Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects
试验速览
- 阶段
- 2 期
- 入组人数
- 1,600
- 试验地点
- 24
- 主要终点
- Immunogenicity
研究概览
简要总结
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.
详细描述
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.
In phase II trial, 100 subjects of immunogenicity group will be enrolled in 3:1 (Test:Placebo) ratio. These 100 subjects will be assessed for safety and immunogenicity outcomes till Day 28 post the first dose of investigational medicinal product (IMP)/placebo administration and will continue with study assessments till Day 180. Safety and immunogenicity data collected till Day 28 will be submitted to the regulatory authority for recommendation to proceed with Phase III recruitment.
In Phase III trial, 1500 subjects will be enrolled and randomized in the ratio of 3:1 (Gam-COVID--Vac : Placebo).
Each subject will participate in this adaptive study phase II/III clinical trial for 180±14 days after the first dose of the IMP/placebo and will have one screening visit and seven on-site visits during the trial period. The IMP/placebo will be administered intramuscularly during vaccination Visits 1 and 3 (Day 1 and Day 21±2). The observation Visits 2, 4, 5, 6, and 7 will be made on Day 19±2, Day 28±2, Day 42±2, Day 90±7, and Day 180±14, respectively. During the observation visits, vital indicators will be assessed in all subjects and changes in the subjects' condition and well being compared to the previous visit will be recorded. The schedule of examination procedures is mentioned in the Schedule of Event tables.
Additionally, the subjects will be able to have remote consultations with the study physician through the weekly telephonic follow-up.
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 —（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+ years
- •Negative human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C test results
- •Negative immunoglobulin M (IgM) and immunoglobulin G (IgG) SARS-CoV-2 antibodies through enzyme immunoassay test result
- •Negative COVID-2019 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit (72 hours prior to Visit 1 [Day 1])
- •No COVID-2019 in the medical history
- •History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects)
- •Consent for using effective methods of contraception during the entire trial 1
- •Negative urine pregnancy test at the screening visit (for child-bearing age women)
- •No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history
- •No acute infectious and/or respiratory diseases within at least 14 days before the enrolment.
排除标准
- •Any vaccination/immunization within 30 days before the enrolment
- •Steroids (except hormonal contraceptives) and immunoglobulins or other blood products therapy not finished 30 days before the enrolment
- •Immunosuppressors therapy finished within 3 months before the enrolment
- •Pregnancy or breast-feeding
- •Acute coronary syndrome or stroke suffered less than one year before the enrolment
- •Tuberculosis, chronic systemic infections
- •Drug allergy (anaphylactic shock, Quincke edema, polymorphic exudative eczema, atopy, serum disease),hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day
- •Subjects who are on drugs that could have potential drug interactions with adenovirus vaccine
- •Medical history of malignancy
- •Donated blood or plasma (450+ mL) within 2 months before the enrolment
- •Splenectomy in the medical history
- •Neutropenia (absolute neutrophil count less than 1,000 mm3), agranulocytosis, significant blood loss,severe anaemia (haemoglobin less than 80 g/L), immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment
- •Active form of a disease caused by the HIV and hepatitis B or C
- •Anorexia, protein deficiency of any origin
- •Tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the IMP or placebo administration
- •Alcohol or drug addiction in the medical history.
- •Participation in any other interventional clinical trial within 1 month prior to the Screening
- •Any other medical condition that would limit the participation of the subject as per Investigator discretion
- •Study centre staff or other employees directly involved in the trial and their families
- •Subjects contraindicated for vaccination
结局指标
主要结局
Immunogenicity
时间窗: For Phase III study - Day 42 after first dose
For Phase III study - Geometric mean titre ratio of SARS-CoV-2 glycoprotein-specific antibodies between IMP and placebo in immunogenicity group
Adverse Events
时间窗: For Phase II study - at Day 28; For Phase III study - till day 180 after first dose
For Phase II study - - Incidence \& severity of adverse events (AEs) after first dose of IMP/Placebo For Phase III study - \- Incidence of related serious adverse events (SAEs) following vaccination during the study
次要结局
- Adverse Events(Baseline to Day 180)
- Percentage of subjects with mild, moderate, severe coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose of the vaccine/placebo(Baseline to Day 180)
- Incidence of coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose in trial subjects(Baseline to Day 180)
- Immunogenicity assessment(Baseline, Day 28, Day 42, Day 90 and Day 180)