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COVID-19 (Healthy Volunteers)Phase 1/2NCT04742738

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

A Phase 1/2 study testing GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1, Normal saline (0.9% sodium chloride solution) - Stage 1 and GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1 in people with COVID-19 (Healthy Volunteers), run by SK Bioscience Co., Ltd. at 12 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 to 85 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 (Healthy Volunteers)
What is being tested?
GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1, Normal saline (0.9% sodium chloride solution) - Stage 1 and GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
260 participants
Where
12 sitesSouth Korea
Study dates
20 Jan 2021to 7 Jul 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • Korea University Ansan Hospital

    Ansan

  • Dong-A University Hospital

    Busan

  • Kyungpook National University Chilgok Hospital

    Daegu

  • Kyungpook National University Hospital

    Daegu

  • Chonnam National University Hospital

    Gwangju

  • Gachon University Gil Medical Center

    Incheon

  • Inha University Hospital

    Incheon

  • Ewha Womans University Medical Center

    Seoul

  • Hallym University Medical Center

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

About this study

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

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.

Read the 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 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 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.

Being tested
GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1, Normal saline (0.9% sodium chloride solution) - Stage 1, GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1, GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2, GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1Biological

    Also called GBP510-Alum-10μg

    Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.

  • Normal saline (0.9% sodium chloride solution) - Stage 1Other

    Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.

  • GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1Biological

    Also called GBP510-Alum-25μg

    Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.

  • Normal saline (0.9% sodium chloride solution) - Stage 1Other

    Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.

  • GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2Biological

    Also called GBP510-Alum-10μg

    Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.

  • GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2Biological

    Also called GBP510-Alum-25μg

    Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.

  • Normal saline (0.9% sodium chloride solution)- Stage 2Other

    Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.

Study groups in NCT04742738
Study groupRoleWhat they receive
Test group 1 - Stage 1 Low dose-level CohortExperimental2 doses of GBP510 adjuvanted with Alum (Receptor Binding Domain (RBD) 10μg/dose), 1 dose each on Days 0 and 28.
Receives: Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1
Placebo group - Stage 1 Low dose-level CohortPlacebo comparator2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
Receives: Other: Normal saline (0.9% sodium chloride solution) - Stage 1
Test group 2 - Stage 1 High dose-level CohortExperimental2 doses of GBP510 adjuvanted with Alum (RBD 25μg/dose), 1 dose each on Days 0 and 28.
Receives: Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1
Placebo group - Stage 1 High dose-level CohortPlacebo comparator2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
Receives: Other: Normal saline (0.9% sodium chloride solution) - Stage 1
Test group 1 - Stage 2Experimental2 doses of GBP510 adjuvanted with Alum (RBD 10μg/dose), 1 dose each on Days 0 and 28.
Receives: Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2
Test group 2 - Stage 2Experimental2 doses of GBP510 adjuvanted with Alum (RBD 25μg/dose), 1 dose each on Days 0 and 28.
Receives: Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2
Placebo group - Stage 2Placebo comparator2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
Receives: Other: Normal saline (0.9% sodium chloride solution)- Stage 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of immediate systemic reactions - Stage 1

    Measured: 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

    Measured: Through 7 days post-vaccination

  3. Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1

    Measured: Through 7 days post-vaccination

  4. Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Through Day 365 post last vaccination

  8. GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 2

    Measured: Through Day 365 post last vaccination

  9. Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Through Day 28 post last vaccination

Secondary outcomes (12)

  1. GMT of IgG antibody to the SARS-CoV-2 RBD measured by ELISA - Stage 1

    Measured: Through Day 365 post last vaccination

  2. GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 1

    Measured: Through Day 365 post last vaccination

  3. Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 1

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Through Day 28 post last vaccination

  8. Occurrence of immediate systemic reactions - Stage 2

    Measured: 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

    Measured: Through 7 days post-vaccination

  10. Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 2

    Measured: Through 7 days post-vaccination

  11. Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 2

    Measured: Through 28 days post-vaccination

  12. Occurrence of SAEs, MAAEs and AESIs during the whole study period - Stage 2

    Measured: Through Day 0 to Day 365 post last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start20 Jan 2021
  3. Primary completion30 Jul 2021
  4. Study completion7 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742738
Sponsor's protocol ID
GBP510_001
Status last verified
Apr 2023
First submitted
4 Feb 2021
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33873199

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1, Normal saline (0.9% sodium chloride solution) - Stage 1 and GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1 in people with COVID-19 (Healthy Volunteers), run by SK Bioscience Co., Ltd. at 12 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of immediate systemic reactions - Stage 1 (time frame: Through 30 minutes (2 hours for sentinel participants) post-vaccination). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742738, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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