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COVID-19Phase 3NCT05501522

Immunogenicity and Safety Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine(GBP510) Adjuvanted with AS03 in Adults Aged 18 Years and Older

A Phase 3 study testing GBP510 adjuvanted with AS03 in people with COVID-19, run by SK Bioscience Co., Ltd. at 4 sites in 2 countries.

Completed

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

Official record
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Trial summary

This is a Phase III, randomized, placebo-controlled, observer-blinded, parallel-group, multi-center study to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
GBP510 adjuvanted with AS03
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
840 participants
Where
4 sitesin 2 countries
Study dates
9 Dec 2022to 17 Aug 2024
Phase
Phase 3
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Participants who received primary vaccination of 1 of 6 different WHO EUA qualified COVID-19 vaccine (mRNA-1273, ChAdOx1 nCOV-19, Ad26.COV2.S, BNT162b2, BBIBP-CorV, CoronaVac) at least 12 weeks prior to study vaccination, and with no history of other COVID-19 vaccination, including booster doses.
  • Participants who have a qualitative test result for antibody to SARS-CoV-2 nucleocapsid proteins at screening for assessment of previous SARS-CoV-2 infection
  • 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 study vaccination to 12 weeks after the study vaccination
  • Female participants with a negative urine or serum pregnancy test at screening.
  • Capable of giving signed informed consent as described in Appendix 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Who cannot join

  • 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 study vaccination. A prospective participant should not be included until 72 hours after the condition has resolved.
  • Concurrent or past SARS-CoV-2 infection within 12 weeks prior to the study vaccination confirmed by virological or serological testing
  • History of virologically or serologically confirmed SARS, or MERS disease
  • History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
  • 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.
Show all 17Show fewer
  • History of malignancy within 1 year prior to the 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 medications or vaccinations intended to prevent COVID-19 except for the pre-defined COVID-19 vaccines expected to be given prior to screening (mRNA-1273, ChAdOx1 nCOV-19, Ad26.COV2.S, BNT162b2, BBIBP-CorV, CoronaVac).
  • Receipt of any vaccine within 4 weeks prior to the study vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination.
  • Receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the 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 study vaccination. The use of topical and nasal glucocorticoids will be permitted.
  • Participation in another clinical study and receipt of study intervention within 4 weeks prior to the study vaccination, or concurrent, planned participation in another clinical study with study intervention during the study period.
  • Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.
  • Donation of ≥450mL of blood product within 4 weeks prior to screening, or planned donation of blood product during the study period

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Colombia2 sites

  • Policlínico Social Del Norte

    Bogotá, Bogota D.C., 1008

  • CAIMED (Centro de Atención e Investigación Médica)

    Chía, Cundinamarca

Other trials in Colombia

Nepal2 sites

  • Dhulikhel

    Kathmandu, Dhulikhel, 45200

  • Institute of Medicine (IOM)

    Kathmandu, Maharajgunj, 44600

Other trials in Nepal

About this study

Official title: A Phase III, Placebo-controlled, Randomized, Observer-blinded, Multi-national, Multi-center Study to Assess the Safety, Reactogenicity, and Immunogenicity of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) Adjuvanted with AS03 in Adults Aged 18 Years and Older

This is a Phase III, randomized, placebo-controlled, observer-blinded, parallel-group, multi-center study to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.

Read the detailed description

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.

Conditions
COVID-19
Being tested
GBP510 adjuvanted with AS03, Placebo (Normal Saline)
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 AS03Biological

