COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of COVID-19 Booster-Dose Vaccine for Re-infection Precaution and Dynamics of Specific Serum Antibodies in the Management of Lung Cancer Patients With Systemic Anti-cancer Treatment

Conditions
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COVID-19 Recurrent, Lung Cancer, Vaccination, Antibody, Chemotherapy, Immune Checkpoint Inhibitor

Intervention / Treatment
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* Biological: Any Chinese government-recommended COVID-19 booster vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who agree to participate in the trial and sign the informed consents. Male or female, ≥18 years old. Diagnosed of lung carcinoma by histological and cytological examinations. Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy. Recorded history of COVID19 infection. Sufficiently functional organs. Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2. Exclusion Criteria: Life expectance less than 3 months. Less than 3 months since last confirmed COVID-19 infection. Patients unable to return the hospital for follow-up. Patients allergic to COVID-19 vaccine. Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccinated group<br>Any booster doses(without limitations in the subtypes or brands of the vaccines) recommended or approved by Chinese government will be administered once in the 6th months after latest confirmed COVID-19 infection and during the following 6 months, any conditions including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded. | Biological: Any Chinese government-recommended COVID-19 booster vaccine<br>* 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.<br>|
| No Intervention: Non-vaccinated group<br>Patients unwilling to get vaccination will be allocated into these group, but any events including recurrent COVID19 infection, critical and/or severe conditions and all-cause death will be recorded in the following six months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence 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. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 8 weeks | 
| All-cause mortality rate | The proportions of patients who died from any causes after enrollment. | up to 8 weeks | 
| Overall survival | The time length from enrollment to death from any causes. | 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. | 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） | up to 8 weeks |