NCT05175950

Safety, Reactogenicity, and Immunogenicity Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510)

A Placebo-controlled, Randomized, Observer-blinded, Multi-center Study to Assess the Safety, Reactogenicity, and Immunogenicity of Booster Vaccination of A SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 770 (estimated)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This is randomized, placebo-controlled, observer-blinded, multi-center study to assess safety, reactogenicity and immunogenicity of booster vaccination of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 19 years and older who received a primary series of vaccination or the 1st booster vaccination against COVID-19 approved in Korea.

Detailed description

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of booster vaccination of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510). (Cohort 1\~5) A total of approximately 550 adults will be divided into 5 cohorts based on primary series vaccines they received - ChAdOx1 nCOV-19, BNT162b2, mRNA-1273, Ad26.COV2.S and heterologous vaccination with ChAdOx1 nCOV-19 \& BNT162b2. (Cohort 6\~7) A total of approximately 220 adults will be divided into 2 cohorts based on primary series \& 1st booster vaccines they received -mRNA vaccines (BNT162b2 or mRNA-1273) and at least more than a single dose of non-mRNA vaccines (ChAdOx1 nCOV-19, Ad26.COV2.S, and NVX-CoV2373) The participants are then randomized at a ratio of 10:1 to either Test Group or Placebo Group. Participants will be subject to follow-up for 12 months after receiving a single booster dose of GBP510 adjuvanted with AS03. Blood sampling for cell-mediated immunity will be undertaken on approximately 20% of the participants in each cohort, who are selected in advance in consideration of the randomization ratio between Test Group and Placebo Group.

Conditions

• COVID-19 (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03	SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03, 1 dose
OTHER	Normal saline	Normal saline

Timeline

• Start date: 2022-01-24
• Primary completion: 2023-08-01
• Completion: 2023-11-01
• First posted: 2022-01-04
• Last updated: 2023-02-14

Locations

9 sites across 1 country: South Korea