- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05087277
Correlation Study of Isotype Switching and Neutralizing Capacity to the COVID-19 Variants Strain
Study on the Correlation of Isotype Switching, Neutralizing Antibody Titer and Cross Immunity Against COVID-19 Variants After Primary and Booster Vaccination
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Beijing, China, 100013
- Center for Disease Control and Prevention
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between the ages of 18 and 59
- Healthy
- No vaccination with COVID-19 before become participant
- Agreed to take a blood sample
Exclusion Criteria:
- who cannot take the COVID-19 vaccine due to some personal reasons
- history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection
- high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with SARS-CoV-2)
- axillary temperature of more than 37·0℃
- history of allergy to any vaccine component.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neutralizing capabilities to variant COVID-19 after primary and booster vaccination
Time Frame: Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at 12 months
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The titers of neutralizing antibodies against live SARS-CoV-2 and Pseudotyped SARS-CoV-2 Variants strain Alpha, Beta and Delta at baseline, after fully vaccinated 1 and 6 months and Within 15 days after booster immunization at 12 months. The neutralizing antibodies was defined as a change from seronegative at baseline to seropositive or a four-fold titer increase. The positive cutoff of the titer for neutralizing antibodies was 1/30. |
Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at 12 months
|
Titer of Subclass of IgG after primary and booster vaccination
Time Frame: Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at an interval of 12 months
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The titers of Subclass RBD-specific IgG1, IgG2,IgG3 and IgG4 at baseline, after fully vaccinated 1 and 6 months and Within 15 days after booster immunization at an interval of 12 months.
The positive for IgG1, IgG2,IgG3 and IgG4 antibodies are defined as the sample titer value ≥1/20.
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Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at an interval of 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Titer of subclass of IgG at different points in time after booster vaccination
Time Frame: 0,3,7,10,14 days
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Titer of subclass of IgG at 0,3,7,10,14 days after booster vaccination.
The positive for IgG1, IgG2,IgG3 and IgG4 antibodies are defined as the sample titer value ≥1/20.
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0,3,7,10,14 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BJCDCWJ202102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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