A Blood Collection Study to Assess the Immunogenicity of Nationally Authorized Homologous COVID-19 Booster Vaccines Among Adult Vaccinees.
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Primary series of mRNA-1273 Manufactured by ModernaTX |
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.
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| Primary series of ChAdOx1 nCOV-19 Manufactured by Astrazeneca or Serum Institute of India Pvt., Ltd |
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.
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| A single dose vaccination of Ad26.COV2.S Manufactured by Janssen Pharmaceuticals/Johnson & Johnson |
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.
|
| Primary series of BNT162b2 Manufactured by Pfizer |
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.
|
| Primary series of BBIBP-CorV Manufactured by Sinopharm |
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.
|
| Primary series of CoronaVac 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.
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Outcome Measures
Primary Outcome Measures
- GMT of neutralizing antibody to SARS-CoV-2 [Through study completion, an average of 1 year]
Measured by wild-type virus neutralization assay
- GMFR and percentage of participants with ≥4-fold rise of neutralizing antibody to SARS-CoV-2 [Through study completion, an average of 1 year]
Measured by Wild-type virus neutralization assay
- GMT of SARS-CoV-2 RBD-binding IgG antibody [Through study completion, an average of 1 year]
Measured by ELISA
- GMFR and percentage of participants with ≥4-fold rise of SARS-CoV-2 RBD-binding IgG antibody [From baseline (Visit 1) to each subsequent time point.]
Measured by ELISA
- Cell-mediated response for both Th1 and Th2 cytokines [through study completion, an average of 1 year (Visit 1,3,6 and 7)]
Measured by ELISpot and/or FluoroSpot, and for both CD4+ and CD8+ T-cells measured by FACS
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant must be 18 years of age and older, at the time of signing the informed consent.
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Participants who are healthy or medically stable as determined by medical evaluation including medical history, physical examination, and medical judgement of the investigator.
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Participants who are able to attend all scheduled visits and comply with all study procedures.
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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.
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Participants who complete a qualitative test for antibody to SARS-CoV-2 nucleocapsid proteins at screening for assessment of previous SARS-CoV-2 infection.
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Female participants with a negative urine or serum pregnancy test at screening.
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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:
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Concurrent or past SARS-CoV-2 infection within 12 weeks prior to the booster study vaccination confirmed by virological or serological testing .
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History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
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History of bleeding disorder or thrombocytopenia which is contraindicating to take blood sample.
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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).
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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.
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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).
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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).
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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.
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Receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the booster vaccination.
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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.
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Participation in another clinical study and or concurrent, planned participation in another clinical study with study intervention during the study period.
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Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.
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Donation of ≥450mL of blood product within 4 weeks prior to screening, or planned donation of blood product during the study period
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- SK Bioscience Co., Ltd.
- International Vaccine Institute
Investigators
- Principal Investigator: Santa K Das, MD, Study Principal Investigator
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GBP510_005