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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

January 20, 2021

Primary Completion Date

July 30, 2021

Study Completion Date

July 7, 2022

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.

Trial Locations (12)

Unknown

Korea University Ansan Hospital, Ansan

Dong-A University Hospital, Busan

Kyungpook National University Chilgok Hospital, Daegu

Kyungpook National University Hospital, Daegu

Chonnam National University Hospital, Gwangju

Gachon University Gil Medical Center, Incheon

Inha University Hospital, Incheon

Ewha Womans University Medical Center, Seoul

Hallym University Medical Center, Seoul

Korea University Anam Hospital, Seoul

Korea University Guro Hospital, Seoul

Ajou University Hospital, Suwon

All Listed Sponsors
collaborator

Coalition for Epidemic Preparedness Innovations

OTHER

lead

SK Bioscience Co., Ltd.

INDUSTRY

NCT04742738 - Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19) | Biotech Hunter | Biotech Hunter