Phase II Trial Evaluating the Immunogenicity and Safety of BBIBP-CorV Vaccine in Adults in Guinea
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Anti-SARS-CoV-2 Spike IgG level
研究概览
简要总结
Phase II, non-randomized, open-label, comparative, single center national trial in Guinea, aimed to assess the humoral vaccine immune response induced by BBIBP-CorV vaccine in 200 adults aged between 18 and 45 years or 55 or older, one month after receiving the complete COVID-19 vaccination schedule.
详细描述
The main objective of this phase II trial is to evaluate the humoral immune response induced by the BBIBP-CorV vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, comparing younger (up to 45 years old) and elderly (55+ years old) populations.
200 participants will be included. The age categories are 18 - 45 years, 55 - 64 years and 65+ years. The number of participants per age group will be distributed as follows 1:1:0,5. There will be no comparison between population on different vaccines.
Participants will receive two doses of BBIBP-CorV at 28 days interval. Vaccines will be administered intramuscular (0.5mL per injection)
Humoral vaccine immune responses, induced by BBIBP-CorV will be measured by ELISA at D0, M1, M2, M6, M12 and M24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age between 18 and 45 years old or 55 years and older
- •Be eligible to receive one of the study vaccines as part of the trial
- •Understand and agree to comply with study procedures (visits, telephone calls)
- •Agree not to participate in any other vaccine study during the time of the study
- •Give written informed consent prior to any examination performed as part of the trial
排除标准
- •Age between 46 and 54 years old
- •Positive SARS-CoV-2 antigenic test
- •Positive SARS-CoV-2 PCR results less than 48 hours old
- •History of infection by COVID-19 confirmed within 3 months prior to inclusion
- •Symptoms compatible with COVID-19: sick or febrile participants (body temperature ≥ 38.0°C)
- •Pregnant or breastfeeding woman
- •Known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection)
- •Anti-coagulant treatment
- •Immunosuppressive treatment
- •Contraindication to the proposed vaccine (according to RCP)
- •Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
- •Previously received at least one injection of a SARS-CoV-2 vaccine
- •A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)
- •Any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study
结局指标
主要结局
Anti-SARS-CoV-2 Spike IgG level
时间窗: 1 month after complete vaccination schema
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test
次要结局
- Anti-SARS-CoV-2 IgM level(Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24)
- Epitope profile(Day 0, Month 2)
- Measurement of ultrasensitive IgA and mucosal IgA and IgM functionality(Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24)
- Rate of adverse events(Month 1 until Month 24)
- Anti-SARS-CoV-2 IgA and level(Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24)
- Neutralizing antibody level for SARS-CoV-2(Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24)
- Fluorospot tests (TH1, TH2, TH17, Cytotoxicity)(Day 0, Month 2, Month 6)
- Anti-SARS-CoV-2 specific IgG level(Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24)
- Mucosal SARS-CoV-2 specific antibody levels(Day 0, Month 1, Month 2, Month 6, Month 12)
- B cell response to vaccine(Day 0, Month 2, Month 6)
- SARS-CoV-2 infection(Day 0 until Month 24)