A Blood Collection Study to Assess the Immunogenicity of Nationally Authorized Homologous COVID-19 Booster Vaccines Among Adult Vaccinees.
Withdrawn
- Conditions
- COVID-19
- Interventions
- Biological: Immune Responses
- Registration Number
- NCT05710289
- Lead Sponsor
- SK Bioscience Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Primary series of mRNA-1273 Immune Responses Manufactured by ModernaTX Primary series of CoronaVac Immune Responses Manufactured by Sinovac Primary series of ChAdOx1 nCOV-19 Immune Responses Manufactured by Astrazeneca or Serum Institute of India Pvt., Ltd Primary series of BNT162b2 Immune Responses Manufactured by Pfizer A single dose vaccination of Ad26.COV2.S Immune Responses Manufactured by Janssen Pharmaceuticals/Johnson \& Johnson Primary series of BBIBP-CorV Immune Responses Manufactured by Sinopharm
- Primary Outcome Measures
Name Time Method 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 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 SARS-CoV-2 RBD-binding IgG antibody From baseline (Visit 1) to each subsequent time point. Measured by ELISA
GMT of neutralizing antibody to SARS-CoV-2 Through study completion, an average of 1 year Measured by wild-type virus neutralization assay
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
- Secondary Outcome Measures
Name Time Method