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

NCT ID: NCT05007951

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4036 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2023-10-02

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Test group (GBP510) - Cohort 1

Immunogenicity Cohort

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

Control group (ChAdOx1-S) - Cohort 1

Immunogenicity Cohort

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

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

Test group (GBP510) - Cohort 2

Safety Cohort

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

Control group (ChAdOx1-S) - Cohort 2

Safety Cohort

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

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

Test group (GBP510) - Cohort 3

Booster Subcohort

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

injection volume of 0.5mL on days 0 (stage2)

Control group (ChAdOx1-S) - Cohort 3

Booster Subcohort

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

injection volume of 0.5mL on days 0 (stage2)

Interventions

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

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

Intervention Type: BIOLOGICAL

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

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

Intervention Type: BIOLOGICAL

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

injection volume of 0.5mL on days 0 (stage2)

Intervention Type: BIOLOGICAL

Eligibility 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;

<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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Vaccine Institute

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Coalition for Epidemic Preparedness Innovations

OTHER

Sponsor Role: collaborator

SK Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hee Jin Cheong

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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, , South Korea

Soonchunhyang university hospital

Seoul, , 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

Countries

New Zealand; Philippines; South Korea; Thailand; Ukraine; Vietnam

References

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.

Reference Type: DERIVED

PMID: 37711219 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35988541 (View on PubMed)

Other Identifiers

GBP510_003

Identifier Type: -

Identifier Source: org_study_id