NCT05774093

Brief Summary

The goal of this observational study is to evaluate the protective effect of immune barrier on secondary infection after COVID-19 (coronavirus disease 2019) vaccination or COVID-19 virus Omicron B A. 5.2 strain infection by dynamically monitoring the COVID-19 antibody titer, cellular immune function and the occurrence of secondary infection of healthy participants, mainly medical staff in our hospital, to understand the cross protective effect of COVID-19 antibody on different variants of Omicron, and explore the best time to use COVID-19 vaccine to strengthen immunity after Omicron mutant infection.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress74%
Mar 2023Jul 2027

Study Start

First participant enrolled

March 6, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Expected
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

March 12, 2023

Last Update Submit

March 15, 2023

Conditions

COVID-19 InfectionImmunization; Infection

Outcome Measures

Primary Outcomes (1)

  • The incidence of COVID-19 reinfection in COVID-19 antibody positive and negative groups.

    This study is an observational study. The incidence of COVID-19 reinfection is mainly based on the participants with positive COVID-19 nucleic acid test. The proportion of participants with positive COVID-19 nucleic acid test in the total number during the observation period after 48 weeks observation will be counted.

    48weeks

Secondary Outcomes (5)

  • Dynamic changes of COVID-19 antibody titer in 48 weeks after COVID-19 infection.

    48weeks

  • Dynamic changes of cellular immune function in 48 weeks after COVID-19 infection.

    48weeks

  • Antibody titer of COVID-19 in uninfected persons.

    48weeks

  • The cellular immune function of COVID-19 in uninfected persons.

    48weeks

  • The change of antibody titer in uninfected people after COVID-19 vaccine.

    48weeks

Study Arms (2)

COVID-19 Antibody Group 1

Participants will be divided into positive group and negative group according to the baseline of COVID-19 antibody titer.Group 1 is for those COVID-19 antibody are positive.

COVID-19 Antibody Group 2

Participants will be divided into positive group and negative group according to the baseline of COVID-19 antibody titer.Group 1 is for those COVID-19 antibody are negative.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The participants need to be sure whether they have ever been infected with COVID-19, and need to be clearly remember the time when they first infected with COVID-19.

You may qualify if:

  • No age limit, no gender limit;
  • Medical staff, administrative and logistics staff who work in the Third Affiliated Hospital of Sun Yat-Sen University or other participants who can cooperate with the follow-up for 48 weeks;
  • The participants need to be sure whether they have ever been infected with COVID-19, and need to be clearly remember the time when they first infected with COVID-19.

You may not qualify if:

  • Have the following serious respiratory diseases: such as asthma, bronchiectasis, chronic obstructive pulmonary disease, pulmonary interstitial disease, tuberculosis and other respiratory diseases that may interfere with symptom observation;
  • Those with other serious diseases or disease history that affect immune function, including but not limited to uncontrolled and unresectable malignant tumors,hematological diseases, cachexia, active bleeding, severe malnutrition, mental diseases, autoimmune diseases, HIV, etc.
  • Those who have long-term assignment plans and cannot return to the hospital regularly for follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (3)

  • Hall VJ, Foulkes S, Charlett A, Atti A, Monk EJM, Simmons R, Wellington E, Cole MJ, Saei A, Oguti B, Munro K, Wallace S, Kirwan PD, Shrotri M, Vusirikala A, Rokadiya S, Kall M, Zambon M, Ramsay M, Brooks T, Brown CS, Chand MA, Hopkins S; SIREN Study Group. SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN). Lancet. 2021 Apr 17;397(10283):1459-1469. doi: 10.1016/S0140-6736(21)00675-9. Epub 2021 Apr 9.

    PMID: 33844963RESULT

  • Michlmayr D, Hansen CH, Gubbels SM, Valentiner-Branth P, Bager P, Obel N, Drewes B, Moller CH, Moller FT, Legarth R, Molbak K, Ethelberg S. Observed protection against SARS-CoV-2 reinfection following a primary infection: A Danish cohort study among unvaccinated using two years of nationwide PCR-test data. Lancet Reg Health Eur. 2022 Sep;20:100452. doi: 10.1016/j.lanepe.2022.100452. Epub 2022 Jun 30.

    PMID: 35791335RESULT

  • Servellita V, Syed AM, Morris MK, Brazer N, Saldhi P, Garcia-Knight M, Sreekumar B, Khalid MM, Ciling A, Chen PY, Kumar GR, Gliwa AS, Nguyen J, Sotomayor-Gonzalez A, Zhang Y, Frias E, Prostko J, Hackett J Jr, Andino R, Wadford DA, Hanson C, Doudna J, Ott M, Chiu CY. Neutralizing immunity in vaccine breakthrough infections from the SARS-CoV-2 Omicron and Delta variants. Cell. 2022 Apr 28;185(9):1539-1548.e5. doi: 10.1016/j.cell.2022.03.019. Epub 2022 Mar 18.

    PMID: 35429436RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

1.peripheral blood sample;2.COVID-19 nucleic acid specimen.

MeSH Terms

Conditions

COVID-19Infections

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 17, 2023

Study Start

March 6, 2023

Primary Completion

April 30, 2024

Study Completion (Estimated)

July 31, 2027

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations

CN(1)