- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04750343
Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19)
A 2-Stage, Phase I/II, Placebo-controlled, Randomized, Observer-blinded, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 in Healthy Younger and Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
- Biological: GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 1
- Biological: GBP510 (RBD 10μg/dose) - Stage 1
- Other: Normal saline (0.9% sodium chloride solution) - Stage 1
- Biological: GBP510 adjuvanted with AS03 (RBD 25μg/dose) - Stage 1
- Biological: GBP510 (RBD 25μg/dose) - Stage 1
- Biological: GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 2
- Biological: GBP510 adjuvanted with AS03 (RBD 25μg/dose)- Stage 2
- Biological: GBP510 (RBD 25μg/dose)- Stage 2
- Other: Normal saline (0.9% sodium chloride solution)- Stage 2
Detailed Description
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the candidate vaccine administered twice with 28-day interval in healthy adults including older adults.
A total of 320 healthy younger and older adults will be enrolled to receive 2 doses of either one GBP510 formulation with AS03 (Test group 1 or 3), or without AS03 (Test group 2 or 4), or placebo saline (Placebo group). Test group 2 will only be included in Stage 1.
This study will consist of 2 stages, and a stepwise approach will be adopted as a safety precaution. Approximately 80 healthy adults aged 19 to 55 years will be enrolled and vaccinated first in Stage 1, and blinded safety data collected through 7 days after the last study vaccination will be reviewed by the sponsor, and then by the independent Data Safety Monitoring Board (DSMB) in an unblinded manner. Advancement to Stage 2 for further enrollment of 240 healthy younger and older adults aged 19 to 85 years will be determined if an acceptable safety profile is confirmed based on the sponsor and DSMB review. DSMB will recommend whether to proceed to the next stage or not, and DSMB may suggest discontinuation of the study or adjustment of dose and dosing regimen based on the safety review.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Ansan, Korea, Republic of
- Korea University Ansan Hospital
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Busan, Korea, Republic of
- Dong-A University Hospital
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Daegu, Korea, Republic of
- Kyungpook National University Hospital
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Daegu, Korea, Republic of
- Kyungpook National University Chilgok Hospital
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Gwangju, Korea, Republic of
- Chonnam National University Hospital
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Incheon, Korea, Republic of
- Inha University Hospital
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Incheon, Korea, Republic of
- Gachon University Gil Medical Center
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Seongnam-si, Korea, Republic of
- Korea University Anam Hospital
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Seoul, Korea, Republic of
- Korea University Guro Hospital
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Seoul, Korea, Republic of
- Severance Hospital
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Seoul, Korea, Republic of
- Ewha womans university medical center
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Seoul, Korea, Republic of
- Hallym University Medical Center
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Suwon, Korea, Republic of
- Ajou University Hospital
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Wonju, Korea, Republic of
- Wonju Severance Christian Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
For Stage 1, participant must be 19 to 55 years of age inclusive, at the time of signing the informed consent.
For Stage 2, participant must be 19 to 85 years of age inclusive, at the time of signing the informed consent
Type of Participant and Disease Characteristics
- Participants who are healthy 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.
Weight
Body mass index (BMI) within the range 18-30 kg/m2 at screening (inclusive)
Sex and Contraceptive/Barrier Requirements
- 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
Informed Consent
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
- 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.
- History of virologically-confirmed COVID-19 disease, or definite or suspected exposure to anyone known to have SARS-CoV-2 infection
- History of virologically-confirmed SARS or MERS disease
- History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease
- Any positive test results for hepatitis B, C, or HIV at screening
- History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion
- History of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, Guillain-Barre syndrome) to any vaccines or components of the study intervention
- History of malignancy within 5 years prior to the 1st study vaccination
- Significant chronic illness that, in the opinion of the investigator, might increase risk of severe COVID-19, or interfere with the evaluation of the study objectives (e.g. asthma, chronic pulmonary disease, cardiovascular disease, chronic liver disease, diabetes mellitus, uncontrolled hypertension, renal disorders)
- History of, or planned surgery under general anesthesia from 1 year prior to the 1st study vaccination through the study period
- Any other conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g. neurologic or psychiatric conditions)
- Female participants who are pregnant or breastfeeding
(Only for Stage 1) Current smokers or a recent smoking history within 12 weeks prior to the 1st study vaccination. Occasional smokers who smoke up to 10 cigarettes per month may be allowed to participate at the investigator's discretion
Prior/Concomitant therapy
- Receipt of any medications or vaccinations intended to prevent COVID-19.
