A Long-term Follow-up Study to the Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of SCB-2019, a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Serum anti-SCB-2019 IgG antibody titers
研究概览
简要总结
To develop an effective vaccine against the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, Clover Biopharmaceuticals is conducting a Phase 1 study (CLO-SCB-2019-001) in healthy volunteers to evaluate the safety and immunogenicity of SCB-2019, a recombinant SARS-CoV-2 trimeric Spike protein (S-protein) subunit vaccine. This study, CLO-SCB-2019-002, will be a long-term follow-up study for subjects who have completed CLO-SCB-2019-001 in order to assess longer safety and immunogenicity up to 24 months after the 1st dose of vaccination.
详细描述
Once a subject enrolled in the dose-escalation part of study CLO-SCB-2019-001 (groups 1-15) has completed the 6-month visit, he/she will enter this study automatically, since subjects were requested to sign the informed consent form for this long-term follow-up study at the same time they consent to study CLO-SCB-2019-001. For a subject who will receive active vaccine (subjects who received placebo in study CLO-SCB-2019-001) or a booster dose during this long-term study, an additional informed consent form will be signed prior to receiving vaccine.
After study CLO-SCB-2019-001 ends and the treatment assignments are unblinded, those subjects who have received placebo will be given the option to receive 2 doses of active study vaccine 21 days apart (defined as treatment cross-over); subjects who do not consent to vaccination will be discontinued from the study. Subjects who consent to vaccination will be followed up until 18 months after the 1st dose of the cross-over vaccination.
Subjects that received SCB-2019 vaccine adjuvanted with AS03 in study CLO-SCB-2019-001 will be followed up for safety only for 12 months after the 1st dose received (V10, day 366).
Of the subjects that received SCB-2019 CpG/Alum-adjuvanted vaccine in study CLO-SCB-2019-001, the first 24 subjects that agree to receive booster dose will be consented to an additional informed consent form prior to receiving a booster dose and included in this long-term follow-up study. These 24 subjects will be followed up until 12 months after the booster dose.
Statistical methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects from study CLO-SCB-2019-001 will automatically move on to this long-term follow-up study if: 1) They have given informed consent for this follow-up study; and 2) They have completed the D184 visit of study CLO-SCB-2019-001 (ie, 6 months post the 1 st vaccination).
排除标准
- •All subjects who did not participate and completed the study or did not signed the inform consent for this follow up study.
研究组 & 干预措施
Subjects Without Treatment Cross-over
these subjects will not receive any vaccination during this study.
Subjects who will receive Booster Vaccine
For subjects out of those who received SCB-2019 CpG/Alum-adjuvanted vaccine in study CLO-SCB-2019-001: the subjects will receive a booster dose.
干预措施: SCB-2019 (Biological)
Subjects With Treatment Cross-over (From 1st Dose of Active Study Vaccine Onwards)
Once the treatment assignments of study CLO-SCB-2019-001 are unblinded, those subjects who have received placebo and provided there is active study vaccine available, will be given the option to receive 2 doses of active study vaccine 21 days apart (ie, treatment cross-over)
干预措施: SCB-2019 (Biological)
结局指标
主要结局
Serum anti-SCB-2019 IgG antibody titers
时间窗: up to 12 months after booster dose
To describe and compare antibody response kinetics in response to vaccination with SCB-2019 up to 12 months after booster dose
Incidence of AESIs and SAEs
时间窗: up to 12 months after booster dose
To evaluate the safety profile of SCB-2019 up to 12 months after booster dose
Incidence of AESIs and SAEs
时间窗: from 6 to 24 months after the 1st vaccination dose
To evaluate the safety profile of SCB-2019 up to 24 months after the 1st vaccination dose
Serum anti-SCB-2019 IgG antibody titers
时间窗: from 6 to 24 months after the 1st vaccination dose
To describe and compare antibody response kinetics in response to vaccination with SCB-2019 up to 24 months after the 1st vaccination dose
次要结局
- Serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based)(up to 12 months after booster dose)
- Serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based)(from 6 to 24 months after the 1st vaccination dose)