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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
770
SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03, 1 dose
Normal saline
Korea University Ansan Hospital
Ansan, South Korea
Dong-A University Hospital
Busan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Comparative GMT (Geometric Mean Titer) of neutralizing antibody to SARS-CoV-2 between the Test Group and Placebo Group, measured by wild-type virus neutralization assay at 2 weeks post heterologous booster vaccination
Time frame: Through Day 365 post last vaccination
GMT (Geometric Mean Titer) of SARS-CoV-2 RBD-binding antibody measured by ECLIA at each time point post heterologous booster vaccination
Time frame: Through Day 365 post last vaccination
GMFR (Geometric Mean Fold Rise) of SARS-CoV-2 RBD-binding antibody from baseline measured by ECLIA at each time point post heterologous booster vaccination
Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥4-fold rise from baseline in SARS-CoV-2 RBD-binding antibody measured by ECLIA at each time point post heterologous booster vaccination
Time frame: Through Day 365 post last vaccination
GMT (Geometric Mean Titer) of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination
Time frame: Through Day 365 post last vaccination
GMFR (Geometric Mean Fold Rise) of neutralizing antibody to SARS-CoV-2 from baseline measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination
Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥4-fold rise from baseline in neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination
Time frame: Through Day 365 post last vaccination
(Only applicable to CMI analysis set) Cell-mediated immunity assessment using IFN-γ ELISpot at each time point post heterologous booster vaccination
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Chonnam National University Hospital
Gwangju, South Korea
Hallym University Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Time frame: Through Day 365 post last vaccination
Occurrence of immediate systemic reactions
Time frame: in 30 minutes post heterologous booster vaccination
Occurrence of solicited local AEs during 7 days post heterologous booster vaccination
Time frame: Through 7 days post-vaccination
Occurrence of solicited systemic AEs during 7 days post heterologous booster vaccination
Time frame: Through 7 days post-vaccination
Occurrence of unsolicited AEs during 28 days post heterologous booster vaccination
Time frame: Through 28 days post-vaccination
Occurrence of SAEs, MAAEs and AESIs during the study period
Time frame: Through Day 0 to Day 365 post vaccination