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.

SK Bioscience Co., Ltd.0 sitesFebruary 2023

ConditionsCOVID-19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COVID-19
Sponsor: SK Bioscience Co., Ltd.
Primary Endpoint: GMT of SARS-CoV-2 RBD-binding IgG antibody
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

February 2023

End Date

February 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

SK Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

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 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).
•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.