Clinical trial NCT05194033: Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 1)
Official title: 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 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV-2
Keywords: Probiotic
lactobacillus plantarum
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
name: Beijing Pinggu District Hospital
name: Peking University Health Science Center Hospital
First posted: 2022-01-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, double-blind, placebo parallel controlled clinical trial.
Primary purpose: OTHER

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 had completed two doses 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 ratio to intervention group or placebo control group.

Eligibility criteria: Inclusion Criteria:

1. 18 ≤age ≤59 years;
2. 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).
3. Not vaccinated third dose vaccination;
4. Voluntarily participate in the study with signed informed consent form.

Exclusion criteria:

1. Pregnancy or lactation period;
2. Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
3. Plan to vaccinate third dose of SARS-CoV-2 vaccine within 2 months;
4. History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.);
5. Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual;
6. Other SARS-CoV-2 vaccination history (not manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
7. End-stage cancer or other terminal diseases with life expectancy \<6 month;
8. 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;
9. Participating in other clinical trials.

Primary outcomes:
measure: The serum neutralizing antibody level of SARS-CoV-2.
timeFrame: 8 weeks
measure: T-cell response level
timeFrame: 8 weeks
Secondary outcomes:
measure: Antibody concentration
timeFrame: 8 weeks
measure: PBMC transcriptome expression
timeFrame: 8 weeks
measure: Serum cytokines
timeFrame: 8 weeks
measure: Serum neutralizing antibody positive rate
timeFrame: 8 weeks
measure: Serum neutralizing antibody positive conversion rate
timeFrame: 8 weeks
measure: Intestinal flora
timeFrame: 8 weeks
measure: Fecal viable culture
timeFrame: 8 weeks
measure: Fecal specific binding antibody IgA
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Blood glucose
timeFrame: 8 weeks
measure: Blood lipid
timeFrame: 8 weeks
Other outcomes:
measure: Safety indicators
timeFrame: 8 weeks
Locations:
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Beijing
country: China
facility: Peking University Health Science Center Hospital
Study officials:
affiliation: Peking University
name: Yangfeng Wu
role: PRINCIPAL_INVESTIGATOR
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