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CompletedNCT05007951Updated Apr 8, 2024

Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19)

A Phase 3 interventional study of GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) and ChAdOx1-S not less than 2.5 × 10^8 infectious units in Covid19, sponsored by SK Bioscience Co., Ltd.. Completed at 38 sites in 6 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by SK Bioscience Co., Ltd. (part of SK Chemicals Co., Ltd.) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
4,036
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a 2-Stage, Phase III, randomized, active-controlled, observer-blind, parallel-group, multi-center study to compare the immunogenicity and safety of SK SARS-CoV-2 recombinant nanoparticle vaccine adjuvanted with AS03 (GBP510) to ChAdOx1-S in adults aged 18 years and older.

Read the detailed description

The purpose of this study is to assess the immunogenicity and safety of SK SARS-CoV-2 recombinant nanoparticle vaccine adjuvanted with AS03 (GBP510) in adults aged 18 years and older.

This study includes 2-dose schedule (28-day interval) of GBP510(Test vaccine) and ChAdOx1-S(Control vaccine) in stage1. Participants are expected to participate for up to a maximum of approximately 13 months. A 12-month study follow-up after the 2nd vaccination will be conducted. One booster dose of GBP510 is scheduled for both test group and control group in Stage2. A 12-month study follow-up after the 3rd vaccination will be conducted.

International Vaccine Institute (IVI) conducts GBP510_003 trial as co-sponsor with SK bioscience.

02

Conditions studied

  • Covid19

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03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 4,036 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

SK Bioscience Co., Ltd. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Browse SK Bioscience Co., Ltd. studies →All SK Chemicals Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must be 18 years of age and older, at the time of signing the informed consent;
  • Participants who are healthy or medically stable as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, and medical judgement of the investigator;
  • Participants who are able to attend all scheduled visits and comply with all study procedures;
  • Female participants of childbearing potential must agree to be heterosexually inactive, or agree to consistently use at least one acceptable method of contraception from at least 4 weeks prior to the 1st study vaccination to 12 weeks after the last study vaccination;
  • Female participants with a negative urine or serum pregnancy test at screening;
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol;

\<Stage2>

  • Participants who have received 2 doses of GBP510 25μg adjuvanted with AS03 or ChAdOx1-S and have blood samples until Visit 7 in Stage 1
  • Participants who received a primary series of GBP510 or ChAdOx1-S at least 12 weeks prior to booster vaccination in Stage 2
  • Participants who are able to attend all additionally scheduled visits and comply with all study procedures.
  • Female participants of childbearing potential must agree to be heterosexually inactive, or agree to consistently use at least one acceptable method of contraception from at least 4 weeks prior to the booster dose (3rd study vaccination) to 12 weeks after the booster dose
  • Female participants with a negative urine or serum pregnancy test prior to the booster dose (the third dose of study vaccine)
  • Capable of giving an informed consent for Stage 2 study in compliance with the requirements and restrictions listed in the informed consent form (ICF) for Stage 2 and in this protocol.

Exclusion criteria

Exclusion Criteria:

  • Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature >38°C), or acute illness within 72 hours prior to the 1st study vaccination. A prospective participant should not be included until 72 hours after the condition has resolved;
  • (Only for Cohort 1) Prior SARS-CoV-2 infection or vaccination confirmed by a positive result of qualitative test for SARS-CoV-2 antibody using a rapid antibody kit at screening;
  • History of virologically-confirmed SARS or MERS disease, or SARS / MERS vaccination;
  • History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease;
  • History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination;
  • History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis, Guillain-Barre syndrome) to any vaccines or components of the study vaccine;
  • History of malignancy within 1 year prior to the 1st study vaccination (with the exception of malignancy with minimal risk of recurrence at the discretion of the investigator);
  • Significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results;
  • Any other conditions which, in the opinion of the investigator, 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;
  • Receipt of any vaccine within 4 weeks prior to the 1st study vaccination or planned receipt of any vaccine from enrollment through 28 days after the last study vaccination (Visit 7), except for influenza vaccination, which may be received at least 2 weeks prior to the 1st study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines;
  • Receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the 1st study vaccination;
  • Receipt of any medications or vaccinations intended to prevent COVID-19;
  • Chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anticancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the 1st vaccination. The use of topical and nasal glucocorticoids will be permitted;
  • Participation in another clinical study involving study intervention within 4 weeks prior to the 1st study vaccination, or concurrent, planned participation in another clinical study with study intervention during the study period.
  • Participants who are subjected to any global or local restrictions in place for use of ChAdOx1-S (e.g. age, gender, or other specific population groups)
  • Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.

