The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Location status: Recruiting
Location contact
Liang Bing Lin, MD
CONTACT
Ying Zi Lei, MD
CONTACT
NCT Number: NCT05774093
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.
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Observational
Guangzhou, Guangdong, 510630, China
Location status: Recruiting
Liang Bing Lin, MD
CONTACT
Ying Zi Lei, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 48weeks
We will test COVID-19 antibody every 4-8 weeks and record the data to observe the dynamic change of titer.
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.
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.
Time frame: 48weeks
We will record and analyze the dynamic change of the cellular immune function by flow-cytometry within 48 weeks.
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.
Sun Yat-sen University
Other
Acronym: COVID
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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