Randomized, Blind, Placebo-controlled Phase- i Study and Randomized, Open Phase Phase-ii Study of QAZCOVID-IN®- COVID-19 Inactivated Vaccine in Healthy Adult Volunteers From 18 Years Old and Elder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- Frequency of adverse events up to 21 days after immunization
研究概览
简要总结
Randomized, blind, placebo-controlled phase- i study and randomized, open phase phase-ii study of QAZCOVID-IN®- COVID-19 inactivated vaccine in healthy adult volunteers from 18 years old and elder
详细描述
Purpose of the Phase-I clinical study Evaluation of the safety,acceptability and immunogenicity of QazCovid-in®-COVID-19 inactivated vaccine when administeredtwice in healthy volunteers aged 18-50 years.
Purpose of the Phase-II clinical study Evaluation of the safety and immunogenicity of QazCovid-in® - COVID-19 inactivated vaccine with single and dual use in healthy volunteers aged 18 and above.
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 18-50 and 50 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.
- •Negative test results for human immunodeficiency virus (HIV), hepatitis B and hepatitis C.
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 fever (body temperature ≥37.1°C) at the time of screening/randomization.
- •Chronic alcohol and/or drug use in history.
- •Clinically significant deviations from normal values during laboratory and/or imaging at screening.
- •Women with a positive urine pregnancy test.
- •Simultaneous treatment with immunosuppressive drugs, including 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, myocardial infarction, severe hypertension not controlled by drugs, etc.), identified based on medical history, physical examination or clinical laboratory tests that, according to the researcher, may affect the study result.
- •Disruption of platelets or other blood clotting disorders, which may cause contraindications to intramuscular administration.
- •Leukemia or neoplasm in history.
- •Persons with autoimmune diseases.
- •Volunteers who received antiviral drugs, immunoglobulin's or blood transfusions or any other investigational drug within 4 weeks prior to study drug administration;
- •Volunteers who received anti-inflammatory drugs 2 days before study drug administration;
- •Participation in any other clinical research within the last 3 months.
- •Volunteers with a concern that they will not comply with the study requirements, or persons with severe physical or mental disabilities that may affect the completion of the study.
- •Voluntary refusal to study.
结局指标
主要结局
Frequency of adverse events up to 21 days after immunization
时间窗: 21 days after each immunization
Frequency of adverse reaction in the 21 days following each immunization per age group
The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo
时间窗: at days 0, 21, 27, 42
The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination compared with a placebo.
Frequency of adverse events up to seven days after immunization
时间窗: Seven days after each immunization
Frequency of adverse reaction in the seven days following each immunization per age group
Changing of virus-neutralizing antibodies to SARS-CoV-2 virus in blood serum samples
时间窗: at days 0, 21, 27, 42
Determination of virus neutralizing antibody titer to SARS-CoV-2 virus in blood serum samples
次要结局
- Incidence of serious adverse events during the study(throughout the study, an average of 42 days)
- Cell-mediated immune profile(at days 0, 7, 21, 27, 42)