Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Rate of anti-SARS-CoV-2 T cell response
Study Overview
Brief Summary
The coronavirus disease 2019 (COVID-19) caused by the infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)，resulting in more than 82 million confirmed cases and caused around 1.8 million deaths, as of 2 January 2021. The ongoing pandemic still poses unprecedented global threat to public health system worldwide. On December 31, 2020, the joint prevention and control agency of China Council announced that Sinopharm SARS-CoV-2 inactivated vaccine had been conditionally approved by National Medical Products Administration, and the protection rate was 79.34%. So far, more than 198 vaccines were currently in preclinical or clinical development. The investigators aimed to initiate an observational cohort of healthy individuals injected with SARS-CoV-2 Vaccine, which will perform a longitudinal, comprehensive analysis of the SARS-CoV-2 vaccine Induced adaptive immune responses.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy and aged between 18 to 59 years
Exclusion Criteria
- •High-risk epidemiology history within 14 days before enrollment
- •SARS-CoV-2 specific IgG or IgM positive in serum
- •Positive PCR test for SARS-CoV-2 from pharyngeal or anal swab samples
- •Axillary temperature of more than 37·0°C
- •Known allergy to any vaccine component
- •Thyroid disease
Outcomes
Primary Outcomes
Rate of anti-SARS-CoV-2 T cell response
Time Frame: 2 years
The rate of SARS-CoV-2 infection
Time Frame: 2 years
Concentration of anti-SARS-CoV-2 neutralizing antibody in serum
Time Frame: 2 years
Concentration of serum anti-SARS-CoV-2 binding antibody
Time Frame: 2 years
Secondary Outcomes
- Rate of anti-SARS-CoV-2 B cell response(2 years)
Investigators
Chao Wu
Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School