NCT05710289撤回不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- GMT of SARS-CoV-2 RBD-binding IgG antibody
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
GMT of SARS-CoV-2 RBD-binding IgG antibody
时间窗: 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
时间窗: 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
时间窗: From baseline (Visit 1) to each subsequent time point.
Measured by ELISA
GMT of neutralizing antibody to SARS-CoV-2
时间窗: Through study completion, an average of 1 year
Measured by wild-type virus neutralization assay
Cell-mediated response for both Th1 and Th2 cytokines
时间窗: 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
次要结局
未报告次要终点
研究者
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