COVID-19NCT05710289
A Blood Collection Study to Assess the Immunogenicity of Nationally Authorized Homologous COVID-19 Booster Vaccines Among Adult Vaccinees.
An observational study of COVID-19, run by SK Bioscience Co., Ltd..
Trial summary
The purpose of this study is to assess the immunogenicity of nationally available pre-defined homologous booster vaccination of a SARS-CoV-2 WHO EUA qualified vaccination in adults aged 18 years and older 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?
- Immune Responses
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Feb 2024
- Phase
- Observational
- 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
Study population: Available WHO EUA qualified homologous booster vaccination against SARS-Cov-2 among adults 18 Years and older participants, regardless of past SARS-CoV-2 infection history confirmed by either serological or virological test method at baseline.
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, 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 of gap prior to first homologous booster vaccination and with no history of other COVID-19 vaccination, including booster doses.
- Participants who complete a qualitative test for antibody to SARS-CoV-2 nucleocapsid proteins at screening for assessment of previous SARS-CoV-2 infection.
- Female participants with a negative urine or serum pregnancy test at screening.
- 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
- Concurrent or past SARS-CoV-2 infection within 12 weeks prior to the booster study vaccination confirmed by virological or serological testing .
- History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
- History of bleeding disorder or thrombocytopenia which is contraindicating to take blood sample.
- History of malignancy within 1 year prior to the screening (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).
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- 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 booster vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the booster vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the booster vaccination.
- Receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the booster 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 booster vaccination. The use of topical and nasal glucocorticoids will be permitted.
- Participation in another clinical study and 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
About this study
Official title: A Prospective Blood Collection Study to Assess the Immunogenicity of Homologous Booster Combinations of COVID-19 Vaccines Available Under Emergency Use Authorization Among Adults of 18 Years and Older.
The purpose of this study is to assess the immunogenicity of nationally available pre-defined homologous booster vaccination of a SARS-CoV-2 WHO EUA qualified vaccination in adults aged 18 years and older
- Conditions
- COVID-19
- Being tested
- Immune Responses
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune ResponsesBiological
To compare the immune responses against the original strain and circulating strain prior to and post homologous dose of WHO EUA qualified COVID-19 vaccine in adults aged 18 years and older regardless of prior history of SARS-CoV-2 infection with immunogenicity profile of single heterologous dose by GBP510 vaccine acquired from GBP510_004 study.
| Study group | Role | What they receive |
|---|---|---|
| Primary series of mRNA-1273 | Manufactured by ModernaTX Receives: Biological: Immune Responses | |
| Primary series of ChAdOx1 nCOV-19 | Manufactured by Astrazeneca or Serum Institute of India Pvt., Ltd Receives: Biological: Immune Responses | |
| A single dose vaccination of Ad26.COV2.S | Manufactured by Janssen Pharmaceuticals/Johnson \& Johnson Receives: Biological: Immune Responses | |
| Primary series of BNT162b2 | Manufactured by Pfizer Receives: Biological: Immune Responses | |
| Primary series of BBIBP-CorV | Manufactured by Sinopharm Receives: Biological: Immune Responses | |
| Primary series of CoronaVac | Manufactured by Sinovac Receives: Biological: Immune Responses |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT of neutralizing antibody to SARS-CoV-2
Measured by wild-type virus neutralization assay
Measured: Through study completion, an average of 1 year
GMFR and percentage of participants with ≥4-fold rise of neutralizing antibody to SARS-CoV-2
Measured by Wild-type virus neutralization assay
Measured: Through study completion, an average of 1 year
GMT of SARS-CoV-2 RBD-binding IgG antibody
Measured by ELISA
Measured: Through study completion, an average of 1 year
GMFR and percentage of participants with ≥4-fold rise of SARS-CoV-2 RBD-binding IgG antibody
Measured by ELISA
Measured: From baseline (Visit 1) to each subsequent time point.
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
Measured: through study completion, an average of 1 year (Visit 1,3,6 and 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Vaccine Institute
- Responsible party
- Sponsor
- Investigators
- Santa K Das, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710289
- Sponsor's protocol ID
- GBP510_005
- Status last verified
- Jul 2023
- First submitted
- 30 Jan 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Blood Collection Study to Assess the Immunogenicity of Homologous Booster Combinations of COVID-19 Vaccines Available Under Emergency Use Authorization Among Adults of 18 Years and Older.
- ClinicalTrials.gov ID
- NCT05710289
- Acronym / sponsor ID
- GBP510_005
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor's decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SK Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- International Vaccine Institute
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the immunogenicity of nationally available pre-defined homologous booster vaccination of a SARS-CoV-2 WHO EUA qualified vaccination in adults aged 18 years and older
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Primary series of mRNA-1273 | – | Biological: Immune ResponsesManufactured by ModernaTX |
| Primary series of ChAdOx1 nCOV-19 | – | Biological: Immune ResponsesManufactured by Astrazeneca or Serum Institute of India Pvt., Ltd |
| A single dose vaccination of Ad26.COV2.S | – | Biological: Immune ResponsesManufactured by Janssen Pharmaceuticals/Johnson \& Johnson |
| Primary series of BNT162b2 | – | Biological: Immune ResponsesManufactured by Pfizer |
| Primary series of BBIBP-CorV | – | Biological: Immune ResponsesManufactured by Sinopharm |
| Primary series of CoronaVac | – | Biological: Immune ResponsesManufactured by Sinovac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Available WHO EUA qualified homologous booster vaccination against SARS-Cov-2 among adults 18 Years and older participants, regardless of past SARS-CoV-2 infection history confirmed by either serological or virological test method at baseline.
Key inclusion criteria (7 listed)
- 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, 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 of gap prior to first homologous booster vaccination and with no history of other COVID-19 vaccination, including booster doses.
- Participants who complete a qualitative test for antibody to SARS-CoV-2 nucleocapsid proteins at screening for assessment of previous SARS-CoV-2 infection.
Key exclusion criteria (13 listed)
- Concurrent or past SARS-CoV-2 infection within 12 weeks prior to the booster study vaccination confirmed by virological or serological testing .
- History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
- History of bleeding disorder or thrombocytopenia which is contraindicating to take blood sample.
- History of malignancy within 1 year prior to the screening (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune ResponsesTo compare the immune responses against the original strain and circulating strain prior to and post homologous dose of WHO EUA qualified COVID-19 vaccine in adults aged 18 years and older regardless of prior history of SARS-CoV-2 infection with immunogenicity profile of single heterologous dose by GBP510 vaccine acquired from GBP510_004 study. | Biological | A single dose vaccination of Ad26.COV2.S, Primary series of BBIBP-CorV, Primary series of BNT162b2, Primary series of ChAdOx1 nCOV-19, Primary series of CoronaVac, Primary series of mRNA-1273 |
Primary outcome
GMT of neutralizing antibody to SARS-CoV-2
Time frame: Through study completion, an average of 1 year
Measured by wild-type virus neutralization assay
GMFR and percentage of participants with ≥4-fold rise of neutralizing antibody to SARS-CoV-2
Time frame: Through study completion, an average of 1 year
Measured by Wild-type virus neutralization assay
GMT of SARS-CoV-2 RBD-binding IgG antibody
Time frame: Through study completion, an average of 1 year
Measured by ELISA
GMFR and percentage of participants with ≥4-fold rise of SARS-CoV-2 RBD-binding IgG antibody
Time frame: From baseline (Visit 1) to each subsequent time point.
Measured by ELISA
Cell-mediated response for both Th1 and Th2 cytokines
Time frame: through study completion, an average of 1 year (Visit 1,3,6 and 7)
Measured by ELISpot and/or FluoroSpot, and for both CD4+ and CD8+ T-cells measured by FACS
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santa K Das, MD principal investigator
Study Principal Investigator
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by SK Bioscience Co., Ltd..
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 7 inclusion and 13 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: withdrawn, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
GMT of neutralizing antibody to SARS-CoV-2 (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.