Phase II Trial Evaluating the Immunogenicity and Safety of Ad26.COV2.S Vaccine in Adult Participants in Mali
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level
研究概览
简要总结
Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.
详细描述
The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations.
200 participants will be included, 200 participants for each vacine. 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.
Ad26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants
Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL.
Humoral vaccine immune responses, induced by Ad26.COV2.S vaccine, 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
- •Positive SARS-CoV-2 antigenic test
- •Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old
- •History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion
- •Symptoms compatible with infection to SARS-CoV-2: 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)
- •Previously received at least one injection of a SARS-CoV-2 vaccine
- •Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
- •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
研究组 & 干预措施
Ad26.COV2.S
Single dose (0.5mL) of SARS-CoV-2 vaccine Ad26.COV2.S.
干预措施: Ad26.COV2.S (Biological)
结局指标
主要结局
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level
时间窗: One month after complete vaccination schema
Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test
次要结局
- B cell response to vaccine(Day 0, Month 2, Month 6)
- Neutralizing antibody level for SARS-CoV-2(Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion)
- Determination of Epitope profile(Day 0 and Month 2)
- Anti-SARS-CoV-2 immunoglobulin M (IgM) level(At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion)
- Anti-SARS-CoV-2 Spike IgG level(At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion)
- Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity)(Inclusion (Day 0) and then 2 and 6 months after inclusion)
- Mucosal SARS-CoV-2 specific antibody levels(Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion)
- SARS-CoV-2 infection(Date of inclusion until 24 months)
- Measurement of ultrasensitive immunoglobulin A (IgA) and mucosal IgA and IgM functionality(Day 0 and then 1, 2, 6, 12, and 24 months after inclusion)
- Rate of adverse events(Between month 1 and month 24 after inclusion)