\<Stage2>

  • Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature >38°C), or acute illness within 72 hours prior to the booster dose (3rd study vaccination). A prospective participant should not be included until 72 hours after the condition has resolved.
  • History of confirmed COVID-19, SARS or MERS disease confirmed by serological, virological assay, or rapid antigen kit
  • Receipt of any medications or vaccinations intended to prevent COVID-19 except for GBP510 or ChAdOx1-S.
  • Receipt of any vaccine within 4 weeks prior to the booster vaccination or planned receipt of any vaccine from enrollment through 28 days after the booster vaccination (Visit 4B), except for influenza vaccination, which may be received at least 2 weeks prior to the booster vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
  • Receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the booster vaccination
  • Chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the booster vaccination. The use of topical and nasal glucocorticoids will be permitted.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
4,036 participants (actual)

Study arms

  • Experimental
    Test group (GBP510) - Cohort 1

    Immunogenicity Cohort

    Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

  • Active comparator
    Control group (ChAdOx1-S) - Cohort 1

    Immunogenicity Cohort

    Biological: ChAdOx1-S not less than 2.5 × 10^8 infectious units

  • Experimental
    Test group (GBP510) - Cohort 2

    Safety Cohort

    Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

  • Active comparator
    Control group (ChAdOx1-S) - Cohort 2

    Safety Cohort

    Biological: ChAdOx1-S not less than 2.5 × 10^8 infectious units

  • Experimental
    Test group (GBP510) - Cohort 3

    Booster Subcohort

    Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

  • Active comparator
    Control group (ChAdOx1-S) - Cohort 3

    Booster Subcohort

    Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

Interventions

  • BiologicalGBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

    injection volume of 0.5mL on days 0 and 28 (stage1)

  • BiologicalChAdOx1-S not less than 2.5 × 10^8 infectious units

    injection volume of 0.5mL on days 0 and 28 (stage1)

  • BiologicalGBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

    injection volume of 0.5mL on days 0 (stage2)

06

What researchers measure

Primary outcomes

  1. Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays

    For Cohort 1

    Time frame: 2 weeks post 2nd vaccination

  2. Percentage of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline

    For Cohort 1

    Time frame: 2 weeks post 2nd vaccination

  3. Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays

    For Cohort 3

    Time frame: 2 weeks post 3rd (booster) and 2nd vaccination

Secondary outcomes

  1. GMT of SARS-CoV-2 Receptor-Binding Domain(RBD)-binding IgG antibody measured by Enzyme-Linked Immunosorbent Assay (ELISA) at each time point post-vaccination

    For Cohort 1

    Time frame: Through Day 365 post last vaccination

  2. Geometric Mean Fold Rise(GMFR) of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline

    For Cohort 1

    Time frame: Through Day 365 post last vaccination

  3. Percentage of participants with ≥ 4-fold rise SARS-CoV-2 RBD-binding IgG titer from baseline

    For Cohort 1

    Time frame: Through Day 365 post last vaccination

  4. GMT of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays

    For Cohort 1

    Time frame: Through Day 365 post last vaccination

  5. GMFR of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays from baseline

    For Cohort 1

    Time frame: Through Day 365 post last vaccination

  6. Percentage of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline

    For Cohort 1

    Time frame: Through Day 365 post last vaccination

  7. Cell-mediated response for both Th1 and Th2 cytokines measured by Enzyme-Linked ImmunoSpot (ELISpot)/ FluoroSpot, and for both CD4+ and CD8+ T-cells measured by Fluorescence-activated cell sorting(FACS)

