An observational study in COVID-19, sponsored by SK Bioscience Co., Ltd.. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by SK Bioscience Co., Ltd. (part of SK Chemicals Co., Ltd.) · Observational
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
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →SK Bioscience Co., Ltd. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Manufactured by ModernaTX
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Manufactured by Pfizer
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Manufactured by Sinopharm
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Manufactured by Sinovac
Biological: Immune Responses
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.
GMT of neutralizing antibody to SARS-CoV-2
Measured by wild-type virus neutralization assay
Time frame: 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
Time frame: Through study completion, an average of 1 year
GMT of SARS-CoV-2 RBD-binding IgG antibody
Measured by ELISA
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year (Visit 1,3,6 and 7)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2023; primary completion for Feb 2024, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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