Follow-up Study of Population Vaccinated With COVID-19 Vaccine

• Conditions: Healthy

• Registration Number: NCT04972591
• Lead Sponsor: Qin Ning

Brief Summary

A multi-centered clinical follow-up study to investigate the long-term dynamic of COVID-19 antibody level after vaccination.

Detailed Description

From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. As of July 6, 2021, more than 180 million confirmed cases and around 4 million deaths have been reported globally. Till now, many treatment methods has gradually formed a consensus. At the same time, several domestic vaccines have been offered to the public for free inoculation in our country. However, due to the urgent form of the epidemic, the short vaccine development cycle and heavy tasks, there is no clear conclusion on the long-term changes in antibody levels after vaccination.Therefore, we plan to carry out a multi-center prospective observational trial to better understand the dynamic changes of the antibody levels in patients after vaccination.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-15
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study First Posted: 2021-07-22
• Last Update Posted: 2021-07-22
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Adult (18 years old or elder) who prepare or have been vaccinated against COVID-19, and has not participated in similar clinical studies.

Exclusion Criteria

• People who are allergic to any active ingredient of the vaccine, any inactive ingredient which was used in the production process, or those who have been allergic to the same kind of vaccine before.
• People who have had severe allergic reaction to vaccine before (such as acute allergic reaction, vascular neuroedema, dyspnea, etc.)
• People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.)
• People who are feverish, or suffering from acute diseases, or suffering from acute episodes of chronic diseases, or with serious chronic diseases without control.
• Pregnant woman
• Juvenile

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
laboratory findings	6months	Clinical laboratory examination were obtained during follow-up.
antibody levels	6months	antibody levels will be collected
symptoms and signs	6months	symptoms and signs after vaccination will be collected

Trial Locations

Locations (1)

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China