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

Study 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

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.

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: Immune Responses


Participation Criteria
=================
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. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary series of mRNA-1273<br>Manufactured by ModernaTX | Biological: Immune Responses<br>* 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.<br>|
| Primary series of ChAdOx1 nCOV-19<br>Manufactured by Astrazeneca or Serum Institute of India Pvt., Ltd | Biological: Immune Responses<br>* 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.<br>|
| A single dose vaccination of Ad26.COV2.S<br>Manufactured by Janssen Pharmaceuticals/Johnson & Johnson | Biological: Immune Responses<br>* 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.<br>|
| Primary series of BNT162b2<br>Manufactured by Pfizer | Biological: Immune Responses<br>* 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.<br>|
| Primary series of BBIBP-CorV<br>Manufactured by Sinopharm | Biological: Immune Responses<br>* 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.<br>|
| Primary series of CoronaVac<br>Manufactured by Sinovac | Biological: Immune Responses<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |