A Phase I/II Partially Randomized, Active-controlled Observer-blind, Dose-selection, Safety and Immunogenicity Study of GLB-COV2-043, an mRNA Vaccine Candidate Against SARS-CoV-2, Administered as a Single-vaccination Booster to Previously Vaccinated Adults
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Safety, including reactogenicity
研究概览
简要总结
The scope of this Phase I/II study is to determine whether GLB-COV2-043 is a promising booster vaccine candidate component for adult participants who have received the 2-dose priming course of the mRNA BNT162b2 vaccine against COVID-19, or the 2-dose priming course and a third BNT162b2 injection (i.e., as a "booster"), and, if so, to select the booster dose for further evaluation and potential development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 (includes GLB-COV2-043 15 μg)
12 eligible adult participants will be randomized to 15 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
干预措施: GLB-COV2-043 (Drug)
Cohort 1 (includes GLB-COV2-043 15 μg)
12 eligible adult participants will be randomized to 15 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
干预措施: BNT162b2/COMIRNATY® (Drug)
Cohort 2 (includes GLB-COV2-043 30 μg)
12 eligible adult participants will be randomized to 30 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
干预措施: GLB-COV2-043 (Drug)
Cohort 2 (includes GLB-COV2-043 30 μg)
12 eligible adult participants will be randomized to 30 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
干预措施: BNT162b2/COMIRNATY® (Drug)
Cohort 3 (includes GLB-COV2-043 60 μg)
12 eligible adult participants will be randomized to 60 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
干预措施: GLB-COV2-043 (Drug)
Cohort 3 (includes GLB-COV2-043 60 μg)
12 eligible adult participants will be randomized to 60 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
干预措施: BNT162b2/COMIRNATY® (Drug)
Cohort 4 (includes GLB-COV2-043 90 μg)
12 eligible adult participants will be randomized to 90 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
干预措施: GLB-COV2-043 (Drug)
Cohort 4 (includes GLB-COV2-043 90 μg)
12 eligible adult participants will be randomized to 90 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
干预措施: BNT162b2/COMIRNATY® (Drug)
结局指标
主要结局
Safety, including reactogenicity
时间窗: Day 0 to Day 28 post-vaccination
* Proportion of participants experiencing severe (Grade ≥ 3) solicited treatment emergent AEs * Proportion of participants with severe (Grade ≥ 3) non-serious unsolicited treatment emergent AEs * Proportion of participants with serious unsolicited treatment emergent AEs (SAEs)
Immunogenicity- neutralizing antibody response
时间窗: Day 0 to Day 28 post-vaccination
Geometric mean titre (GMT) and geometric mean ratios (GMR) relative to baseline of neutralizing IgG antibodies against the spike (S) protein of the SARS-CoV-2 Wuhan strain
次要结局
- Safety, including reactogenicity(Day 0 to Day 168 post-vaccination)
- Antibody-mediated immunogenicity titers (GMT)(baseline (Week 0) and 4, 24 and 52 weeks (7, 28, 168 and 365 days) post-vaccination)
- Antibody-mediated immunogenicity fold-increase (GMR)(baseline (Week 0) and 4, 24 and 52 weeks (7, 28, 168 and 365 days) post-vaccination)
- Antibody-mediated immunogenicity response rate(baseline (Week 0) and 4, 24 and 52 weeks (7, 28, 168 and 365 days) post-vaccination)
- Cell-mediated immunogenicity(4 and 24 weeks (28 and 168 days) post-vaccination)