Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 2)
- Conditions
- SARS-CoV-2
- Interventions
- Dietary Supplement: 1 week placebo(Week 1)Dietary Supplement: 1 week of probiotics(Week 1)Dietary Supplement: 1 week placebo(Week 2)Dietary Supplement: 1 week of probiotics(Week 2)Dietary Supplement: 1 week placebo(Week 3)Dietary Supplement: 1 week of probiotics(Week 3)
- Registration Number
- NCT05195047
- Lead Sponsor
- Peking University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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.
Exclusion criteria:
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotics-Placebo-Placebo 1 week placebo(Week 2) 1 week of consecutively consuming oral probiotics (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day). Placebo-Probiotics-Placebo 1 week placebo(Week 1) 1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then consuming oral probiotics (1 time/day) for 1 week and placebo (1 time/day) for 1 week (1 time/day) respectively. Placebo-Probiotics-Placebo 1 week placebo(Week 3) 1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then consuming oral probiotics (1 time/day) for 1 week and placebo (1 time/day) for 1 week (1 time/day) respectively. Placebo-Probiotics-Placebo 1 week of probiotics(Week 2) 1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then consuming oral probiotics (1 time/day) for 1 week and placebo (1 time/day) for 1 week (1 time/day) respectively. Placebo-Placebo-Probiotics 1 week placebo(Week 1) 1 week of consecutively consuming oral placebo (1 time/day) followed SARS-CoV-2 vaccination, then consuming oral placebo for 1 week (1 time/day) and probiotics for 1 week (1 time/day) respectively. Probiotics-Placebo-Placebo 1 week of probiotics(Week 1) 1 week of consecutively consuming oral probiotics (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day). Probiotics-Placebo-Placebo 1 week placebo(Week 3) 1 week of consecutively consuming oral probiotics (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day). Placebo-Placebo-Probiotics 1 week placebo(Week 2) 1 week of consecutively consuming oral placebo (1 time/day) followed SARS-CoV-2 vaccination, then consuming oral placebo for 1 week (1 time/day) and probiotics for 1 week (1 time/day) respectively. Placebo 1 week placebo(Week 2) 1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day). Placebo-Placebo-Probiotics 1 week of probiotics(Week 3) 1 week of consecutively consuming oral placebo (1 time/day) followed SARS-CoV-2 vaccination, then consuming oral placebo for 1 week (1 time/day) and probiotics for 1 week (1 time/day) respectively. Placebo 1 week placebo(Week 1) 1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day). Placebo 1 week placebo(Week 3) 1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day).
- Primary Outcome Measures
Name Time Method The serum neutralizing antibody level of SARS-CoV-2. 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 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.
- Secondary Outcome Measures
Name Time Method Blood pressure 12-24 weeks The level of blood pressure.
PBMC transcriptome expression 12-24 weeks The expression of PBMC transcriptome
Serum neutralizing antibody positive rate 12-24 weeks The positive rate of serum neutralizing antibody.
Serum neutralizing antibody positive conversion rate 12-24 weeks The positive conversion rate of serum neutralizing antibody.
Fecal viable culture 12-24 weeks The culture of fecal viable
Intestinal flora 12-24 weeks The level of intestinal flora.
Antibody concentration 12-24 weeks The binding antibody concentration of S protein IgG and IgA in SARS-CoV-2 serum.
Serum cytokines 12-24 weeks The test of serum cytokines
Blood lipid 12-24 weeks The level of blood lipid.
Fecal specific binding antibody IgA 12-24 weeks The specific binding antibody IgA of fecal
Blood glucose 12-24 weeks The level of blood glucose.
Trial Locations
- Locations (2)
Beijing Pinggu Hospital
🇨🇳Beijing, China
Peking University Health Science Center Hospital
🇨🇳Beijing, China