This study is to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein subunit vaccine (NBP2001) in healthy adults.
This is a first-in-human, Phase I, randomized, placebo-controlled, observer-blinded study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein subunit vaccine (NBP2001) in healthy adults. A total of 50 healthy adults between 19 and 55 years of age will be enrolled and block-randomized in a 4:1 ratio to receive 2 doses of either one NBP2001 formulation (Test group 1 or 2) or placebo saline (Placebo group). Over the study period, participants will commonly attend 10 planned visits. Telephone calls will be made 7 days after each vaccination (Day 7+3 after Visit 2 and Visit 4). However, sentinel participants will be required to return at Day 7(+ 3 days) after 1st vaccination for rigorous safety assessment. Study vaccination will comprise 2 intramuscular injections of saline placebo, or a 30 or 50μg dose of NBP2001 in an injection volume of approximately 0.5mL. The study vaccines will be injected preferably into the deltoid muscle of the upper arm at a 28-day interval. Halting rules based on reactogenicity and safety outcomes are defined, and enrollment and study vaccination may be paused during the study if any halting rules are met.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
50
Participants will receive intramuscular (IM) injections of NBP2001(RBD 30μg/dose) on Days 0 and 28.
Participants will receive intramuscular (IM) injections of NBP2001(RBD 50μg/dose) on Days 0 and 28.
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
Seoul National University Bundang Hospital
Seongnam-si, Bundang, South Korea
Seoul National University Hospital
Seoul, South Korea
Occurrence of immediate systemic reactions
Time frame: Through 30 minutes (2 hours for sentinel participants) post-vaccination
Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination
Time frame: Through 7 days post-vaccination
Occurrence of solicited systemic AEs during 7 days post each vaccination
Time frame: Through 7 days post-vaccination
Occurrence of unsolicited AEs during 28 days post each vaccination
Time frame: Through 28 days post-vaccination
Occurrence of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs) during the whole study period
Time frame: Through 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)
Time frame: Through Day 365 post last vaccination
GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA
Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer
Time frame: Through Day 365 post last vaccination
GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays
Time frame: Through 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
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Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer
Time frame: Through 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
Time frame: Through Day 28 post last vaccination