- 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
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 1st vaccination. The use of topical and nasal glucocorticoids will be permitted.
Prior/Concurrent Clinical Study Experience
Participation in another clinical study involving study intervention within 6 months prior to the 1st study vaccination, or concurrent, planned participation in another clinical study with study intervention during this study period.
Other Exclusions
- Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.
- Healthcare worker or emergency response personnel in an occupation with a high risk of exposure to SARS-CoV-2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test group 1 - Stage 1 Low dose-level Cohort
2 doses of GBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 10μg/dose), 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 10μg/dose) on Days 0 and 28.
Other Names:
|
Experimental: Test group 2 - Stage 1 Low dose-level Cohort
2 doses of GBP510 (RBD 10μg/dose), 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of GBP510 (RBD 10μg/dose) on Days 0 and 28.
Other Names:
|
Placebo Comparator: Placebo group - Stage 1 Low dose-level Cohort
2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
|
Experimental: Test group 3 - Stage 1 High dose-level Cohort
2 doses of GBP510 adjuvanted with AS03 (RBD 25μg/dose), 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 25μg/dose) on Days 0 and 28.
Other Names:
|
Experimental: Test group 4 - Stage 1 High dose-level Cohort
2 doses of GBP510 (RBD 25μg/dose), 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of GBP510 (RBD 25μg/dose) on Days 0 and 28.
Other Names:
|
Placebo Comparator: Placebo group - Stage 1 High dose-level Cohort
2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
|
Experimental: Test group 1 - Stage 2
2 doses of GBP510 adjuvanted with AS03 (RBD 10μg/dose), 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 10μg/dose) on Days 0 and 28.
Other Names:
|
Experimental: Test group 3 - Stage 2
2 doses of GBP510 adjuvanted with AS03 (RBD 25μg/dose), 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 25μg/dose) on Days 0 and 28.
Other Names:
|
Experimental: Test group 4 - Stage 2
2 doses of GBP510 (RBD 25μg/dose), 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of GBP510 (RBD 25μg/dose) on Days 0 and 28.
Other Names:
|
Placebo Comparator: Placebo group - Stage 2
2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
|
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of immediate systemic reactions - Stage 1
Time Frame: Through 30 minutes (2 hours for sentinel participants) post-vaccination
|
Through 30 minutes (2 hours for sentinel participants) post-vaccination
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Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1
Time Frame: Through 7 days post-vaccination
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Through 7 days post-vaccination
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Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1
Time Frame: Through 7 days post-vaccination
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Through 7 days post-vaccination
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Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1
Time Frame: Through 28 days post-vaccination
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Through 28 days post-vaccination
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Occurrence of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs) during the whole study period - Stage 1
Time Frame: Through Day 0 to Day 365 post last vaccination
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Through Day 0 to Day 365 post last vaccination
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(Only in Sentinel group) Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) during 7 days post 1st vaccination - Stage 1
Time Frame: Through 7 days post 1st vaccination
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Through 7 days post 1st vaccination
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GMT of IgG antibody to the SARS-CoV-2 RBD measured by Enzyme-linked Immunosorbent Assay (ELISA) - Stage 2
Time Frame: Through Day 365 post last vaccination
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Through Day 365 post last vaccination
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GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 2
Time Frame: Through Day 365 post last vaccination
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Through Day 365 post last vaccination
|
Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2
Time Frame: Through Day 365 post last vaccination
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Through Day 365 post last vaccination
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GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 2
Time Frame: Through Day 365 post last vaccination
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Through Day 365 post last vaccination
