administration (such as allergic reactions, respiratory failure, angioedema, abdominal pain).
- •Acute illness with a fever (body temperature ≥37.1 ° C) at the time of screening.
- •History of chronic alcohol abuse and/or drug use. Positive results for antibodies IgM, IgG to SARS-CoV-2 Women with a positive urine pregnancy test. Simultaneous treatment with immunosuppressive drugs, incl. corticosteroids (2 weeks) 4 weeks prior to study drug administration.
- •Acute or chronic clinically significant lesions of the lungs, cardiovascular system, gastrointestinal tract, liver, blood system, skin, endocrine, neurological and psychiatric diseases or impaired renal function (asthma, diabetes, thyroid disease, arrhythmia, heart attack myocardium, severe hypertension not controlled by drugs, etc.), identified based on the data of the medical history, physical examination, which, according to the researcher, may affect the study result.
- •History of platelet disorder or other blood clotting disorders that may cause contraindications to intramuscular administration.
- •History of leukemia or neoplasm. Persons with autoimmune diseases. A history of Guillain-Barré syndrome or other neuroimmunological diseases. Subjects who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to study drug administration; Subjects who received anti-inflammatory drugs 2 days prior to study drug administration; Participation in any other clinical research within the last 6 months. Subjects with regard to whom there is a concern that they will not comply with the requirements of the study, or persons with severe physical or mental disabilities that may affect the completion of the study.
- •Voluntary refusal to study. Vulnerable research subjects.
研究组 & 干预措施
Phase III Adult-Placebo (A Sample, blind study)
Group 1 (phase III): 600 volunteers from 18 years old and elder who will be the Placebo twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
干预措施: Placebo (Other)
Phase III Adult-vaccine (A Sample, blind study)
Group 1 (phase III): 2400 volunteers from 18 years old and elder who will be the QazCovid-in® twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
干预措施: QazCovid-in®-vaccine against COVID-19 (Biological)
结局指标
主要结局
Frequency of confirmed cases of COVID-19
时间窗: through study completion, an average of 6 months
The presence of clinical manifestations and a positive laboratory test for SARS-CoV-2 virus RNA within 6 months after vaccination
Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)
时间窗: at days 0, 21, 42, 90, 180
The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)
To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo
时间窗: at days 0, 21, 42, 90, 180
The geometric mean titer of serum antibodies ELISA to SARS-CoV-2 after vaccination. The multiplicity of the change in the geometric mean titer of serum antibodies to SARS-CoV-2 after vaccination.
次要结局
- Changing of antigen-specific cellular immunity level(at days 0, 90, 180)
- Frequency of adverse events up to 21 days after immunization(21 days after each immunization)
- Incidence of serious adverse events during the study(throughout the study, an average of 6 months)
- Frequency of adverse events up to seven days after immunization(Seven days after each immunization)