Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19)
Condition: COVID-19 (Healthy Volunteers)
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1; Normal saline (0.9% sodium chloride solution) - Stage 1; GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1; Normal saline (0.9% sodium chloride solution) - Stage 1; GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2; GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2; Normal saline (0.9% sodium chloride solution)- Stage 2
Intervention type(s): Biological; Other; Biological; Other; Biological; Biological; Other
Intervention description(s): 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.; 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.
Other intervention name(s): GBP510-Alum-10μg; GBP510-Alum-25μg; GBP510-Alum-10μg; GBP510-Alum-25μg
Intervention MeSH terms: Pharmaceutical Solutions; Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention