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COVID-19 (Healthy Volunteers)Phase 2NCT05175950

Safety, Reactogenicity, and Immunogenicity Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510)

A Phase 2 study testing SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 and Normal saline in people with COVID-19 (Healthy Volunteers), run by Korea University Guro Hospital at 9 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is randomized, placebo-controlled, observer-blinded, multi-center study to assess safety, reactogenicity and immunogenicity of booster vaccination of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 19 years and older who received a primary series of vaccination… Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 (Healthy Volunteers)
What is being tested?
SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 and Normal saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
770 participants
Where
9 sitesSouth Korea
Study dates
24 Jan 2022to Nov 2023
Phase
Phase 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant must be aged 19 years and older at the time of signing the informed consent.
  • Participants who are healthy or medically stabilized according to medical judgment of the investigator based on medical history, physical examination and clinical laboratory tests, etc.
  • Participants who are able to attend all scheduled visits and comply with all study procedures.
  • (Cohort 1~5) Participants who received a primary series of COVID-19 vaccination approved for use in Korea by MFDS and at least 12~24 weeks have passed with no additional COVID-19 vaccination.
  • (Cohort 6~7) Participants who received a primary series of COVID-19 vaccination and the 1st booster vaccination at least 16 weeks ago through a homologous or heterologous vaccination with mRNA vaccines (BNT162b2 (Pfizer) and mRNA-1273 (Moderna)) only or at least more than a single dose of non-mRNA vaccines (ChAdOx1 nCOV-19 (AZ), Ad26.COV2.S (Janssen), and NVX-CoV2373 (Novavax)).
  • Female participants of childbearing potential must agree to be heterosexually inactive, or agree to use at least one acceptable method of contraception from at least 4 weeks prior to the study vaccination (booster vaccination) to 12 weeks after the study vaccination.
  • Female participants with a negative urine or serum pregnancy test at screening (However, female participants who are surgically sterile or postmenopausal with amenorrhea for at least 12 months shall be excluded.
  • Participants who give signed informed consent which include compliance with the requirements and restrictions listed in the informed consent form and in the protocol.

Who cannot join

  • Any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (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).
  • History of virologically-confirmed COVID-19, SARS or MERS disease.
  • History of confirmed SARS-CoV-2 infection within three months before screening.
  • History of congenital or acquired immunodeficiency or autoimmune disease.
  • History of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination.
  • History of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, Guillain-Barre syndrome) to any components of the study intervention.
Show all 16Show fewer
  • History of malignancy within 1 year prior to the study vaccination (Except for a participant judged by the investigator to have a low recurrence risk.)
  • Any other clinically significant conditions such as uncontrollable chronic or acute diseases which, in the opinion of the investigator, might cause a health threat to the participant or interfere with the clinical trial procedures or interpretation of the study results.
  • Any other conditions which 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.
  • History of drug administration other than COVID-19 vaccination intended to treat or prevent COVID-19.
  • History or planned other vaccination within 4 weeks prior to the study vaccination through 28 days after the study vaccination (except for influenza vaccination, which may be received at least 2 weeks prior to the study vaccination).
  • Receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination.
  • Use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy for at least 2 consecutive weeks within 12 weeks prior to the study vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) (However, the use of topical and nasal glucocorticoids will be permitted.)
  • History of participation in another clinical study within 4 weeks prior to the study vaccination or planned participation in another clinical study during this study period.
  • Investigators, study staff who are directly involved in the conduct of this study or supervised by the investigator, or their family members.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Korea University Ansan Hospital

    Ansan

  • Dong-A University Hospital

    Busan

  • Chungbuk National University Hospital

    Cheongju-si

  • Kyungpook National University Hospital

    Daegu

  • Chonnam National University Hospital

    Gwangju

  • Hallym University Medical Center

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Ajou University Hospital

    Suwon

  • Wonju Severance Christian Hospital

    Wŏnju

Other trials in South Korea

About this study

Official title: A Placebo-controlled, Randomized, Observer-blinded, Multi-center Study to Assess the Safety, Reactogenicity, and Immunogenicity of Booster Vaccination of A SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510)

This is randomized, placebo-controlled, observer-blinded, multi-center study to assess safety, reactogenicity and immunogenicity of booster vaccination of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 19 years and older who received a primary series of vaccination or the 1st booster vaccination against COVID-19 approved in Korea.

Read the detailed description

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of booster vaccination of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510).

(Cohort 1~5) A total of approximately 550 adults will be divided into 5 cohorts based on primary series vaccines they received - ChAdOx1 nCOV-19, BNT162b2, mRNA-1273, Ad26.COV2.S and heterologous vaccination with ChAdOx1 nCOV-19 \& BNT162b2.

(Cohort 6~7) A total of approximately 220 adults will be divided into 2 cohorts based on primary series \& 1st booster vaccines they received -mRNA vaccines (BNT162b2 or mRNA-1273) and at least more than a single dose of non-mRNA vaccines (ChAdOx1 nCOV-19, Ad26.COV2.S, and NVX-CoV2373)

The participants are then randomized at a ratio of 10:1 to either Test Group or Placebo Group. Participants will be subject to follow-up for 12 months after receiving a single booster dose of GBP510 adjuvanted with AS03.

Blood sampling for cell-mediated immunity will be undertaken on approximately 20% of the participants in each cohort, who are selected in advance in consideration of the randomization ratio between Test Group and Placebo Group.

Being tested
SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03, 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.

  • SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03Biological

    SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03, 1 dose

  • Normal salineOther

    Normal saline

Study groups in NCT05175950
Study groupRoleWhat they receive
Test group 1: primary vaccination completed with ChAdOx1 nCOV-19ExperimentalGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Receives: Biological: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03
Placebo group 1: primary vaccination completed with ChAdOx1 nCOV-19Placebo comparatorParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Receives: Other: Normal saline
Test group 2: primary vaccination completed with BNT162b2(Pfizer)ExperimentalGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Receives: Biological: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03
Placebo group 2: primary vaccination completed with BNT162b2(Pfizer)Placebo comparatorParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Receives: Other: Normal saline
Test group 3: primary vaccination completed with mRNA-1273(Moderna)ExperimentalGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Receives: Biological: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03
Placebo group 3: primary vaccination completed with mRNA-1273(Moderna)Placebo comparatorParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Receives: Other: Normal saline
Test group 4: primary vaccination completed with Ad26.COV2.S(Janssen)ExperimentalGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Receives: Biological: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03
Placebo group 4: primary vaccination completed with Ad26.COV2.S(Janssen)Placebo comparatorParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Receives: Other: Normal saline
Test group 5: primary vaccination completed with ChAdOx1 nCOV-19(AZ)-BNT162b2(Pfizer)ExperimentalGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Receives: Biological: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03
Placebo group 5: primary vaccination completed with ChAdOx1 nCOV-19-BNT162b2Placebo comparatorParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Receives: Other: Normal saline
Test group 6: primary and 1st booster vaccination completed with mRNA vaccineExperimentalGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Receives: Biological: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03
Placebo group 6: primary and 1st booster vaccination completed with mRNA vaccinePlacebo comparatorParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Receives: Other: Normal saline
Test group 7: primary and 1st booster vaccination completed with ≥1 dose of non-mRNA vaccineExperimentalGBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
Receives: Biological: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03
Placebo group 7: primary and 1st booster vaccination completed with ≥1 dose of non-mRNA vaccinePlacebo comparatorParticipants will receive intramuscular (IM) injections of Normal saline on Days 0
Receives: Other: Normal saline

What is being measured

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

  1. Comparative GMT (Geometric Mean Titer) of neutralizing antibody to SARS-CoV-2 between the Test Group and Placebo Group, measured by wild-type virus neutralization assay at 2 weeks post heterologous booster vaccination

    Measured: Through Day 365 post last vaccination

  2. GMT (Geometric Mean Titer) of SARS-CoV-2 RBD-binding antibody measured by ECLIA at each time point post heterologous booster vaccination

    Measured: Through Day 365 post last vaccination

  3. GMFR (Geometric Mean Fold Rise) of SARS-CoV-2 RBD-binding antibody from baseline measured by ECLIA at each time point post heterologous booster vaccination

    Measured: Through Day 365 post last vaccination

  4. Percentage of participants with ≥4-fold rise from baseline in SARS-CoV-2 RBD-binding antibody measured by ECLIA at each time point post heterologous booster vaccination

    Measured: Through Day 365 post last vaccination

  5. GMT (Geometric Mean Titer) of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination

    Measured: Through Day 365 post last vaccination

  6. GMFR (Geometric Mean Fold Rise) of neutralizing antibody to SARS-CoV-2 from baseline measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination

    Measured: Through Day 365 post last vaccination

  7. Percentage of participants with ≥4-fold rise from baseline in neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination

    Measured: Through Day 365 post last vaccination

  8. (Only applicable to CMI analysis set) Cell-mediated immunity assessment using IFN-γ ELISpot at each time point post heterologous booster vaccination

    Measured: Through Day 365 post last vaccination

Secondary outcomes (5)

  1. Occurrence of immediate systemic reactions

    Measured: in 30 minutes post heterologous booster vaccination

  2. Occurrence of solicited local AEs during 7 days post heterologous booster vaccination

    Measured: Through 7 days post-vaccination

  3. Occurrence of solicited systemic AEs during 7 days post heterologous booster vaccination

    Measured: Through 7 days post-vaccination

  4. Occurrence of unsolicited AEs during 28 days post heterologous booster vaccination

    Measured: Through 28 days post-vaccination

  5. Occurrence of SAEs, MAAEs and AESIs during the study period

    Measured: Through Day 0 to Day 365 post vaccination

Timeline

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

  1. First posted4 Jan 2022
  2. Study start24 Jan 2022
  3. Primary completionAug 2023 (estimated)
  4. Study completionNov 2023 (estimated)

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
770 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05175950
Sponsor's protocol ID
IIS_2021_001
Status last verified
Feb 2023
First submitted
3 Jan 2022
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 and Normal saline in people with COVID-19 (Healthy Volunteers), run by Korea University Guro Hospital at 9 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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 phase mean?

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?

Results are not available in the source record.

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?

Comparative GMT (Geometric Mean Titer) of neutralizing antibody to SARS-CoV-2 between the Test Group and Placebo Group, measured by wild-type virus neutralization assay at 2 weeks post heterologous booster vaccination (time frame: Through Day 365 post last vaccination). The study lists 8 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 NCT05175950.

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 14 Feb 2023.

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