A 2-Stage, Phase I/II, Placebo-controlled, Randomized, Observer-blinded, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 in Healthy Younger and Older Adults
试验速览
- 阶段
- 1 期
- 入组人数
- 328
- 试验地点
- 14
- 主要终点
- Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1
研究概览
简要总结
This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded, age-escalating study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with or without AS03 in healthy younger and older adults.
详细描述
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the candidate vaccine administered twice with 28-day interval in healthy adults including older adults.
A total of 320 healthy younger and older adults will be enrolled to receive 2 doses of either one GBP510 formulation with AS03 (Test group 1 or 3), or without AS03 (Test group 2 or 4), or placebo saline (Placebo group). Test group 2 will only be included in Stage 1.
This study will consist of 2 stages, and a stepwise approach will be adopted as a safety precaution. Approximately 80 healthy adults aged 19 to 55 years will be enrolled and vaccinated first in Stage 1, and blinded safety data collected through 7 days after the last study vaccination will be reviewed by the sponsor, and then by the independent Data Safety Monitoring Board (DSMB) in an unblinded manner. Advancement to Stage 2 for further enrollment of 240 healthy younger and older adults aged 19 to 85 years will be determined if an acceptable safety profile is confirmed based on the sponsor and DSMB review. DSMB will recommend whether to proceed to the next stage or not, and DSMB may suggest discontinuation of the study or adjustment of dose and dosing regimen based on the safety review.
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
- 19 Years 至 85 Years（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
结局指标
主要结局
Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1
时间窗: Through 28 days post-vaccination
GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 2
时间窗: Through Day 365 post last vaccination
Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1
时间窗: Through 7 days post-vaccination
Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1
时间窗: Through 7 days post-vaccination
Occurrence of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs) during the whole study period - Stage 1
时间窗: Through Day 0 to Day 365 post last vaccination
(Only in Sentinel group) Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) during 7 days post 1st vaccination - Stage 1
时间窗: Through 7 days post 1st vaccination
Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using Enzyme-linked ImmunoSpot (ELISpot) or other system) - Stage 2
时间窗: Through Day 28 post last vaccination
GMT of IgG antibody to the SARS-CoV-2 RBD measured by Enzyme-linked Immunosorbent Assay (ELISA) - Stage 2
时间窗: Through Day 365 post last vaccination
GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 2
时间窗: Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 2
时间窗: Through Day 365 post last vaccination
Occurrence of immediate systemic reactions - Stage 1
时间窗: Through 30 minutes (2 hours for sentinel participants) post-vaccination
GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 2
时间窗: Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2
时间窗: Through Day 365 post last vaccination
次要结局
- Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 1(Through Day 365 post last vaccination)
- GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 1(Through Day 365 post last vaccination)
- Occurrence of SAEs, MAAEs and AESIs during the whole study period - Stage 2(Through Day 0 to Day 365 post last vaccination)
- GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 1(Through Day 365 post last vaccination)
- Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using ELISpot or other system) - Stage 1(Through Day 28 post last vaccination)
- Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 2(Through 7 days post-vaccination)
- GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 1(Through Day 365 post last vaccination)
- GMT of IgG antibody to the SARS-CoV-2 RBD measured by ELISA - Stage 1(Through Day 365 post last vaccination)
- Occurrence of solicited local AEs during 7 days post each vaccination - Stage 2(Through 7 days post-vaccination)
- Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 2(Through 28 days post-vaccination)
- Occurrence of immediate systemic reactions - Stage 2(Through 30 minutes (2 hours for elderly participants aged 75 years and older) post-vaccination)
- Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 1(Through Day 365 post last vaccination)