CTRI/2021/05/033665已完成3 期
A Prospective, Randomized, Interventional, Parallel, Multi-Center, Comparative Clinical Trial to Evaluate the Safety and Immunogenicity of COVID-Vac Combined Vector Vaccine (Manufactured by Hetero) in Healthy Adult Human Subjects.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 7
- 主要终点
- Geometric Mean Titre (GMT) Ratio of SARS-CoV-2 glycoprotein-specific antibodies
研究概览
简要总结
This study is a prospective, randomized, interventional, double blind, active controlled, parallel group bridging clinical study to evaluate the safety and immunogenicity of Hetero-COVID-Vac Combined Vector Vaccine compared to Gam-COVID-Vac (Sputnik V - Manufactured for RDIF, Russia) in healthy adult human subjects. All subjects will be administered 2 doses of Hetero-COVID-Vac Combined Vector Vaccine (Component I & Component II) or Gam-COVID-Vac (Sputnik V) (Component I & Component II) with 21 days gap followed by assessments on Day 28 and 42.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male or female volunteers aged 18-65 years (inclusive of both) who are not vaccinated for COVID-19/Influenza and willing to give written, signed and dated informed consent to participate in the study
- •Negative immunoglobulin M (IgM) SARS-CoV-2 antibodies through enzyme immunoassay test result
- •Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit
- •No acute infections and/or respiratory diseases within 14 days before enrollment
- •Negative human immunodeficiency virus (HIV 1 & 2), Syphilis, Hepatitis B and C test results.
排除标准
- •Any vaccination/immunization within 30 days before the enrollment
- •Usage of Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before the enrollment
- •Immunosuppressive therapy within 3 months before the enrollment
- •Donated blood or plasma within 3 months before enrollment
- •Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past 6 months before enrollment
- •Participation in any other interventional clinical trial within 3 months
- •Volunteer is pregnant or breast-feeding 8.
结局指标
主要结局
Geometric Mean Titre (GMT) Ratio of SARS-CoV-2 glycoprotein-specific antibodies
时间窗: Day 28 and Day 42
次要结局
- Incidence of AEs and SAEs following vaccination during the study(All Visits)
- GMT ratio of SARS-CoV-2 glycoprotein-specific antibodies(Day 21)
- Number of proliferating CD4 and CD8 cells in response to mitogen stimulation and their ratios in cell mediated immunogenicity (T-cell mediated immunity)(Day 21, Day 28 and Day 42)
- Incidence of cases of Covid-19(Day 21 and Day 42)
研究者
研究点 (7)
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