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NCT04729374 Clinical Trial

COVID-19 Vaccine Induced Adaptive Immune Responses

COVID-19 Clinical Trial

Official title:
Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04729374
Other study ID # NJGLVAC-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 27, 2021
Est. completion date December 31, 2023

Study information
Verified date February 2021
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Chao Wu, M.D., Ph.D
Phone +8613809022921
Email dr.wu@nju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 59 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Nanjing Drum Tower Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of anti-SARS-CoV-2 neutralizing antibody in serum 2 years
Primary Concentration of serum anti-SARS-CoV-2 binding antibody 2 years
Primary Rate of anti-SARS-CoV-2 T cell response 2 years
Primary The rate of SARS-CoV-2 infection 2 years
Secondary Rate of anti-SARS-CoV-2 B cell response 2 years
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