Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination: A Prospective, Randomized, Double-blind, Placebo-Controlled Trial (Trial 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The serum neutralizing antibody level of SARS-CoV-2.
研究概览
简要总结
Preliminarily explore the effect of oral probiotics in SARS-CoV-2 serum neutralizing antibody titer level and T cell response level (spot formation cell counting).
Provide a reference for determining the appropriate oral regimen. Provide necessary parameters for estimating the sample size of confirmatory clinical trial.
详细描述
In selected communities or assigned clinical trial institutions, participants who intend to complete the third dose of SARS-CoV-2 vaccination will be invited in this study. Informed consent form will give to potential participants with well explained of trial contents during baseline. Participants who gave their signed informed consent form will be blocked randomized in a 1:1:1:1 ratio to intervention group A, intervention group B, intervention group C, or placebo group D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study is double-blinded, which neither participants nor investigators know the results of intervention. In addition, laboratory test of blood samples will also be conducted without knowing the randomization results of participants to ensure the evaluation of outcome measure is objective.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 ≤age ≤59 years;
- •Vaccinated with two doses of SARS-CoV-2 vaccine (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.) (≥6 months from the time of vaccination).
- •Plan to vaccinate third dose vaccination (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
- •Voluntarily participate in the study with signed informed consent form.
排除标准
- •Pregnancy or lactation period;
- •Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
- •History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.);
- •Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual;
- •Other SARS-CoV-2 vaccination history (not manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
- •End-stage cancer or other terminal diseases with life expectancy <6 month;
- •History of severe cardiovascular and cerebrovascular diseases, such as heart failure, uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, or history of myocardial or cerebral infarction within past six months;
- •Participating in other clinical trials.
结局指标
主要结局
The serum neutralizing antibody level of SARS-CoV-2.
时间窗: 12-24 weeks
The serum neutralizing antibody level of SARS-CoV-2 is determined by serum neutralization test, which is used to determine the serum dilution that protects 50% cells from cytopathic effect.
T-cell response level
时间窗: 12-24 weeks
Test of T-cell response level by spot-forming cell(SFC) counting, using Champspot III enzyme-linked spot automated image analysis system.
次要结局
- PBMC transcriptome expression(12-24 weeks)
- Serum neutralizing antibody positive rate(12-24 weeks)
- Serum neutralizing antibody positive conversion rate(12-24 weeks)
- Fecal viable culture(12-24 weeks)
- Intestinal flora(12-24 weeks)
- Antibody concentration(12-24 weeks)
- Serum cytokines(12-24 weeks)
- Blood lipid(12-24 weeks)
- Fecal specific binding antibody IgA(12-24 weeks)
- Blood pressure(12-24 weeks)
- Blood glucose(12-24 weeks)
研究者
Yangfeng Wu
Professor of Epidemiology and Sciences in Clincial Research
Peking University