Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 1)

NCT05194033 | Completed DMC

• 1 other identifier: GUANKE-Trial 1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

SARS-CoV-2

Keywords

Probiotic; lactobacillus plantarum

Outcome Measures

Primary Outcomes (2)

• The serum neutralizing antibody level of SARS-CoV-2.

  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.

  8 weeks

• T-cell response level

  Test of T-cell response level by spot-forming cell(SFC) counting, using Champspot III enzyme-linked spot automated image analysis system.

  8 weeks

Secondary Outcomes (11)

• Antibody concentration

  8 weeks

• PBMC transcriptome expression

  8 weeks

• Serum cytokines

  8 weeks

• Serum neutralizing antibody positive rate

  8 weeks

• Serum neutralizing antibody positive conversion rate

  8 weeks

Other Outcomes (1)

• Safety indicators

  8 weeks

Study Arms (2)

Probiotics

EXPERIMENTAL

The intervention group consumes oral probiotics 1 time/day for 7 consecutive days.

Dietary Supplement: Probiotics daily

Placebos

PLACEBO COMPARATOR

The placebo group consumes oral placebo 1 time/day for 7 consecutive days.

Dietary Supplement: Placebo daily

Interventions

Probiotics daily DIETARY_SUPPLEMENT

Probiotics 1 time/day for 7 consecutive days

Probiotics

Placebo daily DIETARY_SUPPLEMENT

Placebo 1 time/day for 7 consecutive days

Placebos

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≤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).
• Not vaccinated third dose vaccination;
• Voluntarily participate in the study with signed informed consent form.

You may not qualify if:

• Pregnancy or lactation period;
• Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
• Plan to vaccinate third dose of SARS-CoV-2 vaccine within 2 months;
• 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.

Sponsors & Collaborators

• Peking University: lead
• Centers for Disease Control and Prevention, China: collaborator
• Beijing Pinggu District Hospital: collaborator
• Peking University Health Science Center Hospital: collaborator

Study Sites (2)

Beijing Pinggu Hospital

Beijing, China

Location

Peking University Health Science Center Hospital

Beijing, China

Location

Related Publications (25)

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Study Officials

• Yangfeng Wu

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology and Sciences in Clincial Research

Model Details: A prospective, randomized, double-blind, placebo parallel controlled clinical trial.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 18, 2022
• Study Start: March 9, 2022
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

CN (2)