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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05007951
Recruitment Status : Active, not recruiting
First Posted : August 17, 2021
Last Update Posted : May 10, 2022
Sponsor:
Collaborators:
International Vaccine Institute
GlaxoSmithKline
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
SK Bioscience Co., Ltd.

Brief Summary:
This is a 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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) Biological: ChAdOx1-S not less than 2.5 × 10^8 infectious units Phase 3

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 and ChAdOx1-S. 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A 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
Actual Study Start Date : August 30, 2021
Actual Primary Completion Date : March 18, 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test group (GBP510) - Cohort 1
Immunogenicity Cohort
Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)
injection volume of 0.5mL on days 0 and 28

Active Comparator: Control group (ChAdOx1-S) - Cohort 1
Immunogenicity Cohort
Biological: ChAdOx1-S not less than 2.5 × 10^8 infectious units
injection volume of 0.5mL on days 0 and 28

Experimental: Test group (GBP510) - Cohort 2
Safety Cohort
Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)
injection volume of 0.5mL on days 0 and 28

Active Comparator: Control group (ChAdOx1-S) - Cohort 2
Safety Cohort
Biological: ChAdOx1-S not less than 2.5 × 10^8 infectious units
injection volume of 0.5mL on days 0 and 28




Primary Outcome Measures :
  1. 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 ]
    For Cohort 1

  2. Percentage of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline [ Time Frame: 2 weeks post 2nd vaccination ]
    Fo Cohort 1


Secondary Outcome Measures :
  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 [ Time Frame: Through Day 365 post last vaccination ]
    For Cohort 1

  2. Geometric Mean Fold Rise(GMFR) of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline [ Time Frame: Through Day 365 post last vaccination ]
    For Cohort 1

  3. Percentage of participants with ≥ 4-fold rise SARS-CoV-2 RBD-binding IgG titer from baseline [ Time Frame: Through Day 365 post last vaccination ]
    For Cohort 1

  4. GMT of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays [ Time Frame: Through Day 365 post last vaccination ]
    For Cohort 1

  5. GMFR of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays from baseline [ Time Frame: Through Day 365 post last vaccination ]
    For Cohort 1

  6. Percentage of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline [ Time Frame: Through Day 365 post last vaccination ]
    For Cohort 1

  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) [ Time Frame: Through Day 365 post last vaccination ]
    For Cohort 1

  8. Occurrence of immediate systemic reactions in the 30 minutes post each vaccination [ Time Frame: Through 30 minutes post each vaccination ]
    For all Cohort

  9. Occurrence of solicited local Adverse Events(AEs) [ Time Frame: Through 7 days post each vaccination ]
    For all Cohort

  10. Occurrence of solicited systemic AEs [ Time Frame: Through 7 days post each vaccination ]
    For all Cohort

  11. Occurrence of unsolicited AEs [ Time Frame: Through 28 days post each vaccination ]
    For all Cohort

  12. Occurrence of Serious Adverse events(SAEs), Medically attended Adverse Events(MAAEs), AEs leading to study withdrawal, and Adverse Events of Special Interests(AESIs) [ Time Frame: Through Day 365 post last vaccination ]
    For all Cohort



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05007951


Locations
Show Show 26 study locations
Sponsors and Collaborators
SK Bioscience Co., Ltd.
International Vaccine Institute
GlaxoSmithKline
Coalition for Epidemic Preparedness Innovations
Investigators
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Principal Investigator: Hee Jin Cheong Korea University Guro Hospital
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Responsible Party: SK Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT05007951    
Other Study ID Numbers: GBP510_003
First Posted: August 17, 2021    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases