COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research
Recruiting · NCT06168032 · Interventional (participants receive a specific treatment) · Lead sponsor: Peking Union Medical College Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Any Chinese government-recommended COVID-19 booster vaccine
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Peking Union Medical College Hospital - Beijing, China