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Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19)

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ClinicalTrials.gov Identifier: NCT04742738
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
SK Chemicals Co., Ltd. ( SK Bioscience Co., Ltd. )

Brief Summary:
This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded, age-escalating study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with Alum in healthy younger and older adults.

Condition or disease Intervention/treatment Phase
COVID-19 (Healthy Volunteers) Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1 Other: Normal saline (0.9% sodium chloride solution) - Stage 1 Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1 Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2 Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2 Other: Normal saline (0.9% sodium chloride solution)- Stage 2 Phase 1 Phase 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 260 healthy younger and older adults will be enrolled to receive 2 doses of either one GBP510 formulation (Test group 1 or 2) or placebo saline (Placebo group).

This study will consist of 2 stages, and a stepwise approach will be adopted as a safety precaution. Approximately 60 healthy adults aged 19 to 55 years will be enrolled and vaccinated first in Stage 1, and blinded safety data collected through 14 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 200 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 Aluminum Hydroxide in Healthy Younger and Older Adults
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test group 1 - Stage 1 Low dose-level Cohort
2 doses of GBP510 adjuvanted with Alum (Receptor Binding Domain (RBD) 10μg/dose), 1 dose each on Days 0 and 28.
Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.
Other Name: GBP510-Alum-10μg

Placebo Comparator: Placebo group - Stage 1 Low dose-level Cohort
2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
Other: Normal saline (0.9% sodium chloride solution) - Stage 1
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.

Experimental: Test group 2 - Stage 1 High dose-level Cohort
2 doses of GBP510 adjuvanted with Alum (RBD 25μg/dose), 1 dose each on Days 0 and 28.
Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.
Other Name: GBP510-Alum-25μg

Placebo Comparator: Placebo group - Stage 1 High dose-level Cohort
2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
Other: Normal saline (0.9% sodium chloride solution) - Stage 1
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 Alum (RBD 10μg/dose), 1 dose each on Days 0 and 28.
Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.
Other Name: GBP510-Alum-10μg

Experimental: Test group 2 - Stage 2
2 doses of GBP510 adjuvanted with Alum (RBD 25μg/dose), 1 dose each on Days 0 and 28.
Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.
Other Name: GBP510-Alum-25μg

Placebo Comparator: Placebo group - Stage 2
2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
Other: Normal saline (0.9% sodium chloride solution)- Stage 2
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.




Primary Outcome Measures :
  1. Occurrence of immediate systemic reactions - Stage 1 [ Time Frame: Through 30 minutes (2 hours for sentinel participants) post-vaccination ]
  2. Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1 [ Time Frame: Through 7 days post-vaccination ]
  3. Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1 [ Time Frame: Through 7 days post-vaccination ]
  4. Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1 [ Time Frame: Through 28 days post-vaccination ]
  5. 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 ]
  6. (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 ]
  7. 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 ]
  8. 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 ]
  9. Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2 [ Time Frame: Through Day 365 post last vaccination ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]

Secondary Outcome Measures :
  1. GMT of IgG antibody to the SARS-CoV-2 RBD measured by ELISA - Stage 1 [ Time Frame: Through Day 365 post last vaccination ]
  2. 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 ]
  3. Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 1 [ Time Frame: Through Day 365 post last vaccination ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. Occurrence of immediate systemic reactions - Stage 2 [ Time Frame: Through 30 minutes (2 hours for elderly participants aged 75 years and older) post-vaccination ]
  9. Occurrence of solicited local AEs during 7 days post each vaccination - Stage 2 [ Time Frame: Through 7 days post-vaccination ]
  10. Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 2 [ Time Frame: Through 7 days post-vaccination ]
  11. Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 2 [ Time Frame: Through 28 days post-vaccination ]
  12. Occurrence of SAEs, MAAEs and AESIs during the whole study period - Stage 2 [ Time Frame: Through Day 0 to Day 365 post last vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

Age

  1. 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

  2. Participants who are healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, and medical judgement of the investigator
  3. Participants who are able to attend all scheduled visits and comply with all study procedures.

    Weight

  4. Body mass index (BMI) within the range 18-30 kg/m2 at screening (inclusive)

    Sex and Contraceptive/Barrier Requirements

  5. 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
  6. Female participants with a negative urine or serum pregnancy test at screening

    Informed Consent

  7. 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

  1. 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.
  2. History of virologically-confirmed COVID-19 disease, or definite or suspected exposure to anyone known to have SARS-CoV-2 infection
  3. History of virologically-confirmed SARS or MERS disease
  4. History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease
  5. Any positive test results for hepatitis B, C, or HIV at screening
  6. History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion
  7. History of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, Guillain-Barre syndrome) to any vaccines or components of the study intervention
  8. History of malignancy within 5 years prior to the 1st study vaccination
  9. 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)
  10. History of, or planned surgery under general anesthesia from 1 year prior to the 1st study vaccination through the study period
  11. 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)
  12. Female participants who are pregnant or breastfeeding
  13. (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

  14. Receipt of any medications or vaccinations intended to prevent COVID-19.
  15. 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
  16. Receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the 1st study vaccination
  17. 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

  18. 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

  19. Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.
  20. Healthcare worker or emergency response personnel in an occupation with a high risk of exposure to SARS-CoV-2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742738


Contacts
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Contact: Yoonyeong Lee +82 2-2008-2337 yoonyeong@sk.com

Locations
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Korea, Republic of
Korea University Ansan Hospital Not yet recruiting
Ansan, Korea, Republic of
Contact: Won Suk Choi         
Inha University Hospital Not yet recruiting
Incheon, Korea, Republic of
Contact: Jin-Soo Lee         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hee Jin Cheong         
Ajou University Hospital Not yet recruiting
Suwon, Korea, Republic of
Contact: Jung Yeon Heo         
Sponsors and Collaborators
SK Bioscience Co., Ltd.
Coalition for Epidemic Preparedness Innovations
Investigators
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Principal Investigator: Hee Jin Cheong Korea University Guro Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SK Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT04742738    
Other Study ID Numbers: GBP510_001
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharmaceutical Solutions
Aluminum sulfate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs