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

NCT04972591 | Unknown

• 1 other identifier: TJ20210623
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

COVID-19; Vaccination; Anti-body

Outcome Measures

Primary Outcomes (3)

• symptoms and signs

  symptoms and signs after vaccination will be collected

  6months

• antibody levels

  antibody levels will be collected

  6months

• laboratory findings

  Clinical laboratory examination were obtained during follow-up.

  6months

Study Arms (2)

CHB Group

Patients with CHB

Compared Group

Healthy people

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All population who has been vaccinated or are prepared to get vaccinated.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qin Ning: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Yichang Central People's Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Shiyan Renmin Hospital: collaborator
• The second Hospital of JingZhou: collaborator
• Yunnan Provincial Infectious Disease Hospital: collaborator
• WUHAN NO.7 HOSPITAL: collaborator
• Shanxi Bethune Hospital: collaborator

Study Sites (1)

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cell (PBMC)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Qin Ning, Professor

CONTACT

+8613971521450; qning@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 22, 2021
• Study Start: March 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: July 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)