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NCT Number: NCT05774093

Evaluation of COVID-19 Immune Barrier and Reinfection Risk

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This study is a single center, prospective, non-intervention study. It is planned to recruit 300 medical and nursing participants, administrative and logistics participants or other participants who can cooperate with the follow-up for 48 weeks to voluntarily join the group.

Participants will be investigated about the vaccination history of COVID-19 vaccine, whether they have ever been infected with COVID-19, the time of initial infection with COVID-19, and following clinical symptoms.The COVID-19 antibody titer of peripheral blood will be used for baseline.

The participants will be divided into positive group and negative group according to the COVID-19 antibody titer results,then they wii be followed up for 48 weeks.If the participants have no symptoms related to COVID-19 infection, COVID-19 antibody and COVID-19 nucleic acid will be tested every 4-8 weeks according to the epidemic situation (the specific visit time is initially set as 0 week, 6 ± 2 weeks, 12 ± 4 weeks, 20 ± 4 weeks, 28 ± 4 weeks, 36 ± 4 weeks, 48 ± 4 weeks). There will be about 7 visits in total, according to the epidemic situation and the time of secondary infection of the participants). If the nucleic acid turns to be positive, we will consider it as the asymptomatic infection, then we will collect nasal/pharyngeal swabs for gene sequencing of virus strains, and terminate the study.

If the participants get fever, fatigue, sore throat, cough, nasal congestion, runny nose, muscle soreness or headache and other symptoms related to COVID-19 infection during the study period, they need to test the COVID-19 antigen or COVID-19 nucleic acid within 48 hours. If it is positive, we will collect nasal/pharyngeal swabs for gene sequencing of virus strains, and terminate the study in advance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 48weeks

    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.

Secondary outcomes

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

    Time frame: 48weeks

    We will test COVID-19 antibody every 4-8 weeks and record the data to observe the dynamic change of titer.

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

    Time frame: 48weeks

    Flow cytometry will be used to detect the cellular immune function of participants every 4-8 weeks, and record data to analyze its dynamic changes.

  3. Antibody titer of COVID-19 in uninfected persons.

    Time frame: 48weeks

    The "uninfected person" refers to the participant who is still uninfected with COVID-19 at the end of our study. We will record and analyze the dynamic change of COVID-19 antibody titer within 48 weeks.

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

    Time frame: 48weeks

    We will record and analyze the dynamic change of the cellular immune function by flow-cytometry within 48 weeks.

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

    Time frame: 48weeks

    We will test and analyze the changes of COVID-19 antibody titer of uninfected people within 48 weeks after the booster immunization with COVID-19 vaccine.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Acronym: COVID

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Mar 17, 2023
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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