1/2상완료

Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19)

연구 개요

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.

스폰서: 리드: SK바이오사이언스
적응증: COVID-19 (Healthy Volunteers)
중재: 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
목표 등록: 260명
시작일: 2021-01-20
완료(예정): 2022-07-07
등록번호: NCT04742738 · ClinicalTrials.gov ↗

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