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GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 2
Time Frame: Through Day 365 post last vaccination
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Through Day 365 post last vaccination
|
Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 2
Time Frame: Through Day 365 post last vaccination
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Through Day 365 post last vaccination
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Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using Enzyme-linked ImmunoSpot (ELISpot) or other system) - Stage 2
Time Frame: Through Day 28 post last vaccination
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Through Day 28 post last vaccination
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GMT of IgG antibody to the SARS-CoV-2 RBD measured by ELISA - Stage 1
Time Frame: Through Day 365 post last vaccination
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Through Day 365 post last vaccination
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GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 1
Time Frame: Through Day 365 post last vaccination
|
Through Day 365 post last vaccination
|
Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 1
Time Frame: Through Day 365 post last vaccination
|
Through Day 365 post last vaccination
|
GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 1
Time Frame: Through Day 365 post last vaccination
|
Through Day 365 post last vaccination
|
GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 1
Time Frame: Through Day 365 post last vaccination
|
Through Day 365 post last vaccination
|
Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 1
Time Frame: Through Day 365 post last vaccination
|
Through Day 365 post last vaccination
|
Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using ELISpot or other system) - Stage 1
Time Frame: Through Day 28 post last vaccination
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Through Day 28 post last vaccination
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Occurrence of immediate systemic reactions - Stage 2
Time Frame: Through 30 minutes (2 hours for elderly participants aged 75 years and older) post-vaccination
|
Through 30 minutes (2 hours for elderly participants aged 75 years and older) post-vaccination
|
Occurrence of solicited local AEs during 7 days post each vaccination - Stage 2
Time Frame: Through 7 days post-vaccination
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Through 7 days post-vaccination
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Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 2
Time Frame: Through 7 days post-vaccination
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Through 7 days post-vaccination
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Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 2
Time Frame: Through 28 days post-vaccination
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Through 28 days post-vaccination
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Occurrence of SAEs, MAAEs and AESIs during the whole study period - Stage 2
Time Frame: Through Day 0 to Day 365 post last vaccination
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Through Day 0 to Day 365 post last vaccination
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hee Jin Cheong, Korea University Guro Hospital
Publications and helpful links
General Publications
- Song JY, Choi WS, Heo JY, Lee JS, Jung DS, Kim SW, Park KH, Eom JS, Jeong SJ, Lee J, Kwon KT, Choi HJ, Sohn JW, Kim YK, Noh JY, Kim WJ, Roman F, Ceregido MA, Solmi F, Philippot A, Walls AC, Carter L, Veesler D, King NP, Kim H, Ryu JH, Lee SJ, Park YW, Park HK, Cheong HJ. Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: A randomised, placebo-controlled, observer-blinded phase 1/2 trial. EClinicalMedicine. 2022 Jul 22;51:101569. doi: 10.1016/j.eclinm.2022.101569. eCollection 2022 Sep.
- Arunachalam PS, Walls AC, Golden N, Atyeo C, Fischinger S, Li C, Aye P, Navarro MJ, Lai L, Edara VV, Roltgen K, Rogers K, Shirreff L, Ferrell DE, Wrenn S, Pettie D, Kraft JC, Miranda MC, Kepl E, Sydeman C, Brunette N, Murphy M, Fiala B, Carter L, White AG, Trisal M, Hsieh CL, Russell-Lodrigue K, Monjure C, Dufour J, Spencer S, Doyle-Meyers L, Bohm RP, Maness NJ, Roy C, Plante JA, Plante KS, Zhu A, Gorman MJ, Shin S, Shen X, Fontenot J, Gupta S, O'Hagan DT, Van Der Most R, Rappuoli R, Coffman RL, Novack D, McLellan JS, Subramaniam S, Montefiori D, Boyd SD, Flynn JL, Alter G, Villinger F, Kleanthous H, Rappaport J, Suthar MS, King NP, Veesler D, Pulendran B. Adjuvanting a subunit COVID-19 vaccine to induce protective immunity. Nature. 2021 Jun;594(7862):253-258. doi: 10.1038/s41586-021-03530-2. Epub 2021 Apr 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GBP510_002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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