Клинические исследование Covid19: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose), ChAdOx1-S not less than 2.5 × 10^8 infectious units

Спонсоры	Ведущий спонсор: SK Bioscience Co., Ltd. Коллаборационист: International Vaccine Institute GlaxoSmithKline Coalition for Epidemic Preparedness Innovations
Источник	SK Bioscience Co., Ltd.
Краткое содержание	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.

Спонсоры

Ведущий спонсор: SK Bioscience Co., Ltd.

Коллаборационист: International Vaccine Institute
GlaxoSmithKline
Coalition for Epidemic Preparedness Innovations

Источник

SK Bioscience Co., Ltd.

Краткое содержание

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.

Подробное описание

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.

Общий статус

Recruiting

Дата начала

2021-08-30

Дата завершения

2022-09-01

Дата первичного завершения

2022-03-01

Фаза

Phase 3

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays	2 weeks post 2nd vaccination
Percentage of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline	2 weeks post 2nd vaccination

Вторичный результат

Мера	Временное ограничение
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
Percentage of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline	Through Day 365 post last vaccination
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)	Through Day 365 post last vaccination
Occurrence of immediate systemic reactions in the 30 minutes post each vaccination	Through 30 minutes post each vaccination
Occurrence of solicited local Adverse Events(AEs)	Through 7 days post each vaccination
Occurrence of solicited systemic AEs	Through 7 days post each vaccination
Occurrence of unsolicited AEs	Through 28 days post each vaccination
Occurrence of Serious Adverse events(SAEs), Medically attended Adverse Events(MAAEs), AEs leading to study withdrawal, and Adverse Events of Special Interests(AESIs)	Through Day 365 post last vaccination

Регистрация

3990

Состояние	Covid19
Вмешательство	Тип вмешательства: Biological Название вмешательства: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) Описание: injection volume of 0.5mL on days 0 and 28 Тип вмешательства: Biological Название вмешательства: ChAdOx1-S not less than 2.5 × 10^8 infectious units Описание: injection volume of 0.5mL on days 0 and 28
Приемлемость	Критерии: 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. Пол: All Минимальный возраст: 18 Years Максимальный возраст: N/A Здоровые волонтеры: Accepts Healthy Volunteers

Состояние

Covid19

Вмешательство

Тип вмешательства: Biological

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

Описание: injection volume of 0.5mL on days 0 and 28

Тип вмешательства: Biological

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

Описание: injection volume of 0.5mL on days 0 and 28

Приемлемость

Критерии:

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.

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

Accepts Healthy Volunteers

Общий Официальный

Фамилия	Роль	Присоединение
Hee Jin Cheong	Principal Investigator	Korea University Guro Hospital

Общий контакт

Фамилия: Yoonyeong Lee

Телефон: +82 2-2008-2337

Расположение

Объект:	Положение дел:
Korea University Ansan Hostpital \| Ansan, Gyeonggi, Korea, Republic of	Active, not recruiting
Ajou university hospital \| Suwon, Gyeonggi, Korea, Republic of	Active, not recruiting
Dong-A University Hospital \| Busan, Korea, Republic of	Recruiting
Kyungpook National University Chilgok Hospital \| Daegu, Korea, Republic of	Active, not recruiting
Kyungpook National University Hospital \| Daegu, Korea, Republic of	Active, not recruiting
Chonnam National University Hospital \| Gwangju, Korea, Republic of	Active, not recruiting
Gachon University Gil Medical Center \| Incheon, Korea, Republic of	Active, not recruiting
Inha university hospital \| Incheon, Korea, Republic of	Recruiting
Ewha womans university medical center \| Seoul, Korea, Republic of	Active, not recruiting
Hallym university medical center \| Seoul, Korea, Republic of	Recruiting
Korea university Anam hospital \| Seoul, Korea, Republic of	Active, not recruiting
Korea University Guro Hospital \| Seoul, Korea, Republic of	Active, not recruiting
Severance Hospital \| Seoul, Korea, Republic of	Recruiting
Wonju severance christian hospital \| Wonju, Korea, Republic of	Recruiting
Trial site \| Auckland, New Zealand	Not yet recruiting
Trial Site \| Manila, Philippines	Recruiting
Trial site \| Quezon City, Philippines	Recruiting
Trial site \| Bangkok, Thailand	Recruiting
Trial site \| Chiang Mai, Thailand	Recruiting
Trial site \| Khon Kaen, Thailand	Recruiting
Trial site \| Dniprodzerzhyns'k, Dnipropetrovs'k, Ukraine	Recruiting
Trial site \| Dnipro, Ukraine	Recruiting
Trial site \| Kropyvnytskyi, Ukraine	Recruiting
Trial site \| Kyiv, Ukraine	Recruiting
Trial site \| Odesa, Ukraine	Recruiting
Trial site \| Hochiminh city, Vietnam	Recruiting

Расположение Страны	Korea, Republic of New Zealand Philippines Thailand Ukraine Vietnam
Дата проверки	2021-09-01
Ответственная сторона	Тип: Sponsor
Имеет расширенный доступ	No
Состояние Просмотр	COVID-19
Количество рук	4
Группа вооружений	Метка: Test group (GBP510) - Cohort 1 Тип: Experimental Описание: Immunogenicity Cohort Метка: Control group (ChAdOx1-S) - Cohort 1 Тип: Active Comparator Описание: Immunogenicity Cohort Метка: Test group (GBP510) - Cohort 2 Тип: Experimental Описание: Safety Cohort Метка: Control group (ChAdOx1-S) - Cohort 2 Тип: Active Comparator Описание: Safety Cohort
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Prevention Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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