Safety and Immunogenicity of Third Dose SARS-CoV-2 Vaccine Booster in Patients With Liver Diseases Following Two Doses of Inactivated Vaccines (NMCID-CHESS 2201): a Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 19
- 主要终点
- Rate of neutralizing antibody serological conversion after the booster vaccination
研究概览
简要总结
Previous studies should that patients with chronic liver diseases, cirrhosis, hepatocellular carcinoma and post-liver-trasplant status had lower immunological response to SARS-CoV-2 vaccines than healthy population. Along with the waning of antibody and emerging SARS-CoV-2 variants, a third dose SARS-CoV-2 booster vaccination is now considered as an effective strategy. Previous studies showed good safety and immunogenicity of the SARS-CoV-2 booster vaccination in healthy population. However, the relevant information in patients with liver diseases need further research. This study (NMCID-CHESS 2201) aimed to investigate the safety and immunogenicity of the SARS-CoV-2 booster vaccination in population with chronic liver diseases
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
- 否
入选标准
- •Previously vaccinated with two doses of SARS-CoV-2 vaccines and planning to get booster vaccination.
- •Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver diseases, cirrhosis, liver cancer, liver transplant subjects, etc.
- •Understanding and willing to comply with the study procedures and provides written informed consent.
排除标准
- •Pregnancy or lactation.
- •Active or known history of SARS-CoV-2 infection.
- •Diseases causing immunosuppressive or immunodeficient status or autoimmune diseases.
- •A history of discontinuing anti-HBV agents in recent three months.
结局指标
主要结局
Rate of neutralizing antibody serological conversion after the booster vaccination
时间窗: Fourteen to 90 days after the booster vaccine
Neutralizing antibody serological conversion is defined as a change from seronegative at baseline to seropositive or a four-fold titre increase if the participant was seropositive at baseline.
Number and rate of all solicited and non-solicited adverse events
时间窗: Up to 28 days after booster vaccine injection
First 7 days after the booster dose, participants will be required to record and be interviewed for adverse events; from day 8 to day 28 after booster dose, safety data were collected by spontaneous report.
次要结局
- Number and rate of abnormal laboratory testing results after the booster vaccination(Up to 28 days after after booster vaccine injection)
- Concentration and titre of neutralizing antibody after booster vaccination(Baseline and 14 days, 28 days, 90 days, and 180 days after the booster vaccination)