Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults Aged 18 Years or Above: a Multicenter, Parallel Groups, Partially Randomized, Open-label, Blank-controlled Adaptive Platform Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- The incidence of COVID-19 from 14 days to 6 months after the booster immunization.
研究概览
简要总结
This is a multicenter, parallel groups, partially randomized, open-label, blank-controlled adaptive platform study to evaluate the effectiveness of a second COVID-19 vaccine booster in Chinese adults who are charactered as the majority of whom with hybrid immunity of COVID-19 vaccination and COVID-19 breakthrough infection. Individuals aged 18 years and over, include the elderly over 60 years old or those with underlying diseases (history of underlying medical conditions diagnosed by a clinician, including hypertension, diabetes, heart disease, etc). The eligible participants with an interval ≥ 4 months after previous SARS-CoV-2 infection (or had never been infected) and ≥ 6 months from the first COVID-19 vaccine booster will be recruited. Participants who are not willing to receive the second booster but are consent to participate the surveillance for COVID-19, will be included as a blank control. Informed consent will be acquired from eligible participants. Other participants who are willing to receive the second booster and participate the surveillance for COVID-19, will be randomly allocated in a ratio of 1: k (k is the number of vaccine types) to the different investigational vaccines, stratified according to age and history of COVID-19 infection. The symptomatic COVID-19 cases will be reported and documented in both the investigational and control groups. The occurrence of serious adverse events within 6 months after vaccination will be observed. Moreover, blood and nasal mucosa samples will be collected on the day 0 before and day 14, month 3 and 6 after the booster vaccination in a subgroup for humoral, cellular and mucosal immunogenicity analysis. Moreover, oral specimens will be collected once for all participants on the day of enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Adults aged 18 years and over, including the elderly over 60 years and those with underlying diseases.
- •Volunteers are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
- •≥ 4 months from the last SARS-CoV-2 infection (or never been infected), and 6 months or more from the first booster immunization of the COVID-19 vaccine.
排除标准
- •Volunteers have suspected symptoms of COVID-19 when enrolled, such as dry throat, sore throat, cough, etc.
- •The COVID-19 Antigen Quick Test Kit is positive when volunteers are enrolled.
- •Fever, temperature > 37.0°C.
- •Have received a second COVID-19 vaccine booster immunization.
- •Have a history of serious adverse reactions related to the vaccine and/or have a history of severe allergic reactions to any component of the investigational vaccine (only applicable to the vaccine groups).
- •Pregnant or lactating women.
- •HIV infection, tuberculosis, low immunity caused by disease or long-term medication.
- •Acute disease or acute onset of chronic disease.
- •Epilepsy and other progressive neurological disorders.
- •Other situations that are not suitable for participating in this research, according to the judgment of the researcher.
结局指标
主要结局
The incidence of COVID-19 from 14 days to 6 months after the booster immunization.
时间窗: from 14 days to 6 months after the booster dose
次要结局
- The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 28 days to 6 months after the booster immunization.(from 28 days to 6 months the booster dose)
- GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.(On month 3 after the booster vaccination)
- The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 14 days to 6 months after the booster immunization.(from 14 days to 6 months the booster dose)
- GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.(On day 14 after the booster vaccination)
- The incidence of COVID-19 from 28 days to 6 months after the booster immunization.(from 28 days to 6 months the booster dose)
- The incidence of hospitalized COVID-19 from 7 days to 6 months after the booster immunization.(from 7 days to 6 months the booster dose)
- GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.(On month 6 after the booster vaccination)
- GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.(On month 6 after the booster vaccination)
- GMT, GMFI and seroconversion of nasal specific IgA antibodies on day 14 after the booster vaccination in the immunogenic subgroup.(On day 14 after the booster vaccination)
- GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 3 after the booster vaccination in the immunogenic subgroup.(On month 3 after the booster vaccination)
- The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 7 days to 6 months after the booster immunization.(from 7 days to 6 months the booster dose)
- The incidence of hospitalized COVID-19 from 28 days to 6 months after the booster immunization.(from 28 days to 6 months the booster dose)
- Geometric mean titer (GMT), Geometric mean fold increase (GMFI) and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.(On day 14 after the booster vaccination)
- GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.(On month 3 after the booster vaccination)
- The incidence of serious adverse events within 6 months after the booster vaccination.(within 6 months after the booster dose)
- The incidence of COVID-19 from 7 days to 6 months after the booster immunization.(from 7 days to 6 months the booster dose)
- The incidence of hospitalized COVID-19 from 14 days to 6 months after the booster immunization.(from 14 days to 6 months the booster dose)
- GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 6 after the booster vaccination in the immunogenic subgroup.(On month 6 after the booster vaccination)