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

NCT04742738 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

  • COVID-19 (Healthy Volunteers)

Interventions

BIOLOGICAL

GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1

Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (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 Alum (RBD 25μg/dose) - Stage 1

Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (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 Alum (RBD 10μg/dose) - Stage 2

Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.

BIOLOGICAL

GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2

Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (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

  • 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
2021-01-20
Primary Completion
2021-07-30
Completion
2022-07-07

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742738 on ClinicalTrials.gov