A prospective, open-label and parallel non-randomized control trial and biomarker research study is intended to compare incidence of repeated COVID-19 infection, severe pneumonitis and mortality between lung cancer patients undergoing systemic antitumor therapies who get vaccinated with 1 booster dose(majorly against XBB) and those who refuse. Meanwhile, a biomarker research is designed to monitor serum level dynamics of specific antibodies against COVID-19,analyze its correlation with incidence of breakthrough infection and further explore optimal periods for vaccination.
A single booster dose will be administered depending on patients' willingness in the sixth month after symptomatic COVID-19 infection and status including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded during the next 6 months after vaccination or not. For antibody analysis, 5 ml blood samples will be collected from all of the included patients respectively in the 3rd ,4.5th and 6th months after latest occurrence of symptomatic infection and at the same timepoints after booster dose vaccination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,224
Any Chinese government-recommended COVID-19 booster vaccine(such as Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine(Sf9 Cell) and so on) will be once administered in the sixth month after COVID19 infection.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGIncidence of recurrent symptomatic COVID-19 infection among lung cancer patients treated with systemic antitumor therapies who get vaccinated 6 months after COVID-19 infection.
The incidence of any of the following events: confirmed COVID 19 infection by antigen test or PCR test, with at least one related symptom including fever, cough, expectoration, dyspnea, headache, diarrhea and so on.
Time frame: up to 8 weeks
Incidence of critical and/or severe symptomatic COVID-19 infection among lung cancer patients treated with systemic antitumor therapies who get vaccinated 6 months after COVID-19 infection.
The incidence of the following events: COVID 19 infection confirmed by antigen test or PCR test and diagnosed of critical and/or severe pneumonitis.
Time frame: up to 8 weeks
All-cause mortality rate
The proportions of patients who died from any causes after enrollment.
Time frame: up to 8 weeks
Overall survival
The time length from enrollment to death from any causes.
Time frame: up to 8 weeks
Incidence of antitumor drug-related adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Evaluate adverse events of any cause(except cancer-related events), treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0.
Time frame: up to 8 weeks
Incidence of adverse events following immunization
Evaluate immunization-related adverse events including local or systemic symptoms(excluding those caused by cancer or anti-canter treatments like chemotherapies, tyrosine kinase inhibitors, immune checkpoint inhibitors and so on）
Time frame: up to 8 weeks
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