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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
260
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.
Korea University Ansan Hospital
Ansan, South Korea
Dong-A University Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Occurrence of immediate systemic reactions - Stage 1
Time frame: Through 30 minutes (2 hours for sentinel participants) post-vaccination
Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1
Time frame: Through 7 days post-vaccination
Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1
Time frame: Through 7 days post-vaccination
Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1
Time frame: Through 28 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
Time frame: 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
Time frame: Through 7 days post 1st vaccination
GMT of IgG antibody to the SARS-CoV-2 RBD measured by Enzyme-linked Immunosorbent Assay (ELISA) - Stage 2
Time frame: Through Day 365 post last vaccination
GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 2
Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2
Time frame: Through Day 365 post last vaccination
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Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
Kyungpook National University Hospital
Daegu, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Ewha Womans University Medical Center
Seoul, South Korea
Hallym University Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
...and 2 more locations
GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 2
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through Day 28 post last vaccination
GMT of IgG antibody to the SARS-CoV-2 RBD measured by ELISA - Stage 1
Time frame: Through Day 365 post last vaccination
GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 1
Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through Day 28 post last vaccination
Occurrence of immediate systemic reactions - Stage 2
Time frame: Through 30 minutes (2 hours for elderly participants aged 75 years and older) post-vaccination
Occurrence of solicited local AEs during 7 days post each vaccination - Stage 2
Time frame: Through 7 days post-vaccination
Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 2
Time frame: Through 7 days post-vaccination
Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 2
Time frame: Through 28 days post-vaccination
Occurrence of SAEs, MAAEs and AESIs during the whole study period - Stage 2
Time frame: Through Day 0 to Day 365 post last vaccination