A prospective, open-label and parallel non-randomized control trial and biomarkerresearch study is intended to compare incidence of repeated COVID-19 infection, severepneumonitis and mortality between lung cancer patients undergoing systemic antitumortherapies who get vaccinated with 1 booster dose(majorly against XBB) and those whorefuse. Meanwhile, a biomarker research is designed to monitor serum level dynamics ofspecific antibodies against COVID-19,analyze its correlation with incidence ofbreakthrough 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.
Biological: Any Chinese government-recommended COVID-19 booster vaccine
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.
Inclusion Criteria:
1. Patients who agree to participate in the trial and sign the informed consents.
2. Male or female, ≥18 years old.
3. Diagnosed of lung carcinoma by histological and cytological examinations.
4. Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy,
chemoimmunotherapy and targeted therapy.
5. Recorded history of COVID19 infection.
6. Sufficiently functional organs.
7. Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2.
Exclusion Criteria:
1. Life expectance less than 3 months.
2. Less than 3 months since last confirmed COVID-19 infection.
3. Patients unable to return the hospital for follow-up.
4. Patients allergic to COVID-19 vaccine.
5. Patients with histories of severe treatment-related adverse events graded 3rd or
higher, including those caused by antitumor therapies or immunization except
recoverable granulocytopenia.
Peking Union Medical College Hospital
Peking, China
Investigator: Yan Xu, MD
Contact: +8618500296828
maraxu@163.com
Mengzhao Wang, MD
+8613911235467
mengzhaowang@sina.com
Yan Xu, MD
+8618500296828
maraxu@163.com
Mengzhao Wang, MD, Principal Investigator
Peking Union Medical College Hospital