NCT05680896

Brief Summary

At present, COVID-19 vaccine is considered as the safest, economic and effective measure to prevent and control COVID-19. Adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. Cellular immunity includes virus specific B cells and T cells, which can provide long-term memory immunity. For acute viral infection, neutralizing antibody is of great significance in preventing infection, while memory cell immunity can maintain a good broad-spectrum and persistence in controlling mutant strains, which is a key factor in controlling viral replication after infection and reducing severe disease and death. However, there is no systematic study on the specific immune response and infection risk of novel coronavirus, and there is no definite conclusion on which specific protective immune response induced by vaccine can reduce the risk of infection. Therefore, this study aims to establish a prospective real-world cohort, analyze the correlation between multiple baseline immune protection indicators and infection risk, follow up the population with breakthrough infection, and monitor the dynamic specific immune response to COVID-19 in peripheral blood and respiratory mucosa. This study will provide an important scientific basis for us to scientifically assess the risk of individual infection with COVID-19.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2024

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

December 22, 2022

Last Update Submit

January 10, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • SARS-CoV-2 infection

    SARS-CoV-2 infection confirmed by either by nucleic acid testing or antigen testing

    from Dec 2022 to April 2023

  • The severity of COVID-19

    the severity of COVID-19 symptoms including the period from SARS-CoV-2 positive to negative, fever days, etc.

    from Dec 2022 to April 2023

Interventions

inactivated COVID-19 vaccines; orally aerosolized Ad5-nCoVBIOLOGICAL

the protection of COVID-19 vaccines on breakthrough infection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthcare workers in Nanjing Drum Tower Hospital, Nanjing, China

You may qualify if:

  • Age ≥18 years
  • SARS-CoV-2 nucleic acid testing showed negative within 72 hours

You may not qualify if:

  • Do not consent to enroll in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

  • Chen Y, Zhao T, Chen L, Jiang G, Geng Y, Li W, Yin S, Tong X, Tao Y, Ni J, Lu Q, Ning M, Wu C. SARS-CoV-2 Omicron infection augments the magnitude and durability of systemic and mucosal immunity in triple-dose CoronaVac recipients. mBio. 2024 Apr 10;15(4):e0240723. doi: 10.1128/mbio.02407-23. Epub 2024 Mar 8.

    PMID: 38456703DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples and peripheral blood

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chao Wu

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Wu, PhD

CONTACT

+8613809022921dr.wu@nju.edu.cn

Yuxin Chen, PhD

CONTACT

+8617714413628yuxin.chen@nju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 11, 2023

Study Start

February 1, 2023

Primary Completion

March 21, 2023

Study Completion

December 22, 2024

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

CN(1)