NCT04750343

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

A 2-Stage, Phase I/II, Placebo-controlled, Randomized, Observer-blinded, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 in Healthy Younger and Older Adults

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: SK Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Accepted

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 or without AS03 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 320 healthy younger and older adults will be enrolled to receive 2 doses of either one GBP510 formulation with AS03 (Test group 1 or 3), or without AS03 (Test group 2 or 4), or placebo saline (Placebo group). Test group 2 will only be included in Stage 1. This study will consist of 2 stages, and a stepwise approach will be adopted as a safety precaution. Approximately 80 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 240 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.

Conditions

• COVID-19 (Healthy Volunteers)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-03
• Primary completion: 2021-07-28
• Completion: 2022-06-01
• First posted: 2021-02-11
• Last updated: 2022-05-10

Locations

14 sites across 1 country: South Korea