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)
1 other identifier
interventional
770
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2022
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2022
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedStudy Start
First participant enrolled
January 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedFebruary 14, 2023
February 1, 2023
1.5 years
January 3, 2022
February 12, 2023
Conditions
Outcome Measures
Primary Outcomes (8)
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
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
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
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
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
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
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
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
Through Day 365 post last vaccination
Secondary Outcomes (5)
Occurrence of immediate systemic reactions
in 30 minutes post heterologous booster vaccination
Occurrence of solicited local AEs during 7 days post heterologous booster vaccination
Through 7 days post-vaccination
Occurrence of solicited systemic AEs during 7 days post heterologous booster vaccination
Through 7 days post-vaccination
Occurrence of unsolicited AEs during 28 days post heterologous booster vaccination
Through 28 days post-vaccination
Occurrence of SAEs, MAAEs and AESIs during the study period
Through Day 0 to Day 365 post vaccination
Study Arms (14)
Test group 1: primary vaccination completed with ChAdOx1 nCOV-19
EXPERIMENTALGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Placebo group 1: primary vaccination completed with ChAdOx1 nCOV-19
PLACEBO COMPARATORParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Test group 2: primary vaccination completed with BNT162b2(Pfizer)
EXPERIMENTALGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Placebo group 2: primary vaccination completed with BNT162b2(Pfizer)
PLACEBO COMPARATORParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Test group 3: primary vaccination completed with mRNA-1273(Moderna)
EXPERIMENTALGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Placebo group 3: primary vaccination completed with mRNA-1273(Moderna)
PLACEBO COMPARATORParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Test group 4: primary vaccination completed with Ad26.COV2.S(Janssen)
EXPERIMENTALGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Placebo group 4: primary vaccination completed with Ad26.COV2.S(Janssen)
PLACEBO COMPARATORParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Test group 5: primary vaccination completed with ChAdOx1 nCOV-19(AZ)-BNT162b2(Pfizer)
EXPERIMENTALGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Placebo group 5: primary vaccination completed with ChAdOx1 nCOV-19-BNT162b2
PLACEBO COMPARATORParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Test group 6: primary and 1st booster vaccination completed with mRNA vaccine
EXPERIMENTALGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Placebo group 6: primary and 1st booster vaccination completed with mRNA vaccine
PLACEBO COMPARATORParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Test group 7: primary and 1st booster vaccination completed with ≥1 dose of non-mRNA vaccine
EXPERIMENTALGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Placebo group 7: primary and 1st booster vaccination completed with ≥1 dose of non-mRNA vaccine
PLACEBO COMPARATORParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Interventions
SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03, 1 dose
Normal saline
Eligibility Criteria
You may qualify if:
- Participant must be aged 19 years and older at the time of signing the informed consent.
- Participants who are healthy or medically stabilized according to medical judgment of the investigator based on medical history, physical examination and clinical laboratory tests, etc.
- Participants who are able to attend all scheduled visits and comply with all study procedures.
- (Cohort 1\~5) Participants who received a primary series of COVID-19 vaccination approved for use in Korea by MFDS and at least 12\~24 weeks have passed with no additional COVID-19 vaccination.
- (Cohort 6\~7) Participants who received a primary series of COVID-19 vaccination and the 1st booster vaccination at least 16 weeks ago through a homologous or heterologous vaccination with mRNA vaccines (BNT162b2 (Pfizer) and mRNA-1273 (Moderna)) only or at least more than a single dose of non-mRNA vaccines (ChAdOx1 nCOV-19 (AZ), Ad26.COV2.S (Janssen), and NVX-CoV2373 (Novavax)).
- Female participants of childbearing potential must agree to be heterosexually inactive, or agree to use at least one acceptable method of contraception from at least 4 weeks prior to the study vaccination (booster vaccination) to 12 weeks after the study vaccination.
- Female participants with a negative urine or serum pregnancy test at screening (However, female participants who are surgically sterile or postmenopausal with amenorrhea for at least 12 months shall be excluded.
- Participants who give signed informed consent which include compliance with the requirements and restrictions listed in the informed consent form and in the protocol.
You may not qualify if:
- Any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (temperature \>38°C), or acute illness within 72 hours prior to the study vaccination (A prospective participant should not be included until 72 hours after the condition has resolved).
- History of virologically-confirmed COVID-19, SARS or MERS disease.
- History of confirmed SARS-CoV-2 infection within three months before screening.
- History of congenital or acquired immunodeficiency or autoimmune disease.
- History of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination.
- History of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, Guillain-Barre syndrome) to any components of the study intervention.
- History of malignancy within 1 year prior to the study vaccination (Except for a participant judged by the investigator to have a low recurrence risk.)
- Any other clinically significant conditions such as uncontrollable chronic or acute diseases which, in the opinion of the investigator, might cause a health threat to the participant or interfere with the clinical trial procedures or interpretation of the study results.
- Any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions).
- Female participants who are pregnant or breastfeeding.
- History of drug administration other than COVID-19 vaccination intended to treat or prevent COVID-19.
- History or planned other vaccination within 4 weeks prior to the study vaccination through 28 days after the study vaccination (except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination).
- Receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination.
- Use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy for at least 2 consecutive weeks within 12 weeks prior to the study vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) (However, the use of topical and nasal glucocorticoids will be permitted.)
- History of participation in another clinical study within 4 weeks prior to the study vaccination or planned participation in another clinical study during this study period.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 3, 2022
First Posted
January 4, 2022
Study Start
January 24, 2022
Primary Completion
August 1, 2023
Study Completion
November 1, 2023
Last Updated
February 14, 2023
Record last verified: 2023-02