Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of SCB-2023 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5
研究概览
简要总结
The purpose of this study is to assess the immunogenicity and safety of SCB-2023 trivalent vaccine compared to the prototype SCB-2019 monovalent vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female ≥18 years of age.
- •Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
- •Individuals willing and able to give an informed consent, prior to screening.
- •Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
- •Individuals who received three doses of inactivated COVID-19 vaccine.
排除标准
- •Body temperature >37.8°C (axillary), or any acute illness at baseline.
- •Confirmed SARS-CoV-2 infectionor with known history of COVID-
- •Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
- •Any progressive unstable or uncontrolled clinical conditions.
- •Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
- •History of severe adverse reaction associated with a vaccine or severe allergic reaction.
- •History of malignancy within 1 year before screening.
- •Individuals who have received any other investigational product.
- •Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
- •Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
- •Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
- •Administration of intravenous immunoglobulins and/or any blood products.
- •Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
研究组 & 干预措施
SCB-2019 arm
Participants will receive one booster dose with SCB-2019 vaccine on Day 1
干预措施: SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection (Biological)
SCB-2023 arm
Participants will receive one booster dose with SCB-2023 vaccine on Day 1
干预措施: SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection (Biological)
结局指标
主要结局
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5
时间窗: Day 15
GMT ratio
Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine
时间窗: Day 7
Proportion of participants with local and systemic AEs
Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine
时间窗: Up to 1 year post-vaccination
Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
时间窗: Day 15
GMT ratio
Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine
时间窗: Day 29
Proportion of participants with unsolicited AEs
次要结局
- Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5(Day 1, 15, 180)
- Non-inferiority with respect to ratio of the geometric mean of Omicron BA.5 titer in SCB-2023 recipients and SARS-CoV-2 Delta titers in SCB-2019 recipients, as measured by virus neutralization assay.(Day 15)
- Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5.(Day 1, 15, 180)
- Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5(Day 1, 15, 180)
- Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern(Day 1, 15)
- Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against SARS-CoV-2 variants of concern(Day 1, 15)
- Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern(Day 1, 15)
- Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5(Day 1, 15, 180)
- Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against SARS-CoV-2 variants of concern(Day 1, 15)