    For Cohort 1

    Time frame: Through Day 365 post last vaccination

  8. Occurrence of immediate systemic reactions in the 30 minutes post each vaccination

    For all Cohort

    Time frame: Through 30 minutes post each vaccination

  9. Occurrence of solicited local Adverse Events(AEs)

    For all Cohort

    Time frame: Through 7 days post each vaccination

  10. Occurrence of solicited systemic AEs

    For all Cohort

    Time frame: Through 7 days post each vaccination

  11. Occurrence of unsolicited AEs

    For all Cohort

    Time frame: Through 28 days post each vaccination

  12. Occurrence of Serious Adverse events(SAEs), Medically attended Adverse Events(MAAEs), AEs leading to study withdrawal, and Adverse Events of Special Interests(AESIs)

    For all Cohort

    Time frame: Through Day 365 post last vaccination

  13. GMTs of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays

    For Cohort 3

    Time frame: 2 weeks post 3rd (booster) and 2nd vaccination

  14. Percentages of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline (Visit 2)

    For Cohort 3

    Time frame: 2 weeks post 3rd (booster) and 2nd vaccination

  15. GMTs of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays

    For Cohort 3

    Time frame: pre (Visit 1B) and 2 weeks post 3rd (booster) vaccination

  16. GMTs of neutralizing antibody to the SARS-CoV-2 measured by neutralization assays

    For Cohort 3

    Time frame: 2 weeks post 3rd (booster) and 2nd vaccination

  17. GMT of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA at each time point post booster vaccination

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  18. GMFR of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline (Visit 2) to each subsequent time point post booster vaccination

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  19. GMFR of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from prior to booster vaccination (Visit 1B) to each subsequent time point post booster vaccination

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  20. Percentage of participants with ≥4-fold rise in ELISA SARS-CoV-2 RBD-binding IgG titer from baseline (Visit 2) to each subsequent time point post booster vaccination

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  21. Percentage of participants with ≥4-fold rise in ELISA SARS-CoV-2 RBD-binding IgG titer from pre-booster vaccination (Visit 1B) to each subsequent time point post booster vaccination

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  22. GMT of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post booster vaccination

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  23. GMFR of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay from baseline (Visit 2) to each subsequent time point post booster vaccination.

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  24. GMFR of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay from prior to booster vaccination (Visit 1B) to each subsequent time point post booster vaccination

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  25. Percentage of participants with ≥4-fold rise in wild-type virus neutralizing antibody titer to SARS-CoV-2 from baseline (Visit 2) to each subsequent time point post booster vaccination.

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  26. Percentage of participants with ≥4-fold rise in wild-type virus neutralizing antibody titer to SARS-CoV-2 from pre-booster vaccination (Visit 1B) to each subsequent time point post booster vaccination

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

  27. Cell-mediated response for both Th1 and Th2 cytokines (including but not limited to INF-γ, TNF-α, IL-2, and IL-4 produced by T lymphocytes) measured by ELISpot and/or FluoroSpot, and for both CD4+ and CD8+ T-cells measured by FACS

