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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccinated group | Experimental | 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. |
|
| Non-vaccinated group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Any Chinese government-recommended COVID-19 booster vaccine | Biological | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory biomarker analysis | 5 ml blood samples will be collected in the 3rd ,4.5th and 6th months after symptomatic infection and at the same timepoints after booster dose vaccination(the interventional group) or of the successive 6 months(control group) to monitor the titre of specific sero-antibodies against COVID-19. | up to 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengzhao Wang, MD | Contact | +8613911235467 | mengzhaowang@sina.com | |
| Yan Xu, MD | Contact | +8618500296828 | maraxu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Mengzhao Wang, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
The result of the study and all the supporting information will be shared in the form of published article.
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| 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 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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