Status:
COMPLETED
Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 1)
Lead Sponsor:
Peking University
Collaborating Sponsors:
Centers for Disease Control and Prevention, China
Beijing Pinggu District Hospital
Conditions:
SARS-CoV-2
Eligibility:
All Genders
18-59 years
Phase:
NA
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...
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 po...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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).
- Not vaccinated third dose vaccination;
- 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);
- 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.
Exclusion
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05194033
Start Date
March 9 2022
End Date
May 19 2022
Last Update
July 7 2022
Active Locations (2)
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1
Beijing Pinggu Hospital
Beijing, China
2
Peking University Health Science Center Hospital
Beijing, China