    For Cohort 3

    Time frame: Through Day 365 post last vaccination

07

Study locations

38 sites
  • Southern Clinicaltrials Waitemata
    Auckland, New Zealand
  • Southern Clinical Trials Christchurch
    Christchurch, New Zealand
  • Lakeland Clinicaltrials Waikato
    Hamilton, New Zealand
  • Southern Clinical Trials Tasman
    Nelson, New Zealand
  • Lakeland Clinicaltrials Culloden
    Papamoa, New Zealand
  • Lakeland Clinicaltrials Rotorua
    Rotorua, New Zealand
  • Lakeland Clinicaltrials Wellington
    Upper Hutt, New Zealand
  • San Francisco Multi-Purpose Building
    Manila, Philippines
  • University of the East-Ramon Magsaysay Memorial Medical Center Inc.
    Manila, Philippines
  • Health Index Multispeciality Clinic
    Quezon City, Philippines
  • Korea University Ansan Hostpital
    Ansan, Gyeonggi-do, South Korea
  • Ajou university hospital
    Suwon, Gyeonggi-do, South Korea
  • Dong-A University Hospital
    Busan, South Korea
  • Kyungpook National University Chilgok Hospital
    Daegu, South Korea
  • Kyungpook National University Hospital
    Daegu, South Korea
  • Chonnam National University Hospital
    Gwangju, South Korea
  • Gachon University Gil Medical Center
    Incheon, South Korea
  • Inha university hospital
    Incheon, South Korea
  • Seoul national university hosptial
    Seoul, 03080, South Korea
  • Soonchunhyang university hospital
    Seoul, 04401, South Korea
  • Ewha womans university medical center
    Seoul, South Korea
  • Hallym university medical center
    Seoul, South Korea
  • Korea university Anam hospital
    Seoul, South Korea
  • Korea University Guro Hospital
    Seoul, South Korea
  • Severance Hospital
    Seoul, South Korea
  • Wonju severance christian hospital
    Wŏnju, South Korea
  • Armed Forces Research Institute of Medical Sciences
    Bangkok, Thailand
  • Siriraj Hospital
    Bangkok, Thailand
  • Maharaj Nakorn Chiang Mai Hospital
    Chiang Mai, Thailand
  • Sriganarind Hospital
    Khon Kaen, Thailand
  • Medical center "Preventclinic" LLC
    Dniprodzerzhyns'k, Dnipropetrovs'k, Ukraine
  • Treatment and Diagnostic Center of LLC Treatment and Diagnostic Center Adonis Plus
    Dnipro, Ukraine
  • Medical and Diagnostic Сеntег of Рrivatе Еntеrрrisе of Рrivatе Manufacturing Соmрапу Acinus
    Kropyvnytskyi, Ukraine
  • Communal non-profit enterprise Kyiv City Clinical Hospital №6
    Kyiv, Ukraine
  • Medical Center "Ok!Clinic+" of International Institute of Clinical Research LLC
    Kyiv, Ukraine
  • Municipal Nonprofit Enterprise "Khmelnytsky Regional Hospital for War Veterans" of Khmelnytsky Regional Council
    Kyiv, Ukraine
  • Private Clinic LLC Blagomed
    Odesa, Ukraine
  • Pasteur Institute
    Hochiminh City, Vietnam
08

References and documents

Publications

  • Song JY, Choi WS, Heo JY, Kim EJ, Lee JS, Jung DS, Kim SW, Park KH, Eom JS, Jeong SJ, Lee J, Kwon KT, Choi HJ, Sohn JW, Kim YK, Yoo BW, Jang IJ, Capeding MZ, Roman F, Breuer T, Wysocki P, Carter L, Sahastrabuddhe S, Song M, D'Cor N, Kim H, Ryu JH, Lee SJ, Park YW, Cheong HJ; GBP510/AS03 study group. Immunogenicity and safety of SARS-CoV-2 recombinant protein nanoparticle vaccine GBP510 adjuvanted with AS03: interim results of a randomised, active-controlled, observer-blinded, phase 3 trial. EClinicalMedicine. 2023 Sep 7;64:102140. doi: 10.1016/j.eclinm.2023.102140. eCollection 2023 Oct. PubMed 37711219 ↗
  • Walls AC, VanBlargan LA, Wu K, Choi A, Navarro MJ, Lee D, Avena L, Berrueta DM, Pham MN, Elbashir S, Kraft JC, Miranda MC, Kepl E, Johnson M, Blackstone A, Sprouse K, Fiala B, O'Connor MA, Brunette N, Arunachalam PS, Shirreff L, Rogers K, Carter L, Fuller DH, Villinger F, Pulendran B, Diamond MS, Edwards DK, King NP, Veesler D. Distinct sensitivities to SARS-CoV-2 variants in vaccinated humans and mice. Cell Rep. 2022 Aug 30;40(9):111299. doi: 10.1016/j.celrep.2022.111299. Epub 2022 Aug 15. PubMed 35988541 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05007951
Lead sponsor
SK Bioscience Co., Ltd.
Collaborators
International Vaccine Institute, GlaxoSmithKline, Coalition for Epidemic Preparedness Innovations
Responsible party
Sponsor
First posted
Aug 17, 2021
Start date
Aug 30, 2021
Primary completion
Oct 2, 2023
Completion
Oct 2, 2023
Last update
Apr 8, 2024

Study contacts

Hee Jin Cheong
principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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