ClinicalTrials.gg
WithdrawnNCT05710289Updated Jul 27, 2023

A Blood Collection Study to Assess the Immunogenicity of Nationally Authorized Homologous COVID-19 Booster Vaccines Among Adult Vaccinees.

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 Withdrawn.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

Why this study was withdrawn
Sponsor's decision
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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

02

Conditions studied

  • COVID-19

Browse trials for

03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

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.

Inclusion criteria

  • Participant must be 18 years of age and older, at the time of signing the .
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 disease.
  • History of bleeding disorder or thrombocytopenia which is contraindicating to take blood sample.
  • History of 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).
  • 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 therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic 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
Terms in these criteria, in plain language(5)

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.

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.

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.

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Primary series of mRNA-1273

    Manufactured by ModernaTX

    Biological: Immune Responses

  • Primary series of ChAdOx1 nCOV-19

    Manufactured by Astrazeneca or Serum Institute of India Pvt., Ltd

    Biological: Immune Responses

  • A single dose vaccination of Ad26.COV2.S

    Manufactured by Janssen Pharmaceuticals/Johnson \& Johnson

    Biological: Immune Responses

  • Primary series of BNT162b2

    Manufactured by Pfizer

    Biological: Immune Responses

  • Primary series of BBIBP-CorV

    Manufactured by Sinopharm

    Biological: Immune Responses

  • Primary series of CoronaVac

    Manufactured by Sinovac

    Biological: Immune Responses

Interventions

  • BiologicalImmune 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. GMT of SARS-CoV-2 RBD-binding IgG antibody

    Measured by ELISA

    Time frame: Through study completion, an average of 1 year

  4. 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.

  5. 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)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Jan 30, 2023
First posted
Feb 2, 2023
StartEst.
Feb 2023
Primary completionEst.
Feb 2024
CompletionEst.
Feb 2024
Last update
Jul 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05710289
Collaborators
International Vaccine Institute
Responsible party
Sponsor
First posted
Feb 2, 2023
Start date
Feb 2023 (estimated)
Primary completion
Feb 2024 (estimated)
Completion
Feb 2024 (estimated)
Last update
Jul 27, 2023

Study contacts

Santa K Das, MD
principal investigator · Study Principal Investigator

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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