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

NCT05710289 | Withdrawn

• 1 other identifier: GBP510_005
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• GMT of neutralizing antibody to SARS-CoV-2

  Measured by wild-type virus neutralization assay

  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

  Through study completion, an average of 1 year

• GMT of SARS-CoV-2 RBD-binding IgG antibody

  Measured by ELISA

  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

  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

  through study completion, an average of 1 year (Visit 1,3,6 and 7)

Study Arms (6)

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

Immune Responses BIOLOGICAL

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Bioscience Co., Ltd.: lead
• International Vaccine Institute: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

Immunity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Santa K Das, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 2, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share