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

November 2, 2022 updated by: Yangfeng Wu, Peking University

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)

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China
        • Beijing Pinggu Hospital
      • Beijing, China
        • Peking University Health Science Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics-Placebo-Placebo
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).
1 week of consecutively consuming oral probiotics (1 time/day)
1 week of consecutively consuming oral placebo (1 time/day)
1 week of consecutively consuming oral placebo (1 time/day)
Experimental: Placebo-Probiotics-Placebo
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.
1 week of consecutively consuming oral placebo (1 time/day)
1 week of consecutively consuming oral placebo (1 time/day)
1 week of consecutively consuming oral probiotics (1 time/day)
Experimental: Placebo-Placebo-Probiotics
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.
1 week of consecutively consuming oral placebo (1 time/day)
1 week of consecutively consuming oral placebo (1 time/day)
1 week of consecutively consuming oral probiotics (1 time/day)
Placebo Comparator: Placebo
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).
1 week of consecutively consuming oral placebo (1 time/day)
1 week of consecutively consuming oral placebo (1 time/day)
1 week of consecutively consuming oral placebo (1 time/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The serum neutralizing antibody level of SARS-CoV-2.
Time Frame: 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.
12-24 weeks
T-cell response level
Time Frame: 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.
12-24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody concentration
Time Frame: 12-24 weeks
The binding antibody concentration of S protein IgG and IgA in SARS-CoV-2 serum.
12-24 weeks
PBMC transcriptome expression
Time Frame: 12-24 weeks
The expression of PBMC transcriptome
12-24 weeks
Serum cytokines
Time Frame: 12-24 weeks
The test of serum cytokines
12-24 weeks
Serum neutralizing antibody positive rate
Time Frame: 12-24 weeks
The positive rate of serum neutralizing antibody.
12-24 weeks
Serum neutralizing antibody positive conversion rate
Time Frame: 12-24 weeks
The positive conversion rate of serum neutralizing antibody.
12-24 weeks
Intestinal flora
Time Frame: 12-24 weeks
The level of intestinal flora.
12-24 weeks
Fecal viable culture
Time Frame: 12-24 weeks
The culture of fecal viable
12-24 weeks
Fecal specific binding antibody IgA
Time Frame: 12-24 weeks
The specific binding antibody IgA of fecal
12-24 weeks
Blood pressure
Time Frame: 12-24 weeks
The level of blood pressure.
12-24 weeks
Blood glucose
Time Frame: 12-24 weeks
The level of blood glucose.
12-24 weeks
Blood lipid
Time Frame: 12-24 weeks
The level of blood lipid.
12-24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety indicators
Time Frame: 12-24 weeks
Adverse events and serious adverse events.
12-24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2022

Primary Completion (Actual)

August 21, 2022

Study Completion (Actual)

August 21, 2022

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • GUANKE-Trial 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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