COVID-19 Vaccine Induced Adaptive Immune Responses

• Conditions: Vaccine; SARS-CoV-2; COVID-19

• Registration Number: NCT04729374
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study Start: 2021-01-27
• Study First Posted: 2021-01-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-05
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of anti-SARS-CoV-2 T cell response	2 years
The rate of SARS-CoV-2 infection	2 years
Concentration of anti-SARS-CoV-2 neutralizing antibody in serum	2 years
Concentration of serum anti-SARS-CoV-2 binding antibody	2 years

Secondary Outcome Measures

Name	Time	Method
Rate of anti-SARS-CoV-2 B cell response	2 years

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China