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

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05710289
• Other study ID #: GBP510_005
• Status: Withdrawn
• Start date: February 2023
• Est. completion date: February 2024

Study information

• Verified date: July 2023
• Source: SK Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.
• 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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SK Bioscience Co., Ltd.	International Vaccine Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GMT of neutralizing antibody to SARS-CoV-2	Measured by wild-type virus neutralization assay	Through study completion, an average of 1 year
Primary	GMFR and percentage of participants with =4-fold rise of neutralizing antibody to SARS-CoV-2	Measured by Wild-type virus neutralization assay	Through study completion, an average of 1 year
Primary	GMT of SARS-CoV-2 RBD-binding IgG antibody	Measured by ELISA	Through study completion, an average of 1 year
Primary	GMFR and percentage of participants with =4-fold rise of SARS-CoV-2 RBD-binding IgG antibody	Measured by ELISA	From baseline (Visit 1) to each subsequent time point.
Primary	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	through study completion, an average of 1 year (Visit 1,3,6 and 7)