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

NCT05007951 | Completed Phase 3 DMC

• 1 other identifier: GBP510_003
• Study Type: interventional
• Target: 4,036
• Locations: 6 countries
• Sites: 38

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

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

  For Cohort 1

  2 weeks post 2nd vaccination

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

  For Cohort 1

  2 weeks post 2nd vaccination

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

  For Cohort 3

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

Secondary Outcomes (27)

• 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

  Through Day 365 post last vaccination

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

  Through Day 365 post last vaccination

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

  Through Day 365 post last vaccination

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

  Through Day 365 post last vaccination

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

  Through Day 365 post last vaccination

Study Arms (6)

Test group (GBP510) - Cohort 1

EXPERIMENTAL

Immunogenicity Cohort

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

Control group (ChAdOx1-S) - Cohort 1

ACTIVE COMPARATOR

Immunogenicity Cohort

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

Test group (GBP510) - Cohort 2

EXPERIMENTAL

Safety Cohort

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

Control group (ChAdOx1-S) - Cohort 2

ACTIVE COMPARATOR

Safety Cohort

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

Test group (GBP510) - Cohort 3

EXPERIMENTAL

Booster Subcohort

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

Control group (ChAdOx1-S) - Cohort 3

ACTIVE COMPARATOR

Booster Subcohort

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

Interventions

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

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

Test group (GBP510) - Cohort 1; Test group (GBP510) - Cohort 2

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

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

Control group (ChAdOx1-S) - Cohort 1; Control group (ChAdOx1-S) - Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SK Bioscience Co., Ltd.: lead
• International Vaccine Institute: collaborator
• GlaxoSmithKline: collaborator
• Coalition for Epidemic Preparedness Innovations: collaborator

Study Sites (38)

Southern Clinicaltrials Waitemata

Auckland, New Zealand

Location

Southern Clinical Trials Christchurch

Christchurch, New Zealand

Location

Lakeland Clinicaltrials Waikato

Hamilton, New Zealand

Location

Southern Clinical Trials Tasman

Nelson, New Zealand

Location

Lakeland Clinicaltrials Culloden

Papamoa, New Zealand

Location

Lakeland Clinicaltrials Rotorua

Rotorua, New Zealand

Location

Lakeland Clinicaltrials Wellington

Upper Hutt, New Zealand

Location

San Francisco Multi-Purpose Building

Manila, Philippines

Location

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

Manila, Philippines

Location

Health Index Multispeciality Clinic

Quezon City, Philippines

Location

Korea University Ansan Hostpital

Ansan, Gyeonggi-do, South Korea

Location

Ajou university hospital

Suwon, Gyeonggi-do, South Korea

Location

Dong-A University Hospital

Busan, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Inha university hospital

Incheon, South Korea

Location

Seoul national university hosptial

Seoul, 03080, South Korea

Location

Soonchunhyang university hospital

Seoul, 04401, South Korea

Location

Ewha womans university medical center

Seoul, South Korea

Location

Hallym university medical center

Seoul, South Korea

Location

Korea university Anam hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Wonju severance christian hospital

Wŏnju, South Korea

Location

Armed Forces Research Institute of Medical Sciences

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Location

Sriganarind Hospital

Khon Kaen, Thailand

Location

Medical center "Preventclinic" LLC

Dniprodzerzhyns'k, Dnipropetrovs'k, Ukraine

Location

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

Dnipro, Ukraine

Location

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

Kropyvnytskyi, Ukraine

Location

Communal non-profit enterprise Kyiv City Clinical Hospital №6

Kyiv, Ukraine

Location

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

Kyiv, Ukraine

Location

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

Kyiv, Ukraine

Location

Private Clinic LLC Blagomed

Odesa, Ukraine

Location

Pasteur Institute

Hochiminh City, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 37711219 DERIVED

• 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.

  PMID: 35988541 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hee Jin Cheong

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are unblinded after Stage1 interim analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 17, 2021
• Study Start: August 30, 2021
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

VN (1); PH (3); NZ (7); TH (4); UA (7); KR (16)