Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19)
NCT04750343 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 328
Last updated 2022-05-10
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 or without AS03 in healthy younger and older adults.
Conditions
- COVID-19 (Healthy Volunteers)
Interventions
- BIOLOGICAL
-
GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 1
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 10μg/dose) on Days 0 and 28.
- BIOLOGICAL
-
GBP510 (RBD 10μg/dose) - Stage 1
Participants will receive intramuscular (IM) injections of GBP510 (RBD 10μg/dose) on Days 0 and 28.
- OTHER
-
Normal saline (0.9% sodium chloride solution) - Stage 1
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
- BIOLOGICAL
-
GBP510 adjuvanted with AS03 (RBD 25μg/dose) - Stage 1
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 25μg/dose) on Days 0 and 28.
- BIOLOGICAL
-
GBP510 (RBD 25μg/dose) - Stage 1
Participants will receive intramuscular (IM) injections of GBP510 (RBD 25μg/dose) on Days 0 and 28.
- OTHER
-
Normal saline (0.9% sodium chloride solution) - Stage 1
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
- BIOLOGICAL
-
GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 2
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 10μg/dose) on Days 0 and 28.
- BIOLOGICAL
-
GBP510 adjuvanted with AS03 (RBD 25μg/dose)- Stage 2
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 25μg/dose) on Days 0 and 28.
- BIOLOGICAL
-
GBP510 (RBD 25μg/dose)- Stage 2
Participants will receive intramuscular (IM) injections of GBP510 (RBD 25μg/dose) on Days 0 and 28.
- OTHER
-
Normal saline (0.9% sodium chloride solution)- Stage 2
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
Sponsors & Collaborators
-
Coalition for Epidemic Preparedness Innovations
collaborator OTHER - collaborator INDUSTRY
-
SK Bioscience Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Hee Jin Cheong · Korea University Guro Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-02-03
- Primary Completion
- 2021-07-28
- Completion
- 2022-06-30
Countries
- South Korea
Study Locations
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