Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05007951




Registration number
NCT05007951
Ethics application status
Date submitted
9/08/2021
Date registered
17/08/2021
Date last updated
8/04/2024

Titles & IDs
Public title
Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19)
Scientific 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
Secondary ID [1] 0 0
GBP510_003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)
Other interventions - ChAdOx1-S not less than 2.5 × 10^8 infectious units
Other interventions - GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

Experimental: Test group (GBP510) - Cohort 1 - Immunogenicity Cohort

Active Comparator: Control group (ChAdOx1-S) - Cohort 1 - Immunogenicity Cohort

Experimental: Test group (GBP510) - Cohort 2 - Safety Cohort

Active Comparator: Control group (ChAdOx1-S) - Cohort 2 - Safety Cohort

Experimental: Test group (GBP510) - Cohort 3 - Booster Subcohort

Active Comparator: Control group (ChAdOx1-S) - Cohort 3 - Booster Subcohort


Other interventions: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)
injection volume of 0.5mL on days 0 and 28 (stage1)

Other interventions: ChAdOx1-S not less than 2.5 × 10^8 infectious units
injection volume of 0.5mL on days 0 and 28 (stage1)

Other interventions: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)
injection volume of 0.5mL on days 0 (stage2)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
Timepoint [1] 0 0
2 weeks post 2nd vaccination
Primary outcome [2] 0 0
Percentage of participants with = 4-fold rise in wild-type virus neutralizing antibody titer from baseline
Timepoint [2] 0 0
2 weeks post 2nd vaccination
Primary outcome [3] 0 0
Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
Timepoint [3] 0 0
2 weeks post 3rd (booster) and 2nd vaccination
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Through Day 365 post last vaccination
Secondary outcome [2] 0 0
Geometric Mean Fold Rise(GMFR) of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline
Timepoint [2] 0 0
Through Day 365 post last vaccination
Secondary outcome [3] 0 0
Percentage of participants with = 4-fold rise SARS-CoV-2 RBD-binding IgG titer from baseline
Timepoint [3] 0 0
Through Day 365 post last vaccination
Secondary outcome [4] 0 0
GMT of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
Timepoint [4] 0 0
Through Day 365 post last vaccination
Secondary outcome [5] 0 0
GMFR of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays from baseline
Timepoint [5] 0 0
Through Day 365 post last vaccination
Secondary outcome [6] 0 0
Percentage of participants with = 4-fold rise in wild-type virus neutralizing antibody titer from baseline
Timepoint [6] 0 0
Through Day 365 post last vaccination
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Through Day 365 post last vaccination
Secondary outcome [8] 0 0
Occurrence of immediate systemic reactions in the 30 minutes post each vaccination
Timepoint [8] 0 0
Through 30 minutes post each vaccination
Secondary outcome [9] 0 0
Occurrence of solicited local Adverse Events(AEs)
Timepoint [9] 0 0
Through 7 days post each vaccination
Secondary outcome [10] 0 0
Occurrence of solicited systemic AEs
Timepoint [10] 0 0
Through 7 days post each vaccination
Secondary outcome [11] 0 0
Occurrence of unsolicited AEs
Timepoint [11] 0 0
Through 28 days post each vaccination
Secondary outcome [12] 0 0
Occurrence of Serious Adverse events(SAEs), Medically attended Adverse Events(MAAEs), AEs leading to study withdrawal, and Adverse Events of Special Interests(AESIs)
Timepoint [12] 0 0
Through Day 365 post last vaccination
Secondary outcome [13] 0 0
GMTs of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
Timepoint [13] 0 0
2 weeks post 3rd (booster) and 2nd vaccination
Secondary outcome [14] 0 0
Percentages of participants with = 4-fold rise in wild-type virus neutralizing antibody titer from baseline (Visit 2)
Timepoint [14] 0 0
2 weeks post 3rd (booster) and 2nd vaccination
Secondary outcome [15] 0 0
GMTs of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
Timepoint [15] 0 0
pre (Visit 1B) and 2 weeks post 3rd (booster) vaccination
Secondary outcome [16] 0 0
GMTs of neutralizing antibody to the SARS-CoV-2 measured by neutralization assays
Timepoint [16] 0 0
2 weeks post 3rd (booster) and 2nd vaccination
Secondary outcome [17] 0 0
GMT of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA at each time point post booster vaccination
Timepoint [17] 0 0
Through Day 365 post last vaccination
Secondary outcome [18] 0 0
GMFR of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline (Visit 2) to each subsequent time point post booster vaccination
Timepoint [18] 0 0
Through Day 365 post last vaccination
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
Through Day 365 post last vaccination
Secondary outcome [20] 0 0
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
Timepoint [20] 0 0
Through Day 365 post last vaccination
Secondary outcome [21] 0 0
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
Timepoint [21] 0 0
Through Day 365 post last vaccination
Secondary outcome [22] 0 0
GMT of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post booster vaccination
Timepoint [22] 0 0
Through Day 365 post last vaccination
Secondary outcome [23] 0 0
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.
Timepoint [23] 0 0
Through Day 365 post last vaccination
Secondary outcome [24] 0 0
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
Timepoint [24] 0 0
Through Day 365 post last vaccination
Secondary outcome [25] 0 0
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.
Timepoint [25] 0 0
Through Day 365 post last vaccination
Secondary outcome [26] 0 0
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
Timepoint [26] 0 0
Through Day 365 post last vaccination
Secondary outcome [27] 0 0
Cell-mediated response for both Th1 and Th2 cytokines (including but not limited to INF-?, TNF-a, 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
Timepoint [27] 0 0
Through Day 365 post last vaccination

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/10/2023
Sample size
Target
Accrual to date
Final
4036
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Gyeonggi
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Busan
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Daegu
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Gwangju
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Incheon
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Wonju
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
New Zealand
State/province [9] 0 0
Christchurch
Country [10] 0 0
New Zealand
State/province [10] 0 0
Hamilton
Country [11] 0 0
New Zealand
State/province [11] 0 0
Nelson
Country [12] 0 0
New Zealand
State/province [12] 0 0
Papamoa
Country [13] 0 0
New Zealand
State/province [13] 0 0
Rotorua
Country [14] 0 0
New Zealand
State/province [14] 0 0
Upper Hutt
Country [15] 0 0
Philippines
State/province [15] 0 0
Manila
Country [16] 0 0
Philippines
State/province [16] 0 0
Quezon City
Country [17] 0 0
Thailand
State/province [17] 0 0
Bangkok
Country [18] 0 0
Thailand
State/province [18] 0 0
Chiang Mai
Country [19] 0 0
Thailand
State/province [19] 0 0
Khon Kaen
Country [20] 0 0
Ukraine
State/province [20] 0 0
Dnipropetrovs'k
Country [21] 0 0
Ukraine
State/province [21] 0 0
Dnipro
Country [22] 0 0
Ukraine
State/province [22] 0 0
Kropyvnytskyi
Country [23] 0 0
Ukraine
State/province [23] 0 0
Kyiv
Country [24] 0 0
Ukraine
State/province [24] 0 0
Odesa
Country [25] 0 0
Vietnam
State/province [25] 0 0
Hochiminh city

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
SK Bioscience Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
International Vaccine Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
GlaxoSmithKline
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Coalition for Epidemic Preparedness Innovations
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05007951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hee Jin Cheong
Address 0 0
Korea University Guro Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries