NCT04750343 - Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19) | Biotech Hunter

Enrollment

328

Participants

Timeline

Start Date

February 3, 2021

Primary Completion Date

July 28, 2021

Study Completion Date

June 30, 2022

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.

Trial Locations (14)

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

Korea University Anam Hospital, Seongnam-si

Ewha Womans University Medical Center, Seoul

Hallym University Medical Center, Seoul

Korea University Guro Hospital, Seoul

Severance Hospital, Seoul

Ajou University Hospital, Suwon

Wonju Severance Christian Hospital, Wŏnju