COVID-19 Vaccine Induced Adaptive Immune Responses

February 2, 2021 updated by: Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chao Wu, M.D., Ph.D
  • Phone Number: +8613809022921
  • Email: dr.wu@nju.edu.cn

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
          • Yuxin Chen
        • Principal Investigator:
          • Chao Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy individuals to be injected with COVID-19 vaccine

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of anti-SARS-CoV-2 neutralizing antibody in serum
Time Frame: 2 years
2 years
Concentration of serum anti-SARS-CoV-2 binding antibody
Time Frame: 2 years
2 years
Rate of anti-SARS-CoV-2 T cell response
Time Frame: 2 years
2 years
The rate of SARS-CoV-2 infection
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of anti-SARS-CoV-2 B cell response
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Yuxin Chen, Nanjing Drum Tower Hospital, Nanjing University Medical School
  • Principal Investigator: Han Shen, Nanjing Drum Tower Hospital, Nanjing University Medical School
  • Principal Investigator: Rui Huang, Nanjing Drum Tower Hospital, Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 27, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (ACTUAL)

January 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJGLVAC-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe