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

Phase 1
Completed
Conditions
COVID-19 (Healthy Volunteers)
Registration Number
NCT04742738
Lead Sponsor
SK Bioscience Co., Ltd.
Brief 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.

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 260 healthy younger and older adults will be enrolled to receive 2 doses of either one GBP510 formulation (Test group 1 or 2) or placebo saline (Placebo group).

This study will consist of 2 stages, and a stepwise approach will be adopted as a safety precaution. Approximately 60 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 200 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
260
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Occurrence of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs) during the whole study period - Stage 1Through Day 0 to Day 365 post last vaccination
GMT of IgG antibody to the SARS-CoV-2 RBD measured by Enzyme-linked Immunosorbent Assay (ELISA) - Stage 2Through Day 365 post last vaccination
GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 2Through Day 365 post last vaccination
GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 2Through Day 365 post last vaccination
Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1Through 7 days post-vaccination
Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1Through 7 days post-vaccination
Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1Through 28 days post-vaccination
Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2Through Day 365 post last vaccination
Occurrence of immediate systemic reactions - Stage 1Through 30 minutes (2 hours for sentinel participants) post-vaccination
(Only in Sentinel group) Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) during 7 days post 1st vaccination - Stage 1Through 7 days post 1st vaccination
GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 2Through Day 365 post last vaccination
Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using Enzyme-linked ImmunoSpot (ELISpot) or other system) - Stage 2Through Day 28 post last vaccination
Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 2Through Day 365 post last vaccination
Secondary Outcome Measures
NameTimeMethod
Occurrence of SAEs, MAAEs and AESIs during the whole study period - Stage 2Through Day 0 to Day 365 post last vaccination
Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using ELISpot or other system) - Stage 1Through Day 28 post last vaccination
Occurrence of immediate systemic reactions - Stage 2Through 30 minutes (2 hours for elderly participants aged 75 years and older) post-vaccination
GMT of IgG antibody to the SARS-CoV-2 RBD measured by ELISA - Stage 1Through Day 365 post last vaccination
GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 1Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 1Through Day 365 post last vaccination
GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 1Through Day 365 post last vaccination
GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 1Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 1Through Day 365 post last vaccination
Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 2Through 7 days post-vaccination
Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 2Through 28 days post-vaccination
Occurrence of solicited local AEs during 7 days post each vaccination - Stage 2Through 7 days post-vaccination

Trial Locations

Locations (12)

Korea University Ansan Hospital

🇰🇷

Ansan, Korea, Republic of

Dong-A University Hospital

🇰🇷

Busan, Korea, Republic of

Kyungpook National University Chilgok Hospital

🇰🇷

Daegu, Korea, Republic of

Kyungpook National University Hospital

🇰🇷

Daegu, Korea, Republic of

Chonnam National University Hospital

🇰🇷

Gwangju, Korea, Republic of

Gachon University Gil Medical Center

🇰🇷

Incheon, Korea, Republic of

Inha University Hospital

🇰🇷

Incheon, Korea, Republic of

Ewha Womans University Medical Center

🇰🇷

Seoul, Korea, Republic of

Hallym University Medical Center

🇰🇷

Seoul, Korea, Republic of

Korea University Anam Hospital

🇰🇷

Seoul, Korea, Republic of

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Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of

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