Evaluation of COVID-19 Immune Barrier and Reinfection Risk

Overview

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.

Detailed description

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.

Primary outcome measures

• The incidence of COVID-19 reinfection in COVID-19 antibody positive and negative groups. [Time frame: 48weeks]

Secondary outcome measures (5)

• Dynamic changes of COVID-19 antibody titer in 48 weeks after COVID-19 infection. [Time frame: 48weeks]
• Dynamic changes of cellular immune function in 48 weeks after COVID-19 infection. [Time frame: 48weeks]
• Antibody titer of COVID-19 in uninfected persons. [Time frame: 48weeks]
• The cellular immune function of COVID-19 in uninfected persons. [Time frame: 48weeks]
• The change of antibody titer in uninfected people after COVID-19 vaccine. [Time frame: 48weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 1 center

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou

Publications

• 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, prospecti PMID 33844963
• 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 PMID 35791335
• 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):153 PMID 35429436

Identifiers

NCT: NCT05774093 · COVID-19 Immune Barrier Study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