    injection volume of 0.5mL on Day 0

  • Placebo (Normal Saline)Other

    injection volume of 0.5mL on Day 0

Study groups in NCT05501522
Study groupRoleWhat they receive
Primary series of mRNA-1273 manufactured by ModernaTX, Inc.Experimentalparticipants who received primary vaccination of a mRNA-1273 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine).
Receives: Biological: GBP510 adjuvanted with AS03
Primary series of mRNA-1273 manufactured by ModernaTX, Inc. (Placebo)Placebo comparatorparticipants who received primary vaccination of a mRNA-1273 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive placebo.
Receives: Other: Placebo (Normal Saline)
Primary series of ChAdOx1 nCOV-19 manufactured by Astrazeneca or S.I of India Pvt., Ltd.Experimentalparticipants who received primary vaccination of a ChAdOx1 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine).
Receives: Biological: GBP510 adjuvanted with AS03
Primary series of ChAdOx1 nCOV-19 manufactured by Astrazeneca or S.I of India Pvt., Ltd. (Placebo)Placebo comparatorparticipants who received primary vaccination of a ChAdOx1 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive placebo.
Receives: Other: Placebo (Normal Saline)
A single dose vaccination of Ad26.COV2.S manufactured by Janssen Pharmaceuticals/Johnson & JohnsonExperimentalparticipants who received primary vaccination of a Ad26.COV2.S at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine).
Receives: Biological: GBP510 adjuvanted with AS03
A single dose vaccination of Ad26.COV2.S manufactured by Janssen Pharmaceuticals/J&J (Placebo)Placebo comparatorparticipants who received primary vaccination of a Ad26.COV2.S at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive Placebo.
Receives: Other: Placebo (Normal Saline)
Primary series of BNT162b2 manufactured by Pfizer/BioNTechActive comparatorparticipants who received primary vaccination of a BNT162b2 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine).
Receives: Biological: GBP510 adjuvanted with AS03
Primary series of BNT162b2 manufactured by Pfizer/BioNTech (Placebo)Placebo comparatorparticipants who received primary vaccination of a BNT162b2 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive placebo.
Receives: Other: Placebo (Normal Saline)
Primary series of BBIBP-CorV manufactured by SinopharmExperimentalparticipants who received primary vaccination of a BBIBP-CorV at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine).
Receives: Biological: GBP510 adjuvanted with AS03
Primary series of BBIBP-CorV manufactured by Sinopharm (Placebo)Placebo comparatorparticipants who received primary vaccination of a BBIBP-CorV at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive placebo
Receives: Other: Placebo (Normal Saline)
Primary series of CoronaVacActive comparatorparticipants who received primary vaccination of a CoronaVac at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine).
Receives: Biological: GBP510 adjuvanted with AS03
Primary series of CoronaVac (Placebo)Placebo comparatorparticipants who received primary vaccination of a CoronaVac at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose Placebo
Receives: Other: Placebo (Normal Saline)

What is being measured

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

  1. GMFR (Geometric Mean Fold Rise) of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay from baseline(Visit 2) to2 weeks post heterologous booster vaccinationfor each cohort

    For all cohort

    Measured: 2 weeks post heterologous booster vaccination for eachcohort

Secondary outcomes (11)

  1. GMT of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination.

    For all cohort

    Measured: Through Day 365 post vaccination

  2. 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 heterologous booster vaccination.

    For all cohort

    Measured: Through Day 365 post vaccination

  3. 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 heterologous booster vaccination.

    For all cohort

    Measured: Through Day 365 post vaccination

  4. GMT of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA at each time point post heterologous booster vaccination

    For all cohort

    Measured: Through Day 365 post vaccination

  5. GMFR of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline (Visit 2) to each subsequent time point post heterologous booster vaccination

    For all cohort

    Measured: Through Day 365 post vaccination

  6. 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 heterologous booster vaccination.

    For all cohort

    Measured: Through Day 365 post vaccination

  7. Cell-mediated response for both Th1 and Th2 cytokines measured by ELISpot and/or FluoroSpot, and for both CD4+ and CD8+ T-cells measured by FACS

    For all cohort (in a subset of participants)

    Measured: Through Day 365 post vaccination

  8. Occurrence of immediate systemic reactions in 30 minutes post heterologous booster vaccination.

    For all cohort

    Measured: Through 30 minutes post booster vaccination

  9. Occurrence of solicited local/systemic Adverse Events(AEs)

    For all cohort

    Measured: Through 7 days post booster vaccination

  10. Occurrence of unsolicited AEs

    For all cohort

    Measured: Through 28 days post booster vaccination

  11. Occurrence of SAEs, MAAEs, AEs leading to study withdrawal, and AESIs during the whole study period.

    Through 7 days post booster vaccination

    Measured: Through Day 365 post booster vaccination

Timeline

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

  1. First posted15 Aug 2022
  2. Study start9 Dec 2022
  3. Primary completion22 Aug 2023
  4. Study completion17 Aug 2024

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501522
Sponsor's protocol ID
GBP510_004
Status last verified
Oct 2024
First submitted
11 Aug 2022
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GBP510 adjuvanted with AS03 in people with COVID-19, run by SK Bioscience Co., Ltd. at 4 sites in 2 countries.

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 8 inclusion and 17 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Colombia, Nepal. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

GMFR (Geometric Mean Fold Rise) of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay from baseline(Visit 2) to2 weeks post heterologous booster vaccinationfor each cohort (time frame: 2 weeks post heterologous booster vaccination for eachcohort). 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 NCT05501522.

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 16 Oct 2024.

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