Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 2)

Peking University

Status: Completed

Conditions: SARS-CoV-2

Treatments: Dietary Supplement: 1 week of probiotics(Week 3); Dietary Supplement: 1 week of probiotics(Week 1); Dietary Supplement: 1 week placebo(Week 2); Dietary Supplement: 1 week placebo(Week 1); Dietary Supplement: 1 week of probiotics(Week 2); Dietary Supplement: 1 week placebo(Week 3)

Study type: Interventional

Funder types: Other

Identifiers

NCT05195047

GUANKE-Trial 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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. Plan to vaccinate third dose vaccination (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
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. History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.);
4. Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual;
5. Other SARS-CoV-2 vaccination history (not manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
6. End-stage cancer or other terminal diseases with life expectancy <6 month;
7. 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;
8. Participating in other clinical trials.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 4 patient groups, including a placebo group

Probiotics-Placebo-Placebo

Experimental group

Description:

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).

Treatment:

Dietary Supplement: 1 week of probiotics(Week 1)

Dietary Supplement: 1 week placebo(Week 2)

Dietary Supplement: 1 week placebo(Week 3)

Placebo-Probiotics-Placebo

Experimental group

Description:

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.

Treatment:

Dietary Supplement: 1 week placebo(Week 1)

Dietary Supplement: 1 week of probiotics(Week 2)

Dietary Supplement: 1 week placebo(Week 3)

Placebo-Placebo-Probiotics

Experimental group

Description:

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.

Treatment:

Dietary Supplement: 1 week of probiotics(Week 3)

Dietary Supplement: 1 week placebo(Week 1)

Dietary Supplement: 1 week placebo(Week 2)

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: 1 week placebo(Week 1)

Dietary Supplement: 1 week placebo(Week 2)

Dietary Supplement: 1 week placebo(Week 3)