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Covid19Phase 3NCT05007951

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

A Phase 3 study testing GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) and ChAdOx1-S not less than 2.5 × 10^8 infectious units in people with Covid19, run by SK Bioscience Co., Ltd. at 38 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) and ChAdOx1-S not less than 2.5 × 10^8 infectious units
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,036 participants
Where
38 sitesin 6 countries
Study dates
30 Aug 2021to 2 Oct 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 13Show fewer
  • <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.

Who cannot join

  • 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;
Show all 24Show fewer
  • 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.

Trial locations and contacts

38 sites in 6 countries.

38 sites in 6 countries

South Korea16 sites

  • Korea University Ansan Hostpital

    Ansan, Gyeonggi-do

  • Dong-A University Hospital

    Busan

  • Kyungpook National University Chilgok Hospital

    Daegu

  • Kyungpook National University Hospital

    Daegu

  • Chonnam National University Hospital

    Gwangju

  • Gachon University Gil Medical Center

    Incheon

  • Inha university hospital

    Incheon

  • Seoul national university hosptial

    Seoul, 03080

  • Soonchunhyang university hospital

    Seoul, 04401

  • Ewha womans university medical center

    Seoul

  • Hallym university medical center

    Seoul

  • Korea university Anam hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Severance Hospital

    Seoul

  • Ajou university hospital

    Suwon, Gyeonggi-do

  • Wonju severance christian hospital

    Wŏnju

Other trials in South Korea

New Zealand7 sites

  • Southern Clinicaltrials Waitemata

    Auckland

  • Southern Clinical Trials Christchurch

    Christchurch

  • Lakeland Clinicaltrials Waikato

    Hamilton

  • Southern Clinical Trials Tasman

    Nelson

  • Lakeland Clinicaltrials Culloden

    Papamoa

  • Lakeland Clinicaltrials Rotorua

    Rotorua

  • Lakeland Clinicaltrials Wellington

    Upper Hutt

Other trials in New Zealand

Ukraine7 sites

  • Treatment and Diagnostic Center of LLC Treatment and Diagnostic Center Adonis Plus

    Dnipro

  • Medical center "Preventclinic" LLC

    Dniprodzerzhyns'k, Dnipropetrovs'k

  • Medical and Diagnostic Сеntег of Рrivatе Еntеrрrisе of Рrivatе Manufacturing Соmрапу Acinus

    Kropyvnytskyi

  • Communal non-profit enterprise Kyiv City Clinical Hospital №6

    Kyiv

  • Medical Center "Ok!Clinic+" of International Institute of Clinical Research LLC

    Kyiv

  • Municipal Nonprofit Enterprise "Khmelnytsky Regional Hospital for War Veterans" of Khmelnytsky Regional Council

    Kyiv

  • Private Clinic LLC Blagomed

    Odesa

Other trials in Ukraine

Thailand4 sites

  • Armed Forces Research Institute of Medical Sciences

    Bangkok

  • Siriraj Hospital

    Bangkok

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai

  • Sriganarind Hospital

    Khon Kaen

Other trials in Thailand

Philippines3 sites

  • San Francisco Multi-Purpose Building

    Manila

  • University of the East-Ramon Magsaysay Memorial Medical Center Inc.

    Manila

  • Health Index Multispeciality Clinic

    Quezon City

Other trials in Philippines

Vietnam1 site

  • Pasteur Institute

    Hochiminh City

Other trials in Vietnam

About this study

Official title: A 2-Stage, Phase III, Randomized, Active-controlled, Observer-blind, Parallel-group, Multi-center Study 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 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.

Conditions
Covid19
Being tested
GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose), ChAdOx1-S not less than 2.5 × 10^8 infectious units
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • ChAdOx1-S not less than 2.5 × 10^8 infectious unitsBiological

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

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

    injection volume of 0.5mL on days 0 (stage2)

Study groups in NCT05007951
Study groupRoleWhat they receive
Test group (GBP510) - Cohort 1ExperimentalImmunogenicity Cohort
Receives: Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)
Control group (ChAdOx1-S) - Cohort 1Active comparatorImmunogenicity Cohort
Receives: Biological: ChAdOx1-S not less than 2.5 × 10^8 infectious units
Test group (GBP510) - Cohort 2ExperimentalSafety Cohort
Receives: Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)
Control group (ChAdOx1-S) - Cohort 2Active comparatorSafety Cohort
Receives: Biological: ChAdOx1-S not less than 2.5 × 10^8 infectious units
Test group (GBP510) - Cohort 3ExperimentalBooster Subcohort
Receives: Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)
Control group (ChAdOx1-S) - Cohort 3Active comparatorBooster Subcohort
Receives: Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    For Cohort 1

    Measured: 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

    Measured: 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

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

Secondary outcomes (27)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Through Day 365 post last vaccination

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

    For all Cohort

    Measured: Through 30 minutes post each vaccination

  9. Occurrence of solicited local Adverse Events(AEs)

    For all Cohort

    Measured: Through 7 days post each vaccination

  10. Occurrence of solicited systemic AEs

    For all Cohort

    Measured: Through 7 days post each vaccination

  11. Occurrence of unsolicited AEs

    For all Cohort

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Through Day 365 post last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start30 Aug 2021
  3. Primary completion2 Oct 2023
  4. Study completion2 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,036 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007951
Sponsor's protocol ID
GBP510_003
Status last verified
Apr 2024
First submitted
9 Aug 2021
Last updated
8 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) and ChAdOx1-S not less than 2.5 × 10^8 infectious units in people with Covid19, run by SK Bioscience Co., Ltd. at 38 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in South Korea, New Zealand, Ukraine, Thailand, Philippines and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays (time frame: 2 weeks post 2nd vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007951, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

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