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COVID-19 Vaccine Induced Adaptive Immune Responses

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT04729374
Collaborator
(none)
200
Enrollment
1
Location
35.1
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses
    Actual Study Start Date :
    Jan 27, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Concentration of anti-SARS-CoV-2 neutralizing antibody in serum [2 years]

    2. Concentration of serum anti-SARS-CoV-2 binding antibody [2 years]

    3. Rate of anti-SARS-CoV-2 T cell response [2 years]

    4. The rate of SARS-CoV-2 infection [2 years]

    Secondary Outcome Measures

    1. Rate of anti-SARS-CoV-2 B cell response [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanjing Drum Tower Hospital Nanjing Jiangsu China 210008

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chao Wu, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    ClinicalTrials.gov Identifier:
    NCT04729374
    Other Study ID Numbers:
    • NJGLVAC-001
    First Posted:
    Jan 28, 2021
    Last Update Posted:
    Feb 5, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Feb 5, 2021