Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19)
- Conditions
- COVID-19 (Healthy Volunteers)
- Interventions
- Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2Other: Normal saline (0.9% sodium chloride solution) - Stage 1Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1Other: Normal saline (0.9% sodium chloride solution)- Stage 2Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2
- Registration Number
- NCT04742738
- Lead Sponsor
- SK Bioscience Co., Ltd.
- Brief Summary
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 Alum in healthy younger and older adults.
- Detailed Description
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 260 healthy younger and older adults will be enrolled to receive 2 doses of either one GBP510 formulation (Test group 1 or 2) or placebo saline (Placebo group).
This study will consist of 2 stages, and a stepwise approach will be adopted as a safety precaution. Approximately 60 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 200 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group 2 - Stage 2 GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2 2 doses of GBP510 adjuvanted with Alum (RBD 25μg/dose), 1 dose each on Days 0 and 28. Placebo group - Stage 1 Low dose-level Cohort Normal saline (0.9% sodium chloride solution) - Stage 1 2 doses of Placebo Saline, 1 dose each on Days 0 and 28. Test group 1 - Stage 1 Low dose-level Cohort GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1 2 doses of GBP510 adjuvanted with Alum (Receptor Binding Domain (RBD) 10μg/dose), 1 dose each on Days 0 and 28. Placebo group - Stage 2 Normal saline (0.9% sodium chloride solution)- Stage 2 2 doses of Placebo Saline, 1 dose each on Days 0 and 28. Test group 2 - Stage 1 High dose-level Cohort GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1 2 doses of GBP510 adjuvanted with Alum (RBD 25μg/dose), 1 dose each on Days 0 and 28. Test group 1 - Stage 2 GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2 2 doses of GBP510 adjuvanted with Alum (RBD 10μg/dose), 1 dose each on Days 0 and 28. Placebo group - Stage 1 High dose-level Cohort Normal saline (0.9% sodium chloride solution) - Stage 1 2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
- Primary Outcome Measures
Name Time Method 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 Through Day 0 to Day 365 post last vaccination GMT of IgG antibody to the SARS-CoV-2 RBD measured by Enzyme-linked Immunosorbent Assay (ELISA) - Stage 2 Through Day 365 post last vaccination GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 2 Through Day 365 post last vaccination GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 2 Through Day 365 post last vaccination Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1 Through 7 days post-vaccination Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1 Through 7 days post-vaccination Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1 Through 28 days post-vaccination Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2 Through Day 365 post last vaccination Occurrence of immediate systemic reactions - Stage 1 Through 30 minutes (2 hours for sentinel participants) post-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 Through 7 days post 1st vaccination GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 2 Through Day 365 post last 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 Through Day 28 post last vaccination Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 2 Through Day 365 post last vaccination
- Secondary Outcome Measures
Name Time Method 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 immediate systemic reactions - Stage 2 Through 30 minutes (2 hours for elderly participants aged 75 years and older) post-vaccination GMT of IgG antibody to the SARS-CoV-2 RBD measured by ELISA - Stage 1 Through Day 365 post last vaccination GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 1 Through Day 365 post last vaccination Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 1 Through 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 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 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 Occurrence of solicited systemic 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 solicited local AEs during 7 days post each vaccination - Stage 2 Through 7 days post-vaccination Occurrence of SAEs, MAAEs and AESIs during the whole study period - Stage 2 Through Day 0 to Day 365 post last vaccination
Trial Locations
- Locations (12)
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Ewha Womans University Medical Center
🇰🇷Seoul, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Medical Center
🇰🇷Seoul, Korea, Republic of